Evidence Report/Technology Assessment Number 208 8. Improving Health Care and Palliative Care for Advanced and Serious Illness Closing the Quality Gap: Revisiting the State of the Science Agency for Healthcare Research and Quality Advancing Excellence in Health Care • www.ahrq.gov Evidence-Based Practice Evidence Report/Technology Assessment Number 208 8. Improving Health Care and Palliative Care for Advanced and Serious Illness Closing the Quality Gap: Revisiting the State of the Science Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-2007-10061-I Prepared by: Johns Hopkins University Evidence-based Practice Center Baltimore, MD Investigators: Sydney M. Dy, M.D., M.Sc. Rebecca Aslakson, M.D., M.Sc. Renee F. Wilson, M.S. Oluwakemi A. Fawole, M.B.Ch.B. Brandyn D. Lau, S.B. Kathryn A. Martinez, M.P.H. Daniela Vollenweider, M.D. Colleen Apostol, M.S.N., R.N. Eric B. Bass, M.D., M.P.H. AHRQ Publication No. 12(13)-E014-EF October 2012 This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10061-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. This document is in the public domain and may be used and reprinted without special permission except those copyrighted materials that are clearly noted in the document. Further reproduction of those copyrighted materials is prohibited without the specific permission of copyright holders. Persons using assistive technology may not be able to fully access information in this report. For assistance contact info@ahrq.gov. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. Suggested citation: Dy SM, Aslakson R, Wilson RF, Fawole OA, Lau BD, Martinez KA, Vollenweider D, Apostol C, Bass EB. Improving Health Care and Palliative Care for Advanced and Serious Illness. Closing the Quality Gap: Revisiting the State of the Science. Evidence Report No. 208. (Prepared by Johns Hopkins University Evidence-based Practice Center under Contract No. 290-2007-10061-I.) AHRQ Publication No. 12(13)-E014-EF. Rockville, MD: Agency for Healthcare Research and Quality. October 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions, and new health care technologies and strategies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. In 2004, AHRQ launched a collection of evidence reports, Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies, to bring data to bear on quality improvement opportunities. These reports summarized the evidence on quality improvement strategies related to chronic conditions, practice areas, and cross-cutting priorities. This evidence report is part of a new series, Closing the Quality Gap: Revisiting the State of the Science. This series broadens the scope of settings, interventions, and clinical conditions, while continuing the focus on improving the quality of health care through critical assessment of relevant evidence. Targeting multiple audiences and uses, this series assembles evidence about strategies aimed at closing the “quality gap,” the difference between what is expected to work well for patients based on known evidence and what actually happens in day-to-day clinical practice across populations of patients. All readers of these reports may expect a deeper understanding of the nature and extent of selected high-priority quality gaps, as well as the systemic changes and scientific advances necessary to close them. AHRQ expects that the EPC evidence reports will inform consumers, health plans, other purchasers, providers, and policymakers, as well as the health care system as a whole, by providing important information to help improve health care quality. We welcome comments on this evidence report or the series as a whole. Comments may be sent by mail to the Task Order Officer named in this report to: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by email to epc@ahrq.hhs.gov. Carolyn M. Clancy, M.D. Director Agency for Healthcare Research and Quality Jean Slutsky, P.A., M.S.P.H. Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Director Evidence-based Practice Program Center for Outcomes and Evidence Agency for Healthcare Research and Quality Supriya Janakiraman, M.D., M.P.H. Task Order Officer Center for Outcomes and Evidence Agency for Healthcare Research and Quality Kathryn McDonald, M.M. Lead EPC Investigator and Associate Editor, Closing the Quality Gap Series Stanford University Christine Chang, M.D., M.P.H. Task Order Officer, Closing the Quality Gap Series Center for Outcomes and Evidence Agency for Healthcare Research and Quality Judith Sangl, Sc.D. Center for Quality Improvement and Patient Safety Agency for Healthcare Research and Quality iii Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: Eric Vohr and Nancy Hutton, M.D. Technical Expert Panel Margaret Campbell, Ph.D., R.N. Wayne State University College of Nursing Detroit, MI J. Randall Curtis, M.D., M.P.H. Harborview Medical Center Seattle, WA Cindy Massuda Centers for Medicare & Medicaid Services Baltimore, MD Jeri Miller, Ph.D. National Institute of Nursing Research Bethesda, MD Joan Teno, M.D. Brown Medical School Providence, RI Joanne Wolfe, M.D., M.P.H. Dana-Farber Cancer Institute Boston, MA Joan Zlotnik, Ph.D., ACSW Social Work Policy Institute National Association of Social Workers Foundation Washington, DC iv Peer Reviewers June Lunney Director of Research Hospice and Palliative Care Nurses' Association (HPNA) Arlington, VA Amy Abernethy Division of Medical Oncology Department of Medicine Duke University School of Medicine Director, Duke Cancer Care Research Program Durham, NC Naomi Naierman President and CEO American Hospice Foundation Washington, DC Constance Dahlin Clinical Director Palliative Care Services Massachusetts General Hospital Boston, MA Joyce Reitzner Healthcare Informatics, Practice and Research American College of Chest Physicians Northbrook, IL Betty Ferrell Nursing Research and Education 2012 City of Hope Duarte, CA Susie Sherman Coordinator, Public Affairs & Advocacy American Geriatrics Society New York, NY Laura Hanson Division of Geriatric Medicine Associate Director of the Fellowship Program School of Medicine Co-Director, UNC Palliative Care Program Division of Geriatric Medicine School of Medicine University of North Carolina Chapel Hill, NC v Improving Health Care and Palliative Care for Advanced and Serious Illness Closing the Quality Gap: Revisiting the State of the Science Structured Abstract Objective. To systematically review the evidence on the effectiveness of health care and palliative care interventions to improve outcomes for patients with advanced and serious illness. Data Sources. We searched MEDLINE®, CINAHL, PsycINFO, Cochrane, and DARE from 2000 through 2011. We identified additional studies from reference lists of eligible articles and relevant reviews, as well as from technical experts. Review Methods. We developed questions in collaboration with technical experts. We excluded retrospective and uncontrolled studies. Two investigators independently screened search results and abstracted data from eligible studies. We adapted previous frameworks to categorize included studies (e.g., by improvement target, setting). Because many studies did not report effect sizes and almost all studies were small (<200 studies), in order to be able to quantitatively describe the literature, we calculated the percentage of studies with a significant improvement in outcomes with the intervention compared to control group for each category. We also checked that all other studies did not report significant results in the opposite direction and checked that there were not differences between larger and smaller studies. Results. We included 90 studies described in 96 articles. Of the 23 studies targeting continuity, coordination, and transitions, 33 percent of studies that evaluated quality of life as an outcome, 67 percent that evaluated patient satisfaction, and 31 percent that evaluated health care utilization (admissions and length of stay) found a statistically significant improvement with the intervention. Of the 21 studies targeting pain, almost all focused on patient education and selfmanagement; 48 percent of them found a statistically significant improvement with the intervention. Findings for larger (>100) and smaller (≤100) studies were similar. For distress, only 29 percent of the seven included studies found a statistically significant impact. Of the 20 studies in communication and decisionmaking, only 22 percent of studies addressing patient or family satisfaction found a statistically significant improvement for this outcome, compared to 73 percent for the outcome of health care utilization. We found only two studies within hospice programs, both of which found a statistically significant improvement in at least one outcome; nine studies were in nursing homes, 78 percent of which demonstrated a significant improvement with the intervention. In terms of types of quality improvement, for the target of continuity, studies including patient-centered quality improvement types, such as education and self-management, had the strongest evidence of effectiveness on patient- and family-centered domains such as satisfaction and quality of life. Studies of provider-focused interventions (e.g., education, reminders) were more likely to have an impact on health care utilization. Only one of five studies addressing multiple targets and focusing on facilitated relay of clinical data to providers demonstrated a statistically significant improvement in either quality of life or satisfaction. In terms of consultative and integrative interventions, for the target of communication and decisionmaking, three-quarters of consultative interventions showed a statistically significant improvement with vi the intervention, compared to half of integrative interventions. The literature was too heterogeneous and effect sizes were too infrequently reported for quantitative synthesis. There was moderate strength of evidence for the target of continuity, coordination, and transitions and the outcome of patient and caregiver satisfaction but low strength of evidence for other outcomes. For the target of pain, there was moderate strength of evidence for pain as an outcome. For the target of communication and decisionmaking, there was moderate strength of evidence for the outcome of health care utilization but low strength of evidence for other outcomes. Conclusions. We found that evidence was strongest (moderate strength of evidence) for interventions for pain, and for the targets of communication and decisionmaking and continuity for selected outcomes. While a few high- and medium-quality, well-designed health care and palliative care interventions have been conducted to improve outcomes for patients with advanced and serious illness, this report highlights the continued presence of variable findings, quality deficiencies, vaguely defined interventions, and variable outcome measurement tools and reporting in much of this intervention literature. The evidence has a number of gaps, including few studies in the hospice setting or pediatrics. Future research needs include techniques for improving recruitment and retention to assure adequate sample size, better development and description of interventions, and further development and standardization of outcome measures and tools. vii Contents Executive Summary .................................................................................................................ES-1 Introduction ...................................................................................................................................1 Background and Context............................................................................................................1 Continuity, Coordination of Care, and Transitions ..............................................................2 Pain ......................................................................................................................................3 Distress .................................................................................................................................4 Communication and Decisionmaking ..................................................................................4 Settings of Care ....................................................................................................................4 Scope ..........................................................................................................................................5 Framework for the Systematic Review ......................................................................................5 Key Questions ............................................................................................................................6 Uses of This Report ...................................................................................................................7 Methods ...........................................................................................................................................9 Overview ....................................................................................................................................9 Advanced and Serious Illness ..............................................................................................9 Interventions To Improve Care and Quality Improvement..................................................9 Taxonomy of Quality Improvement ..................................................................................11 Topic Refinement and Review Protocol ..................................................................................11 Literature Search Strategy........................................................................................................12 Gray Literature ...................................................................................................................12 Inclusion and Exclusion Criteria..............................................................................................12 Population(s) ......................................................................................................................13 Interventions ......................................................................................................................13 Comparators .......................................................................................................................13 Outcomes Measures for Each Key Question .....................................................................13 Timing ................................................................................................................................14 Settings ...............................................................................................................................14 Technical Expert Panel ............................................................................................................14 Study Selection ........................................................................................................................14 Abstract Screen ..................................................................................................................14 Article Screen.....................................................................................................................14 Data Abstraction ................................................................................................................15 Risk of Bias Assessment of Individual Studies .......................................................................15 Applicability ............................................................................................................................16 Strength of the Body of Evidence ............................................................................................16 Data Synthesis ..........................................................................................................................17 Peer Review and Public Commentary .....................................................................................17 Results ...........................................................................................................................................18 Results of the Literature Search ...............................................................................................18 Report Organization .................................................................................................................18 Description of the Types of Studies Retrieved ........................................................................19 Continuity, Coordination of Care, and Transitions ..................................................................19 Study Characteristics .........................................................................................................19 Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care?......................................................................20 viii Key Question 2. What is the evidence for different quality improvement models for improving palliative care? ............................................................................................23 Grading of the Evidence ....................................................................................................24 Pain ..........................................................................................................................................29 Study Characteristics .........................................................................................................29 Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care?......................................................................30 Key Question 2. What is the evidence for different quality improvement models for improving palliative care? ............................................................................................31 Grading of the Evidence ....................................................................................................32 Distress .....................................................................................................................................36 Key Points ..........................................................................................................................36 Study Characteristics .........................................................................................................36 Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care?......................................................................37 Key Question 2. What is the evidence for different quality improvement models for improving palliative care? ............................................................................................38 Grading of the Evidence ....................................................................................................38 Communication and Decisionmaking ......................................................................................39 Study Characteristics .........................................................................................................39 Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care?......................................................................40 Key Question 2. What is the evidence for different quality improvement models for improving palliative care? ............................................................................................42 Grading of the Evidence ....................................................................................................42 Interventions With Multiple or Other Targets .........................................................................46 Key Points ..........................................................................................................................46 Study Characteristics .........................................................................................................46 Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care?......................................................................46 Key Question 2. What is the evidence for different quality improvement models for improving palliative care? ............................................................................................47 Grading of the Evidence ....................................................................................................51 Discussion......................................................................................................................................56 Summary of Key Findings and Strength of Evidence .............................................................56 Clinical Context and Applicability of Evidence for Decisionmaking .....................................58 Limitations of the Review Process ..........................................................................................59 Strengths and Limitations of the Literature .............................................................................60 Future Research .......................................................................................................................62 Conclusions ..............................................................................................................................63 References .....................................................................................................................................64 Tables Table A. Summary of Key Data, by Target, for All Types of Quality Improvement Interventions and Settings ................................................................................................................................ES-8 Table 1. Quality Improvement Definitions Relevant to Palliative Care ........................................10 Table 2. Types of Quality Improvement in Hospice and Palliative Care (Adapted From CQG) ..12 ix Table 3. Overview of Characteristics of Studies Addressing Continuity ......................................25 Table 4. Outcomes of Studies Addressing Continuity ...................................................................27 Table 5. Evidence Grading for Continuity (KQ1a and KQ2a) ......................................................29 Table 6. Characteristics of Studies Targeting Pain ........................................................................33 Table 7. Outcomes for Studies Targeting Pain ..............................................................................34 Table 8. BPI Results for Studies Targeting Pain ...........................................................................35 Table 9. Grading of the Evidence on Studies Addressing Pain (KQ1a and KQ2a).......................36 Table 10. Study Characteristics of Studies Addressing Distress ...................................................38 Table 11. Outcomes for Studies Targeting Distress ......................................................................39 Table 12. Grading of Evidence for Distress (KQ1a and KQ2a). ...................................................39 Table 13. Characteristics of Studies Addressing Communication and Decisionmaking...............43 Table 14. Outcomes of Studies Addressing Communication and Decisionmaking ......................44 Table 15. Evidence Grading for Studies Addressing Communication and Decisionmaking (KQ1a and KQ2b) ..........................................................................................................................45 Table 16. Characteristics of Studies Addressing Multiple or Other Targets .................................52 Table 17. Outcomes of Studies Addressing Multiple and Other Targets ......................................53 Table 18. Grading of Studies in Multiple or Other Targets (KQ2a) ..............................................55 Figures Figure A. Analytic Framework for Interventions for Advanced and Serious Illness Systematic Review .......................................................................................................................................ES-2 Figure B. Results of the Literature Search .................................................................................ES-7 Figure 1. Analytic Framework for Interventions for Advanced and Serious Illness Systematic Review .............................................................................................................................................8 Figure 2. Results of the Literature Search .....................................................................................20 Appendixes Appendix A. Acronyms Appendix B. Detailed Search Strategies Appendix C. Screening Forms Appendix D. Excluded Articles Appendix E. Evidence Tables Appendix F. Evidence Grading: Hospice and Nursing Homes x Executive Summary Background Although extensive evidence supports the effectiveness of clinical interventions for improving palliative care for patients with advanced and serious illness, many studies have found that these interventions are often not used sufficiently in practice.1,2 As part of a larger review of interventions aimed at reducing the quality gap (the difference between health care processes or outcomes observed in practice and evidence-based practices potentially obtainable on the basis of current professional knowledge), we conducted a review focusing on interventions to improve care and outcomes in patients with advanced and serious illness. We defined the included population as seriously ill patients and those with advanced disease (such as people living with advanced cancer or intensive care unit patients at high risk of dying) who are unlikely to be cured, recover, or stabilize.3,4 We classified interventions to improve care for this population by the framework shown in Figure A.5 The framework shows the literature in palliative care as a grid, with different populations, domains of care, targets of quality improvement, settings (and integrated care), conditions, and categories of relevant interventions. The targets show the areas where an intervention might focus—such as an intervention specifically targeting pain management in patients with advanced disease. Areas that were the focus of this review are underlined in the figure. Objectives and Key Questions The objective of this report was to evaluate the effectiveness of health care and palliative care interventions on patient-centered outcomes relevant to palliative care, including quality improvement interventions. For the purpose of this review, we focused on targets related to palliative care, including pain; communication and decisionmaking; continuity, coordination, and transitions of care; and patient and family distress (defined as an unpleasant emotional experience that can be psychological, social, and/or spiritual). We also focused specifically on interventions within hospice care and in the nursing home setting. We analyzed studies to address how different types of quality improvement interventions can improve these targets of care in terms of populations, settings, and outcomes. The Key Questions for the report follow. Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care? a. Specific targets: What is the effectiveness in terms of processes and outcomes for pain; communication and decisionmaking; continuity, coordination, and transitions of care; and patient and family distress in palliative care populations? b. Specific settings: What is the effectiveness of interventions for any target of palliative care within hospice programs or nursing homes? ES-1 Figure A. Analytic framework for interventions for advanced and serious illness systematic review Note: Areas that were the focus of this review are underlined. Key Question 2: What is the evidence for different quality improvement models for improving palliative care? a. What is the evidence for different types of quality improvement interventions? b. What is the evidence for different models in palliative care: integrative compared with consultative? We evaluated each target for whether Key Question 2a or 2b was more applicable, and only one of these questions was analyzed for each target. (They were mutually exclusive.) “Health care and palliative care interventions” apply to interventions to improve care, including quality improvement interventions. The intent of the Key Questions was to describe the evidence in each area (e.g., target, quality improvement type, setting), not to compare the different areas with each other. “Targets” relate to the targets of the intervention, such as pain; communication and decisionmaking; continuity, coordination, and transitions; and patient and family distress, and not to outcomes. (See column 3 in Figure A.) “Integrative” refers to interventions that embed palliative care principles and interventions into daily practice, and “consultative” refers to interventions that increase the use and effectiveness of palliative care consultants or other nonintegrative interventions (See column 5 in Figure A).6 ES-2 Methods Inclusion and Exclusion Criteria We included studies on seriously ill patients and those with advanced disease who met the population definition given below, including studies on pediatric and geriatric populations. We also included studies with outcomes related to the families/caregivers of these patients. Patients with all conditions (e.g., cancer, heart failure, end-stage lung disease, dementia, and frailty) were included. Since there are high-quality studies in this field, we excluded all retrospective and uncontrolled studies of interventions. We excluded individual studies published before 2000 because the nature of both quality improvement and palliative care practice has changed substantially since that time. Palliative care has grown markedly as a specialty and service since 2000, and the populations served by hospice care were also markedly different before 2000. In addition, the pre-2000 data have been thoroughly addressed in a previous Evidence-based Practice Center report7 and an extensive National Institute for Clinical Excellence (United Kingdom) report.8,9 We included any timing of followup, including interviews after the patient’s death with families/caregivers. We addressed all settings, both inpatient and outpatient, as well as interventions in inpatient or outpatient hospice or palliative care programs. The detailed PICOTS (populations, interventions, comparators, outcomes, timing, and setting) eligibility criteria used for inclusion/exclusion of articles for Key Questions 1 and 2 in this topic area follow. Population(s) We defined the relevant population as “seriously ill patients and those with advanced disease (such as people living with advanced cancer or intensive care unit patients at high risk of dying), who are unlikely to be cured, recover, or stabilize” (adapted from the National Consensus Project3). Interventions We included studies evaluating health care and palliative care interventions, including quality improvement interventions, such as patient education and self-management, and provider audit and feedback. Comparators We included all comparators. For most studies, this was usual health care, but some studies tested interventions that were added to usual hospice or palliative care. Outcome Measures for Each Key Question For both Key Questions, we included all relevant patient or family/caregiver-centered outcomes, including: • Patient and family satisfaction/perceptions of palliative care • Patient symptoms, needs, distress, and quality of life ES-3 • • • Health care utilization, such as hospital admissions or do-not-resuscitate orders (but not costs) Quality-of-care measures, such as timeliness of response to pain and other symptoms Family/caregiver psychosocial symptoms, support, needs, quality of life, and grief/bereavement We excluded studies that did not report measurements of any of these outcomes or that only had outcomes not related directly to the target populations (e.g., staff knowledge or perceptions of care). Timing We included any timing of followup, including interviews after the patient’s death with families/caregivers. Settings We addressed all settings, both inpatient and outpatient, with a specific focus on the nursing home setting (primary) and hospice program setting (specialty), as underlined in the analytic framework. (See column 4 in Figure A.) Input From Experts We developed questions in consultation with a variety of technical experts from areas of research, clinical care, and policy. Data Sources and Selection We searched PubMed®, CINAHL, PsycINFO, Cochrane, and DARE from 2000 through 2011. We identified additional studies from reference lists of eligible articles and relevant reviews, as well as from technical experts. We limited our review to prospective intervention studies that included a control group. Data Extraction and Quality Assessment Each abstract was independently screened by two reviewers. These reviewers included a trained article screener and a content expert. Abstracts were promoted to be screened using the full-text article if both reviewers agreed that the abstract could apply to one or more of the Key Questions. An abstract could be excluded for different reasons by the two reviewers. Disagreements about the eligibility of an abstract were resolved by discussion between the two reviewers or by adjudication of a third reviewer. Full-text articles underwent another independent review by paired investigators. If articles were deemed to have applicable information, they were included for data abstraction. Articles were promoted to data abstraction if both reviewers agreed. An article could be excluded for different reasons by the two reviewers. Disagreements about the eligibility of an article were resolved by discussion between the two reviewers or by adjudication of a third reviewer. All screening was completed using the DistillerSR Web-based systematic review software (Evidence Partners, Ontario, Canada). ES-4 No forms were used for data abstraction in this systematic review. Due to the nature of the data (narrative), we used a consecutive two-reviewer process to abstract data from the included articles. In this process, a research assistant abstracted data directly to tables, and these data were checked by a senior investigator. Periodically, senior investigators cross-checked the work of the other senior investigators to ensure that abstractions were done appropriately. Reviewers were not masked to the articles’ authors, institutions, or journal.10 Disagreements that could not be resolved between the reviewers were resolved through consensus adjudication at team meetings. We used a tool implemented successfully in past Evidence-based Practice Center projects, including the Cochrane Collaboration Tool for Assessing Risk of Bias from the Cochrane Handbook for Systematic Reviews of Interventions for assessing randomized controlled trials.11 Data abstraction forms were not developed for this phase of the review, and elements of the data abstraction can be found in the evidence tables. We assessed the risk of bias and appropriateness of all studies that met our eligibility criteria, following the guidance contained in chapter 6 of the Agency for Healthcare Research and Quality’s Methods Guide for Effectiveness and Comparative Effectiveness Reviews.10 We used a limited number of the key criteria that are most appropriate for each study design and that are most important for determining the validity of the studies. After the pool of included articles in this review was determined, the core team of investigators determined that the Cochrane Collaboration tool11 was the tool most appropriate for all risk-of-bias assessments. Although we considered assessing risk of bias separately for nonrandomized studies, we were unable to identify any validated tools that worked well in this literature and could be compared with riskof-bias tools designed for randomized trials. We did not factor in the quality score for blinding of the intervention; we did this because blinding of patients and personnel was generally not feasible in these interventions, although blinding of outcomes assessors would have been possible. A low risk of bias was assessed if six or more of the items were scored as a “yes.” A medium risk of bias was assessed if four or five of the items were scored as a “yes” or “unclear.” A high risk of bias was assessed if zero to three items were scored as a “yes.” Data Synthesis We adapted previous frameworks5 to categorize included studies by target and setting of the intervention, including a category for interventions that focused on multiple targets or targets other than the primary ones for this review, and evaluated each target category for applicability to each Key Question. Each target category was evaluated for applicability to either Key Question 2a (types of quality interventions) or Key Question 2b (integrative compared with consultative model) and evaluated only for that part of Key Question 2. To determine whether results could be quantitatively synthesized, we evaluated the diversity of studies, measurement tools, and outcome reporting. Because effect sizes were often not reported, most studies were small (<200 patients), interventions and outcomes were diverse, and there was concern for selective outcome reporting, we judged that quantitative synthesis was not appropriate due to clinical and methodological diversity. Therefore, to be consistent with most previous systematic reviews in this literature, for each category, we calculated the percentage of studies with a statistically significant improvement in outcomes with the intervention compared to control. We also checked that all other studies did not report significant results in the opposite direction. ES-5 Grading We assessed the strength of the best available evidence, including the risk of bias in relevant studies, as well as aspects of consistency, directness, and precision where applicable.12 Based on these aspects, evidence for each outcome was graded as insufficient, low, moderate, or high. Results Results are summarized in Table A by target and outcome, and in the text below by Key Questions addressed for each target from Figure A. We included 90 studies described in 96 articles in the review (Figure B). We described the information abstracted in a systematic manner but did not conduct any meta-analyses. The interventions, outcomes, and outcome reporting were too diverse to allow for any synthesis. Interventions Targeting Continuity, Coordination of Care, and Transitions Key Question 1a. Evidence About Target We found 23 studies described in 26 articles focusing on the targets of continuity, coordination of care, and/or transitions in care, including interventions such as palliative care consultation, case management, and hospice screening and referral. Twelve studies were randomized controlled trials (RCTs). The studies addressed a wide variety of populations, settings, and outcomes, with most studies evaluating multiple types of outcomes. Of the nine studies that evaluated patient quality of life, only three (33 percent) showed a statistically significant improvement with the intervention compared with the control group. Of the six trials that evaluated patient satisfaction, four (67 percent) showed a statistically significant improvement with the intervention. Three of the five studies (60 percent) that evaluated family satisfaction showed a significant improvement. None of the eight studies that measured the effect on overall symptoms demonstrated a significant improvement with the intervention on this outcome. Only 5 of the 16 studies (31 percent) that evaluated health care utilization found a statistically significant improvement with the intervention on this outcome. Interventions and outcomes were too diverse for meta-analysis. Strength of evidence was low for improvement in patient quality of life, symptoms, and health care utilization, and moderate for improvement in patient and family satisfaction. Key Question 1b. Evidence About Settings For hospice care, one RCT that examined systematic feedback from standardized assessments and interdisciplinary team discussions showed a statistically significant improvement with the intervention on one outcome. For nursing homes, one of three studies on care pathways showed a statistically significant improvement with the intervention, as did one study on screening for hospice eligibility. ES-6 Figure B. Results of the literature search ES-7 Table A. Summary of key data, by target, for all types of quality improvement interventions and settings Target a Outcome Strength of Evidence That the Intervention Improved Outcomes Compared With the Control Group Low Continuity, Coordination of Care, and Transitions (KQ1a and KQ2a) Patient quality of life Patient Moderate satisfaction Caregiver Low burden Caregiver Moderate satisfaction Overall Low symptoms Health care Low utilization Pain (KQ1a and KQ2a) Pain Moderate Quality of life Low Distress (KQ1a and KQ2a) Distress Low Depression Low Communication and Decisionmaking Patient Low satisfaction (KQ1a and KQ2b) Family Insufficient satisfaction Health care Moderate utilization Quality of life Low Symptom control Low Multiple and Other Targets (KQ2a) Quality of life Low Satisfaction Low Quality of care Low Patient Low symptoms Psychosocial Low support a Strength of evidence is based mainly on the strength of the study designs (with randomized trials considered the strongest design) and on consistency based on the percentage of studies with a statistically significant improvement in the outcome, while checking that no studies had a significant worsening of the outcome. This approach was necessary because of inconsistent reporting of outcomes across studies and frequent lack of reporting of effect size or confidence intervals. Note: KQ = Key Question. KQ2a or KQ2b was analyzed for each target as more appropriate; they were mutually exclusive. Table does not address KQ1b; some targets did not have any hospice or nursing home studies, and none had more than a few— insufficient for strength of evidence by target. There were insufficient numbers of studies to compare different quality improvement types or quality improvement models within any of the targets. Key Question 2a. Evidence About Types of Quality Improvement For the outcomes of quality of life and satisfaction, studies using patient-centered quality improvement types, such as patient/family/caregiver education and promotion of selfmanagement, showed a significant improvement in satisfaction and quality of life in six of nine studies. Of six studies that included provider-centered quality improvement interventions (provider reminder systems, facilitated relay of clinical data to providers, or provider education) but did not include patient-centered quality improvement interventions, none demonstrated effectiveness on quality of life or satisfaction. For the outcome of health care utilization, such as admissions or length of stay, only 5 of the 16 studies (31 percent) reported a statistically significant improvement with the intervention compared to the control group. ES-8 Key Question 2b. Evidence About Integrative and Consultative Models This Key Question was not analyzed for this target. Interventions Targeting Pain Key Question 1a. Evidence About Target We found 21 studies addressing the target of pain in patients with advanced and serious illness; 19 were in cancer populations. Sixteen studies were in the ambulatory setting, and 18 were RCTs. Fourteen studies used the Brief Pain Inventory as the pain measurement tool. Ten of the studies (48 percent) found that the interventions had a statistically significant effect on improving pain scores. Similar findings were noted when including only larger studies (100-200 patients); 5 of these 11 studies (45 percent) had significant findings. The interventions and outcome measurement and reporting were too diverse, and reporting of effect sizes was too inconsistent, for quantitative synthesis, and there was concern about selective outcome reporting. Eight of the studies also measured quality of life as an outcome; only one of those studies found any effect of the intervention on quality of life, and this study found improvement on only a single subscale. Strength of evidence was moderate for improvement in pain and low for improvement in quality of life. Key Question 1b. Evidence About Settings Two RCTs targeted pain in nursing homes using pain screening interventions for end-stage dementia. Both found a statistically significant improvement with the intervention. Key Question 2a. Evidence About Types of Quality Improvement Three studies used provider-level interventions only, and 18 employed patient and/or family caregiver education and self-management. Half of the studies employing patient and/or family caregiver education and self-management used print or video material to enhance the intervention. Four of the six studies that used an educational video followed by printed materials to enhance the educational intervention showed statistically significant improvement in pain scores, compared with one of the three studies that used either print material alone or video material alone. Key Question 2b. Evidence About Integrative and Consultative Models This Key Question was not analyzed for this target. Interventions Targeting Distress Key Question 1a. Evidence About Target We found seven studies of interventions that targeted patient distress in patients with advanced and serious illness. All seven studies were RCTs. Four of these studies were based in ambulatory settings, and six were in cancer populations. Only two of the seven studies (29 percent) demonstrated a significant improvement in distress with the intervention compared to the control group. One study examined detailed distress screening combined with personalized telephone triage for referral to resources, and a second study looked at telephone-based coping skills training in lung transplant candidates. Interventions and outcomes were too diverse for meta-analysis. Strength of evidence was low for improvement in distress and depression. ES-9 Key Question 1b. Evidence About Settings There were no studies in hospice or nursing homes for this target. Key Question 2a. Evidence About Types of Quality Improvement Six of the seven studies focused on patient education and self-management as a quality improvement method; only one of these six studies found a statistically significant improvement with the intervention. Key Question 2b. Evidence About Integrative and Consultative Models This Key Question was not analyzed for this target. Interventions Targeting Communication and Decisionmaking Key Question 1a. Evidence About Target We found 20 studies of interventions targeting communication and decisionmaking with patients with advanced and serious illness. Nine were RCTs, 13 were conducted in an intensive care unit, and most were in mixed-illness populations. Interventions included family meetings with the usual health care team (11 studies), interdisciplinary palliative care teams (4 studies), ethics consultations (2 studies), and physician-patient communication (2 studies). Only one of eight studies that evaluated patient satisfaction showed a statistically significant improvement with the intervention on this outcome, and one of three studies that evaluated family satisfaction showed a significant impact. On the other hand, of 15 studies that evaluated health care utilization as an outcome, 11 (73 percent) showed a statistically significant improvement with the intervention. Interventions and outcomes were too diverse for meta-analysis. Strength of evidence was low for improvement in satisfaction and moderate for improvement in health care utilization. Key Question 1b. Evidence About Settings No studies addressed hospice. One study, measuring end-of-life outcomes in nursing homes, found that educating providers, patients, and families about advance directives improved health care utilization, but there was no impact on satisfaction. Key Question 2a. Evidence About Types of Quality Improvement This Key Question was not analyzed for this target. Key Question 2b. Evidence About Integrative and Consultative Models Eight interventions were integrative, and four of the eight (50 percent) showed a statistically significant improvement with the intervention. Eight interventions were consultative, and six of the eight (75 percent) found a statistically significant improvement with the intervention. Only four studies combined integrative and consultative models. Interventions Targeting Multiple and Other Targets Key Question 1a. Evidence About Target This Key Question was not analyzed for multiple and other targets. ES-10 Key Question 1b. Evidence About Settings For the hospice setting, one study on training caregivers in symptom management techniques found a statistically significant improvement with the intervention. For the nursing home setting, one study of a provider education intervention showed a statistically significant improvement with the intervention, as did one study including multiple quality improvement types. Key Question 2a. Evidence About Types of Quality Improvement For facilitated relay of clinical data to providers, we found six publications on five studies. All were RCTs in cancer patients. The interventions involved health-related quality of life surveys with feedback to physicians. Only one of the five studies demonstrated that the intervention had a significant effect on quality of life or satisfaction. Of two studies of audit and feedback, a multicenter study found significant improvements, but a single-center study found no impact on measures of quality of care. The one study focusing on provider education in nursing homes found the intervention had a statistically significant improvement on measures of quality of care. For patient/caregiver education and self-management, we found six publications on five studies that addressed multiple targets and symptoms or quality of life. Four of the five studies found statistically significant improvement with the intervention. We found one study focusing on organizational change (a before-after study of a rapid-response clinic for palliative radiotherapy), which found a statistically significant improvement in the use of single-fraction treatment (guideline-recommended care) and a reduction in time to treatment. We did not identify any studies for provider reminder systems or for financial incentives, regulation, and policy. We identified three studies that focused on multiple quality improvement types and multiple targets. One study was an RCT based on an initial non-RCT. This RCT (in intensive care units) found no significant impact on any outcomes. Another study in the nursing home setting found a statistically significant improvement for multiple outcomes. Finally, we found two studies that did not fit any of the quality improvement types. Both evaluated new clinical services in palliative care. One found no significant impact of a palliative daycare intervention and the second, an RCT of hospital services provided in the home setting for palliative care, found a statistically significant improvement with the intervention on only one of multiple outcomes measured. Interventions and outcomes were too diverse for meta-analysis, and strength of evidence was low for improvement in outcomes. Key Question 2b. Evidence About Integrative and Consultative Models This Key Question was not analyzed for multiple and other targets. Discussion Brief Review of Main Findings Among the types of interventions evaluated in this report, for the target of continuity, coordination, and transitions, we found moderate strength of evidence for improvement in satisfaction but low strength of evidence for improvement in quality of life and health care utilization. In contrast, we found moderate strength of evidence for the target of communication and decisionmaking for improvement in the outcome of health care utilization but not for ES-11 improvement in satisfaction; three-quarters of the interventions that evaluated utilization (mostly in the intensive care unit setting) found a statistically significant impact on health care utilization outcomes. Moderate strength of evidence was found for patient-centered pain interventions for improvement in the outcome of pain, and strength of evidence was low for improvement in distress. For studies addressing multiple targets, only one of five studies of facilitated relay of clinical data to providers found a statistically significant improvement with the intervention. In reference to the question of integrative compared with consultative interventions, for the target of communication and decisionmaking, three-quarters of consultative interventions showed a statistically significant improvement with the intervention, compared to half of integrative interventions. Seven of the nine interventions to improve care in the nursing home setting showed an improvement in at least one outcome. Although the quality of studies overall was mixed, we noted the presence of selected high- and medium-quality, well-designed studies for most of the target areas and Key Questions. Description of Clinical Context and Applicability of Evidence for Decisionmaking Several high- and medium-quality, well-designed, multicenter interventions to improve health care for patients with advanced and serious illness with consistent results across outcomes now exist. However, this report highlights the continued presence of variable findings, study quality deficiencies, ill-defined interventions, and insufficient use of appropriate measurement tools for the intervention and for patients with advanced and serious illness in much of the literature. For policymakers, this report underscores the continuing strong need for research funding for well-designed studies to evaluate quality improvement and policy interventions, particularly in areas that are advancing rapidly in health care policy (e.g., feedback and financial and regulatory interventions) but have not been rigorously evaluated. Summary of Weaknesses or Gaps of the Evidence and Description of Limitations of the Review As with all systematic reviews, our results and conclusions depend on the quality of the published literature. Due to clinical and methodological diversity in outcomes, populations, interventions, and measurement tools; concerns about selective outcome reporting; and lack of reporting of effect sizes or confidence intervals in most studies, we judged that qualitative description of the literature was more appropriate than quantitative synthesis. The quality of many studies was moderate to low. Common quality issues included small sample sizes, often due to insufficient recruitment and high rates of attrition, and issues with outcome measures not designed for advanced or serious illness or not well coordinated with the purpose of the intervention. Descriptions of interventions were often limited, difficult to interpret, and challenging to categorize into the quality improvement types. Few studies reported information on disparities, context, or theory or logic models. Implications for Future Research We identified several key areas for future research. The field of palliative care has clearly advanced significantly since the 2004 evidence report on end-of-life care and outcomes.8 The quality of research in this field could be improved by recruitment and retention efforts to assure ES-12 adequate sample size, better development and description of interventions, inclusion of theory and quality improvement techniques, consideration of context, matching and pilot testing of outcomes for interventions, standardization of outcome measures across interventions, and clearer and consistent reporting of outcomes. Development of measurement instruments specific to this population has advanced, but more development is needed for measuring certain domains and to better understand how to match outcome measures to interventions. We identified few studies in hospice populations and no studies focusing on reducing disparities in outcomes. In both these areas, there is significant need, and there are significant challenges in developing and evaluating quality improvement interventions. Finally, the use of different quality improvement types was limited in studies focusing on populations with serious and advanced illness, particularly for the targets of pain and distress. Conclusions In conclusion, we found the most consistent evidence in a large number of studies, including several high- and medium-quality studies, for the effectiveness of interventions targeting continuity for improvement in the outcome of patient satisfaction, targeting pain using patientcentered interventions, and targeting communication and decisionmaking for impacting health care utilization outcomes in the intensive care unit setting. The evidence has multiple gaps, including studies in illnesses other than cancer for symptom management; in pediatric populations and hospice settings; and addressing diverse populations and disparities in care. More coordinated initiatives across multiple settings and providers, and following patient populations over longer periods of time, will be needed to better understand how best to improve care and outcomes for patients with advanced and serious illness. References 1. Johnson VM, Teno JM, Bourbonniere M, et al. Palliative care needs of cancer patients in U.S. nursing homes. J Palliat Med. 2005;8(2):273-9. 2. Connor SR, Teno J, Spence C, et al. Family evaluation of hospice care: results from voluntary submission of data via website. J Pain Symptom Manage. 2005 Jul;30(1):917. 3. National Consensus Project for Quality Palliative Care (NCP). Clinical Practice Guidelines for Quality Palliative Care, 2nd ed.; 2009. www.nationalconsensusproject.org. 4. National Quality Forum releases palliative care framework document. J Pain Palliat Care Pharmacother. 2006;20(4):130-1. 5. Seow H, Snyder CF, Mularski RA, et al. A framework for assessing quality indicators for cancer care at the end of life. J Pain Symptom Manage. 2009;38(6):903-12. ES-13 6. Nelson JE, Bassett R, Boss RD, et al. Models for structuring a clinical initiative to enhance palliative care in the intensive care unit: a report from the IPAL-ICU Project (Improving Palliative Care in the ICU). Crit Care Med. 2010;38(9):1765-72. 7. Lorenz KA, Lynn J, Dy SM, et al. Evidence for improving palliative care at the end of life: a systematic review. Ann Intern Med. 2008;148(2):147-59. 8. Lorenz K, Lynn J, Morton SC, et al. End-oflife care and outcomes. Evid Rep Technol Assess (Summ). 2004 Dec;(110):1-6. 9. Gysels M, Higginson IJ, eds. Improving Supportive and Palliative Care for Adults With Cancer. Research Evidence Manual. London: National Institute for Clinical Excellence; 2004. http://guidance.nice.org.uk/CSGSP/. 10. Agency for Healthcare Research and Quality. Methods Guide for Effectiveness and Comparative Effectiveness Reviews. www.effectivehealthcare.ahrq.gov. 11. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2. The Cochrane Collaboration; 2009. 12. ES-14 Owens DK, Lohr KN, Atkins D, et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventions--Agency for Healthcare Research and Quality and the effective health-care program. J Clin Epidemiol. 2010;63(5):513-23. Introduction Background and Context Extensive evidence supports the effectiveness of clinical interventions for improving patientcentered outcomes for patients with advanced and serious illness. For example, many types of medications and other interventions to treat pain,1 can lead to significant reductions in pain severity and pain-related outcomes such as quality of life.2 However, studies in different areas have found that these are often not well integrated into medical practice. For pain, despite widely accepted pain screening and clinical practice guidelines,3 pain continues to be undertreated, particularly for vulnerable populations such as nursing home patients.4 For communication and decisionmaking, in a study of audiotaped initial oncology consultations for patients with terminal cancer, fewer than half of oncologists offered alternatives to chemotherapy as an option. In addition, only 58 percent of patients were informed of their life expectancy and only 60 percent were aware of uncertainty about the benefits of chemotherapy.5 And despite wide availability and insurance coverage of hospice care, in 2009, only 42 percent of patients who died in the United States received any hospice care, and, of those, only half received more than three weeks of care.6 This report is part of a larger review of interventions aimed at reducing the quality gap (the difference between health care processes or outcomes observed in practice and evidence-based practices potentially obtainable on the basis of current professional knowledge).7 Given the critical importance of interventions to improve health care and palliative care in this population, we focused on these types of interventions in this report. These interventions can include changes in the way care is provided within a system, such as palliative care consultation services, and interventions to change how patients/families interact with the health care system, such as a patient self-management program for pain that is integrated with patients’ health care. They can also include quality improvement interventions, (quality improvement; see Appendix A for a list of acronyms) which can be defined as any type of intervention to improve care with some element of system change, including change in how patients/families interact with the health care system, and can be delivered through a variety of quality improvement methods, such as continuous quality improvement. The common purpose of these types of interventions is to improve care and self-management to maximize the quality of life of people facing advanced and serious illnesses and the end of life and of their families. This includes relief from physical and psychosocial symptoms; psychosocial and spiritual support for both the patient and their families and other caregivers; excellent communication about topics such as prognosis; person-centered care, with compassion, personalization, and cultural sensitivity; care planning and prevention of crises; and opportunities for comfortable dying, life closure, and control of the circumstances of death. For the purposes of this review, we address the needs of patients with advanced and serious illnesses through the three interrelated areas of palliative care, end-of-life care, and hospice care. Palliative care is defined as medical care focused on improving the quality of life of people facing serious or life-threatening illness, including the end of life. It is often provided as a service or quality improvement intervention, and can be delivered in any setting. Emphasis is placed on pain and symptom management, communication, and coordinated care. End-of-life care is defined as care delivered to dying patients, and is a small subset of palliative care. Hospice is also a subset of palliative care and is defined as a care delivery system and insurance benefit for patients in the last months of life who have chosen quality of life as the primary goal of care, and 1 which is provided, in the United States, wherever the patient resides. In the United States, these include the home, special inpatient units, and nursing homes. We focused on several specific targets that are critical to improving care in this population: continuity, coordination of care, and transitions; pain; distress; and communication and decisionmaking. The next sections define these targets and health care and palliative care interventions that might improve them, and summarize evidence from previous systematic reviews for the targets and settings that are the focus of this review. Continuity, Coordination of Care, and Transitions Continuity can be defined as the exchange of knowledge and the relationships between providers and patients/families, or between providers and/or provider groups. Continuity includes three areas: relational continuity, focusing on the relationship between patients/families and providers; management continuity, focusing on the relationship between providers (e.g., developing interdisciplinary teams); and informational continuity, focused on improving information exchange (e.g., improving patient assessment in palliative care domains). Coordination of care is a challenge for many patients with serious illness, including aligning care across settings; communicating with physicians; and incorporating multiple complex treatments for the patient. Improving transitions includes both improving the process of transitions that occur, and facilitating the initiation of appropriate transitions, such as enrollment in hospice care. Specialized palliative care services usually involve an interdisciplinary team, usually a physician and a nurse, social worker, pharmacist, and/or chaplain. Services focus on continuity and coordination of care, including assisting with transitions to hospice, and also include communication, decisionmaking support, and care planning, symptom management, and psychosocial, spiritual, and bereavement support. Because of these services’ focus on continuity and coordination, and for consistency with an earlier systematic review,8 we classified these services in the target of continuity. Several previous systematic reviews have addressed the target of continuity in palliative care, although one review addressed populations with serious illness much more broadly, and the other two focused solely on specialized palliative care interventions, and none of the reviews addressed broader quality improvement interventions in this target or the role of quality improvement within palliative care interventions. A review through 2006 on evidence for improving palliative care, addressing broader populations with chronic illness,8 defined continuity as addressing relationships with providers over time. The review found that studies in congestive heart failure, dementia, and nursing homes (many focusing on case management and transitions), generally did not focus on end-of-life populations or issues. The review also found two previous systematic reviews on this topic in end-of-life care. One review of case management in end-of-life care identified four RCTs, with two that evaluated utilization, having mixed effects. A review of improved coordination for supportive cancer care identified nine RCTs of portable records (mostly negative studies) or palliative care–home care coordination (with mixed effects for patient and caregiver outcomes and utilization). The review identified one additional study specific to end-of-life care, which found that palliative case managers increased advance directives and lowered utilization. Several systematic reviews have addressed the effectiveness of specialized palliative care both generally,8-12 and in AIDS13 and cancer14,15 populations. The most recent review addressing all populations11 focused on RCTs of specialized palliative care (trained professionals) published through 2007. Outcomes included quality of life, satisfaction, or costs; half were in the home 2 setting, and half focused on cancer patients; 12 of the studies evaluated a multidisciplinary team. The review found the strongest evidence for effectiveness in the area of satisfaction (seven out of the 10 studies evaluated that outcome found a significant impact of the intervention), compared to four out of the 13 studies that evaluated quality of life outcomes (although almost all of these studies were underpowered) and only one out of seven studies evaluating the outcome of cost. The most recent review on specialized palliative care in cancer14 focused on similar outcomes, and concluded that there was evidence for effectiveness for palliative care in both the home and hospital setting, mainly for the outcomes of pain and symptom management, hospital admissions, and satisfaction. Some improvements were also noted in anxiety and depression and caregiver quality of life. This review also found less evidence for effectiveness in patient quality of life. Pain Pain is one of the most common symptoms in individuals with cancer that is directly associated with significantly reduced quality of life.16,17 Poorly-managed cancer pain is an important quality of care outcome and a high priority for patients, clinicians, and health care policy. A recent systematic review estimated that among individuals with metastatic cancer, an average of 64 percent of patients experienced pain.18 Cancer pain is most commonly the result of tumor load,19 but is also frequently associated with treatments, such as surgery or chemotherapy. Because pain is implicated with disease progression, frequent reassessment and changes in management are required to ensure quality of life and care.20 Yet, despite the importance of pain ascertainment and management, under-treatment is common,21 affecting as many as 40 percent of patients.22 Quality improvement strategies to improve pain management in patients with advanced and serious illness include patient and caregiver education, provider education, systematic pain assessment, and use of clinical decision tools to improve appropriate prescribing of analgesia. Several prior systematic reviews addressing the impact of quality improvement interventions for pain in patients in various stages of cancer, have demonstrated mixed findings. A 2001 review of pain management interventions found evidence that quality improvement interventions focused on providers improved provider knowledge and attitudes, but did not have significant positive impact on patient pain ratings.23 While provider-focused interventions were not found to be effective in this review, nurse-led patient directed educational interventions were found to have a positive effect on patient pain levels. Moreover, systematic pain assessment was found to have some promise in improving patient pain outcomes. A 2009 systematic review and meta-analysis of patient-based educational interventions24 included 21 trials (19 RCTs), 15 of which were included in a meta-analysis which found that interventions successfully reduced both average and worst pain intensity. A systematic review focusing on studies of hospitalized cancer patients25 found five studies addressing education, audit and feedback, decision support, and pain consultation. Some evidence was found for the impact of interventions on satisfaction and quality of care, but not for pain outcomes. A 2007 review26 found effective studies in the domains of institutionalization models (e.g., routine pain assessment), clinical pathways, and pain consultation. A 2011 review of knowledge translation interventions targeted at improving cancer pain through either health care providers or patients and family caregivers found that, generally, knowledge translation had a positive impact on pain outcomes. Better outcomes were observed with higher frequency and intensity of educational programs.27 These reviews all addressed pain in broad populations with 3 cancer or hospitalized patients, and did not focus on patients with advanced disease or serious illness, who have different types of pain management needs and may require different quality improvement approaches. Distress Distress can be defined as a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with illness, its physical symptoms and its treatment.28 The term is broader than specific psychiatric diagnoses such as depression, and can apply to the psychosocial and emotional impact of illness on both patients and caregivers/families. Recommended interventions to include distress include screening in the cancer care setting, psychosocial interventions such as social work consultation and counseling, and spiritual counseling. Several systematic reviews have addressed psychosocial interventions for family caregivers in palliative care29 and in adult30 and adolescent31 cancer patients, as well as psychotherapy for depression in incurable cancer patients.32 Although these reviews did find some evidence for the effectiveness of these types of interventions, they generally did not focus on distress as an outcome or end-stage illnesses, and did not address the issue of quality improvement for this target. Communication and Decisionmaking Effective communication and decisionmaking between providers, and between providers and patients and families, constitutes the foundation for the tasks of palliative care. Thus, the quality of communication for patients with advanced and serious illness is a key determinant of patient and family outcomes. Key aspects of communication and decisionmaking with this population include: sharing information about diagnosis, prognosis and goals of care; engaging families in treatment decisionmaking; and offering psychosocial support. Interventions include increasing the frequency of communication about these issues (such as regularly scheduled family meetings), and increasing the quality of communication (such as implementing structured templates). Several previous systematic reviews have focused on quality improvement in communication in relevant areas. Lorenz et al,9 in a 2008 systematic review, found moderate evidence supporting effectiveness of interventions to increase advance directive rates, although little evidence on patient outcomes. The review also identified studies supporting the effectiveness of a variety of communication interventions. In a 2008 review, Walling et al.33 found similar results, and also found that broader end-of-life communication interventions had demonstrated effectiveness for patient satisfaction and psychological outcomes. Finally, a 2011 review of studies focusing on communication in the intensive care setting34 found evidence supporting the effectiveness of regular, structured communication and palliative care and ethics consultations for the outcomes of distress and health care utilization. Settings of Care End-of-life care occurs across all settings, and interventions identified in previous systematic reviews have focused mainly on the hospital and home setting, with some interventions in the outpatient, hospice, and nursing home setting. Quality improvement is important in hospices, 4 which are specifically focused on end-of-life care, because variation in quality also exists within hospice programs. In the Family Evaluation of Hospice Care from the National Hospice and Palliative Care Organization,35 (completed, in a general hospice population including patients with cancer and other illnesses, by families after hospice patients’ deaths), 18.2 percent of family members noted problems with attention to family needs for support (variation among hospices, 25th and 75th percentiles, 12.6 and 21.4 percent), and 9.8 percent of family members reported unmet need for emotional support (variation among hospices, 25th and 75th percentiles, 5.4 and 13.3 percent).36 No previous systematic reviews focused on quality improvement in the hospice setting. Because of this, and because of the importance of hospice care in end-of-life care and current quality improvement initiatives, we focused specifically on this setting as part of our review. Approximately 20 percent of deaths in the United States occur in nursing homes or shortly after transfer from a nursing home to a hospital.37 Evidence on palliative care in nursing homes has demonstrated major deficits in palliative care processes such as advance care planning, pain management, and psychosocial support. Two systematic reviews have focused on quality improvement in nursing homes, but did not focus on end-of-life populations. One of these reviews, targeting pain management,38 identified a variety of quality improvement studies using provider education, decision support, and systems changes, but found few high-quality studies and high reliance on process rather than patient outcomes. Because of the lack of previous reviews focusing on end-of-life care in the nursing home setting, and because of the importance of this setting to end-of-life care, we also focused on this setting in our review. Scope Current approaches to providing palliative care or improving quality in key patient-centered targets in advanced and serious illness (e.g., the targets of communication and pain) vary widely, and there is clear need for information on what types of interventions can improve palliative care for patients. Although there have been a number of systematic reviews related to this topic, recent reviews have focused mainly on palliative care and hospice interventions and on specific domains, settings, or populations (e.g., communication, intensive care unit, cancer), and none have used the perspective of quality improvement. There are some studies of different types of interventions (case management, ordersets, and improvement of communication), but they are not specifically addressed in these reviews, and key reviews of pain interventions in cancer and nursing homes have not focused on patients with advanced illness. With regard to hospice, in spite of the huge range of quality improvement interventions (case management, provider and patient education, targeted patient interventions, structured ordersets, and patient screening for eligibility for palliative care services or specific needs), little systematic information is available on which types of interventions work for hospice. This lack of evidence is especially notable since providers are now required by the Center for Medicare and Medicaid Services to have a quality assurance program with a quality improvement component. Framework for the Systematic Review The framework (Figure 1) is derived from the National Quality Forum palliative care framework and a recent consensus project conducted to develop a framework for end-of-life cancer quality measurement.39,40 The framework shows the literature in end-of-life care as a grid, with different populations, domains of care, targets of quality improvement, settings (and integrated care), and categories of quality improvement relevant to palliative care. 5 The targets show the areas where an intervention might focus—such as an intervention specifically targeting pain management in patients with advanced disease To apply the framework for prioritizing areas for the review, we conducted an initial environmental scan of systematic reviews, consulted with experts, and considered needs of key stakeholders and audiences for the review, to determine domains and settings where this review would be most valuable. Underlined areas show where we prioritized the searches and review, but all areas in the framework were included. For the first Key Question, we included targets where there was a substantial literature but not covered in recent reviews, and two settings of particular interest to key audiences and not covered in recent reviews. In the second Key Question, we focus on types and models of quality improvement, applying them to studies both in specific target areas and to studies addressing multiple targets. We designed the scope in this way to focus on key areas in end-of-life care that had not been addressed in previous reviews and to make the results of our review focused enough to draw clear conclusions. Key Questions Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care? a. Specific targets: What is the effectiveness in terms of processes and outcomes for pain; communication and decisionmaking; continuity, coordination, and transitions; and patient and family distress; in palliative care populations? (See Figure 1, Framework for end-oflife and hospice care, column 3, for a listing of targets of quality improvement.) b. Specific settings: What is the effectiveness for interventions for any target of palliative care within hospice programs or nursing homes? Key Question 2: What is the evidence for different quality improvement models for improving palliative care? a. What is the evidence for different types of quality improvement interventions? (See the Interventions section below and framework, column 5 of Figure 1.) b. What is the evidence for different models in palliative care: integrative, compared with consultative? (See column 5 of Figure 1, framework, for definitions.) We evaluated each target for whether Key Question 2a or 2b was most applicable, and only one of these questions was analyzed for each target (they were mutually exclusive). The intent of the Key Questions was to describe the evidence in each area (e.g., target, quality improvement type, setting), not to compare the different areas to each other. “Targets” relate to the targets of the intervention, e.g. pain; communication and decisionmaking; continuity, coordination, and transitions; and patient and family distress, and not outcomes (see column 3 in the framework). “Integrative” refers to interventions that embed palliative care principles and interventions into daily practice, and “consultative” refers to interventions that increase the use and effectiveness of palliative care consultants or other non-integrative interventions (see column 5 in the framework) 6 Uses of This Report Audiences who might find value from the report include professionals in both palliative care and hospice programs, as well as those in other settings with a significant percentage of patients with serious and advanced disease, such as cancer centers, medicine inpatient units, and nursing homes. Other potential audiences include health care professionals (e.g., physicians, nurses, social workers, and pharmacists) and relevant health care professional organizations (e.g., Academy of Hospice and Palliative Medicine, Hospice and Palliative Nurses Association), for quality initiatives and education; key funders in this area (e.g., National Cancer Institute, National Institute on Aging, National Institute of Nursing Research); and staff of organizations investing in palliative care quality improvement and systems initiatives (e.g., Center for Medicare and Medicaid Services, Veterans Health Administration, Kaiser, Institute for Healthcare Improvement), as well as organizations representing hospice and palliative care programs (e.g., the National Hospice and Palliative Care Organization). Researchers in palliative care and relevant fields, as well as relevant policymakers (e.g., The National Quality Forum’s National Priorities Partnership39) and members and staff of advocacy groups (e.g., American Cancer Society) will also be able to use the contents of the review. This report may be useful to help researchers plan areas to target and intervention types and outcome measures to use; and for health care organizations’ decisionmaking on what types of programs to implement. 7 Figure 1. Analytic framework for interventions for advanced and serious illness systematic review 8 Methods Overview Advanced and Serious Illness For the purposes of this review, we defined the relevant population as “seriously ill patients and those with advanced disease (such as people living with advanced cancer or intensive care unit patients at high risk of dying), who are unlikely to be cured, recover, or stabilize.” We adapted this definition from the National Consensus Project41 definition of palliative care, which covers a broader population, to keep the scope of the review relatively focused on patients with advanced and serious illness. We covered the entire lifespan, including populations from pediatrics to geriatrics. We also included outcomes related to families and caregivers of these patients (e.g., depressive symptoms of family members of intensive care unit (ICU) patients). We included patients with all conditions meeting the population definition (e.g., critically ill patients and those with heart failure, end-stage lung disease, dementia, and advanced or metastatic cancer). Many studies included diverse populations (e.g., cancer survivors, patients with early-stage disease, and patients with advanced disease). In these situations, we included studies where more than 50 percent of the included population would fit the above definition, or where results were reported separately for the advanced disease population. Where results were reported separately, we included the results only for the relevant portion of the population. For studies where the “seriously ill” portion of the definition of end-of-life care was most relevant (e.g., ICU populations), we included studies where the expected one-year mortality of the included population would be at least 50 percent. Interventions To Improve Care and Quality Improvement In determining how to define and categorize health care and palliative care interventions to improve care in this field, including quality improvement, we considered several ways that care for patients with advanced and serious illness may differ from care in prevention or chronic illness. Palliative care is a diverse field that often addresses complex and diverse diseases using a multidisciplinary approach. This type of care can have many different types of targets and outcomes, and can therefore involve many different types of interventions. Palliative care interventions can include palliative care consultation or case management programs; ordersets addressing multiple targets or programs targeting transitions between settings; and interventions targeting nonmedical aspects of care, such as psychosocial stresses or caregiver burden. These types of palliative care interventions will likely require different types of quality improvement, as well as different targets, and outcomes, than would be needed in more medical, unidimensional illnesses (such as asthma or hypertension). In addition, a key informant study of palliative care and hospice providers42 identified potential external barriers to quality improvement, such as the lack of resources and models for quality improvement, lack of evidence for best practices, and concerns that traditional models of quality improvement may not work well for hospice. Finally, improvement efforts in this area often involve interventions such as counseling for psychosocial and/or spiritual distress, which are more challenging to discern from quality improvement because of the inclusion of interpersonal interactions than, for example, administration of a medication. 9 We reviewed definitions from systematic reviews of quality improvement, (Table 1) including the Closing the Quality Gap series,7,43 as well as the reviews themselves to better understand how the definition was applied to different clinical areas like care coordination, asthma, and hypertension. We reviewed resources developed by the Cochrane Effective Practice and Organization of Care Group (http://epoc.cochrane.org/), which focuses on systematic reviews of interventions designed to improve the delivery, practice, and organization of health care services. We examined another review on quality improvement studies that evaluated the reliability of a definition for identifying quality improvement interventions, and a review on quality improvement theory.43,44 Because psychological distress and support were targets of our review, we also contacted experts and searched for definitions of quality improvement in mental health care used in reviews of mental health quality improvement interventions, but did not locate any that were relevant. We used these definitions to develop a clear definition for quality improvement in patients with advanced and serious illness that met the needs of this review. Table 1. Quality improvement definitions relevant to palliative care Definition of Quality Improvement Interventions aimed at reducing the quality gap (the difference between health care processes or outcomes observed in practice and those potentially obtainable on the basis of current professional knowledge) for a group of patients representative of those encountered in routine practice. The intervention targeted implementation of a particular process of care (or set of processes) believed to benefit patients with the priority condition(s); i.e., interventions designed to improve provider adherence to a clinical best practice guideline, or those intended to increase the proportion of patients who received recommended care. The intervention targeted implementation of a structural or organizational feature believed to benefit patients with the priority condition; i.e., interventions that changed the care provider, added supplemental personnel, or made clinical information systems part of the treatment protocol. Studies were identified as relevant to quality improvement for the CQG if any one of the following applied: 1. The intervention was designed to increase the proportion of patients receiving recommended processes of care (i.e, those demonstrated to improve outcomes for patients with the condition of interest), including aspects of diagnosis and screening, therapeutic interventions, and patient education or counseling. 2. The intervention implemented organizational or structural features likely to benefit patients with the condition of interest. An effort to change/improve the clinical structure, process, and/or outcomes of care by means of an organizational or structural change Definition for effectiveness, impacts, or success: Effectiveness: The comparative effectiveness of the intervention relative to an alternative intervention or usual care Impacts: The degree to which the intervention results in changes over time in relevant outcomes for the patients and organizations involved Success: The degree to which the intervention achieves its goals relative to 1) achieving benchmarks or targets for clinical care, acceptability, adoption, implementation, spread, or sustainability/maintenance, and 2) the logic model for the intervention Quality improvement theory was defined as a set of principles that involve knowledge, skills, and methods used to evaluate and implement change in a health care system using a systems-based approach. Abbreviation: CQG= Closing the Quality Gap Systematic Review 43 CQG, 2004 CQG, 2004 43 45 Danz, 2010 Boonyasai, 2007 46 Based on this review, we developed the following definition of quality improvement as applied to patients with advanced or serious illness and palliative care: Interventions targeting improvement for patients with advanced or serious illness that are conducted within or linked with the health care system and that have at least some element of 10 system change, or intended change in how the patient/family/caregiver would interact with the system, and address one of the palliative care targets. Taxonomy of Quality Improvement We based our categories on the taxonomy from the Closing the Quality Gap Series,43 but adapted them slightly to meet the literature in this area, and added one category on provider training/support on quality improvement skills, as well as a category for “other” for any interventions that did not fit these categories. Interventions could include multiple types of quality improvement interventions (Table 2). A consensus report published by the Improving Palliative Care in the ICU group in September 2010 noted that there are “two main models for ICU-palliative care integration: (1) the ‘consultative model,’ which focuses on increasing the involvement and effectiveness of palliative care consultants in the care of ICU patients and their families… and (2) the ‘integrative model,’ which seeks to embed palliative care principles and interventions into daily practice by the ICU team for all patients and families facing critical illness.” 47 The consensus report listed multiple examples of consultative versus integrative palliative care initiatives for ICU patients, but noted that it is unclear which “structure of a palliative care initiative... can best meet the needs of ICU patients, their loved ones, clinicians, and the hospital.” A complete systematic review of these initiatives with initiative classification as primarily “integrative” or “consultative” could determine which model is more efficacious, and would be applicable to most settings outside the ICU as well where palliative and other medical services could work together. From a comparative effectiveness perspective, understanding in what circumstances each model is best supported by the evidence can help practitioners choose which model to adopt in particular situations. Topic Refinement and Review Protocol Topics for the Closing the Quality Gap series were solicited from the portfolio leads at AHRQ. The nominations included a brief background and context; the importance and/or rationale for the topic; the focus or population of interest; relevant outcomes; and references to recent or ongoing work. Among the topics that were nominated, the following considerations were made in selection for inclusion in the series: the ability to focus and clarify the topic area appropriately; relevance to quality improvement and a systems approach; applicability to the Evidence-based Practice Center program/amenable to systematic review; the potential for duplication and/or overlap with other known or ongoing work; relevance and potential impact in improving care; and fit of the topics as a whole in reflecting the AHRQ portfolios. 11 43 Table 2. Types of quality improvement in hospice and palliative care (adapted from CQG ) Physician/other provider reminder systems (such as prompts in paper charts or computer-based reminders) (would include comfort care or other ordersets, structured communication templates for providers) Facilitated relay of clinical data to providers (patient data transmitted by telephone call or fax, from outpatient specialty clinics to primary care physicians) (would include structured documentation tools, collection of patientreported outcomes) Audit and feedback (physician performance tracking and reviews, using quality indicators and reports, comparisons with national/State quality report cards, publicly released performance data, and benchmark outcomes data). Physician/other provider education (workshops and professional conferences, educational outreach visits, distribution of educational materials). Provider training/support on quality improvement skills Patient education (classes, parent and family education, pamphlets and other media, etc.). Promotion of self-management (workshops, materials such as structured prompt sheets for patients to ask physicians about palliative care issues). Patient reminder systems (telephone calls or postcards from physicians to their patients). Organizational changes (PDSA, collaboratives, multidisciplinary teams, shifting from paper-based to computer-based recordkeeping, long-distance case discussion between professional peers). Financial incentives, regulation, and policy (performance-based bonuses and alternative reimbursement systems for physicians, positive or negative financial incentives for patients, and changes in professional licensure requirements) (would include state policy, POLST or similar programs, advance directive policy) Other types of interventions Abbreviations: CQG=Closing the Quality Gap; POLST= Physicians Orders for Life Sustaining Treatment Literature Search Strategy Comprehensive search strategies were developed through an analysis of studies known to be eligible for this review and related systematic reviews. These strategies combined controlled vocabulary terms (e.g., MeSH, EMTREE terms) with free-text terms (Appendix B, Detailed Search Strategies). In order to ensure that the search was comprehensive without capturing articles that did not apply to certain targets, separate searches were developed to capture studies on: (1) palliative care/patients with advanced and serious illness and quality improvement (Appendix Table B.1); (2) cancer/cancer care and communication/distress/pain management (Appendix Table B.2); and (3) nursing homes and care planning/pain management (Appendix Table B.3). Each of the search strategies was developed using PubMed and comparable searches were developed using the following databases: CINAHL, PsycINFO, Cochrane, and DARE (Appendix Tables B.1–B.3). We reviewed reference lists of included articles for potentially relevant studies. We also identified systematic reviews that might contain relevant articles and reviewed these reference lists as well. Searches were updated through December 31, 2011, and were downloaded to the ProCite® reference database. Gray Literature We sought supplemental publications from our technical expert panel, including requests for any “gray literature” sources, and reviewed these publications as well as their references for potentially eligible articles. We did not conduct any additional gray literature searches, since another systematic review in palliative care found that addition of the gray literature did not affect the results.48 Inclusion and Exclusion Criteria We included studies on seriously ill patients and those with advanced disease that met the population definition, including studies on pediatric and geriatric populations. We also included 12 studies with outcomes related to the families/caregivers of these patients. Patients with all conditions (e.g., cancer, heart failure, end-stage lung disease, dementia, and frailty) were included. Since there are high-quality studies in this field, we excluded all retrospective and uncontrolled studies of quality improvement interventions. We excluded individual studies published before 2000 because the nature of both quality improvement and palliative care practice has changed substantially since that time; and the populations served by hospice care were also markedly different before 2000. In addition, the pre-2000 data have been thoroughly addressed in a previous AHRQ Evidence-based Practice Center report9 and an extensive National Institute for Clinical Excellence (United Kingdom) report.8,49 In each section of the report, we describe previous systematic reviews that addressed the pre-2000 literature. Our search was not limited to English-language studies, since a significant proportion of the palliative care quality improvement studies have been conducted in non-US settings. We did not identify any eligible studies not published in English. We included any timing of followup, including after-death interviews with families/caregivers. We addressed all settings, both inpatient and outpatient, as well as quality improvement interventions in inpatient or outpatient hospice or palliative care programs. The detailed PICOTS criteria used for Key Questions 1 and 2 inclusion/exclusion for articles in this topic area follows: Population(s) We defined the relevant population as “…seriously ill patients and those with advanced disease (such as persons living with advanced cancer or intensive care unit patients at high risk of dying), who are unlikely to be cured, recover, or stabilize” (adapted from the National Consensus Project41). Interventions We included studies evaluating health care and palliative care interventions, including quality improvement interventions, such as patient education and self-management and provider audit and feedback. Comparators We included all comparators. For most studies, this was usual health care, but some studies tested interventions that were added on to usual hospice or palliative care. Outcomes Measures for Each Key Question For both Key Questions, we included all relevant patient or family/caregiver outcomes, including: • Patient and family satisfaction/perceptions of palliative care. • Patient symptoms, needs, distress, and quality of life. • Health care utilization, such as hospital admissions or do-not-resuscitate orders (but not costs). • Quality of care measures, such as timeliness of response to pain and other symptoms. 13 • Family/caregiver psychosocial symptoms, support, needs, quality of life, and grief/bereavement. We excluded studies that did not report measurements of any of these outcomes or that only had outcomes not related directly to the target populations (e.g., staff knowledge or perceptions of care). Timing We included any timing of followup, including after-death interviews with families/caregivers. Settings We addressed all settings, both inpatient and outpatient, with a specific focus on the nursing home setting (primary) and hospice program setting (specialty), as underlined in the Analytic Framework (see column 4 in Figure 1). Technical Expert Panel We discussed areas of focus with the Technical Expert Panel, which included a number of stakeholder perspectives. These included researchers in the field of hospice and palliative care; representatives of different disciplines (e.g., social work, nursing) and key settings (nursing home, hospice, and intensive care); and payers. Study Selection Abstract Screen Each abstract was independently screened by two reviewers. These reviewers included a trained article screener and a content expert. An abstract was excluded at this level if it was not a study of a health care or palliative care intervention, did not address palliative care populations, did not include patient and/or family outcomes in the results, or was not an included study design. (Appendix C, Abstract Review Form). Abstracts were promoted to be screened using full text article if both reviewers agreed that the abstract could apply to one or more of the Key Questions. An abstract could be excluded for different reasons by the two reviewers. Disagreements about the eligibility of an abstract were resolved by discussion between the two reviewers or by adjudication of a third reviewer; this person was either a trained screener or a principle investigator on the project. Article Screen Full text articles underwent another independent review by paired investigators to determine whether they should be included in the full data abstraction (see Appendix C, Article Inclusion/Exclusion Form). If articles were deemed to have applicable information, they were included in the data abstraction. Articles could be excluded at this level for the same set of reasons used at the abstract screen level. Articles were promoted to data abstraction if both reviewers agreed. An article could be excluded for different reasons by the two reviewers. Disagreements about the eligibility of an 14 article were resolved by discussion between the two reviewers or by adjudication of a third reviewer. All screening was completed using the Distiller SR web-based systematic review software (Evidence Partners, Ontario, CA). Data Abstraction No forms were used for data abstraction in this systematic review. Due to the nature of the data (narrative), the senior investigators agreed that the data should be abstracted directly to tables. We used a consecutive two-reviewer process to abstract data from the included articles. In this process, a research assistant abstracted data directly to tables, and this data was checked by a senior investigator. Periodically, senior investigators cross-checked the work of the other senior investigators to ensure that abstractions were done appropriately. Reviewers were not masked to the articles’ authors, institutions, or journal. Disagreements that could not be resolved between the reviewers were resolved through consensus adjudication at team meetings. For all articles, reviewers extracted information on general study and population characteristics: population, disease, study settings, single vs. multi center, study design and description of the intervention. For study design, we classified all articles as RCTs and nonrandomized controlled studies (almost all of which were pre-post or concurrent non-randomized controlled studies). Data abstracted on the interventions included: integrative vs. consultative, target of the intervention, and quality improvement elements. Outcomes included: sample size, disparities, specific outcome measure, other outcome measures and harms and benefits. We abstracted effect size whenever possible, and both numerical and statistical results. Since forms were not used for this phase of data abstraction, the elements that were abstracted can be seen in the evidence tables (Appendix E). Risk of Bias Assessment of Individual Studies We used a tool implemented successfully in past Evidence-based Practice Center projects, including the Cochrane Collaboration Tool for Assessing Risk of Bias from the Cochrane Handbook for Systematic Reviews of Interventions for assessing randomized controlled trials50. Data abstraction forms were not developed for this phase of the review and elements of the data abstraction can be found in the evidence tables. We assessed the risk of bias and appropriateness of all studies that met our eligibility criteria, following the guidance contained in chapter 6 of the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness Reviews (hereafter, Methods Guide).51 We used a limited number of key criteria that are most appropriate for each study design and that are most important for determining the validity of the studies. After the pool of included articles in this review was determined, the core team of investigators determined that the Cochrane Collaboration tool50 was most appropriate for all risk of bias assessments. Although we considered assessing risk of bias separately for non-randomized studies, we were unable to identify any validated tools that worked well in this literature and could be compared to risk of bias tools designed for randomized trials. The quality of individual studies was classified as “good,” “fair,” or “poor” based on the degree to which the studies adhered to the defined criteria. We did not factor in the quality score for blinding of the intervention; we did this because blinding of patients and personnel was generally not feasible in these interventions, but blinding of outcomes assessors would have been possible. A low risk of bias was assessed if six or more of the items were scored as a “yes.” A medium risk of bias was assessed if four or five of the 15 items were scored as a “yes” or “unclear”. A high risk of bias was assessed if zero to three items were scored as a “yes.” Applicability To assess applicability, we used criteria stipulated in the Methods Guide1,51 and input from the expert panel concerning what criteria would be most useful to stakeholders. We addressed applicability in two ways. First, we assessed studies to ensure that they included a relevant palliative care population and outcome, as defined in the methods section on the population. For example, an intervention to improve advance directive completion by healthy patients might not translate well for ill cancer patients. An outcome of improved adherence to chemotherapy may not necessarily translate into improved quality of life. Secondly, to evaluate applicability for included studies, we extracted the relevant patient population (e.g., cancer type, stage, etc.) and setting (e.g., size, teaching vs. community hospital) information from each study in the evidence tables. For example, an intervention study on improving pain management in cancer patients may not translate well to the frail elderly, for whom the treatment of pain is very different. An intervention study that is successful in a hospital setting likely will not translate well to the nursing home setting. Finally, we abstracted details from articles about feasibility or settingspecific issues that could be relevant to translation to other settings. Strength of the Body of Evidence At the completion of our review, we assessed the quantity, quality, and consistency of the body of available evidence addressing Key Questions 1 and 2. We used the GRADE Working Group criteria adapted by AHRQ in its Methods Guide51 and published in the Journal of Clinical Epidemiology.52 We considered the strength of the study designs, with RCTs having the highest level of evidence, followed by non-randomized studies. If an outcome was evaluated by at least one randomized controlled trial in addition to non-randomized studies, our evidence grade was based on the randomized controlled trials, followed by the quality of the non-randomized studies. If an outcome was not evaluated in any randomized controlled trial, our evidence grade is based on the best available non-randomized study. We assessed the strength of the best available evidence, including the risk of bias in relevant studies, as well as aspects of consistency, directness, and precision as described in the Methods Guide.51 52 As described in the Methods Guide, consistency was graded based on both the direction and range of effect size, including the percentage of studies with a statistically significant effect on the outcome. Directness was graded based on the whether the measured outcome was directly related to patient-centered outcomes. In particular, health care utilization may be related to patient-centered outcomes, such as improved satisfaction with communication, but this relationship has not been established in the palliative care research literature, and utilization does not measure patient-centeredness directly. This outcome was therefore graded as indirect. Precision was graded only if the measurement tools and reporting of outcomes was homogenous enough to allow for quantitative synthesis; if not, precision was graded as not applicable. The direction of effect was listed for each (improvement with intervention if any of the studies showed improvement). The overall strength of evidence was then graded for each outcome, based on all of these different dimensions. For each outcome of interest, two investigators graded the major outcomes for each Key Question. Unless otherwise noted, all strength of evidence assessments are for improvements to the outcome of interest. 16 Data Synthesis We organized the review by target of the intervention, including a category for interventions that focused on multiple targets or targets other than the primary ones for this review, and evaluated each target category for applicability to each Key Question. Since many studies did not report effect size but only a p value, for each category, we calculated the percentage of studies with a statistically significant improvement in outcomes with the intervention compared to control. We also checked that all other studies did not report significant results in the opposite direction. Because the results of higher-quality studies might differ from those of lower-quality studies (more likely to have methodological issues and lower sample size), we evaluated for potential differences in results in two ways. In the grading process, we compared the strength of the evidence for both RCTs and non-RCTs. Also, because interventions on the organizational level often cannot be conducted as an RCT and these studies would therefore not be graded as high-quality, as a sensitivity analysis, for the target of continuity, we determined whether results of the evidence synthesis were different when including only the high- and medium-quality studies. To determine whether quantitative synthesis was appropriate, we evaluated the clinical and methodological diversity of studies, measurement tools, and outcome reporting, and assessed for evidence of selective outcome reporting and reporting of effect sizes or confidence intervals. Peer Review and Public Commentary Experts in palliative care in nursing home, hospice, and intensive care unit settings, as well as experts from the disciplines of nursing and social work and individuals representing stakeholder and user communities were invited to provide external peer review of this CER; AHRQ and an associate editor also provided comments. The draft report was posted on the AHRQ website for 4 weeks to elicit public comment. We addressed all reviewer comments, revising the text as appropriate, and documented everything in a disposition of comments report that will be made available 3 months after the Agency posts the final CER on the AHRQ website. 17 Results Results of the Literature Search The literature search process identified 13,014 unique citations. During the abstract review process, we excluded 12,567 abstracts that did not meet one or more of the eligibility criteria (see Methods for details). At article review, we excluded an additional 351 articles that did not meet one or more of the eligibility criteria (see Appendix D, Excluded Articles). Ninety studies described in 96 articles were eligible for inclusion in the review (Figure 2). We described the information abstracted in a systematic manner, but did not conduct any meta-analyses. The outcomes were too diverse to allow for quantitative synthesis. Report Organization We first divided the interventions into the four key target areas or into an additional category for multiple and other targets. The results section is organized into these five sections, by target area: • Continuity, Coordination of Care, and Transitions • Pain • Distress • Communication and Decisionmaking • Interventions with multiple or other targets (this section also mostly details studies that fit into a narrower definition of quality improvement). Each target area section is then further divided into subsections based on the Key Questions. Key Question 1a broadly addresses health care and palliative care interventions within the target area and their impact on outcomes and Key Question 1b addresses the settings of care. Key Question 2a addresses different quality improvement types and Key Question 2a addresses different models—integrative compared to consultative. Either Key Question 2a or 2b is then addressed for each section (whichever was most appropriate for the intervention types within that section—these were mutually exclusive). The four sections focusing on individual targets are organized as follows: • Study characteristics • Key Question 1a (results for target): results summarized by key outcomes • Key Question 1b: results for hospice and nursing home studies • Key Question 2a (results for quality improvement types): results summarized by key outcomes (except for communication and decisionmaking, where Key Question 2b is addressed instead and a short summary of the results is given) • Grading of the evidence • Summary tables for the studies For the last section on multiple and other targets focusing on quality improvement, since Key Question 1a was not analyzed, the results are organized somewhat differently, as follows: • Study characteristics • Key Question 1b: results for hospice and nursing home studies • Key Question 2a: results summarized by quality improvement type 18 • • Grading of the evidence Summary tables for the studies Each section includes an assessment of the strength of evidence for Key Question 1 and 2, except for the strength of evidence for Key Question 1b, on settings. This strength of evidence is summarized in Appendix F. Description of the Types of Studies Retrieved There were 23 studies described in 26 articles that applied to continuity and addressed Key Questions 1a, 2 and 2a; 21 studies described in 23 articles applied to pain and addressed Key Questions 1a and 2a; seven studies described distress and addressed Key Question 1a; 20 studies described communication and addressed Key Questions 1a, 2a and 2b; 19 studies described in 20 articles described multiple and other targets and addressed Key Question 2a; two studies described in three articles discussed hospice and addressed Key Question 1b; seven studies discussed nursing homes and addressed Key Question 1b. Continuity, Coordination of Care, and Transitions Study Characteristics We found 23 studies detailed in 26 articles addressing this target. The 23 studies were published between the years 2000 and 2011 and had sample sizes in the range of 40 to 710 patients with 17 studies (74 percent) between 100 and 300 patients. Of the 23 studies, 12 were randomized clinical trials (RCTs) and 11 were non-RCTs. Of the 11 non-RCTs, seven were before-after studies conducted in the same setting with a different set of patients as the control group. Five studies were conducted in an inpatient setting, four in a home care setting, four in an ambulatory setting, three in nursing homes, one in hospice, one in a rehabilitation unit, and five in mixed settings. Fifteen studies (65 percent) were multicenter studies. One study reported only within-group comparisons and therefore the outcomes are not further analyzed here53 (Table 3, Appendix E, Evidence Table 1). All studies compared the intervention to usual care. The populations in these studies were adults with a mean age (by study) between 62 and 84. Most of the studies included patients with mixed illnesses (n=9) or cancer patients only (n=7). Five studies focused on cancer, chronic obstructive pulmonary disease or chronic heart failure patients, one study included dialysis patients, and one included chronic heart failure and chronic obstructive pulmonary disease patients. None of the studies reported anything on disparities (Table 3, Appendix E, Evidence Table 1). In 20 (87 percent) of studies, the interventions addressed multiple targets of palliative care. All but two included targets of coordination of care or an interdisciplinary team as part of the intervention. The two studies54,55 that did not include one of these targets focused on facilitated referrals to hospices. In 11 studies, the existing staff provided the intervention, in nine studies an external team or consultant provided the intervention, and in three studies a mix of these two provided the intervention. Studies addressed a wide range of interventions and outcomes, and quantitative synthesis was judged not to be appropriate due to this diversity (Table 3, Appendix E, Evidence Tables 2 and 3). Risk-of-bias (ROB) scores were high for 10 studies, medium for eight, and low for five. Eleven of the studies were non-RCTs, some RCTs did not adequately report the randomization 19 process, and most did not report blinding of outcome assessment (Appendix E, Evidence Table 4). Figure 2. Results of the literature search Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care? Key Question 1a. Specific Targets See Figure 1, Framework, column 3, for a listing of targets. 20 Key Points There was a moderate strength of evidence for improvement in satisfaction, based on six medium-quality studies for patients and four for caregivers, both with consistent results. Patient Quality of Life and Satisfaction Nine studies evaluated quality of life (QOL) of patients;56-64 eight were RCTs. Only three studies (33 percent) showed a statistically significant improvement in patient QOL with the intervention.57,58,64 Whether or not the instrument used for QOL measurement was specifically designed for that population had no influence on the results. In addition, the sample size was the same in the studies that showed an effect compared to the studies showing no effect. Also, neither the intervention targets nor the setting explained the likelihood of a significant finding (Table 4, Appendix E, Evidence Table 5). Seven studies assessed patient satisfaction (every study used a different satisfaction scale).58,62,63,65-68 Four studies were RCTs. One study reported within-group comparison only, and was therefore not included in the analysis.65 Of the other six studies, four (67 percent) showed statistically significant effects for this outcome in favor of the intervention.62,65,67,68 The quality of the studies, the sample size, the settings and the target of intervention did not influence the likelihood of a significant finding (Table 4; Appendix E, Evidence Table 1 though 4). Three studies measured both patient satisfaction and QOL.58,62,63 Findings for the two outcomes were different for two of the studies (one statistically significant, one not) and the same for only for one study63 (both were not statistically significant) (Table 4, Appendix E, Evidence Table 5). Five out of seven studies that reported significant improvement in QOL or satisfaction in the intervention group included coordination of care processes in the intervention. On the other hand, only one of four studies not using coordination of care processes showed significant results in one of these outcomes (Table 4, Appendix E, Evidence Table 5). Caregiver Satisfaction, Quality of Life, and Burden Six studies reported caregiver satisfaction.58,68-71 Four of these studies (67%) showed statistically significant improvement with the intervention,58,68,70 including three RCTs and a non-RCT. The targets of the interventions and the sample size were comparable among the studies. The instruments used to measure satisfaction had no influence on the likelihood of a statistically significant finding. One study with a positive result on satisfaction evaluated grief as well, which showed no difference between the groups (Table 4, Appendix E, Evidence Table 5).72 Only one study reported caregiver QOL.68 This study evaluated QOL with two different instruments and both showed statistically significant improvement with the intervention. Three studies reported caregiver burden;58,61,69 two were RCTs. None of the studies showed a significant difference between the intervention and control group (Table 4, Appendix E, Evidence Table 5). Among the three studies evaluating at least two of these three outcomes, two had conflicting findings for the different outcomes and one had a similar finding among outcomes; in that study, neither caregiver burden or satisfaction showed a statistically significant improvement with the intervention (Table 4, Appendix E, Evidence Table 5).69 21 Symptoms Eight studies in the target of continuity, coordination, and transitions assessed patient symptoms;56,57,60,63,64,68,69,73 five were RCTs. None of the studies showed statistically significantly improvement of overall symptoms in the intervention group versus the control group. In five of these eight studies,57,60,63,64,68 a specific symptom showed a statistically significant improvement in the intervention compared to the control group: in three RCTs,57,60,64 there was a statistically significant improvement with the intervention on depression symptoms; one non-RCT reported a statistically significant improvement for dyspnea, and another non-RCT showed a statistically significant improvement for pain. (Table 4, Appendix E, Evidence Table 5). Health Care Utilization (Decreased Admissions or Length of Stay, Increased Hospice Referral) Sixteen studies reported impact on health care utilization,56-58,62,64-66,68-69,71-72,74-76 characterized by length of stay or different types of admissions; one did not report statistics on the results. Seven of these studies were RCTs. Only five of the 16 studies (31 percent) reported a statistically significant improvement with the intervention compared to the control group (four decreased admissions or length of stay, and one improved hospice referral.54,65,66,68,74 (Table 4, Appendix E, Evidence Table 5). Location of Death Six studies reported location of death (e.g., whether the patient died at home or in his or her preferred location),54,64,69,74,77-78 three of which were RCTs. In three studies (50 percent), two of which were RCTs, the intervention had a statistically significant impact in the percentage of patients who died at home or in their preferred location.64,74,78 The sample sizes and patient mix were comparable among all studies (Table 4, Appendix E, Evidence Table 5). Specialized Palliative Care Usage Four studies reported enrollment in hospices, use of hospice services or placing patients on a comfort care plan.54,55,64,75 One RCT, which focused on the outcome of improving hospice referrals in nursing homes, reported significant results in favor of the intervention at 30 days but not at time of death.54 A non-randomized study55 and a RCT64 (of a broader intervention and not powered for this outcome) reported non-significant results, while another very small non-RCT reported significant results in favor of the intervention. (Table 4, Appendix E, Evidence Table 5)75 Key Question 1b. Specific Settings Key Points Too few studies to draw conclusions in the hospice or nursing home setting. One study was conducted in hospice and four included the nursing home setting (Table 4, Appendix E, Evidence Table 5); there were too few studies in these settings to draw conclusions. An RCT of systematic feedback of standardized assessments and interdisciplinary team discussions in hospices60 found a statistically significant improvement with the intervention in patient depression, but not in patient symptoms or caregiver depression (Table 4, Appendix E, Evidence Table 5). 22 Three studies evaluated care pathways in nursing homes, and one focused on increasing hospice referrals. A 2010 non-RCT evaluated the Liverpool Care Pathway for the Dying Patient across hospital, nursing home, and home settings; among the 80 nursing home patients included, the intervention did not significantly increase the quality of care measure of do-not-resuscitate orders. A 2009 study of the Gold Standards Framework,74 addressing symptoms, needs, and coordination in 49 nursing homes, found statistically significant reductions in deaths in the nursing home and crisis hospitalizations with the intervention. A multicenter study of a different care pathway in nursing homes found no improvement in bereaved families’ satisfaction.71 Finally, Casarett et al.54 conducted an RCT identifying nursing home residents appropriate for hospice care and communicating this information to their physicians. The intervention resulted in statistically significant improvements in hospice enrollment (1 percent for the control group compared to 20 percent for the intervention group, p=0.001) and patient satisfaction, and found statistically significant decreases in hospital utilization (Table 4, Appendix E, Evidence Table 5, Appendix F). Key Question 2. What is the evidence for different quality improvement models for improving palliative care? Key Question 2a. Different Types of Quality Improvement Interventions Key Points Six of the nine studies (67%) using patient-centered quality improvement types such as patient/family/caregiver education and promotion of self-management showed a significant improvement with the intervention for the outcomes of patient quality of life or satisfaction, compared to three of nine studies (33%) using provider-centered interventions. Quality Improvement Types The interventions in the studies for continuity, coordination, and transitions included between one and five quality improvement (quality improvement) types (for details see methods, Table 2); 13 (57 percent) included three or four quality improvement types. Fifteen studies included organizational change; 13 included facilitating relay of clinical data to providers; nine included promotion of self-management or patient/family/caregiver education; nine included provider reminder systems and provider education; and four included training for implementation of quality improvement (Table 4, Appendix E, Evidence Tables 2 and 3). Patient Quality of Life and Satisfaction Of the nine studies56-59,63-64,66-68 identified that used patient-centered quality improvement types such as patient/family/caregiver education and promotion of self-management, six (67 percent) showed a significant effect in favor of the intervention on satisfaction or QOL. One of the three non-significant studies reported that some of the control group received specialized palliative care as well.59 Of the ten studies56,59-63,66-68 using provider-centered interventions (such as provider reminder systems, facilitated relay of clinical data to providers, or provider education), only three (30 percent) had a significant effect on QOL or satisfaction in favor of the intervention. All three studies that did show an effect of the intervention also included patientcentered quality improvement types (Table 4, Appendix E, Evidence Table 5). 23 Caregiver Satisfaction, Quality of Life, and Burden Of the three studies using patient and family-centered quality improvement types (such as patient/ family/ caregiver education and promotion of self-management), all showed a statistically significant improvement in caregiver satisfaction with the intervention.58,68,72 The three studies showing no effect on any of these three outcomes were studies that included only provider-centered quality improvement types or organizational change, and did not include patient- and family-centered quality improvement types61 69 (Table 4, Appendix E, Evidence Table 5). Symptoms The eight studies for the targets of continuity, coordination, and transitions which evaluated overall symptoms as an outcome, which showed no statistically significant impact from the intervention, most commonly included the following quality improvement types: facilitated relay of clinical data to providers (seven studies), organizational change (six studies), provider reminder systems (five studies), and patient/family/caregiver education (five studies) (Table 4, Appendix E, Evidence Table 5). Health Care Utilization (Decreased Admissions or Length of Stay, Increased Hospice Referral) Of the 16 studies reporting statistics which evaluated this outcome, seven used the quality improvement type provider education. Of these seven studies, four (57 percent)65,66,68,74 found a statistically significant improvement in health care utilization (decreased admissions or length of stay) in the intervention compared to the control group. Also, two of four studies (50 percent) using provider reminder systems68,74 in the intervention and two of three studies (66 percent) using quality improvement training to implement the intervention68,74 reported a significant improvement with the intervention. Only three of the nine studies using the quality improvement type facilitated relay of data to providers54,68,74 were associated with significant results. Studies using patient-centered quality improvement strategies like patient/family/caregiver education and promotion of self-management reported a statistically significant improvement in utilization outcomes with the intervention in only three of the eight (38 percent) of the studies.65,66,68 Three of the ten studies (30 percent)65,66,74 which used some version of organizational change found a statistically significant improvement (Table 4, Appendix E, Evidence Table 5). Specialized Palliative Care Usage and Location of Death We did not find any association between quality improvement strategies and study findings for the outcome of specialized palliative care usage or location of death. For all outcomes, when including only the results of the high- and medium-quality studies (excluding the low-quality studies), the overall findings were consistent. Key Question 2b. Different Models in Palliative Care: Integrative Compared With Consultative This Key Question was not analyzed for this target. Grading of the Evidence Risk of bias was generally low to medium for RCTs and medium to high for non-RCTs. All outcomes were direct except health care utilization, which was graded as indirect because it is 24 considered a surrogate outcome in palliative care, and has not been shown to be directly related to patient-centered outcomes such as satisfaction. Precision was not applicable due to diversity of outcomes measurement tools, and study diversity was high for all outcomes, with a wide variety of different types of interventions. Study results did not generally differ between the RCTs and non-RCTs or between high-and medium- and low-quality studies. For QOL, most studies were RCTs with medium risk of bias and evidence was inconsistent. For patient satisfaction, evidence was consistent for both RCTs and non-RCTs. For caregiver burden, evidence was consistent for the two RCTs; for caregiver satisfaction, evidence was consistent for both the RCTs and the nonRCTs. For symptoms, evidence was consistent for the five RCTs and consistent for the three non-RCTs. For health care utilization, evidence was consistent for both the RCTs and non-RCTs. Strength of evidence was low across all outcomes except for satisfaction, where it was moderate. (Table 5). Table 3. Overview of characteristics of studies addressing continuity Author/Year/ refID 56 Aiken, 2006 Badger, 74 2009 Study Design Sample Size RCT 192 Population (disease, mean age) COPD, CHF 69 Setting(s) Home care Non-RCT Mixed illnesses, 437 no age reported Nursing home Non-RCT Mixed illnesses 203 68 Hospital Bakitas, 57 2009 RCT 322 Ambulatory Bookbinder, 53 2005 Non-RCT Mixed illnesses 257 >70 Hospital, Brumley, 65 2003 Non-RCT COPD, CHF, 300 cancer 74 RCT COPD, CHF, 297 cancer 72 RCT Mixed illnesses 205 84 Home care Non-RCT Dialysis patients 133 with poor prognosis 70 Non-RCT Mixed cancer 200 66 Ambulatory Bailey, 2005 77 Brumley, 66 2007 Casarett, 54 2005 55 Cohen, 2010 Dudgeon, 69 2008 Mixed cancer 65 Home care Nursing home Ambulatory, hospital, home care 25 Description of Intervention Home-based case management by nurse case managers, in coordination with patients’ existing source of medical care Gold Standards Framework in Care Homes Identifying, assessing and treating needs and symptoms, Improving coordination within institution and outside Inpatient Comfort Care Program - Staff education and support to identify actively dying patients and implement comfort care order set template Multicomponent telephone-based interventionEducation, encourage patient activation, selfmanagement, and empowerment Palliative Care for Advanced Disease (PCAD) pathway - daily flow sheet, standard orders for symptom control Home-Based Palliative Care - Care team (physician, nurse, social worker) assesses, coordinates and manages care As above Structured interview and notification of residents’ physicians about residents’ preference for hospice care Intervention to facilitate hospice referral - Renal supportive care teams encouraged care planning, discussed hospice resources, offered general support Palliative care integration project - Implementation of assessment tools, collaborative care plans, symptom management guidelines Table 3. Overview of characteristics of studies addressing continuity (continued) Study Design Sample Size RCT 275 58 RCT 188 78 RCT 434 Population (disease, mean age) COPD, CHF mixed cancer 70 Mixed illnesses 70 Mixed cancer 68 NonRCT 39 RCT 709 Mixed illnesses 72 Mixed cancer 73 RCT 159 NonRCT 90 Mixed illnesses 65-72 Lung cancer 67 CHF, COPD, mixed cancer, Cirrhosis 76 COPD, CHF, cancer 68 NonRCT 299 Mixed illnesses Not reported NonRCT 169 Mixed illnesses (majority dementia) 84 Metastatic lung Ambulatory cancer 65 Author/Year/ refID Engelhardt, 67 2006 Hughes, 2000 Jordhoy, 2000 , 59 2001 , Ringdal 72 79 2002 , 2001 * Luhrs, 2005 75 McMillan, 2011 Mitchell, 2008 Moore, 2002 60 61 62 Pantilat, 2010 Rabow, 2004 RCT 202 RCT 107 73 63 71 Reymond, 2011 Woo, 2011 68 Temel, 2010 64 RCT 151 Setting(s) Hospital, home care Home care Home care, ambulatory, palliative medicine unit Hospital Hospice Ambulatory, hospital Ambulatory Hospital Description of Intervention Advanced illness coordinated care program- 6 sessions with care coordinator who helps with provider communication, care coordination, support Team-Managed Home-Based Primary Care - care manager, 24-hour contact, prior approval of hospital readmissions, discharge planning Comprehensive palliative care - All in- and outpatient services occurred on Palliative Medicine Unit, Unit staff served as link to community, predefined guidelines, educational programs for community Palliative Care for Advanced Disease (PCAD) pathway - daily flow sheet, standard orders for symptom control Systematic feedback of assessment to interdisciplinary teams (IDTs) - Standardized assessment followed by two interdisciplinary team (IDT) discussions Specialist-general practitioner case conferences: General practitioner phoning in to a routine specialist team meeting Nurse led followup: Nurse specialists assessed patients monthly or as needed by phone or in clinic Hospital-based palliative care consultation: daily during hospitalization, palliative care physician assessed patient, discussed treatment preferences Comprehensive care team - Primary care physician received palliative care team consultations, patients received care planning, psychosocial support, family caregiver training. Nursing home Residential aged end-of-life care pathway Identifying and training nurse champions, networking facilities with specialty palliative care, educating physicians, development and implementation of endof-life clinical management care pathway Rehabilitation and Continuous quality improvement initiative (Plan-doconvalescent unit study-act) - Service reengineering, provision of guidelines, educational material, and interactive sessions to achieve culture change Ambulatory Early palliative care integrated with standard oncologic care - Palliative care physician/advance practice nurse consult within 3 months of diagnosis and then monthly; addressed physical and psychosocial symptoms, goals of care, treatment decisionmaking, coordination 80 v.d Heide, 2010 NonMixed cancer Hospital, nursing Liverpool Care Pathway for the Dying Patient RCT 64-75 home, home care Structuring care, facilitating audit by standardizing 298 the monitoring of care Abbreviations: RCT = randomized controlled trial; CHF = chronic health failure; COPD = chronic obstructive pulmonary disease *Multiple publications on the same study 26 Table 4. Outcomes of studies addressing continuity Study Design; Sample Size Author, Year Aiken, 2006 56 ROB Results Statistically Significant Improvement With the Intervention vs. the Control Group Patient Patient Symptom Health Care QOL; Satisfaction; Control Utilization Caregiver Family Burden or Satisfaction QOL No No No Low Bookbinder, 53 2005 RCT 192 Non-RCT 437 Non-RCT 203 RCT 322 Non-RCT 257 Brumley, 65 2003 Non-RCT 300 Medium Brumley, 66 2007 Casarett, 54 2005 55 Cohen, 2010 RCT 297 RCT 205 Non-RCT 133 Low No between group significance testing Yes Low Yes Dudgeon, 69 2008 Engelhardt, 67 2006 Hughes, 58 2000 Non-RCT 200 RCT 275 RCT 188 High Medium Yes; No No; Yes No Jordhoy, 78 59 2000 , 2001 , Ringdal 72 79 2002 , 2001 75 Luhrs, 2005 RCT 434 High No Yes No Non-RCT 39 RCT 709 RCT 159 RCT 202 Medium Badger, 2009 Bailey, 2005 74 77 57 Bakitas, 2009 McMillan, 60 2011 Mitchell, 61 2008 62 Moore, 2002 High Yes Medium No Medium Yes No High No between group significance testing Yes Yes Yes (hospice referral) No High n/a No No High No No Yes No High No Low No No No Low No No Yes 27 No Table 4. Outcomes of studies addressing continuity (continued) Author, Year 73 Pantilat, 2010 Rabow, 2004 63 Reymond, 71 2011 68 Woo, 2011 Temel, 2010 v.d Heide, 80 2010 64 Study Design; Sample Size RCT 107 Non-RCT 90 ROB High Results Statistically Significant Improvement With the Intervention vs. the Control Group No Medium No Non-RCT 299 Non-RCT 169 High High N/A No RCT 151 High Yes Non-RCT 298 High No No No No No significance testing Yes No Yes Yes (only depression measured) No for all Yes for patients who died None of these outcomes measured Abbreviations: RCT = randomized controlled trial; QOL = Quality of life; COPD = chronic obstructive pulmonary disease; CHF = chronic heart failure; ROB = risk of bias 28 Table 5. Evidence grading for continuity (KQ1a and KQ2a) Number of Studies; Subjects Patient QOL 8; 2562 1; 90 Domains Pertaining to Strength of Evidence, by Key Outcomes Risk of bias Consistency Directness for outcome Precision; Study diversity RCT/ medium Inconsistent Direct Non-RCT/ medium Not applicable Direct not applicable; high not applicable; not applicable Patient Satisfaction 4; 962 RCT/ medium Consistent Direct 3; 559 Non-RCT / high Consistent Direct Low SOE Low Low Moderate SOE Caregiver Burden 2; 448 RCT/ medium Consistent 1; 200 Non-RCT / high Not applicable Direct not applicable; high not applicable; high Moderate Low Low SOE Direct Caregiver Satisfaction 3; 472 RCT/ medium Consistent Direct 3; 668 Non-RCT / high Consistent Direct Symptoms 5; 1481 RCT/ medium 3; 459 Strength of Evidence That the Intervention Improved Outcomes Compared With the Control Group not applicable; high not applicable; not applicable Low Low Low SOE not applicable; high not applicable; high Consistent (no Direct effect) Non-RCT / high Consistent Direct (no effect) Health Care Utilization* 7; 1641 RCT/medium Inconsistent 6; 1634 Non-RCT /high Inconsistent not applicable; high not applicable; high Low Low Low SOE Low Low Low SOE Indirect for surrogate outcome Indirect for surrogate outcome not applicable; high Low not applicable; high Low * admissions, length of stay, interventions Abbreviations: KQ=Key Question; SOE = strength of evidence; RCT= randomized controlled trial; QOL = quality of life Pain Study Characteristics The 21 included studies described in 23 articles spanning the years 2000 to 2011. The median sample size was 105 patients (range: 43-187). Sixteen studies examined mixed cancer populations, while one study examined gynecologic cancers,81 two studies examined lung cancer only,82,83 and two focused on patients with severe dementia.84,85 Sixteen studies were conducted in an ambulatory setting, two were conducted in nursing homes,84,85 two in home care,86,87 and one in a hospital.88 Mean age of study participants ranged from 52 years to approximately 86.5 29 years of age, with a median of 59.7 years of age. Median followup time following the initiation of the intervention was eight weeks (range: 2-24 weeks), excluding one study89 which performed followup to the patient’s death. Fourteen out of the 21 studies were conducted in the United States (67 percent), two studies were conducted in Canada,84,86 one in Australia,88 one in Italy,89 and three in the Netherlands (Table 6, Appendix E, Evidence Tables 1, 6 and 7).87,90 Out of the 21 studies, 18 (86 percent) were RCTs. Nineteen randomized at the patient level, one study randomized by institution block,91 and one study randomized by nursing home unit level.84 The three remaining studies used non-equivalent control groups.83,86,92 Six studies were conducted in a single setting, and 15 were conducted in multiple settings, ranging from two to 21 sites.83,92 All compared the intervention to usual care. Patient pain was the target in all 21 (100 percent) of the studies (Table 6, Appendix E, Evidence Tables 1, 6 and 7). Five of the studies (24 percent) used facilitated relay of data to providers as a quality improvement element.83,84,87,89,93,94 Five studies (24 percent) used provider education as a component of the intervention,83,85,86,91,95 while 18 studies (86 percent) employed patient, family, and/or caregiver education. Five of these studies utilized print and video materials to enhance the educational intervention.86,87,93,96,97,98 One study used print material alone,81 and one study used video material alone.82 Risk-of-bias scores were high for five studies, medium for six, and low for ten. Three of the studies were non-RCTs, some RCTs did not adequately report the randomization process, and many did not report blinding of outcome assessment (Table 6, Appendix E, Evidence Table 8). Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care? Key Question 1a. Specific Targets See Figure 1, Framework, column 3, for a listing of targets. Key Points There was a moderate strength of evidence for outcome of improvement in pain, based on 21 medium-quality studies (18 RCTs) with inconsistent results; 18 of the studies were patient/caregiver education/self-management. Pain All 21 included studies assessed pain as an outcome. Fourteen out of 21 studies (67 percent) used the Brief Pain Inventory (BPI) as the pain measurement tool. One study83 used the Quality of Life Scale/Cancer Patient Tool, one study95 used the Symptom Experience Scale, one study89 used a visual analog scale, and one82 used the McGill Pain Questionnaire. One other study used treatment data to determine patient pain experience.92 Of the two studies focusing on dementia, one study84 used the Pain Assessment Checklist for Seniors with Limited Ability to Communicate, and the other used the Discomfort-Dementia of the Alzheimer’s Type. (Table 7, Appendix E, Evidence Table 9).85 Additional issues with outcome reporting of these studies that precluded quantitative synthesis included inconsistent reporting of the BPI, which raised concerns for selective outcome reporting (e.g., only nine of the 14 studies reported average pain). Only five of the studies reported confidence intervals or effect sizes, and reported time to outcome also varied. (Table 8) 30 Ten of the 21 studies showed statistically significant improvement with the interventions on pain scores compared to the control group. This was similar for small studies (<100) and larger studies (100-200, 5 of 11 (45%) showed significant improvement). Types of reported pain scores measured by the BPI included worst pain, average pain, usual pain, current pain, least pain, pain relief, and pain interference. Of those studies using the BPI to measure pain outcomes, two studies88,93 demonstrated significant improvement with the interventions on both average and worst pain scores, two studies87,99 showed significant differences by group on scores for current pain, three studies found significant effects for usual or average pain.86,91,96 and one study found significant effects for average and current pain.90 Two studies, which used visual analog scales to measure pain rather than the BPI, found significant pain improvements in the intervention group relative to controls. (Table 7, Appendix E, Evidence Table 9).85,89 Among interventions with significant impact on patient pain outcomes, number of encounters ranged from one86,88 to six.93 Among those interventions shown to have no significant impact on pain outcomes, number of encounters ranged from one100 to 10.84 Of the seven effective interventions that targeted patients and caregivers, four (57 percent) were conducted in ambulatory settings,88,90,96,99 two in home care,86,87 and one in a hospital.93,94 Only two studies out of the eight showing a significant improvement with the intervention were conducted at a single site89,90 (Table 7, Appendix E, Evidence Table 9). Quality of Life Nine of the 21 (43 percent) studies measured QOL as an outcome. Of these nine studies, only one93,94 found any improvement with the intervention on QOL. Moreover, this study only found an improvement on a single sub-scale of a quality of life measure. There was no consistency among these eight studies in the measurement of QOL; every study used a different instrument. Even in the cases where the intervention demonstrated significant positive outcomes for pain, there were no commensurate significant gains in QOL (Table 7, Appendix E, Evidence Table 9). Key Question 1b. Specific Settings No studies were in the hospice setting. Two studies targeted pain in nursing homes. One multicenter RCT of 21 nursing units evaluated routine observational pain assessment checklist for patients with dementia;84 the study found a statistically significant improvement with the intervention for pain medication use. The study did not report the impact of the intervention on patients’ pain. A multicenter RCT in 14 nursing homes that looked at implementation a protocol for assessing discomfort found a significant improvement with the intervention both on nurses’ assessments and on patient discomfort (Table 7, Appendix E, Evidence Table 9, Appendix F). Key Question 2. What is the evidence for different quality improvement models for improving palliative care? Key Question 2a. Different Types of Quality Improvement Interventions Key Points Eighteen of the 21 studies targeting pain used patient/family/caregiver education and/or promotion of self-management as quality improvement types. 31 Patient, Family, and/or Caregiver Education All studies that used patient, family, and/or caregiver education also used promotion of patient/caregiver self-management. One study82 used a patient and caregiver reminder system as a component of the intervention. One study83 used organizational change in their intervention. None of the studies used financial incentives, regulations or policy to affect pain outcomes (Table 7, Appendix E, Evidence Table 9). Among those 18 studies that used patient, family, and caregiver education and promotion of self-management, 12 of the studies included multiple contacts with the patient.82,87,90,92,9395,97,98,101,102-104 The number of followup contacts among these studies ranged from one brief 10minute followup96 or followup phone call97 to 10 individual contacts over the course of 20 weeks95 (Table 7, Appendix E, Evidence Table 9). The majority (86 percent) of the studies examined patient-directed educational interventions. Three studies focused on provider-level interventions only. One of these studies89 focused on the use of strong opioids as first-line therapy in cancer pain management as the intervention under study, one91 employed a provider education program about using an algorithm to improve cancer pain management, and one85 used a serial trial intervention--a protocol for assessing the needs of people with dementia (Table 7, Appendix E, Evidence Table 9). The nine studies demonstrating a significant positive impact of interventions on patient pain outcomes varied in scope, intensity, and target of intervention. Moreover, studies were diverse in the respect that interventions were delivered at different points in patients’ illness trajectories, and study participants varied in health status at the time of the interventions. Three of these studies focused on provider behavior. One study91 implemented a provider training program to improve provider adherence to a previously tested cancer pain management algorithm. The other provider-focused study used a systems-change approach (testing the efficacy of using strong opioids as first-line therapy in cancer pain management, relative to the WHO Analgesic Ladder89), and the other used a serialtrial intervention to help nurses and staff assess unmet needs of patients85 The other seven studies demonstrating improvements in pain management focused on patient and caregiver education and promotion of self-management (Table 7, Appendix E, Evidence Table 9). Eight studies focused on patient, family, and caregiver education as well as promotion of self-management.86-88,90,93,96,97,105 In addition to patient education and promotion of selfmanagement, two of these studies also included facilitated relay of clinical data to providers,87,93 and one also included pain consultation.90 One study included provider education in addition to patient education and promotion of self-management.86 Of the three positive studies not including patient and caregiver education, two included provider education alone,85,91 and the other consisted of facilitated relay of clinical data to providers (Table 7, Appendix E, Evidence Table 9).89 Key Question 2b. Different Models in Palliative Care: Integrative Compared With Consultative This Key Question was not analyzed for this target. Grading of the Evidence Risk of bias was low for RCTs and medium for non-RCTs. Precision was not applicable because study results could not be quantitatively combined; outcomes were reported differently and effect sizes were not reported consistently. Study diversity was moderate for both outcomes; although almost all populations were mixed cancer and interventions focused on patient 32 education, the timing, nature, and scope of the interventions was relatively diverse. Because of their patient-centeredness, both outcomes were direct: pain interventions should impact directly on pain outcomes, and pain is also an element of many QOL measurement tools and directly affects quality of life. For pain, a direct outcome, most studies were RCTs and evidence was inconsistent in the direction of improvement, and for QOL, all studies were RCTs and evidence was consistent with no effect. Strength of evidence was moderate for pain, given directness and relatively consistent results, and low for quality of life given consistent findings of no effect. (Table 9). Table 6. Characteristics of studies targeting pain Study Design RCT Sample Size* 97 Non-RCT Non-RCT Non-RCT RCT RCT 80 46 157 127 105 RCT 173 95 RCT 113 102 RCT 78 RCT 114 RCT 185 RCT RCT 92 174 167 72 Author/Year 106 Anderson 2004 86 Aubin, 2006 83 Borneman, 2008 92 Borneman, 2010 104 Dalton, 2004 91 Du Pen, 2000 Fuchs-Lacelle, 2008 Given, 2002 84 Keefe, 2005 Kovach 2006 85 88 Lovell, 2010 89 Marinangeli, 2004 93 Miaskowski, 2004 and 94 Miaskowski 2007 ** 90 Oldenmenger 2011 RCT Setting Intervention Ambulatory Patient education consisting of race- and gendertailored video, followed by a nurse-led meeting and a followup call. Home care One-time educational intervention Ambulatory Four-part educational intervention Ambulatory Four-part educational intervention Ambulatory Profile-tailored CBT treatment program Ambulatory Provider focused education intervention on implementing a previously tested algorithm for cancer pain management Nursing Nurse-led systematic pain assessment Home Ambulatory Ten-part nurse-implemented pain and fatigue management educational intervention Home care Three-session nurse-led partner-guided pain management intervention Nursing Serial trial intervention, a protocol of assessing needs Home of people with dementia Hospital Pain management educational intervention utilizing a booklet and a video Ambulatory Use of strong opioids as first line therapy Ambulatory Six-week nurse-led psychoeducational intervention Ambulatory Pain consult plus specialized nurse-conducted patient education program (PEP). 99 Oliver, 2001 RCT 67 Ambulatory One-time individualized education and coaching 107 Kalauokalani, 2007 ** session 96 Syrjala, 2008 RCT 78 Ambulatory Patient training in cancer pain management using integrated print and video materials 87 van der Peet, 2004 RCT 120 Home care Three-visit nurse-led pain education program 81 Ward, 2000 RCT 43 Ambulatory Nurse-led individually tailored information 100 Ward, 2008 RCT 176 Ambulatory Single one-on-one psychoeducational session based on the representation approach to patient education 98 Wells, 2003 RCT 64 Ambulatory Pain education with a hotline and pain education with provider-initiated followup telephone calls 82 Wilkie, 2010 RCT 151 Ambulatory Individualized pain coaching on self monitoring and reporting Abbreviations: RCT = randomized controlled trial; CBT = cognitive behavioral therapy * All studies conducted in populations of cancer patients, besides Fuchs-Lacelle and Kovach, which focused on advanced dementia patients. ** Articles are listed together when more than one article provided results on the same study. 33 Table 7. Outcomes for studies targeting pain Author/Year 106 Anderson 2004 86 Aubin, 2006 83 Borneman, 2008 92 Borneman, 2010 104 Dalton, 2004 91 Pain NS S NS NS NS QOL NS NS BPI* Y Y N N Y Du Pen, 2000 Fuchs-Lacelle, 84 2008 95 Given, 2002 102 Keefe, 2005 85 Kovach 2006 88 Lovell, 2010 Marinangeli, 89 2004 Miaskowski, 93 2004 and Miaskowski 94 2007 Oldenmenger 90 2011 99 Oliver, 2001 Kalauokalani, 107 2007 96 Syrjala, 2008 S NS van der Peet, 87 2004 81 Ward, 2000 100 Ward, 2008 S NS Y NS NS NS NS Y Y Wells, 2003 98 NS NS S S S S Y N NS NS NS NS (except for one subscale) N Y N Y N Y S Y S Y S Y NS Y 82 BPI Measure Reported* Worst pain, pain interference Average pain, worst pain Worst, least, average, pain now, pain right now, pain Interference with walking, sleep, relationships, activity, composite severity score, composite interference score Aggregate score of worst pain and usual pain Worst pain, usual pain Average pain, worst pain, pain interference 93 Least pain, average pain, worst pain Total interference score, individual scores for activity, mood, walking, work, relations with others, sleep, enjoyment of life, sexual activity Current pain, average pain, worst pain in past 24 hours; pain interference Average pain 94 Usual pain, worst pain, interference with function (overall) Present pain Worst pain, pain interference composite score BPI severity composite score, pain interference composite score Worst pain, average pain, pain interference, pain relief Wilkie, 2010 NS N Abbreviations: S = significant; NS = not significant; BPI = Brief Pain Inventory *Whether or not BPI was the measurement tool used for the pain outcome, and which aspect of the BPI measure was reported. These were assessed to determine whether the measurement tools used, and the aspects reported, were homogeneous enough across studies for quantitative synthesis of the literature. BPI was used in many studies, but different aspects were reported across studies, making quantitative synthesis impractical. 34 Table 8. BPI results for studies targeting pain Author/year N Pain Quality Of Life Brief Pain Inventory (BPI) Anderson 2004 Worst pain, pain interference 97 NS 80 S 46 157 NS NS NS Y Aubin, 2006 Borneman, 2008 Borneman, 2010 Dalton, 2004 Average pain, worst pain 127 NS Y NS Y Du Pen, 2000 Fuchs-Lacelle, 2008 Given, 2002 Keefe, 2005 Kovach 2006 Lovell, 2010 Marinangeli, 2004 Miaskowski, 2004 and Miaskowski 2007* 105 S 173 113 NS NS 78 NS 114 S 185 92 174 Oldenmenger 2011{#40373} Oliver, 2001 and Kalauokalani, 2007* Syrjala, 2008 BPI Measure Reported Y NS Y S NS Y S NS S NS (except for one subscal e) Y 72 S Y 67 S Y 78 S Y 35 Reporting Issues for Studies Using BPI With Positive Findings 2 week and 1 month post-intervention assessment, no confidence intervals (CIs) 2 week and 4 week post-intervention assessment Worst, least, average, pain now, pain Interference with walking, sleep, relationships, activity, composite severity score, composite interference score Aggregate score of worst pain and average pain Assessment immediately postintervention, 1month, and 6 months; no CIs Worst pain, average pain Assessment approximately one week after intervention; standard deviations, no CIs Average pain, worst pain, pain interference Unclear whether reporting 2 week or 4 week measurement in results Least pain, average pain, worst pain Total interference score, individual scores for activity, mood, walking, work, relations with others, sleep, enjoyment of life, sexual activity Current pain, average pain, worst pain in past 24 hours; pain interference Average pain No CIs Average pain, worst pain, interference with function (overall) 1 month, between 2.5 and 4 month postintervention assessment; no CIs 2 week, 1 month and 2 month assessment following intervention; No CIs 2 week postintervention assessment 1 month, 3 month, and 6 month assessment post-intervention; No CIs Table 8. BPI results for studies targeting pain (continued) Author/Year N Pain Quality Of Life Brief Pain Inventory (BPI) 120 S NS Y 43 NS NS Y 176 NS NS Y 64 NS 151 NS van der Peet, 2004 Present pain Ward, 2000 Ward, 2008 Wells, 2003 Wilkie, 2010 BPI Measure Reported Y Worst pain, pain interference composite score BPI severity composite score, pain interference composite score Worst pain, average pain, pain interference, pain relief Reporting Issues for Studies Using BPI With Positive Findings 4 week assessment post-intervention, no CIs 1 and 2 month post intervention followup, no data on BPI 1 month and 2 month assessment postintervention 1 month postintervention followup, continued monthly followup for six months; no CIs Table 9. Grading of the evidence on studies addressing pain (KQ1a and KQ2a) Number of Studies; Subjects Pain 18; 2176 3; 313 Quality of Life 7; 1259 Domains Pertaining to Strength of Evidence, by Key Outcomes Strength of Evidence That the Intervention Risk of bias: Consistency Directness for Precision; Improved Outcomes outcome Study diversity Compared With the Control Group Moderate SOE RCT/ Consistent Direct Not applicable; Moderate Medium Medium Non-RCT/ Inconsistent Direct Not applicable: Low Medium Medium Low SOE RCT/ Medium Consistent (no Direct effect) Not applicable; Medium Low Distress Key Points There was a low strength of evidence for outcome of distress, based on 7 high- and mediumquality RCTs with consistent results finding no improvement with the intervention. Study Characteristics We found seven studies that met our inclusion criteria for interventions in patients with serious and advanced illness and focused on the target of distress. The seven studies were published between 2005–2010 and had sample sizes ranging from 28-1,134 patients. All seven studies were RCTs. Of the seven studies, four were based in ambulatory settings, two were home-based and one was a combination of home and ambulatory settings. Five studies were multicenter and two were single-center trials. Six studies were in cancer populations and one study focused on patients eligible for lung transplant. All compared the intervention to usual care, except for one intervention that measured three different methods of distress screening. Because of the small number of interventions included in this section, study characteristics are 36 described for each individual study listed below. (Table 10, Appendix E, Evidence Tables 1, 10 and 11). Studies addressing distress were less diverse in design than studies addressing continuity and pain. All but one study received risk of bias assessment of low. The one study assessed as having a medium risk of bias differed from the others in that it was unclear how the study handled sequence generation and allocation concealment. (For details on how each individual study was assessed see Appendix E, Evidence Table 12). Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care? Key Question 1a. Specific Targets See Figure 1, Framework, column 3, for a listing of targets. Only two of the seven studies demonstrated a significantly significant difference between the intervention and control groups. One RCT108 evaluated 1,134 outpatients with lung (549 patients) or breast cancer randomized to one of three online methods of distress screening--a minimal screening group assessed using a distress thermometer only, a full screening intervention group using the problem checklist and a cancer-oriented psychological screen for anxiety and depression with a personalized feedback report, and a triage intervention group using and the full screen and personalized phone triage with an offer of referral to relevant resources. In the patients with advanced disease (the lung cancer group), the study108 reported no change in distress among patients in the distress thermometer-only group or full screening group. They did find that, after the intervention, the triage intervention group had a significant improvement in the primary outcome of distress and fewer patients over the distress cutoff (30.7 percent), compared to the minimal screening group at 51.3 percent (p=0.001). There were no significant improvements in depression or anxiety (Table 11, Appendix E. Evidence Table 13). Another RCT109 randomized 328 lung transplant candidates to receive telephone-based coping skills training. For 12 weeks, they received weekly supportive counseling and training in cognitive-behavioral coping skills and education on stress and health, using a standardized program and trained therapists. For the primary outcomes of depression and distress, the study found that both depression and distress reduction in the intervention group was greater than the control group (11.1 to 9.8 vs. 12.6 to 8.8, p=0.003 and 45.2 to 43.2 vs. 48.1 to 39.7, p=0.035, respectively). There were no significant differences in several measures of QOL (Table 11, Appendix E. Evidence Table 13). The five negative studies were all patient-oriented trials in cancer populations. One study110 enrolled 271 caregivers of patients dying of cancer at home, providing them six visits by advisors to assess needs and provide advice and support. Another111 provided coaching on self-care, stress reduction, and communication strategies to 106 patients. A physician received summary results for assessment and conducted a telephone followup one week later. Porter112 enrolled 233 lung cancer patients to receive caregiver-assisted coping skills training. The study randomized patient and caregiver groups to receive either 14 telephone-based, caregiver-assisted coping skills training sessions or 14 telephone-based, caregiver-assisted education/support sessions. In a small study, Steel113 randomized 28 patients to receive an individually tailored psychosocial intervention. Patients chose from a list of concerns that were most distressing (symptoms, psychological, and end of life issues) and received strategies to treat each problem. The final study114 enrolled 106 caregivers to evaluate a psycho-educational intervention for family 37 members. Nurses delivered the intervention during two home visits and a phone call. Caregivers received a guidebook and audiotape on caregiver role, self-care and care of the dying (Table 11, Appendix E. Evidence Table 13). Key Question 1b. Specific Settings No studies addressing this target applied to this Key Question. Key Question 2. What is the evidence for different quality improvement models for improving palliative care? Key Question 2a. Different Types of Quality Improvement Interventions Key Points Six of the seven studies for distress were patient education and self-management-oriented interventions. Only one of these studies found a significant improvement with the intervention. Key Question 2b. Different Models in Palliative Care: Integrative Compared With Consultative This Key Question was not analyzed for this target. Grading of the Evidence For distress, all studies were RCTs, and for both the outcomes of distress and depression, the risk of bias was medium, evidence was inconsistent, the outcome was direct, and precision was not applicable. Study diversity was high for distress and moderate for depression, and strength of evidence was low. (Table 12). Table 10. Study characteristics of studies addressing distress Author/Year 111 Aranda, 2006 Study Design RCT Sample Size 106 patients Setting Ambulatory Blumenthal, 109 2006 108 Carlson, 2010 RCT 328 patients Home-based RCT 1134 patients Ambulatory 114 RCT 106 patients Home-based RCT 233 patients Ambulatory RCT 28 patients Ambulatory RCT 271 patients Homebased/Ambulatory Hudson, 2005 Porter, 2010 Steel, 2007 112 113 Walsh, 2007 110 Abbreviation: RCT = randomized controlled trial 38 Intervention Coaching on self-care, stress reduction and communication Telephone-based coping skills Psychological screen with personalized feedback Guidebook on caregiver role and self-care Telephone-based coping skills, education and support Patient identification of distress symptoms Needs assessment, advice and support Table 11. Outcomes for studies targeting distress Outcomes Author/Year Distress Depression 111 Aranda, 2006 NS Blumenthal, S S 109 2006 Carlson, S NS 108 2010 Hudson, NS NS 114 2005 112 Porter, 2010 NS 113 Steel, 2007 NS NS 110 Walsh, 2007 NS Abbreviations: S= significant; NS = not significant Anxiety NS NS Table 12. Grading of evidence for distress (KQ1a and KQ2a) Number of Studies; Subjects Distress 7; 2206 Domains Pertaining to Strength of Evidence, by Key Outcomes Risk of bias Consistency Directness for Precision; Diversity of outcome comparisons RCT/ Medium Depression 4; 1596 RCT/Medium Consistent (no effect) Direct Not applicable; Moderate Consistent (no effect) Direct Not applicable; Moderate Strength of Evidence That the Intervention Improved Outcomes Compared With The Control Group Low SOE Low Low SOE Low Communication and Decisionmaking Study Characteristics The sample sizes of the 20 studies were in the range of 63-2,891 patients with 57 percent between 150-900 patients and a mean sample size of 526. In total, 13 out of the 20 studies were conducted in an intensive care unit (ICU) with one of these in a neonatal ICU.115 The remaining seven studies were conducted in non-ICU settings: one nursing home, two ambulatory and four hospital. Of all the identified 20 studies, 50 percent were carried out in multiple centers and 50 percent in single centers; nine of the 20 studies were RCTs comparing the results of patients receiving an intervention to those receiving usual care, and the remaining 11 studies were nonRCTs. Of the 11 non-RCTs, seven were pre-post prospective studies conducted in the same setting with different sets of patients (Table 13, Appendix E, Evidence Table 1). All but one of the populations in these studies consisted of adults with a mean age between 40 and 87. Most of the studies included patients with mixed illnesses (n=15) while others included mixed cancer patients only (n=2), advanced dementia patients only (n=1), trauma patients only (n=1) and pediatric patients with very low birth-weight (n=1) (Table 13, Appendix E, Evidence Table 1). All studies compared the intervention to usual care, except for one study of a question prompt list where both groups were seen by palliative care. The types of interventions were categorized into four groups (Table 13): 1. Family meetings with one or more of the patient’s usual health providers, usually a physician, nurse, and/or social worker. These family meetings were information sharing 39 and/or decisionmaking meetings with patients and families to improve communication, particularly around end-of-life issues. Eleven studies used this type of intervention. 2. Interdisciplinary palliative care teams. Four studies116-119 used this type of intervention, including a palliative care physician and nurse, hospital social worker and/or chaplain that met with the patient/family and usual care clinical team to address issues such as patient symptoms, diagnosis, prognosis, and goals of care. One of these interventions also focused on advance care planning.116 3. Ethics consultations. Two studies120,121 examined the impact of ethics consultations, defined as the use of specialized help in identifying, analyzing, and resolving ethical problems that arise in the care of the patient to resolve conflicts about life-sustaining interventions. 4. Physician-patient communication. Two studies were in this category. One study evaluated the use of a question prompt list for patients with advanced cancer receiving palliative care consultation to assist patients to ask questions about end-of-life issues and improve patient-physician communication around prognosis/ end-of-life care issues.122 For the other study,123 physicians in the intervention group used a CD-ROM training program on communication skills that was tailored with examples from their own clinic visits. The target of intervention for 13 studies (65 percent) was the interdisciplinary team.45,48,118121,124-130 Three studies (16 percent) addressed psychosocial and spiritual support in palliative 117,120,122 care, while two RCTs focused on ethical issues in palliative care.120 121 Fourteen studies (70 percent) targeted advanced care planning and decisionmaking on goals of care in end-of-life care45,48,115,119,124-133 (Table 13, Appendix E, Evidence Tables 14 and 15). All the studies (100 percent) on interventions for communication used patient, family and/or caregiver education as a quality improvement element. Eighty-five percent of these studies included promotion of self-management as an element of quality improvement.45,48,115,117,118,120122,124-126,128-133 Eleven studies (55 percent) used facilitated relay of clinical data to providers as a component of intervention,45,48,117-120,122,126,127,129,130 and only one used provider reminder system for quality improvement.119 Other quality improvement elements used in these studies include provider education (50 percent),48,115,119-121,123,125,127,131,132 coaching and collaborative skills training to implement quality improvement (40 percent),48,119-121,125,127,129,131 audit and feedback (25 percent),45,48,117,129,130 organizational change (10 percent),117,119 and patient and family reminders (5 percent).118None of these studies used financial incentives, regulations or policy as a quality improvement element for interventions to improve communication and decisionmaking in palliative care (Table 13, Appendix E, Evidence Tables 14 and 15). Risk-of-bias scores were low for seven studies and medium for the remainder. In general, risk of bias was medium for the RCTs (Appendix E, Evidence Table 16). Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care? Key Question 1a. Specific Targets See Figure 1, Framework, column 3, for a listing of targets. 40 Key Points There was a moderate strength of evidence for the indirect outcome of health care utilization, based on 6 medium-quality RCTs and 9 RCTs with consistent results (11 of 15 studies showed improvement with the intervention). Patient and Family Satisfaction Eight studies evaluated patient satisfaction.45,115,117,118,122,123,129,131 Five of these eight studies were RCTs and three were non-RCTs. Only one RCT (14 percent) showed a statistically significant improvement on patient satisfaction;117 it used interdisciplinary palliative care service as an intervention to address patient and family needs for information and decisionmaking on goals of care. The studies with no significant improvement on patient satisfaction mainly used standardized family meetings with a physician, nurse, or social worker (not a palliative care team) as an intervention to improve communication and decisionmaking. (Table 14, Appendix E, Evidence Table 17). Three studies assessed family satisfaction; two RCTs131,133 including one131 with a large sample size (n= 1,133) showed no significant improvement in family satisfaction, and a nonRCT with a small sample size (n= 88) showed significant improvement with the intervention in family satisfaction129 (Table 14, Appendix E, Evidence Table 17). Health Care Utilization We categorized studies that evaluated ICU length of stay, hospital length of stay, and/or use of advance directives, as evaluations of health care utilization. Six RCTs of medium quality evaluated health care utilization in terminally ill patients.117,118,120,121,131,132 Four of these six studies (66.7 percent) showed a statistically significant improvement with the intervention compared to the control group (e.g., reduced ICU length of stay).117,120,121,131 Nine non-RCTs evaluated health care utilization. Seven of these nine non-RCTs (77.7 percent) showed a statistically significant improvement with the intervention.45,119,124-128 The sample size, intervention type, targets of the intervention, or setting, did not explain the difference in the four studies that showed non-significant results (Table 14, Appendix E, Evidence Table 17). Quality of Life Two good-quality RCTs assessed the QOL of patients.117,118 They both showed no significant improvement on QOL of patients in the intervention and usual care groups. These two studies independently used the same type of intervention (palliative care consultation) among different sample populations in similar settings to improve provider-patient and family communication and decisionmaking in palliative care (Table 14, Appendix E, Evidence Table 17). Symptom Control Four studies evaluated symptom control of patients: three of these four were good-quality RCTs,117,118,132 and the last was a medium-quality non-RCT.129 Only one of these four studies (25 percent), an RCT,132 showed a statistically significant improvement in symptom control. It also had the smallest sample size (n= 63) of all the studies (Table 14, Appendix E, Evidence Table 17). Key Question 1b. Specific Settings We found no studies in hospice, but did find one study in the nursing home setting for this target. In a 2000 study, Molloy et al131 conducted an RCT educating providers, patients, and 41 families about advance directives, measuring end-of-life outcomes. Although there was no significant impact of the intervention on satisfaction, there was an impact on the rate of hospitalizations and hospital length of stay (2.61 vs. 5.86 days, p=0.01) (Table 14, Appendix E, Evidence Table 17, Appendix F). Key Question 2. What is the evidence for different quality improvement models for improving palliative care? Key Question 2a. Different Types of Quality Improvement Interventions This Key Question was not analyzed for this target. Key Question 2b. Different Models in Palliative Care: Integrative Compared With Consultative Key Points Four of the eight (50 percent) integrative studies had a significant improvement with the intervention, compared to six of the eight (75 percent) consultative studies. Eight interventions were integrative and four of the eight (50 percent) had a significant improvement in at least one key outcome in the intervention compared to the control group. In contrast, eight interventions were consultative in nature and six of the eight (75 percent) had a significant improvement with the intervention in at least one key outcome. The interventions from four studies were combined (included both integrative and consultative models). Interventions were highly diverse and the number of studies in each classification group was small (Table 14, Appendix E, Evidence Table 17). Grading of the Evidence All outcomes were direct except health care utilization, and precision was not applicable because of heterogenous outcomes and outcome reporting. For patient satisfaction, both RCTs and non-RCTs had medium risk of bias; evidence was consistent (no effect), and strength of evidence was low. For family satisfaction, evidence was inconsistent, and strength of evidence was low. For health care utilization, risk of bias was medium for both RCTs and non-RCTs, evidence was consistent for impact of improvement in outcomes with the intervention, and strength of evidence was moderate: overall 11 out of the 15 studies (73 percent) showed an improvement with the intervention for this outcome. For QOL, risk of bias was low for two nonRCTs, evidence was consistent (no improvement with the intervention in either study), and strength of evidence was low. For symptom control, risk of bias was low for three RCTs and medium for non-RCTs; evidence was consistent for the RCTs (no improvement with the intervention) and strength of evidence was low. Strength of evidence was the same across RCTs and non-RCTs (Table 15). 42 Table 13. Characteristics of studies addressing communication and decisionmaking Author, Year Study Design Sample Setting Size Centers Mean Age Disease Population 151 81 174 ICU ICU Ambulatory Adult Adult 65 Non-RCT 873 ICU 61 Mixed illnesses Yes Mixed illnesses Mixed Cancer Mixed illnesses Yes RCT 517 Hospital 73.6 Mixed illnesses Yes RCT 261 Hospital 68.4 Mixed illnesses Yes Non-RCT Non-RCT RCT 899 88 63 Hospital ICU ICU 530 2891 ICU ICU 62.9 Adult 6874 58-60 59 Mixed illnesses Mixed illnesses Yes Mixed illnesses Yes Non-RCT Non-RCT single Single Multicenter Multicenter Multicenter Multicenter Single Single Multicenter Single Single RCT 1133 367 480 Non-RCT Non-RCT 191 154 ICU NICU RCT 32 Hospital Multicenter Single Multicenter Single Multicenter single 83.1 Non-RCT Non-RCT Nursing Homes ICU ICU RCT 70 ICU Single RCT 546 ICU 45.952.4 67.5 127 Ahrens, 2003 Non-RCT 119 Campbell, 2003 Non-RCT 122 Clayton, 2007 RCT Cowan, 2003 Gade, 2008 45 117 Hanks, 2002 118 125 Jacobsen, 2011 129 Kaufer, 2008 132 Laurette, 2007 126 Lilly, 2000 124 Lilly, 2003 Molloy, 2000 131 128 Mosenthal, 2008 48 Muir, 2010 130 Norton, 2007 134 Penticuff, 2005 Sampson, 2011 Schneiderman, 121 2000 Schneiderman, 120 2003 123 Tulsky, 2011 133 Family Meeting PhysicianPalliative Care Patient Team Communication Ethics Consultation Yes Yes Mixed illnesses Yes Mixed Yes illnesses Mixed illnesses 40 5356 66.1 VLBW Trauma Yes Mixed illnesses Yes Mixed illnesses Pediatric Yes Yes 87 Advanced Dementia Mixed illnesses Yes MultiMixed illnesses center RCT 264 Ambulatory Multi61 Mixed Cancer center Abbreviations: VLBW = very low birth weights; ICU = intensive care unit; NICU = neonatal intensive care unit 43 Yes Yes Yes Table 14. Outcomes of studies addressing communication and decisionmaking Author, Year 127 Ahrens, 2003 119 Campbell, 2003 122 Clayton, 2007 45 Cowan, 2003 117 Gade, 2008 Hanks, 2002 118 125 Jacobsen, 2011 129 Kaufer, 2008 132 Laurette, 2007 126 Lilly, 2000 124 Lilly, 2003 131 Molloy, 2000 128 Mosenthal, 2008 48 Muir, 2010 130 Norton, 2007 134 Penticuff, 2005 133 Sampson, 2011 Schneiderman, 121 2000 Schneiderman, 120 2003 123 Tulsky, 2011 Study Design Non-RCT Non-RCT RCT Non-RCT RCT Sample Size 151 81 174 873 517 Risk of Bias Low Medium Low Medium Low Patient Satisfaction Not Significant Not Significant Significant Significant Significant RCT 261 Low Not Significant Not Significant Non-RCT Non-RCT 899 88 Medium Medium Not Significant RCT Non-RCT Non-RCT RCT Non-RCT Non-RCT Non-RCT Non-RCT RCT RCT 63 530 2891 1133 367 480 191 154 32 70 Low Medium Medium Medium Medium Medium Medium Medium Medium Medium RCT 546 Low RCT 264 Low Number of studies addressing outcome Number with statistically significant impact Family Satisfaction Health Care Utilization Significant Significant Quality of Life Symptoms Not Significant Not Significant Not Significant Not Significant Significant Not Significant Significant Not Significant Not Significant Significant Not Significant Significant Significant Significant Significant Not Significant Not Significant Consultative Integrative Consultative Significant Combined Integrative Integrative Integrative Combined Integrative Consultative Integrative Combined Consultative Significant Consultative Not Significant Not Significant Not significant Patient Satisfaction 8 1 Integrative v. Consultative Combined Consultative Integrative Consultative Consultative Integrative Family Satisfaction 3 1 44 Health care utilization 15 11 Quality of Life 2 0 Symptoms 4 1 Table 15. Evidence grading for studies addressing communication and decisionmaking (KQ1a and KQ2b) Number of Studies; Subjects Domains Pertaining to Strength of Evidence, by Key Outcomes Risk of bias: Consistency Directness Precision for outcome Patient Satisfaction 5; 2349 RCT/ medium 3;1115 Non-RCT/ medium Family satisfaction 2; 1165 RCT/ medium 1;88 Health care utilization* 6; 2590 9; 6463 QOL 2;778 Non-RCT/ medium Consistent (no effect) Direct Not applicable Strength of Evidence That the Intervention Improved Outcomes Compared With the Control Group Low SOE Low Consistent (no effect) Direct Not applicable Low Inconsistent Direct Not applicable Low Not applicable Direct Not applicable Insufficient Low SOE Moderate SOE RCT/ medium Consistent Indirect Not applicable Moderate Non-RCT/ medium Consistent Indirect Not applicable Moderate RCT/ low Consistent (no effect) Direct Not applicable Low Direct Not applicable Not applicable Low SOE 0 Non-RCT/ not applicable Not applicable Symptom control 3; 841 RCT/ low Consistent (no effect) Direct Not applicable Low 1; 88 Non-RCT/ medium Not applicable Not applicable Insufficient Low SOE Direct * Intensive care unit or hospital length of stay, advance directive completion 45 Interventions With Multiple or Other Targets Key Points Low strength of evidence was found across outcomes, including improvement of quality of life and symptom relief, for interventions with multiple or other targets. Study Characteristics This section includes studies that met the inclusion criteria but mainly focused on multiple targets or, in a few cases, addressed a target outside the four key targets (e.g., timeliness of treatment). Given the diversity of studies, this section is organized differently than previous sections—by type of quality improvement intervention. These studies mostly fit a narrower definition of quality improvement and address the evidence specifically for these quality improvement types. The sample sizes of the 19 studies described in 21 articles were in the range of 53–822 patients (and one study addressing 644 clinical sites).135 Ten studies were in the ambulatory setting, two in an ICU, two in the home setting, two in a nursing home, one in hospice, one in multiple sites, and one in another setting (palliative day-care center). Eleven were RCTs (Table 16, Appendix E, Evidence Tables 1, 18 and 19). Because this group of studies was so diverse, characteristics of each study are described separately rather than summarized for the entire section. Risk of bias was low for four studies, medium for 14 studies, and high for one. In general, RCTs had low or medium risk of bias. Most studies did not report blinding, and some RCTs did not report details of randomization or allocation (Appendix E, Evidence Table 20). Key Question 1. What is the effectiveness of health care and palliative care interventions for improving the quality of palliative care? Key Question 1a. Specific Targets See Figure 1, Framework, column 3, for a listing of targets. This Key Question was not analyzed for these studies which focused on multiple or other targets. Key Question 1b. Specific Settings We found one study (described in two publications) in the hospice setting and two studies in nursing homes. For hospice, one RCT136,137 randomized caregivers to the Creativity, Optimism, Planning, Expert (COPE) information intervention, compared to standard hospice care. The study found significant improvements with the intervention on caregiver QOL (estimate 0.096, p=0.04) and task burden (estimate 0.01, p=0.04), as well as patient distress (estimate 0.101, p=0.009) (Table 17, Appendix E, Evidence Table 21). For nursing homes, one study addressed provider education and one included multiple quality improvement types. Keay138 conducted a half-day physician education multicenter RCT that provided quality improvement improvement suggestions to the medical directors. The study found statistically significant improvements in symptom control during dying for quality indicators related to terminal care in nursing homes (19 to 45 percent, p<0.001). Hanson et al139 46 conducted a non-RCT including multiple quality improvement types in nine nursing homes. Post-intervention, there was a significant increase in hospice enrollment from 4 to 6.8 percent (p=0.01), and in the use of pain assessments (18 to 60 percent, p<0.001) and advance care planning discussions (4 to 17 percent, p<0.001). Use of pain interventions did not change (Table 17, Appendix E, Evidence Table 21, Appendix F). Key Question 2. What is the evidence for different quality improvement models for improving palliative care? Key Question 2a. Different Types of Quality Improvement Interventions Physician/Other Provider Reminder Systems We did not find any additional studies focusing on this quality improvement type other than those summarized in the target sections above (Table 17, Appendix E, Evidence Table 21). Facilitated Relay of Clinical Data to Providers We found six publications on five studies meeting our inclusion criteria focusing on relay of clinical information for quality improvement. The studies were published between 2000-2011 and had patient sample sizes ranging from 53-286. All five studies were RCTs conducted in ambulatory settings; four were single-centers treating in-patients with metastatic cancer, and one was multicenter, treating lung cancer patients (Table 17, Appendix E, Evidence Table 21). Only one of the five studies demonstrated a significant improvement with the intervention on QOL or satisfaction. Velikova, 2004140 conducted a three-arm RCT, randomizing patients to complete a touch-screen health-related QOL survey that provided feedback to physicians, to complete the QOL survey without feedback to physicians, or to not complete a survey. After three visits post-randomization, a higher number of symptoms were mentioned during the clinical encounter in the intervention group (where patients completed the survey that provided feedback to the physician) than in the other two control groups (Estimate Effect: 4.51; p=0.03). The intervention improved QOL when compared to the control group (Estimate Effect: 8.01, p=0.006). In an study reporting analysis of secondary outcomes of evaluations of care141, patients in the intervention group reported significantly higher ratings for communication (p=0.03) but not for two other subscales or for satisfaction with care (Table 17, Appendix E, Evidence Table 21). Mills, 2009142 studied the use of a structured patient-held QOL diary at home weekly for 16 weeks; patients were encouraged to share it with their health care providers. There were no significant differences between the groups for the primary QOL measure or for satisfaction. However, there were some significantly worse secondary QOL outcomes in the intervention group compared to the control group. Most patients did not give feedback to their providers (Table 17, Appendix E, Evidence Table 21). Detmar143 used a QOL questionnaire among patients undergoing palliative chemotherapy at three consecutive visits to determine the effect on patient-physician communication. Ten physicians were enrolled in a randomized, crossover study to receive a graphic summary of responses to the questionnaire prior to consultation. After three visits, patients in the intervention group reported significantly greater communication on QOL issues with their physicians than 47 those in the control (Mean: 4.7 vs. 3.7; p=0.01), but there was no significant differences in secondary outcomes of QOL or patient satisfaction (Table 17, Appendix E, Evidence Table 21). Two studies144,145 found no differences in any reported outcomes between their intervention and control groups. Rosenbloom, 2007144 evaluated the improvement with QOL screening with physician interpretive assistance on QOL outcomes and satisfaction among patients with metastatic cancer. This three-arm study randomized 213 patients to complete a QOL survey with followup interview and discussion, complete a QOL survey without followup or receive usual care. After followup at three and six months, the study saw no significant improvement in QOL and satisfaction among the groups Taenzer, 2000,145 evaluated the effect of a computerized screening on physician behavior and patient satisfaction. The study randomized 53 patients with lung cancer undergoing treatment to complete a computerized QOL survey prior to consultation that clinical staff reviewed. The study saw no significant differences in patient satisfaction or physician charting between the two groups (Table 17, Appendix E, Evidence Table 21). Audit and Feedback We identified two studies focusing on audit and feedback. Campion et al.135 reported the evaluation of end-of-life outcome measures in the American Society for Clinical Oncology (ASCO) Quality Oncology Practice Initiative (QOPI) in 644 clinical sites. This voluntary initiative includes a twice-yearly data reporting and analysis cycle and offers participating practices extensive, site-specific, and benchmarking reports that describe the continuum of care. Sites reporting in multiple periods vs. sites reporting only in Fall 2010 had statistically significantly better performance on multiple quality measures, including all four measures for pain management, two of three dyspnea measures, and four of seven measures on hospice and palliative care discussions and referrals; there was no difference in chemotherapy use at the end of life. Jacobs et al.146 conducted a non-RCT where physicians received three biannual palliative care reports on patients where death was likely, including patient/family satisfaction and reported symptom relief and timeliness of advance directive discussions. The study found no difference in quality of care on 10 items evaluated through chart reviews. Physicians may not have reviewed their reports, and feedback may have been too delayed (between 3 and 9 months after care) (Table 17, Appendix E, Evidence Table 21). Provider Education We identified one non-RCT addressing only this quality improvement type that met the inclusion criteria. Keay138 conducted a half-day education seminar for five nursing homes and provided quality improvement suggestions targeting medical directors and physicians with the majority of patients. A before-after evaluation found statically significant improvements in symptom control during dying for quality indicators for terminal care for nursing homes (19 to 45 percent, p<0.001). Patient/Caregiver Education and Self-Management We identified six publications on five studies that met inclusion criteria and focused on this quality improvement type but addressed multiple targets and symptoms. Four of the studies136,147,148 focused on reducing symptom severity, one study149 focused on maintaining QOL for patients with advanced cancer. These studies were published between 2005 and 2007 and had sample sizes ranging between 115 and 437. The patient populations in these studies had a cancer diagnosis. All studies were randomized, controlled trials. Two of the studies147,149 were 48 in ambulatory settings, one148 in the home setting, one136 in hospice, and one in multiple settings. Two150 were a multicenter studies while the others were single-center. All studies had a consultative approach (Table 17, Appendix E, Evidence Table 21). One study147 randomized 124 patients with stage III or stage IV cancer receiving chemotherapy to either standard of care or standard of care plus a cognitive behavioral intervention targeted to decrease severity of symptoms. Experienced oncology nurses delivered five contacts over an 8-week time period aimed at teaching problem-solving techniques to reduce symptom severity. The nurses contacted the patients in person for the first and last sessions, and held the second, third and fourth sessions via telephone. They held the sessions at two-week intervals. The study assessed symptom severity and depressive effect at baseline, 10 weeks, and 20 weeks. The study used The Center for Epidemiologic Studies-Depression Scale to measure depressive symptoms. Patients rated the severity of their symptoms using a 0-10 scale, with 0 representing symptom not present, and 10 representing as severe as it could possibly be. Patients in the intervention group had a mean symptom severity score of 19.1 at 10 weeks (SD=13.1) versus 27.7 (SD=18.9) for the control group. At 20 weeks patients in the intervention group had a mean symptom severity score of 22.1 (SD=15.2) versus 28.2 (SD=19.6) in the control group. Participating in the intervention proved a predictor of lower symptom severity at 20 weeks (p=0.02). The top two reasons for attrition were death (43 percent, N=17) and advancing disease (33 percent, n=13) (Table 17, Appendix E, Evidence Table 21). The second study148 randomized 437 patients with cancer undergoing chemotherapy to either nurse-assisted symptom management (NASM) or automated telephone symptom management (ATSM). The study compared the impact of a six-contact, 8-week ATSM intervention delivered through an automated system with a NASM intervention (which had previously been found to improve outcomes compared to standard care) delivered by experienced cancer nurses. The study looked at reducing the severity of 17 common symptoms experienced by patients receiving chemotherapy. The study148 assessed severity of 17 symptoms scored by patients using a 0-10 scale (where 0 was no symptom and 10 was the worst severity possible at baseline), at each of the six intervention contacts and at 10 weeks. The study set a threshold at below four or four and higher. It used a Rasch analysis for the data collected at each of the six intervention contacts. The study found no significant differences between the NASM and the ATSM groups post intervention. This study noted a difference in symptom severity between lung and non-lung cancer patients and suggests this as an area for further study (Table 17, Appendix E, Evidence Table 21). The third study136,137 randomized caregivers of hospice patients to the Creativity, Optimism, Planning, Expert (COPE) information intervention with three home visits and two interim calls to assist with symptom management, compared to standard hospice care. For the primary outcomes, which were caregiver outcomes,137 the study found an impact on caregiver QOL (estimate 0.096, p=0.04) and task burden (estimate 0.01, p=0.04), as well as the burden of patient symptoms. For patient symptoms,136 the study found no impact on dyspnea or pain, but did find an impact on distress (estimate 0.101, p=0.009) (Table 17, Appendix E, Evidence Table 21). The fourth study also used the COPE intervention for patient-caregiver dyads for advanced cancer patients participating in clinical trials, over three educational sessions. The study found statistically significant improvements in caregiver (p=0.02), but not patient, quality of life, but neither patients nor caregivers showed any change in problem-solving skills.151 The fifth study149 randomized 115 advanced cancer patients to either eight structured multidisciplinary sessions or to standard of care. The eight structured sessions lasted for 90 49 minutes each and addressed the domains of QOL, including cognitive, physical, emotional, spiritual and social functioning. The participants in the intervention group received a manual reviewing material covered in the eight sessions. The study used the Spitzer QOL Uniscale for the primary outcome measure, overall QOL, and the Linear Analog Scale of Assessment of QOL for 12 secondary outcome measures. QOL was assessed at baseline, week four, week eight and week 27. The end of week four marked the end of the intervention in the study. While the results showed a significant difference between intervention and control groups for the primary outcome measure, overall QOL, at the week-four comparison (P=0.047), the results did not show any significant difference between the groups at weeks eight and 27. There was no significant difference found between the control group and intervention group in regards to secondary outcome measures except for spiritual wellbeing (p=0.003) at week four. Additional secondary outcome measures were assessed using the Symptom Distress Scale, Profile of Mood StatesShort Form, and the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being, but none were significant in this study. Of note, this study cost $2,000 for each participant, and recruitment was low: although the participants were all enrolled in radiation therapy and coming to the center daily for treatment, of 418 potential study participants asked to join the study, only 115 enrolled (Table 17, Appendix E, Evidence Table 21). In summary, four of the five studies of interventions focusing on patient and caregiver education for multiple patient symptoms or QOL had statistically significant findings for at least one key outcome, although one was significant only at one of three time points (Table 17, Appendix E, Evidence Table 21). Organizational Change We identified one study focusing on organizational change. Holt152 conducted a before-after study of a rapid-response clinic for patients referred for palliative radiotherapy to reduce wait times and have patients seen same-day if possible. They found a statistically significant increase in single-fraction treatment (which is guideline-recommended care) (65 vs. 42 percent, p-0.002), and a statistically significant reduction in time-to-treatment (<24 hours) (74 vs. 27 percent, p<0.001) but found no improvement in waiting times for consultation (Table 17, Appendix E, Evidence Table 21). Financial Incentives, Regulation, and Policy We did not identify any additional studies for this quality improvement type outside of continuity of care (Table 17, Appendix E, Evidence Table 21). Multiple Quality Improvement Types We identified three studies that focused on multiple quality improvement types and multiple targets; two studies evaluated the same intervention, one in a non-RCT and the second in a multicenter RCT. Curtis et al.153,154 conducted the Integrating Palliative Care in the ICU study. The study included the quality improvement types clinician education, local champions, academic detailing, feedback to clinicians, and system support, in an integrative intervention with no consultative component. The non-RCT of the intervention found no significant impact on family-completed Quality of Dying and Death or satisfaction153 However, the median length of stay in the ICU was significantly lower in the intervention group compared to the control group (3.85 vs. 3.06, p=0.01). In the multicenter RCT in 12 hospitals, there were no significant differences in any of these outcomes (Table 17, Appendix E, Evidence Table 21).154 50 Hanson et al.139 conducted a quality improvement non-RCT over a six month period that included multiple quality improvement types in nine nursing homes. The intervention used a plan-do-study-act structure with feedback of performance data at three time points. The quality improvement types studied included recruitment and training of palliative care leadership in each facility, in-depth education and technical assistance meetings for team members, as well as educational sessions for nursing staff. Post-intervention, there was a significant increase in hospice enrollment from 4 to 6.8 percent (p=0.01), and in the use of pain assessments (18 to 60 percent, p<0.001) and advance care planning discussions (4 to 17 percent, p<0.001); use of pain interventions did not change. The nursing homes were relatively diverse, and all volunteered to participate in this study (Table 17, Appendix E, Evidence Table 21). Other In this category, we identified two studies evaluating new clinical services in palliative care and addressing multiple targets. Goodwin et al.155 found no significant impact on QOL in 173 United Kingdom patients at a palliative daycare center who received a variety of social, recreational, and therapeutic activities for five hours, one day a week, compared to usual palliative care. The needed sample size was not reached in this study and the outcome measures may not have effectively matched the goals of the intervention. Grande et al.156 conducted a single-center RCT published in 2000 of hospital at home for palliative care; the intervention had an impact on only one of seven symptoms and no impact on psychosocial symptoms and support or the percentage who spent time at home in the last two weeks of life (Table 17, Appendix E, Evidence Table 21). Key Question 2b. Different Models in Palliative Care: Integrative Compared With Consultative This Key Question was not analyzed for this target. Grading of the Evidence Study diversity was high amongst these studies, and due to diversity of outcomes, precision was not applicable. All outcomes were direct, except quality of care (since this is not a directly patient-centered outcome), all had medium risk of bias for both RCTs and non-RCTs, and all had inconsistent data where applicable. For the outcome of QOL, there were six RCTs and two nonRCTs. For satisfaction, there were five RCTs and one non-RCT. For quality of care, there was one RCT and two non-RCTs. For patient symptoms, there were five RCTs and one non-RCT. For psychosocial support, there were two non-RCTs (Table 18). Strength of evidence was low overall, and the same for RCTs and non-RCTs 51 Table 16. Characteristics of studies addressing multiple or other targets Targets Author/Year Study Design RCT Sample Size 214 Setting Intervention Facilitated relay of clinical data Detmar, 2002 Ambulatory Mills, 2009 Rosenbloom, 144 2007 145 Taenzer, 2000 RCT RCT 115 213 Ambulatory Ambulatory RCT 53 Ambulatory 140 RCT 286 Ambulatory Non-RCT 644 sites Ambulatory Non-RCT 194 Hospital Non-RCT 176 Nursing home RCT 124 Ambulatory RCT 435 Home RCT 709 Hospice RCT 476 Ambulatory/home RCT 115 Ambulatory Non-RCT 292 Ambulatory 153 Non-RCT 590 ICU 154 RCT Non-RCT 822 458 ICU Nursing home Non-RCT RCT 173 229 Other Home Preconsultation QOL survey Patient-held QOL diary QOL survey with interpretive assistance Preconsultation QOL survey Preconsultation QOL survey Performance measurement program Evaluative feedback to individual physicians Half-day physician education with audit and feedback Cognitive-behavioral intervention for symptoms Nurse-assisted symptom management Training family caregivers to assist with symptom management Problem-solving with patient-caregiver dyads Structured multidisciplinary QOL intervention Clinic providing more accessible, efficient palliative radiotherapy Education, local champions, feedback, system support Same as above Plan-do-study-act with education, training, feedback, leadership Palliative day care Hospital at home for palliative care 143 142 Audit and feedback Velikova, 2004 , 141 Velikova, 2010 135 Campion, 2011 Jacobs, 2002 146 138 Provider education Keay, 2003 Patient/caregiver education and selfmanagement Sherwood, 2005 Sikorskii, 2007 148 McMillan, 2007 137 2006 Meyers, 2011 147 136 151 Rummans, 149 2006 152 Organizational change Holt, 2010 Multiple quality improvement types Curtis, 2008 Curtis, 2011 139 Hanson, 2005 Other (new clinical services) 155 Goodwin, 2003 156 Grande, 2000 52 Table 17. Outcomes of studies addressing multiple and other targets* Target Author, Year Facilitated Detmar, 143 relay of 2002 clinical data Mills, 142 2009 Rosenbloom, 144 2007 Taenzer, 145 2000 Velikova, 140 2004 , Velikova, 141 2010 Audit and Campion, 135 feedback 2011 Jacobs, 146 2002 Provider Keay, 138 education 2003 Patient/ Sherwood, 147 caregiver 2005 education Sikorskii, 148 and self2007 manageMcMillan, 136 ment 2007 137 2006 Meyers, 151 2011 Rummans, 149 2006 152 OrganizaHolt, 2010 tional change Study Design Sample Size QOL Satisfaction RCT 214 NS NS RCT 115 NS NS RCT 213 NS NS RCT 53 RCT 286 NonRCT NonRCT NonRCT RCT 644 sites 124 S RCT 435 NS RCT 709 NS pain, S distress RCT 476 NS RCT 115 S NonRCT 292 NS S Qualityof Patient Care symptoms Caregiver QOL Caregiver psychosocial support S S NS NS S (10/15 measures) NS (9/10 items) S 194 176 S NS S 53 Hospice Use Health PsychoCare Use social Support Symptoms Table 17. Outcomes of studies addressing multiple and other targets* (continued) Target Author, Year Study Design Sample Size QOL Multiple quality improvem ent types Other (new clinical services) Non-RCT RCT Non-RCT 590 822 458 NS NS NS NS Non-RCT 173 NS (9/10 items) RCT 229 Satisfaction Quality of Care Patient symptoms Caregiver QOL Caregiver psychosocial support Hospice Use Healthcare use Psycho -social Support S NS S Symptoms Non-RCT RCT Non-RCT S Non-RCT NS * empty cells = not reported Abbreviations: RCT = randomized controlled trial; NS = not significant; S = significant; QOL = quality of life 54 NS NS (6/7 items) RCT Table 18. Grading of studies in multiple or other targets (KQ2a) Number of Studies; Subjects Quality of Life 7; 1300 2; 763 Domains Pertaining to Strength of Evidence Risk of bias: Consistency Directness for outcome Precision; Diversity of comparisons Strength of Evidence That the Intervention Improved Outcomes Compared With the Control Group Low SOE RCT/medium Inconsistent Direct Not applicable; High Low Non-RCT/ medium Inconsistent Direct Not applicable; High Low Not applicable; High Not applicable Low SOE Low Low Satisfaction 5; 881 RCT/ medium Inconsistent Direct 1; 590 NonNot applicable Direct RCT/medium Quality of Care 1; 53 RCT/ medium Not applicable Indirect 3; >486* Non-RCT/ Inconsistent Indirect medium Patient Symptoms 5; 1612 RCT/ medium Inconsistent Direct 1; 176 Non-RCT/ Not applicable Direct medium Psychosoci al Support 2; 938 NonInconsistent Direct RCT/medium *One study did not report # of patients—conducted in 644 sites 55 Low SOE Not applicable Not applicable; High Low Low Low SOE Not applicable; High Not applicable Low Low Low SOE Not applicable; High Low Discussion Summary of Key Findings and Strength of Evidence In summary, we found a significant number and wide variety of studies of interventions to improve health care and palliative care for patients with advanced and serious illness. Studies were highly heterogenous across most targets for study interventions, quality, and outcomes, with many studies evaluating multiple outcomes. Many studies addressed a variety of different types of quality improvement types, particularly for the target of continuity, coordination and transitions. For this target, strength of evidence was moderate for the outcomes of patient and caregiver satisfaction, where four of six studies (67 percent) for patients and four of six studies (67 percent) for caregivers of found a statistically significant improvement with the intervention, and low for other outcomes: three of nine studies (33 percent) found a statistically significant improvement for the outcome of quality of life and none found improvement for the outcome of overall symptoms. Only five of 16 studies (31 percent) of those that evaluated health care utilization as an outcome found a statistically significant effect in favor of the intervention. Studies that included patient-centered quality improvement types, such as education and selfmanagement, had the strongest evidence of effectiveness on patient- and family-centered outcomes such as satisfaction and quality of life, compared to types such as organizational change. On the other hand, studies focusing on provider-focused interventions (e.g., education, reminders) were more likely to have an impact on the outcome of health care utilization than studies focusing on other quality improvement types, although these studies were mainly nonrandomized clinical trials (RCTs). Strength of evidence was moderate for the target and outcome of pain, where almost all of the 21 studies that we included focused on patient education and self-management: 10 studies (47 percent) found a statistically significant improvement of the intervention on pain outcomes compared to the control group. Patient/caregiver education and self-management encompassed most of the pain and distress studies: strength of evidence was moderate for pain, with approximately half of studies showing a significant improvement with the intervention Strength of evidence was low for distress, where only two of seven included studies (29 percent) found a statistically significant improvement with the intervention on the outcome of distress or depression – a detailed psychosocial screen in the cancer care setting with triage to appropriate services, and a support program for lung transplant candidates; no patient education/self-management programs in cancer patients found an impact. For communication and decisionmaking, strength of evidence was moderate only for the outcome of health care utilization, where 11 of 15 studies (73 percent) that reported this outcome found a statistically significant impact in favor of the intervention, compared to only 22 percent of studies addressing patient or family satisfaction. Comparing the integrative and consultative models for quality improvement in this target, three-quarters of studies evaluating consultative interventions found a statistically significant improvement with the intervention on at least one key outcome, compared to half of the integrative interventions; no studies directly compared the two models. In studies addressing other or multiple targets, patient/caregiver education/self-management and facilitated relay of clinical data to providers were the most common quality improvement types. Of four studies focusing on a broad variety of symptoms using patient education/selfmanagement, three had statistically significant findings in favor of the intervention for symptom outcomes. Of studies addressing multiple targets and focusing on the quality improvement type 56 of facilitated relay of clinical data to providers, only one of five demonstrated a statistically significant improvement on either quality of life or satisfaction outcomes. We found only two studies in hospices that met our inclusion criteria, both of which found a statistically significant improvement on at least one key outcome, and nine in nursing homes, seven of which demonstrated a significant improvement of the intervention on at least one outcome (with too few studies and diverse outcomes to make substantive conclusions about strength of evidence). In this literature, we found that studies addressed a wide variety of illnesses, with many in mixed-cancer or mixed-illness populations. A number of studies also addressed specific cancer types, advanced pulmonary disease, and congestive heart failure, and one study focused on communication in extremely-low birthweight infants. We found a wide distribution of studies focusing on combinations of many different types of quality improvement interventions, as well as a variety of studies focusing on just one type of quality improvement intervention. Certain interventions, (e.g., self-management) received more attention than others (e.g., financial and regulatory). We also found a number of studies with multi-faceted interventions that used many quality improvement categories simultaneously. The taxonomy of quality improvement types generally fit well, although application of the taxonomy to the field of palliative care did require some adjustments in definitions and types of interventions that were included in each category. For example, we found several studies addressing ordersets (usually for comfort care at the end of life), which we categorized as part of provider reminder interventions. We did add one additional category to the quality improvement type taxonomy, provider training in quality improvement methods, although few studies included this element. Across the different targets, the types of quality improvement differed as well, partly because of our inclusion criteria but also because of issues specific to the targets. Both pain and distress studies tended to be focused on patients or caregivers; few system-level distress studies exist, and system-level pain studies are also relatively rare and were not generally limited to patients with advanced disease.25 Continuity interventions included a wide variety of quality improvement types. In addition, the added dimension of different quality improvement models, separate from the taxonomy of quality improvement types, was important for analyzing quality improvement in this field. Consultation (addition of new services) was important for this area (palliative care consultation is an important element of quality improvement). We used the added dimension of integrative compared to consultative care to capture whether patients’ usual providers or added providers were giving care. For the target of communication and decisionmaking, the dichotomy of integrative compared to consultative interventions fit better for study classification than the types of quality improvement. In terms of the Institute of Medicine domains of quality intervention--efficacy, equity, safety, timeliness, patient-centeredness, and efficiency--studies generally focused on efficacy, patientcenteredness, and effectiveness. For efficacy, symptom outcomes were common, including pain and distress, as well as quality of life and outcomes addressing the causal pathway of interventions, such as pain barriers questionnaire for pain outcomes. We identified only one intervention focused on improving the efficiency and timeliness of care, in providing palliative radiotherapy. In terms of study design, results were generally consistent between RCTs and nonRCTs and between single-center and multi-center studies. In several instances, an initial nonRCT or single-center RCT was followed by a larger multicenter RCT, and results were generally consistent in the higher-quality studies. 57 Because of the diversity of the literature and outcomes, we were unable to draw conclusions about the influence of context (United States versus other), although studies of many effective interventions were conducted in the U.S. We also could not evaluate other context issues such as year of publication, or other organizational characteristics such as hospital size. A significant percentage of studies across the targets were multicenter studies. Descriptions of the contextsensitivity of interventions were minimal in the published studies. Time to followup was often short because of the severity of illness in included patient populations. Few studies evaluated followup at multiple time points, and for those who did, the results were often not consistent between time points (although sample sizes in these studies were often relatively small). Details of the impact of implementation strategies were often absent or minimally reported, although a number of studies not evaluating effectiveness did report on implementation issues, such as challenges with recruitment and retention or low provider uptake of interventions. Many interventions did report on intermediate outcomes to help explain the causal pathway of the intervention, by using pain barriers questionnaires to assess the effectiveness of pain education interventions or measuring physician-provider communication about symptoms in studies evaluating facilitated relay of clinical data to providers. Clinical Context and Applicability of Evidence for Decisionmaking For the four key targets, we found moderate strength of evidence for at least one key outcome for all but distress. For continuity, although studies were relatively diverse, evidence supports the use of interventions with patient-centered components; strength of evidence was moderate for the outcome of satisfaction. Many studies measured multiple outcomes and results were not consistent across outcomes (e.g., significant results for health care utilization but not for patient satisfaction). However, we found several well-conducted, high- and medium-quality studies that found statistically significant improvements of the intervention compared to the control group across multiple patient-centered outcomes, such as an RCT of outpatient palliative care for lung cancer64 and an RCT of facilitating hospice referrals for eligible nursing home patients.54 These studies can serve as potential models for translation elsewhere. For pain, strength of evidence was moderate and almost entirely limited to cancer and patient-centered interventions, We found moderate strength of evidence that communication and decisionmaking interventions, including structured family meetings and palliative care and ethics consultations, can impact health care utilization. However, studies were mostly limited to the intensive care unit setting, and applicability to other settings is unclear. It is important to note that interventions were classified and analyzed by target, and therefore this report will be best used by first deciding what target is the focus, and then reviewing the strength of evidence for different outcomes, and reviewing the different intervention and quality improvement types that were used. We found evidence for effectiveness of certain quality improvement strategies in palliative care, and consultative models were more likely to be effective than those of integrative ones. For pain, nurse-led patient and family caregiver-directed educational interventions demonstrated some improved outcomes; however, half of the included studies focusing on this quality improvement type showed no significant reduction in pain scores. Although only three studies out of the 19 included studies focused specifically on provider behavior (application of a pain management algorithm,91 the use of strong opioids as first-line therapy,89 and a serial trial intervention to assess patients’ unmet needs85), all found significant improvements in patient 58 pain levels. Overall, due to the diversity of interventions included in this review, it is difficult to conclude what types of interventions are the most effective at reducing patient pain levels for patients with advanced and serious illness. Based on this review, no evidence exists about the effectiveness of other types of quality improvement, such as provider reminder systems or financial incentives, on improving patient pain outcomes. For distress, one study of psychosocial screening combined with triage to appropriate services showed evidence of effectiveness. For facilitated relay of clinical data, mainly use of quality of life questionnaires in outpatient oncology, evidence for effectiveness was weak. For other quality improvement types, and for the hospice setting, the number of studies was too small to draw conclusions. For the comparison between integrative, consultative, and combined models of palliative care, there were few combined studies. However, high- and medium-quality studies with strong evidence of effectiveness were found for both integrative and consultative models of care. Few studies were found in the hospice and nursing home setting. Most studies focused on cancer patients, and only one study addressed pediatrics (in the neonatal intensive care unit), which limits applicability of this evidence to other populations. Limitations of the Review Process Although our focus on studies only meeting a definition of quality improvement, and our including or separately reporting results for patients with advanced or life-threatening illness, improves the applicability of the results, many types of studies were not included in this review, particularly those that did not focus on patients with very advanced or serious disease (only 96 studies were included in this review from a much larger literature). The definition that we developed, studies with a majority of patients with advanced or serious illness, was sometimes challenging to apply to studies because illness characteristics were not reported in detail, and also may have excluded some studies including some relevant populations. For example, we found that many studies, such as an evaluation of telecare management for pain and depression, included a majority of patients who were cancer survivors or had early-stage disease157 or did not report the percentage of the population with advanced disease. In addition, although 25 percent of patients end their life in a nursing home, general nursing home populations would not have met the definition for “a majority of patients with advanced or serious illness” and studies in these populations were excluded. This was also an issue for distress, where many interventions addressed general cancer populations or early-stage rather than advanced-stage disease. Few of these studies reported results for end-stage disease separately, so that we could abstract results; abstracting results for the whole population would have limited applicability, since patients’ needs at different stages of illness may vary markedly. Many of these areas where we provided a more focused review and excluded studies have been well-addressed in other systematic reviews in broader populations, such as pain management in nursing homes,38 broader cancer pain interventions,27 and studies addressing broader populations for communication in the intensive care unit.34 For pain management, most included studies were patient- and caregiver-oriented interventions targeting this population specifically through study inclusion criteria and recruitment. This is due primarily to the fact that most institutional studies (e.g., in a hospital unit or entire nursing home) addressed broader populations or did not report results separately for advanced disease. Most advance care planning studies were excluded because they did not fit the definition of quality improvement (i.e., studies linked to the health care system and including an element of system 59 change); and most studies to improve rates of care planning were in populations that did not fit our definition, such as general primary care or nursing home populations. Our focus on studies only with prospective components also excluded some relevant studies and quality improvement types. The inclusion criteria for patient-centered outcomes also excluded studies focusing only on intermediate or indirect outcomes such as quantity of communication or provider assessments of quality of care. These exclusion criteria limited the inclusion of most studies of regulatory or policy interventions, which usually were retrospective or did not include patient-centered outcomes, such as the Physicians Orders for Life-Sustaining Treatment in the United States, or the Gold Standards Framework in the United Kingdom. Although these exclusions did limit the scope of the review somewhat, they also improved the applicability by including only higher-quality studies with direct patient- or family caregiverrelated outcomes. Due to our focus on clinical outcomes, we also did not address the issue of costs. The inclusion criteria for published, peer-reviewed evaluations also limited the inclusion of the experience evaluating interventions in areas less linked to academic medical centers and the research community, such as hospice and social work interventions,158 and in areas that are less developed or where sample sizes are likely to be more limited, such as pediatrics. We used a relatively broad definition of interventions to improve health care and quality improvement based on the original Closing the Quality Gap report, including studies conducted within or linked with the health care system and that have at least some element of system change. Palliative care consultation interventions, and interventions focusing on patient education and self-management, were included as part of this definition. Although these may not always be considered as quality improvement studies, they were included here because they are important methods for improving quality of care in patients with advanced and serious illness, particularly for pain management. Due to the diversity in the types of studies and the need to use one method for assessment of study quality across all studies, we used a risk of bias assessment tool for randomized trials, which did not capture many issues of methodologic quality within non-randomized quality improvement studies. Finally, our focus on specific targets may have excluded some relevant studies, although we did include a variety of targets in the section on studies focusing on quality improvement. Included studies addressed a variety of targets, ranging from spirituality to timeliness and efficiency of care, with studies across all settings and in a variety of populations. Despite this focus, studies were still very heterogenous, and even descriptive synthesis across such different studies has limitations. Strengths and Limitations of the Literature Although we identified a few high- and medium-quality studies with consistent findings within studies across outcomes, findings were often inconsistent among outcomes within the studies (e.g, statistically significant findings for health care utilization but not for satisfaction or symptoms) and many studies were of low quality or had methodological issues.54,64 RCTs are important in this field, and many of the highest-quality studies were RCTs, but since RCTs are often challenging or may not be the most appropriate study design for quality improvement interventions requiring institutional change, including the non-RCT literature was also important for this review. Common quality issues included small sample sizes, often due to insufficient recruitment, and lack of power for adequate statistical analysis. Even in many studies with adequate sample sizes, rates of recruitment were often low, reflecting the difficulty of conducting research in patients with advanced disease. Attrition was also a common issue, with a significant 60 percentage of patients dying before the followup assessment or being unable to complete the assessment, even with short followup times for many studies (one month or less); studies with multiple points of followup often had insufficient sample sizes for later evaluations or found inconsistent results across time points. Because of the diversity of interventions, outcomes, and reporting in the included studies, we judged that quantitative synthesis was not appropriate for any of the targets. Even for the target of pain (where all included studies evaluated pain as an outcome and 67 percent of the studies used the BPI to measure and report pain), due to the differential reporting (with concern for selective outcome reporting) of the BPI components (e.g. average pain, worst pain) and infrequent reporting of confidence intervals, as well as diversity of study interventions and populations, we judged that quantitative synthesis was not appropriate. We adapted the approach of quantifying the number of studies with statistically significant improvement with the intervention for each key outcome across studies that was used in most previous systematic reviews of this literature. Many studies included outcomes not designed for advanced disease or end-of-life populations, which may have limited the effectiveness of evaluating the impact of interventions. Studies often reported many outcomes and did not designate primary outcomes, making interpretation of results difficult and diluting the impact of study outcomes (e.g., reporting on a long list of outcomes rather than focusing on those most likely to be impacted by the intervention). For example, no interventions in the target of continuity found an impact on overall symptom scores, although this was reported as an outcome for a significant percentage of studies. In addition, evidence for different outcomes were often inconsistent within interventions and targets. For example, for continuity, statistically significant differences were twice as common for patient satisfaction as for quality of life, a finding consistent with systematic reviews evaluating the pre-2000 studies in this field.15 Three of four studies that evaluated caregiver satisfaction showed a significant effect on this outcome, but none found an effect on caregiver burden, not even within the same study. These findings could also be due to limitations in outcome measures or to the modifiability of some outcomes in patients with advanced disease. For example, although satisfaction, or reports of patient/caregiver experience, is an important metric that can integrate patient/caregiver experiences of health care, it is also challenging to measure in patients with advanced and serious illness. It is usually measured retrospectively, so previous care, grief, and suffering all influence ratings. Studies also used a variety of tools, many of which were not specifically developed for end-of-life populations. Finally, many studies in continuity and communication focused on the indirect outcome of health care utilization. While this outcome is important and clearly modifiable by interventions, these studies often did not measure or did not show similar effectiveness for patient-centered outcomes. Finally, we identified a number of limitations in the reporting of studies, which made interpretation difficult in general and for the purposes of this review. Studies often did not clearly report study design or details on the intervention. Although we only included studies with comparison groups, many studies focused on differences within the intervention group in the reporting of outcomes, not the comparison of interest. Studies often did not report effect size or complete results, which did not allow for estimation of the magnitude of effect. Studies often did not report the percentage of patients with advanced disease, and few separated out outcomes in palliative care compared to other populations. Descriptions of interventions were often limited, difficult to interpret, and challenging to translate into the quality improvement types. Few studies 61 identified theory or logic models; interventions often had not been well-evaluated in pilot studies identifying the most appropriate steps and outcomes, and often were not clearly developed based on existing literature. RCTs often did not report key elements, such as blinding or allocation, which lowered scores on risk of bias. Finally, studies often did not describe areas of context which might be helpful for understanding the strengths and limitations of settings and whether interventions could be replicated, such as local support for quality improvement, involvement of leadership, and funding and support for sustainability. Future Research We identified several key areas for future research. Development of measurement instruments specific for this special population has improved since earlier systematic reviews8 in some domains, such as quality of life and satisfaction, and we did find moderate strength of evidence for satisfaction for the target of continuity and a few key studies found effectiveness for quality of life. However, the lack of overall effectiveness results, particularly for quality of life, indicates that further development of measurement instruments for some outcomes may be warranted. Well-developed instruments may still be lacking in some key areas, such as caregiver burden. In addition, few studies evaluated caregiver burden as an outcome; this is a critical area for seriously ill patients that requires further research. For areas where instruments are welldeveloped, such as pain, standards for outcome measures and for how they are reported would help future attempts to compare and synthesize the literature. In addition, similar outcomes were often used across targets but not necessarily customized to those targets; further research could better define how to best tailor an outcome such as satisfaction to a target or intervention type, or better understand interactions between different types of outcomes commonly used together such as quality of life and satisfaction. We identified few published studies in the hospice setting, pediatric populations, or addressing the target of distress in this population, or any studies focusing on diverse populations or reducing disparities in outcomes, areas where there is significant need but challenges in developing and evaluating quality improvement interventions. Examples of disparities in end-oflife care that should be addressed include lower ratings by families of black and Hispanic patients on the quality of hospice care in the domains of emotional support, communication, and honoring patients’ preferences. Although significant effort has focused on quality improvement in hospices in recent years, hospices have traditionally been relatively separated from researchers and often independent of academic connections, leading to the lack of published research. Few studies focused on specific non-cancer populations, such as patients with heart failure. Particularly in some areas, there were few studies on specific types of quality improvement. Pain and distress management studies included mainly patient-centered intervention types. Few studies evaluated regulatory or policy interventions using patient-centered outcomes, few studies used quality improvement methodological approaches such as collaboratives, Plan-Do-Study-Act cycles, and audit and feedback, and few studies evaluated care across settings. No studies compared consultative to integrative intervention approaches. Finally, we identified several highand medium quality studies using specific types of interventions with significant results across several outcomes, that would benefit from replication, evaluations of dissemination, methods of implementation, and effectiveness in different settings.54,64 62 Conclusions In conclusion, we found the most consistent evidence in a large number of studies, including several high- and medium-quality studies, for the effectiveness of interventions targeting continuity for the outcome of patient satisfaction; targeting pain using patient-centered interventions; targeting communication and decisionmaking on health care utilization outcomes in the intensive care unit setting. A quality improvement taxonomy fit relatively well in this field of research with some modifications, including the addition of the integrative-consultative model framework for the target of communication and decisionmaking. The evidence has multiple gaps, including studies in illnesses other than cancer for symptom management; pediatric populations and hospice settings; and addressing diverse populations and disparities in care. Methods to achieve adequate retention and recruitment, and appropriate targeting of outcome measures to interventions and development and selection of the most appropriate measurement tools, are also needed to maximize the value of these studies. Finally, studies evaluating the impact of policy changes on patient outcomes are needed. This review provides a basis for researchers to understand which study methods, quality improvement types, and elements of interventions are best supported by current evidence, and for clinicians, quality improvement staff, and policymakers to conclude how best to target evidence-based efforts to improve the quality of care for patients with advanced and serious illness. 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General search strings PubMed PsycINFO CINAHL Cochrane 1 2 3 4 5 6 7 8 9 10 11 12 DARE (("end of life"[tiab] OR "palliative care"[mh] OR "palliative care"[tiab] OR "hospice care"[mh] OR "hospice care"[tiab] OR "supportive care"[tiab] OR "terminally ill"[tiab] OR "terminal care"[tiab]) AND ("quality improvement"[mh] OR "quality improvement"[tiab] OR "quality assurance, health care"[mh] OR "quality assurance"[tiab] OR "continuity of patient care"[mh] OR "patient care planning"[mh] OR "patient care planning"[tiab] OR consult[tiab] OR "systematic measurement"[tiab] OR "systematic assessment"[tiab])) NOT (editorial[pt] OR comment[pt]) (End of life OR palliative care OR hospice care OR supportive care OR terminally ill OR terminal care ) AND (Quality improvement OR quality assurance OR continuity of patient care OR patient care planning OR consult OR systematic measurement) from 2000 to 2011 (End of life OR palliative care OR hospice care OR supportive care OR terminally ill OR terminal care ) AND (Quality improvement OR quality assurance OR continuity of patient care OR patient care planning OR consult OR systematic measurement) from 2000 to 2011 3419 Palliative care OR Palliative care MeSH Hospice care OR Hospice care MeSH Quality assurance, health care MeSH Continuity of patient care MeSH Patient care planning OR patient care planning MeSH End of life OR supportive care OR terminally ill OR terminal care #1 OR #2 OR #6 Quality assurance OR quality assurance, health care MeSH Patient care planning OR patient care planning MeSH Quality improvement OR (quality assurance, health care MeSH OR quality assurance) OR continuity of patient care MeSH OR (patient care planning OR patient care planning MeSH) OR consult OR systematic measurement OR systematic assessment #7 AND #10 #11 from 2000 to 2011 (End of life OR palliative care OR hospice care OR supportive care OR terminally ill OR terminal care ) AND (Quality improvement OR quality assurance OR continuity of patient care OR patient care planning OR consult OR systematic measurement) from 2000 to 2011 1592 154 750 437 408 B-1 Limited to 2000-2011 Apr 2011 through Dec 2011 222 170 23 1020 73 4532 5864 988 1680 12296 1209 989 42919420530 71 0 Appendix Table B2. Cancer management and pain search strings PubMed PsycInfo CINAHL 1 2 3 4 5 6 Cochrane 1 2 3 4 5 6 7 8 9 10 11 DARE ((Cancer[tiab] AND care[tiab]) AND (communication[mh] OR communication[tiab] OR psychosocial[tiab] OR distress[tiab] OR (pain[tiab] AND management[tiab]))) NOT (editorial[pt] OR comment[pt]) (Cancer AND Care) AND Communication OR psychosocial OR distress OR (Pain AND management) from 2000 to 2011 4536 1059 186 Cancer AND care Communication OR psychosocial OR distress Pain AND management S2 OR S3 S1 AND S4 S1 AND S4 from 2000 to 2011 83460 234643 51896 279667 18212 2251 402 Cancer AND care Communication MeSH (Cancer AND care) AND (Communication) Communication (Cancer AND care) AND (Communication MeSH OR Communication tiab) Psychosocial OR distress Pain MeSH Pain Management (Cancer AND care) AND (Communication MeSH OR Communication tiab OR psychosocial OR distress OR ((pain MeSH OR pain tiab) AND management)) (Cancer AND care) AND (Communication MeSH OR Communication tiab OR psychosocial OR distress OR ((pain MeSH OR pain tiab) AND management)) from 2000 to 2011 Cancer AND care AND (communication OR psychosocial OR distress OR (pain AND management)) from 2000-2011 4880 1002 63 4739 182 B-2 Limited to 2000-2011 Apr 2011 through Dec 2011 623 8672 8539 51077 29126 601 454 330 1891076121 3 Appendix Table B.3. Nursing home and care planning pain search strings PubMed PsycINFO CINAHL Cochrane 1 2 3 4 5 6 DARE ("nursing homes"[mh] OR "nursing homes"[tiab] OR 653 "nursing home"[tiab]) AND (“patient care planning”[mh] OR “patient care planning”[tiab] OR (pain[tiab] AND management[tiab])) NOT (editorial[pt] OR comment[pt]) (Nursing homes OR nursing home) AND patient care 149 planning OR (pain and management) from 20002011 (Nursing homes OR nursing home) AND patient care 520 planning OR (pain and management) from 20002011 Nursing homes MeSH Patient care planning MeSH Nursing homes OR nursing home OR nursing homes MeSH Patient care planning OR patient care planning MeSH Pain and management #3 AND (#4 OR #5) (Nursing homes OR nursing home) AND patient care planning OR (pain and management) from 20002011 B-3 Apr 2011 through Dec 2011 Limited to 2000- 41 2011 0 0 855 408 3070 1680 4507 172 100757234986 1 0 Appendix C. Screening Forms Abstract Screen (Include) C-1 Abstract Screen (Exclude) C-2 C-3 Article Screen (Include) C-4 C-5 Article Screen (Exclude) C-6 C-7 Appendix D. Excluded Articles Does Not Address a Palliative Care Intervention or Population A Nurse Delivered Management Programme for Depression in People With Cancer Reduces Depressive Symptoms Compared With Usual Care.. Evidence-Based Mental Health 200902:9 Acton, G. J. and Kang, J. Interventions to reduce the burden of caregiving for an adult with dementia: a meta-analysis. Res Nurs Health 2001:349-60 Adegbehingbe, O. O., Akinyoola, A. L., Ariyibi, A. L., and Oginni, L. M.. Direct integration of government funding and family support for musculoskeletal tumor care in a resource-constrained country. Oncology 2009:398-404 Alexander, B. J., Plank, P., Carlson, M. B., Hanson, P., Picken, K., and Schwebke, K.. Methods of pain assessment in residents of long-term care facilities: a pilot study. J Am Med Dir Assoc 2005:137-43 Allen, R. 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G., Duncan, B. W., McDonald, K. M., Wachter, R. M., and Markowitz, A. J.. Making health care safer: a critical analysis of patient safety practices. Evid Rep Technol Assess (Summ) 2001:i-x, 1-668 Silveira, M. J., Given, C. W., Cease, K. B., Sikorskii, A., Given, B., Northouse, L. L., and Piette, J. D.. Cancer CarePartners: Improving patients' symptom management by engaging informal caregivers. BMC Palliat Care 2011:21 Sitzia, J., Cotterell, P., and Richardson, A.. Interprofessional collaboration with service users in the development of cancer services: the Cancer Partnership Project. J Interprof Care 2006:60-74 Sr Marie Ruegg, Schirm, V., and Boyce, B.. Making "caring connections". A new program enhances end-of-life care in a retirement community in Ohio. Health Prog 2004:34-7 Stevenson, K. M., Dahl, J. L., Berry, P. H., Beck, S. L., and Griffie, J.. Institutionalizing effective pain management practices: practice change programs to improve the quality of pain management in small health care organizations. J Pain Symptom Manage 2006:248-61 D-26 Taplin, S. H. and Rodgers, A. B.. Toward improving the quality of cancer care: addressing the interfaces of primary and oncology-related subspecialty care. J Natl Cancer Inst Monogr 2010:310 Taplin, S. H., Clauser, S., Rodgers, A. B., Breslau, E., and Rayson, D.. Interfaces across the cancer continuum offer opportunities to improve the process of care. J Natl Cancer Inst Monogr 2010:104-10 Tattersall, M. H., Gattellari, M., Voigt, K., and Butow, P. N.. When the treatment goal is not cure: are patients informed adequately?. Support Care Cancer 2002:314-21 Valgus, J., Jarr, S., Schwartz, R., Rice, M., and Bernard, S. A.. Pharmacist-led, interdisciplinary model for delivery of supportive care in the ambulatory cancer clinic setting. J Oncol Pract 2010:e1-4 Vandenberg, E. V., Tvrdik, A., and Keller, B. K.. Use of the quality improvement process in assessing end-of-life care in the nursing home. J Am Med Dir Assoc 2005:334-9 Velikova, G., Brown, J. M., Smith, A. B., and Selby, P. J.. Computer-based quality of life questionnaires may contribute to doctor-patient interactions in oncology. Br J Cancer 2002:51-9 Velji, K.. Effect of an Individualized Symptom Education Program on the Symptom Distress of Women Receiving Radiation Therapy for Gynecological Cancers.. 2006:167 p Volker, D. L., Kahn, D., and Penticuff, J. H.. Patient control and end-of-life care part II: the advanced practice nurse perspective. Oncol Nurs Forum 2004:954-60 Walker, J., Cassidy, J., and Sharpe, M.. The third symptom management research trial in oncology (SMaRT oncology-3): a randomised trial to determine the efficacy of adding a complex intervention for major depressive disorder (depression care for people with lung cancer) to usual care, compared to usual care alone in patients with lung cancer. Trials 2009:92 Wilson, S., Wahler, R., Brown, J., Doloresco, F., and Monte, S. V.. Impact of Pharmacist Intervention on Clinical Outcomes in the Palliative Care Setting. Am J Hosp Palliat Care 2010: Wilson, Shelley, Wahler, Robert, Brown, Jack, Doloresco, Fred, and Monte, Scott V.. Impact of Pharmacist Intervention on Clinical Outcomes in the Palliative Care Setting.. American Journal of Hospice & Palliative Medicine 2011:316-320 Woo, J., Lo, R. S. K., Lee, J., Cheng, J. O., Lum, C. M., Hui, E., Wong, F., Yeung, F., and Or, K. K.. Improving End-of-Life Care for Non-Cancer Patients in Hospitals: Description of a Continuous Quality Improvement Initiative.. Journal of Nursing & Healthcare of Chronic Illnesses 200909:237, 244 Published Before 2000 Dufault, M. A. and Willey-Lessne, C.J Nurs Care Qual. .:19-33 Sarna, L.. Effectiveness of structured nursing assessment of symptom distress in advanced lung cancer. Oncol Nurs Forum 98:1041-8 D-27 Other Harding, R. and Higginson, I. J.. What is the best way to help caregivers in cancer and palliative care? A systematic literature review of interventions and their effectiveness. Palliat Med 2003:63-74 McQuay Henry, J., Collins Sally, Carroll Dawn, and Moore, R. Andrew. Radiotherapy for the palliation of painful bone metastases. McQuay Henry J, Collins Sally , Carroll Dawn, Moore R Andrew. Radiotherapy for the palliation of painful bone metastases. Cochrane Database of Systematic Reviews: Reviews 1999 Issue 3 John Wiley & Sons, Ltd Chichester, UK DOI: 10.100214651858.CD001793 99: Oldenmenger, W. H., Sillevis Smitt, P. A., van Dooren, S., Stoter, G., and van der Rijt, C. C.. A systematic review on barriers hindering adequate cancer pain management and interventions to reduce them: a critical appraisal (Structured abstract). European Journal of Cancer 2009:13701380 D-28 Appendix E. Evidence Tables Evidence Table 1. Population and study characteristics of all included studies Author, year Ahrens et al, 2003 Aiken, 2006 2 3 Anderson, 2004 Aranda, 2006 4 1 Population Disease Setting(s) Single vs. Multicenter Single center Study Design Adult Mixed ICU Adult, 69 COPD, CHF Home care Multicenter, 7 organizations RCT, 6 month Case management and coordinated care adult cancer ambulatory multi-center (6 onc clinics) RCT Education- video and booklet combination Adult; Median age 55 (control) and 57 (intervention) Breast cancer Ambulatory Multicenter4 centers RCT Nurse-delivered intervention to address needs E-1 Controlled trial Description of intervention Specific defined roles and EOL communication by physician & clinical nurse specialists Description of intervention Whenever a certain ICU attending was on service, a clinical nurse specialist trained palliative care saw patientsfamilies daily were involved to ensure optimal communication. Home-based case management provided by registered nurse casemanagers, in coordination with patients’ existing medical care. Program foci included disease and symptom management, patient self-management and knowledge of illness-related resources, preparation for endof life, physical and mental functioning, utilization of medical services Education specific to patient racegender, highlighting misconceptions for pain relief, and how to talk to their provider about pain experience, followed by a 30minute nurse-led meeting following the video administration, and one follow up call within three days. Assessment and coaching on self-care, stress reduction, communication strategies, summary provided to physician; telephone follow-up at 1 week Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Population Disease Setting(s) 5 Adult, mean age 65 Mixed cancer population Home care Adults, no age reported Mixed illnesses Nursing home Adult, 68 Mixed illnesses Adult, 65 Adult Aubin, 2006 Badger, 2009 Bailey, 2005 6 7 8 Bakitas, 2009 Blumenthal, 2006 9 Single vs. Multicenter Multi-center, four community based primary care centers providing home care services Multicenter, 49 homes Study Design Description of intervention One-time educational intervention Description of intervention Controlled trial, before-after Gold Standards Framework in Care Homes Single, 135 beds Controlled trial, before-after Inpatient Comfort Care Program Ambulatory Multicenter, 2 centers RCT, 3 months or until patient die Multi-component, psycho educational intervention Home Multicenter-2 RCT, 12 weeks Telephone based coping skills training Includes identifying individuals' needs, assess and treat their needs and symptoms, Improve coordination within institution and outside, reducing avoidable hospital admissions. Intervention included staff education and support to identify patients who were actively dying and implement care plans guided by a comfort care order set template for the last days or hours of life The intervention (telephone calls), based on the chronic care model, used a case management, educational approach to encourage patient activation, self-management, and empowerment Lung transplant candidates 12 weeks - supportive counseling and training in cognitive– behavioral coping skills, by social worker or psychologist; per protocol; education on stress and health Hospital Cancer mixed Lung disease E-2 Controlled trial, follow up collected at baseline, 2 weeks, and 4 weeks Included a pain diary, didactic material including a 15 minute video tape and a booklet, and pain monitoring recommendations Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Population Disease Setting (s) Adult, >70 Mixed illnesses Hospital, 11 Adult, mean age 64 Lung cancer Ambulatory Single 12 Adult; mean Mixed cancer Ambulatory age 59.7 years population Single Adult,74 Multicenter, 3 Kaiser Permanente Bookbinder, 2005 10 Borneman, 2008 Borneman, 2010 13 Brumley, 2003 COPD, CHF, Home care cancer Single vs. Multicenter Single, 5 units E-3 Study Design Description of intervention Controlled Palliative Care for trial(beforeAdvanced Disease after), 4 months pathway Description of intervention Includes a care path, a daily flow sheet, and a physician order sheet with standard orders for symptom control Controlled trial, 4-part educational Information pertaining to pain follow up at 1 intervention assessment, pain management, month and 3 delivered by a fatigue assessment, and fatigue months post nurse to address management was provided intervention pain and fatigue. follow by bi-weekly phone contact Controlled trial, Intervention group NCCN Supportive Care outcome received four Guidelines, "Passport to measures for educational Comfort" both control and sessions on intervention painfatigue collected at assessment and baseline, 1 management. month, and 3 Written material on months post self-management intervention of fatigue and pain also distributed. Controlled trial, Home-Based The care team (patient and 60 days Palliative Care family plus a physician, nurse, and social worker) is responsible for coordinating and managing care and providing assessment, evaluation, planning, care delivery, follow-up, monitoring and continuous reassessment of care Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year 14 Brumley, 2007 Burns, 2003 15 Campbell, 2003 Campion, 2011 Carlson, 2010 16 17 18 Population Disease Setting (s) Single vs. Multicenter Multicenter, 2 HMO Study Design Adult, 72 COPD, CHF, cancer Home care Adult mean age 61years Mixed illnesses ICU Multicenter (7 ICU) Nonrandomized controlled trial Intervention to facilitate deliberative decision making. Adult Mixed ICU Single center Pre-post study Proactive casefinding approach to palliative care consultation Adult Mixed Cancer Ambulatory Multicenter Controlled trial; not reported Voluntary selfexamination and process improvement system Adult; 63.5 (control), 61.5 (Full) and 62.7 (triage) Mixed cancer Ambulatory Single Center RCT, 3 months Distress screening with optional resource referral E-4 RCT, 120 days Description of intervention Home-Based Palliative Care Description of intervention The care team (patient and family plus a physician, nurse, and social worker) is responsible for coordinating, managing care and providing assessment, evaluation, planning, care delivery, followup, monitoring and continuous reassessment of care Social workers interviewed families of patients at high risk for decisional conflict and provided feedback to clinicians to facilitate decision making Trigger criteria were used for medical ICU patients with global cerebral ischemia after CPR or with >3 system organ failure. Proactive palliative care was incorporated in the care of patients who met criteria. Twice-yearly data reporting and analysis cycle and offers participating practices extensive, site-specific, and benchmarking reports that describe the continuum of care Distress thermometer, problem checklist, psychological screen for anxiety and depression, personalized report and personalized phone triage with referral to resources Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Casarett, 2005 Clayton, 2007 20 21 Cohen, 2010 Dalton, 2004 23 Daly, 2010 19 22 Population Disease Setting (s) Adult, 84 Mixed illnesses Nursing home Single vs. Multicenter Multiple. 3 sites Study Design RCT, 6 months Description of intervention Identify nursing home residents preference for hospice care Description of intervention A structured interview identified residents whose goals for care, treatment preferences, and palliative care needs made them appropriate for hospice care. The residents’ physicians were notified and asked to authorize a hospice informational visit Assists patients to ask questions about end-of-life issues and improve patient-physician communication Adult mean Mixed cancer Other: Palliative 9 centers age: 65 population care centers (CONTROL 64.6, INTERVENTIO N 65.5) Adult, 70 Dialysis Ambulatory Multicenter, 5 patients with centers poor prognosis RCT Question prompt list for patient consultation Controlled trial, 17 months Intervention to facilitate hospice referral Adult, mean age: 52 Mixed cancer Ambulatory population Multicenter - 3 RCT with three cancer treatment groups - follow centers and 1 up for 6 months hospital Adult patients mean age 56years and family caregivers mean age 53years Mixed illnesses Multicenter (5 ICU) Profile-tailored CBT treatment program, matching individual responses to pain to specific CBT interventions Other (Pre-Post An intensive The ICS included a family design) communication meeting within 5 days of adm to system assist in goal setting, facilitate decision making, and reduce use of ineffective resources in the ICU; family meeting than weekly after. ICU E-5 Organization of Renal supportive care teams who contacted subjects andor family members to encourage advance care planning, discuss hospice resources, and offer general support Five one-hour treatment sessions Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Population Disease Setting (s) Single vs. Multicenter Single center Detmar, 2002 24 Adult; 57 Mixed cancer Ambulatory Du Pen, 2000 25 Adult, mean age 61 years Mixed Cancers Adult, 66 Mixed cancer Ambulatory, Multicenter, 5 hospital, home sites? care Adult, 70 COPD chronic Hospital, home Multicenter, 4 heart failure, care sites mixed cancer Adult, mean age ~85 years Dementia Dudgeon, 2008 26 Engelhardt, 2006 27 Fuchs-Lacelle, 2008 28 Ambulatory Multiple (9) Nursing Homes 12 (average number of beds was 56) E-6 Study Design RCT; timing of follow-up not reported Description of intervention Pre-consultation HRQL questionnaire Description of intervention HRQL questionnaire at 3 consecutive visits, with graphic summary given to patients and physicians before consultation RCT by Educational Role model physiciannurse institution blocks, intervention to teams were the core faculty for a transfer knowledge day-long seminar. Written 4 months on implementing reference materials and a previously tested documentation tools were algorithm for provided to the trained cancer pain physiciannurse teams. management provider focused Controlled trial, PCIP=palliative Implementation of common 12 months(for care integration assessment tools, intervention) project. collaborative care plans, and symptom management guidelines. RCT, 3 and 6 AICCP= advanced 6 sessions with care coordinator months illness coordinated helps with provider care program. communication, care coordination, and support RCT (at the Nurse -led Nursing staff regularly assessed nursing unit systematic pain dementia patients’ pain level), assessment through the use of the Pain comparative Assessment Checklist for longitudinal Seniors with Limited Ability to design, 3 months Communicate Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Population Disease Setting (s) 29 Adult mean age: 73.6 Mixed illnesses Hospital 30 Adult, Mixed cancer Ambulatory intervention: 59 population years, control: 57 years Multicenter - 2 RCT, 20 weeks comprehensive cancer centers, 2 community oncology clinics Adult mean age Mixed 68.4 illnesses Multicenter Gade, 2008 Given, 2002 Hanks, 2002 31 Hudson, 2005 32 Adult Hughes, 2000 33 Adult, mean age 70 for study overall Hospital Caregivers of Home patients dying of cancer at home Mixed Home care illnesses Single vs. Multicenter 3 hospitals Study Design RCT RCT Two community RCT (home based) Multi, 16 sites E-7 RCT, 1 year or until death Description of intervention Interdisciplinary palliative care service for patients. Description of intervention Team-Managed Home-Based Primary Care Home-based primary care including a primary care manager, 24-hour contact for patients, prior approval of hospital readmissions, and HBPC team participation in discharge planning The IPCS teams included a palliative care physician and nurse, hospital social worker and chaplain. The team met prior to each consultation to share what was known about the patient from the medical record, baseline questionnaire, and hospital providers. The entire team then met with the patientfamily to address symptoms, diagnosis, prognosis, and goals of care. Nurse Consisted of 10 contacts, 6 in implemented pain person and 4 via telephone, and fatigue occurring at two-week intervals management over a 20-week period using through patient evidence-based computer education and guidance for problem solving support with patients Full palliative care The effectiveness of a hospital team advice and Palliative Care Team on physical symptoms and health-related support quality of life of patients and family career. Evaluation of psycho-educational Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Population 34 Jacobsen, 2011 35 Adult mean age Mixed 62.9 (control), illnesses 63.5 (intervention) Jordhoy, 2000 Jordoy, Adult, 68 36 37 2001 , Ringdal 2002 , 38 Ringdal, 2001 39 Kaufer, 2008 40 Keefe, 2005 Disease Setting (s) Hospital Mixed cancer Home, ambulatory, and palliative medicine unit Adult patients Mixed mean age illnesses unclear (Just stated above 50 years and below 50 years) ICU Adult, mean Mixed cancer Home care age 60.5 years population Single vs. Multicenter Single center Study Design Description of intervention Nursing and physician education about how to approach ACP, focused ACP discussions (information-sharing meetings andor decision making meetings) with patients and families Single center Cluster RCT, Comprehensive Multidisciplinary approach to 12 bed unit palliative care care, outpatient and inpatient palliative managed by PMU , PMU staff medicine unit served as link to community, community education, predefined guidelines for interaction between palliative care and community Single center Other (Pre-Post An intervention To improve the quality of end-ofdesign) consisting of early life care, particularly by communication, increasing family members’ family meetings, satisfaction with decisionmaking, and psychosocial communication with physicians support with and nurses, and the death and support by the dying process. hospital palliative care team and family support team. Multi-center RCT, Nurse-led partner- Nurse-led intervention to recruited from an approximately 20 guided pain educate patient and partner unspecific days management about pain and pain number of intervention -three management and to train the hospices as well sessions partner to support the patient in as two major pain management cancer centers E-8 Controlled trial Description of intervention Cognitive model for advance care planning (ACP) discussion Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Kovach, 2006 41 Lautrette et al, 2007 Lilly, 2000 43 Lilly, 2003 44 42 Population Disease Setting (s) Single vs. Study Design Multicenter Nursing Homes Multisite: 14 RCT Nursing Homes, average of 114 beds Adult, mean age 86.5 Dementia Adult, median age 68 in control, 74 in intervention Control - mean age 60, intervention mean age 58 Mixed - ICU population Hospital - ICU Mixed illnesses ICU Multi-center, all in France, 22 icus, median of 16 bedsICU Single center Adult mean age: 59 Mixed illnesses ICU, Hospital Single center E-9 RCT Description of intervention Serial trial intervention, a protocol of assessing needs of people with dementia Proactive EOL conference & brochure Description of intervention Intervention to identify behavioral symptoms of discomfort by using an explicit schedule and procedures for nurses and ancillary staff Family conference used detailed guidelines with five objectives of VALUE pneumonic and families given bereavement brochure. Prospective; Intensive Multidisciplinary family meetings before and after communication and at 72 hrs after admission to ICU. use of critical care Process that was designed to study encourage the use of advanced supportive technology when it is of benefit, but to limit its burdens when it is ineffective. Other Intensive A defined, coordinated, prospective: 4- communication for proactive process of year follow-up patients or family communication in which an initial formal family meeting was by providers preceded by communication among providers with regard to the plan of care and the outcome goals. Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Population Disease Setting (s) 45 Adult; 62 Mixed cancer 46 Adult,72 Lovell, 2010 Luhrs, 2005 Marinangeli, 2004 Mcmillan, 2011 47 48 Miaskowski, 2004 49 Miaskowski, 2007 50 51 Mills, 2009 Study Design Hospital Single vs. Multicenter Multicenter: 21 Mixed illnesses Hospital, Single, 3 units Adult; control: 61.3, intervention: 63.9 Mixed cancer population Ambulatory Single Controlled trial(beforeafter), follow up unclear RCT, follow up to patient death Adult, 73 Mixed cancer Hospice Multicenter, 2 sites RCT, 2 weeks Adult, mean age intervention: 60.0, control: 58.8 Mixed cancer population Ambulatory Multi-center, 7 centers RCT, six weeks Adult, 64 Lung cancer Hospital 3 center RCT, 16 weeks E-10 RCT, four weeks Description of intervention Pain management educational intervention, four treatment arms 1) standard care, 2) standard care plus a booklet, 3) standard care plus a video, 4) standard care plus a booklet and a video Palliative Care for Advanced Disease (PCAD) pathway Use of strong opioids as the 1st step in pain management versus the WHO analgesic ladder Systematic feedback of standardized assessment to IDTS Nurse-led psychoeducational intervention - in person contacts at weeks 1, 3, and 6, phone contact at 2,4, and 5 Weekly QOL questionnaire Description of intervention Educational intervention consisting of a booklet for adults with cancer pain designed to improve knowledge and attitudes about cancer pain management, pain levels, pain interference, anxiety, QOL, and analgesic use - single contact Includes a care path, a daily flow sheet, and a physician order sheet with standard orders for symptom control Comparison group- WHO guidelines where strong opioid is first line, all other pain treatments were the same; palliative care pts Standardized assessment followed by two interdisciplinary team discussions PRO-SELF group patients were seen by specially trained nurses; psycho-educational intervention, - given written instructions on how to communicate with their physician about unrelieved pain QOL questionnaire, patients are encourage to share it with health care provider Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Population Disease Setting (s) Adult, median age between 65-72 Mixed illnesses Ambulatory, hospital 53 Adult mean age 83.14 (calc from Table 1) Mixed illnesses Nursing homes Multicenter 54 Adult, 67 Lung cancer Ambulatory Multicenter4 centers RCT, 3 months Nurse led follow up Adult mean age 40 years Trauma ICU Single center 14bed ICU in an academic tertiary care center Prospective Adult Mixed Cancer Not Specified Cancer Centers Multicenter Randomized Controlled Trial Structured communication between physician and families of dying trauma patients. Education sessions to learn COPE problem solving model Mitchell, 2008 Molloy, 2000 Moore, 2002 52 55 Mosenthal, 2008 Meyers, 2011 56 Single vs. Multicenter Multicenter, 2 centers E-11 Study Design RCT, 3 weeks(for primary outcome) RCT Description of intervention Specialist- GP case conferences Description of intervention The let me decide advance directive program included educating providers, patients and families about advance directives Educating staff in local hospitals and nursing homes, residents, and families about advance directives and offering competent residents or next-of-kin of mentally incompetent residents an advance directive that provided a range of health care choices for lifethreatening illness, cardiac arrest, and nutrition. Nurse specialists assessed patients monthly or as needed by phone or in clinic to identify disease progression, symptoms warranting intervention, or serious complications Bereavementpsychosocial support for patients and families, Interdisciplinary family meeting with physician and nurse GP phoning in to a routine specialist team meeting Dyads participating in three conjoint educational sessions during the first month, learning the COPE problem solving model. Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year 57 Norton, 2007 Penticuff, 2005 Porter, 2011 62 63 Rabow, 2004 Population Disease Adult, 76 CHF, COPD, Hospital mixed cancer, Cirrhosis Pediatrics (Very Other low birth weight infants immediately after birth) Setting (s) NICU (neonatal 2 centers ICU) Adult 64 65 Reymond, 2011 Single vs. Multicenter Single, 560 bed Study Design RCT, 2 weeks after discharge Controlled trial Lung Cancer Ambulatory Stage I,II or III Adult, 68 years COPD, CHF, Ambulatory cancer Multicenter RCT Single 12 months, controlled trial Adult Multicenter, 7 sites non-RCT Mixed Nursing home Illnesses, mean age not reported E-12 Description of intervention Hospital-Based Palliative Medicine Consultation Description of intervention 5week during hospitalization the PMC physician assessed symptoms, psychosocial and spiritual needs, discussed treatment preferences, consulted pharmacist and chaplain as needed, communicated findings and recommendations to the patient’s team via a medical chart note and by phone. Infant Progress An intervention to improve parents' comprehension of infant Chart and Care Planning Meetings medical condition and satisfaction with collaboration in treatment decisions - care planning, 3 meetings, including goal-setting with complications and development of poor prognosis Care giver-assisted coping skills training Comprehensive Primary care physicians Care Team received multiple palliative care team consultations, and patients received advance care planning, psychosocial support, and family caregiver training. Residential aged Identifying and training nurse end-of-life care champions, networking facilities pathway with specialty palliative care, educating physicians, development and implementation of end-of-life clinical management care pathway Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year 66 Rosenbloom, 2007 Sampson, 2011 Schneiderman, 68 2000 67 Population Disease Setting (s) Single vs. Multicenter Single center Study Design Adult Breast, lung, colorectal Ambulatory Adult mean age: 87 Advanced dementia Hospital: acute medical wards single RCT Palliative care consultation and advanced care plan discussion with carer. Control mean age 45.9, intervention mean age 52.4 Mixed illnesses ICU Single center RCT Impact of ethics consultations on patients, families and providers E-13 RCT, 6 months Description of intervention Health related quality of life (HRQL) assessment of patients Description of intervention HRQL assessments given to treating nurse in 1 group; in another group, HRQL assessment followed by structured interview and discussion The clinical team had structured discussions with carers to understand cultural, spiritual, health, social and financial needs experienced by the carer and the psychological support available to them. They inquired whether the person with dementia had made any previous advance directives or statements or had expressed any preferences for care. They provided basic education on dementia as a neurodegenerative disease, the prognosis of advanced dementia, the role of palliative care (focusing on palliative care as appropriate active care, NOT withdrawal of treatment) and advance care planning. Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Population Schneiderman, 2003 Steel, 2007 70 71 Syrjala, 2008 Taenzer, 2000 Temel, 2010 73 72 69 Disease Adult mean age Mixed 67.5 - both illnesses groups ICU Single vs. Multicenter Multicenter Adult Ambulatory Single center Adult, 57.77 for Mixed cancer Ambulatory intervention, population 53.37 for control Multicenter: 6 centers Adult Single center Hepatobiliary Setting (s) Lung cancer Ambulatory Adult (65years) Metastatic lung cancer Ambulatory Single center (Hospital: oncology clinic) E-14 Study Design Patients chose from list of concerns which were most distressing (symptoms, psychological, and end of life issues) and strategies offered to treat each problem RCT, six months Patient training in Study RN reviewed materials cancer pain with the patient; patient filled out management using checklist with RN on barriers to integrated pain relief, and reviewed with print and video RN; patient encouraged to take materials checklist to next doctor's appt; 1 10-minute follow-up Controlled trial, Provide patientStaff instructed in how to use the specific QOL info QOL report to identify specific duration not domains to guide their to staff before specified appointments discussion Palliative care physicianadvance RCT, 12 weeks Early palliative practice RN outpatient care integrated consultation within 3 months of with standard diagnosis and at least monthly oncologic thereafter; based on palliative care care guidelines, including physical and psychosocial symptoms, goals of care, decision making regarding treatment, and coordinating care; concurrent with usual oncology care RCT RCT Description of intervention Ethics consultations to resolve conflicts about life-sustaining interventions. Individually tailored psychosocial intervention Description of intervention Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Tulsky,2011 74 Van der Peet, 2004 75 Population Disease Setting (s) Intervention 62.2, Control 59.9 mixed cancer Oncology population outpatient clinic Adult, Mixed cancer Home care intervention: 62, population control: 60.5 years 76 ADULT, 64-75 Mixed cancer Hospital, nursing home, home care 77 Adult; 54.9 (12.3) Mixed cancer Ambulatory Vd heide, 2010 Velikova, 2004 ; 78 Velikova, 2010 Single vs. Multicenter multicenter Study Design Description of intervention Oncologists in the intervention group received an interactive CD-ROM training program on communication skills that was tailored with exemplars from their own audio-recorded clinic visits. This intervention was designed to enhance oncologists’ ability to respond effectively to patients’ emotional concerns. Multicenter RCT, 8 weeks Nursing-based pain The PEP consists of the outpatient clinics education program following three components: (1) and one - three home visits enhancement of patients’ pain radiotherapy knowledge and pain department management by means of a brochure, (2) instruction of patients as to how they should record their pain intensity in a pain diary, and (3) stimulation of patients’ help-seeking behavior. Multicenter. 6 Controlled trial Liverpool Care Structuring care in the last days centers or (before-after), Pathway for the of life and at facilitating audit by organizations Dying Patient standardizing the monitoring of care Patients were (1) asked to Single center RCT; unclear (3 Health-related complete a touch-screen visits) quality of life HRQOL survey that provided survey with feedback to physicians or (2) feedback to asked to complete the HRQOL physicians survey that did not provide feedback or (3) were not asked to complete a survey - 3 visits; providers were provided detailed training & asked to review & use the HRQOL information during encounters E-15 RCT Description of intervention Computer based training to improve communication between oncologists and patients Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Walsh, 2007 79 Population Disease Setting (s) Adult; 56.3 Mixed cancer Home, ambulatory Single vs. Multicenter 3 cancer networks Ward, 2000 80 Adult, 58 years Gynecologic Ambulatory Cancers Single Ward, 2008 81 Adult, 55.11 years Multicenter - 2 clinics 82 Adult, 53 years Mixed cancer Ambulatory population Single Adult; mean Lung cancer Ambulatory age intervention: 63.4, mean age controls: 60.1 Multicenter - 11 sites Wells, 2003 83 Wilkie, 2010 Mixed cancer Ambulatory population E-16 Study Design RCT Description of intervention Career-focused intervention added to palliative care Description of intervention Six visits to careers by advisors with background in nursing and social work: needs assessment, advice and support focusing on 7 domains of care RCT, two Nurse led Concerns (barriers) and side months individually tailored effect management, used a information booklet developed through comprehensive process, tailored based on patient's barriers and side effects questionnaire; with booster follow-up call RCT, two Educational Single 1:1 face-to-face psycho months intervention based educational on the session that lasts from 20 representational minutes to an hour. approach to patient education RCT, six months Two interventions All treatment arms were shown a 1)Pain education videotape and received individual counseling - both with a hot line 2) intervention arms had access to Pain education a hotline, the telephone follow up with providerinitiated follow-up intervention arm received four follow up calls telephone calls, compared to usual care control RCT, 4 weeks Individualized pain 12-minute videotape of trained coaching on self actress -pain perception and monitoring and monitoring, instruction in using a reporting Coaching tool at home and giving information to their provider; also several reinforcement coachings Evidence Table 1. Population and study characteristics of all included studies (continued) Author, year Woo, 2011 84 Population Disease Setting (s) Adults,84 Mixed illnesses (majority dementia) Rehabilitation and convalescent unit Single vs. Multicenter Single, 227 beds Study Design Controlled trial, before-after, 3 months Description of intervention Continuous initiative (Plando-study-act) Description of intervention Service reengineering, provision of guidelines and educational material, and interactive sessions to achieve culture change among staff. Abbreviations: ACP=American College of Physicians; AICCP=Palliative Care Integration Project; CHF=Cardiac Heart Failure; COPD=Chronic Obstructive Pulmonary Disease; EOL=End of Life; HMO=Health Maintenance Organization; HRQL=Health Related Quality of Life; ICS=An intensive communication system; ICU=Intensive Care Unit; Medicine Consultation; NCCN=National Comprehensive Cancer Network; NICU=Neonatal Intensive Care Unit; PACSLAC=Pain Assessment Checklist for Seniors with Limited Ability to Communicate; PCIP=Palliative Care Integration project; PCS=Palliative Care Service; PMC=Palliative Management Care; PMU=Pain Management Unit; QPL=Question Prompts Lists; RCT=Randomized Control Trial Evidence Table 1 Reference List 1. 2. Ahrens T, Yancey V, Kollef M. Improving family communications at the end of life: implications for length of stay in the intensive care unit and resource use. Am J Crit Care 2003; 12(4):317-23; discussion 324. Project ENABLE II randomized controlled trial. JAMA 2009; 302(7):741-9. 9. Blumenthal JA, Babyak MA, Keefe FJ et al. Telephone-based coping skills training for patients awaiting lung transplantation. Journal of Consulting and Clinical Psychology 2006; 74(3):535-44. Aiken LS, Butner J, Lockhart CA, Volk-Craft BE, Hamilton G, Williams FG. Outcome evaluation of a randomized trial of the PhoenixCare intervention: program of case management and coordinated care for the seriously chronically ill. J Palliat Med 2006; 9(1):111-26. 10. Bookbinder M, Blank AE, Arney E et al. Improving end-of-life care: development and pilot-test of a clinical pathway. J Pain Symptom Manage 2005; 29(6):529-43. 3. Anderson KO, Mendoza TR, Payne R et al. Pain education for underserved minority cancer patients: a randomized controlled trial. J Clin Oncol 2004; 22(24):4918-25. 11. Borneman T, Koczywas M, Cristea M, Reckamp K, Sun V, Ferrell B. An interdisciplinary care approach for integration of palliative care in lung cancer. Clin Lung Cancer 2008; 9(6):352-60. 4. Aranda S, Schofield P, Weih L, Milne D, Yates P, Faulkner R. Meeting the support and information needs of women with advanced breast cancer: a randomised controlled trial. Br J Cancer 2006; 95(6):667-73. 12. Borneman T, Koczywas M, Sun VC, Piper BF, Uman G, Ferrell B. Reducing patient barriers to pain and fatigue management. J Pain Symptom Manage 2010; 39(3):486-501. 5. Aubin M, Vezina L, Parent R et al. Impact of an educational program on pain management in patients with cancer living at home. Oncol Nurs Forum 2006; 33(6):1183-8. 13. Brumley RD, Enguidanos S, Cherin DA. Effectiveness of a home-based palliative care program for end-of-life. J Palliat Med 2003; 6(5):715-24. 6. Badger F, Clifford C, Hewison A, Thomas K. An evaluation of the implementation of a programme to improve end-of-life care in nursing homes. Palliat Med 2009; 23(6):502-11. 14. Brumley R, Enguidanos S, Jamison P et al. Increased satisfaction with care and lower costs: results of a randomized trial of in-home palliative care. J Am Geriatr Soc 2007; 55(7):993-1000. 7. Bailey FA, Burgio KL, Woodby LL et al. Improving processes of hospital care during the last hours of life. Arch Intern Med 2005; 165(15):1722-7. 15. Danz MS, Rubenstein LV, Hempel S et al. Identifying quality improvement intervention evaluations: is consensus achievable? Qual Saf Health Care 2010; 19(4):279-83. 8. Bakitas M, Lyons KD, Hegel MT et al. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the 16. Campbell ML, Guzman JA. Impact of a proactive approach to improve endof-life care in a medical ICU. Chest 2003; 123(1):266-71. E-17 17. Campion FX, Larson LR, Kadlubek PJ, Earle CC, Neuss MN. Advancing performance measurement in oncology. Am J Manag Care 2011; 17 Suppl 5 Developing:SP32-6. 30. Given B, Given CW, McCorkle R et al. Pain and fatigue management: results of a nursing randomized clinical trial. Oncol Nurs Forum 2002; 29(6):949-56. 18. Carlson LE, Groff SL, Maciejewski O, Bultz BD. Screening for distress in lung and breast cancer outpatients: a randomized controlled trial. J Clin Oncol 2010; 28(33):4884-91. 31. Hanks GW, Robbins M, Sharp D et al. The imPaCT study: a randomised controlled trial to evaluate a hospital palliative care team. British Journal of Cancer 2002; 87(7):733-9. 19. Casarett D, Karlawish J, Morales K, Crowley R, Mirsch T, Asch DA. Improving the use of hospice services in nursing homes: a randomized controlled trial. JAMA 2005; 294(2):211-7. 32. Hudson PL, Aranda S, Hayman-White K. A psycho-educational intervention for family caregivers of patients receiving palliative care: a randomized controlled trial. J Pain Symptom Manage 2005; 30(4):329-41. 20. Clayton JM, Butow PN, Tattersall MH et al. Randomized controlled trial of a prompt list to help advanced cancer patients and their caregivers to ask questions about prognosis and end-of-life care. J Clin Oncol 2007; 25(6):715-23. 33. Hughes SL, Weaver FM, Giobbie-Hurder A et al. Effectiveness of teammanaged home-based primary care: a randomized multicenter trial. JAMA: the Journal of the American Medical Association 2000; 284(22):2877-85. 34. 21. Cohen LM, Ruthazer R, Germain MJ. Increasing hospice services for elderly patients maintained with hemodialysis. J Palliat Med 2010; 13(7):847-54. 22. Dalton JA, Keefe FJ, Carlson J, Youngblood R. Tailoring cognitivebehavioral treatment for cancer pain. 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Quality of life in palliative cancer care: results from a cluster randomized trial. J Clin Oncol 2001; 19(18):3884-94. 25. Du Pen AR, Du Pen S, Hansberry J et al. An educational implementation of a cancer pain algorithm for ambulatory care. Pain Manag Nurs 2000; 1(4):116-28. 37. - Ringdal GI, - Jordhoy MS, - Kaasa S. - Family Satisfaction With End-ofLife Care for Cancer Patients in a Cluster Randomized Trial. - Journal of Pain & Symptom Management - 200207; - 24(- 1):- 53, - 63. 26. Dudgeon DJ, Knott C, Eichholz M et al. Palliative Care Integration Project (PCIP) quality improvement strategy evaluation. J Pain Symptom Manage 2008; 35(6):573-82. 38. - Ringdal GI, - Jordhoy MS, - Ringdal K, - Kaasa S. - The First Year of Grief and Bereavement in Close Family Members to Individuals Who Have Died of Cancer. - Palliative Medicine - 200103; - 15(- 2):- 91, - 105. 27. Engelhardt JB, McClive-Reed KP, Toseland RW, Smith TL, Larson DG, Tobin DR. Effects of a program for coordinated care of advanced illness on patients, surrogates, and healthcare costs: a randomized trial. Am J Manag Care 2006; 12(2):93-100. 39. Kaufer M, Murphy P, Barker K, Mosenthal A. Family satisfaction following the death of a loved one in an inner city MICU. Am J Hosp Palliat Care 2008; 25(4):318-25. 28. - Fuchs-Lacelle S, - Hadjistavropoulos T, - Lix L. - Pain Assessment as Intervention: a Study of Older Adults With Severe Dementia. - Clinical Journal of Pain - 200810; - 24(- 8):- 697, - 707. 40. Keefe FJ, Ahles TA, Sutton L et al. Partner-guided cancer pain management at the end of life: a preliminary study. J Pain Symptom Manage 2005; 29(3):263-72. 29. Gade G, Venohr I, Conner D et al. Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med 2008; 11(2):180-90. 41. Kovach CR, Logan BR, Noonan PE et al. Effects of the Serial Trial Intervention on discomfort and behavior of nursing home residents with dementia. American Journal of Alzheimer's Disease and Other Dementias E-18 2006; 21(3):147-55. 42. 43. medical follow up in management of patients with lung cancer: randomised trial. BMJ 2002; 325(7373):1145. Lautrette A, Darmon M, Megarbane B et al. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med 2007; 356(5):469-78. Lilly CM, De Meo DL, Sonna LA et al. An intensive communication intervention for the critically ill. Am J Med 2000; 109(6):469-75. 44. Lilly CM, Sonna LA, Haley KJ, Massaro AF. Intensive communication: four-year follow-up from a clinical practice study. Crit Care Med 2003; 31(5 Suppl):S394-9. 45. Lovell MR, Forder PM, Stockler MR et al. A randomized controlled trial of a standardized educational intervention for patients with cancer pain. J Pain Symptom Manage 2010; 40(1):49-59. 46. Luhrs CA, Meghani S, Homel P et al. Pilot of a pathway to improve the care of imminently dying oncology inpatients in a Veterans Affairs Medical Center. J Pain Symptom Manage 2005; 29(6):544-51. 55. Mosenthal AC, Murphy PA, Barker LK, Lavery R, Retano A, Livingston DH. Changing the culture around end-of-life care in the trauma intensive care unit. J Trauma 2008; 64(6):1587-93. 56. Meyers FJ, Carducci M, Loscalzo MJ, Linder J, Greasby T, Beckett LA. Effects of a problem-solving intervention (COPE) on quality of life for patients with advanced cancer on clinical trials and their caregivers: simultaneous care educational intervention (SCEI): linking palliation and clinical trials. (1557-7740 (Electronic). 1557-7740 (Linking)). 57. Norton SA, Hogan LA, Holloway RG, Temkin-Greener H, Buckley MJ, Quill TE. Proactive palliative care in the medical intensive care unit: effects on length of stay for selected high-risk patients. Crit Care Med 2007; 35(6):1530-5. 58. Oldenmenger WH, Sillevis Smitt PA, van Montfort CA, de Raaf PJ, van der Rijt CC. A combined pain consultation and pain education program decreases average and current pain and decreases interference in daily life by pain in oncology outpatients: a randomized controlled trial. Pain 2011; 152(11):2632-9. 59. Oliver JW, Kravitz RL, Kaplan SH, Meyers FJ. Individualized patient education and coaching to improve pain control among cancer outpatients. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 2001; 19(8):2206-12. 47. Marinangeli F, Ciccozzi A, Leonardis M et al. Use of strong opioids in advanced cancer pain: a randomized trial. J Pain Symptom Manage 2004; 27(5):409-16. 48. McMillan SC, Small BJ, Haley WE. Improving hospice outcomes through systematic assessment: a clinical trial. Cancer Nurs 2011; 34(2):89-97. 49. Miaskowski C, Dodd M, West C et al. Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. J Clin Oncol 2004; 22(9):1713-20. 60. Miaskowski C, Dodd M, West C et al. The use of a responder analysis to identify differences in patient outcomes following a self-care intervention to improve cancer pain management. Pain 2007; 129(1-2):55-63. Kalauokalani D, Franks P, Oliver JW, Meyers FJ, Kravitz RL. Can patient coaching reduce racialethnic disparities in cancer pain control? Secondary analysis of a randomized controlled trial. Pain Med 2007; 8(1):17-24. 61. Mills ME, Murray LJ, Johnston BT, Cardwell C, Donnelly M. Does a patient-held quality-of-life diary benefit patients with inoperable lung cancer? J Clin Oncol 2009; 27(1):70-7. Pantilat SZ, O'Riordan DL, Dibble SL, Landefeld CS. Hospital-based palliative medicine consultation: a randomized controlled trial. Arch Intern Med 2010; 170(22):2038-40. 62. Ritchie L. Planning end-of-life care. Nurs N Z 2011; 17(9):23. 50. 51. 52. Mitchell GK, Del Mar CB, O'Rourke PK, Clavarino AM. Do case conferences between general practitioners and specialist palliative care services improve quality of life? A randomised controlled trial (ISRCTN 52269003). Palliative Medicine 2008; 22(8):904-12. 63. Porter LS, Keefe FJ, Garst J et al. Caregiver-Assisted Coping Skills Training for Lung Cancer: Results of a Randomized Clinical Trial. J Pain Symptom Manage 2010. 64. 53. Molloy DW, Guyatt GH, Russo R et al. Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial. JAMA 2000; 283(11):1437-44. Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med 2004; 164(1):83-91. 65. 54. Moore S, Corner J, Haviland J et al. Nurse led follow up and conventional Reymond L, Israel FJ, Charles MA. A residential aged care end-of-life care pathway (RAC EoLCP) for Australian aged care facilities. Aust Health Rev E-19 2011; 35(3):350-6. 66. 67. 68. 69. 70. nursing-based pain education program for cancer outpatients suffering from pain. Support Care Cancer 2008. - Rosenbloom SK, - Victorson DE, - Hahn EA, - Peterman AH, - Cella David. - Assessment Is Not Enough: a Randomized Controlled Trial of the Effects of Hqrl Assessment on Quality of Life and Satisfaction in Oncology Clinical Practice. - Psycho-Oncology - 200712; - 16(- 12):- 1069, - 1079. 76. Sampson EL, Jones L, Thune-Boyle IC et al. Palliative assessment and advance care planning in severe dementia: an exploratory randomized controlled trial of a complex intervention. Palliat Med 2011; 25(3):197-209. van der Heide A, Veerbeek L, Swart S, van der Rijt C, van der Maas PJ, van Zuylen L. End-of-life decision making for cancer patients in different clinical settings and the impact of the LCP. J Pain Symptom Manage 2010; 39(1):33-43. 77. Schneiderman LJ, Gilmer T, Teetzel HD. Impact of ethics consultations in the intensive care setting: a randomized, controlled trial. Crit Care Med 2000; 28(12):3920-4. Velikova G, Booth L, Smith AB et al. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 2004; 22(4):714-24. 78. Schneiderman LJ, Gilmer T, Teetzel HD et al. Effect of ethics consultations on nonbeneficial life-sustaining treatments in the intensive care setting: a randomized controlled trial. JAMA 2003; 290(9):1166-72. Velikova G, Keding A, Harley C et al. Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. Eur J Cancer 2010; 46(13):2381-8. 79. Steel JL, Nadeau K, Olek M, Carr BI. Preliminary results of an individually tailored psychosocial intervention for patients with advanced hepatobiliary carcinoma. J Psychosoc Oncol 2007; 25(3):19-42. Walsh K, Jones L, Tookman A et al. Reducing emotional distress in people caring for patients receiving specialist palliative care. Randomised trial. Br J Psychiatry 2007; 190:142-7. 80. Ward S, Donovan HS, Owen B, Grosen E, Serlin R. An individualized intervention to overcome patient-related barriers to pain management in women with gynecologic cancers. Research in Nursing & Health 2000; 23(5):393-405. 81. Ward S, Donovan H, Gunnarsdottir S, Serlin RC, Shapiro GR, Hughes S. A randomized trial of a representational intervention to decrease cancer pain (RIDcancerPain). Health Psychol 2008; 27(1):59-67. 82. Wells N, Hepworth JT, Murphy BA, Wujcik D, Johnson R. Improving cancer pain management through patient and family education. J Pain Symptom Manage 2003; 25(4):344-56. 83. Wilkie D, Berry D, Cain K et al. Effects of coaching patients with lung cancer to report cancer pain. Western Journal of Nursing Research 2010; 32(1):23-46. 84. Woo J, Cheng JO, Lee J et al. Evaluation of a continuous quality improvement initiative for end-of-life care for older noncancer patients. J Am Med Dir Assoc 2011; 12(2):105-13. 71. Syrjala KL, Abrams JR, Polissar NL et al. Patient training in cancer pain management using integrated print and video materials: a multisite randomized controlled trial. Pain 2008; 135(1-2):175-86. 72. Taenzer P, Bultz BD, Carlson LE et al. Impact of computerized quality of life screening on physician behaviour and patient satisfaction in lung cancer outpatients. Psychooncology 2000; 9(3):203-13. 73. Temel JS, Greer JA, Muzikansky A et al. Early palliative care for patients with metastatic non-small-cell lung cancer. The New England Journal of Medicine 2010; 363(8):733-42. 74. Tulsky J, Arnold R, Alexander S et al. Enhancing communication between oncologists and patients with a computer-based training program: a randomized trial. Annals of Internal Medicine 2011; 155(9):593-601. 75. van der Peet EH, van den Beuken-van Everdingen MH, Patijn J, Schouten HC, van Kleef M, Courtens AM. Randomized clinical trial of an intensive E-20 Evidence Table 2. Description of interventions for studies addressing continuity, coordination of care, and transitions Author, year 1 Aiken, 2006, Integrative vs. consultative Consultative: interacts with both 2 Badger, 2009 3 Bailey, 2005 4 Bakitas, 2009 5 Bookbinder, 2005 6 Consultative: interacts with both Consultative: interacts with both 8 Integrative Consultative: interacts with patientfamily Integrative Combined: interacts with patientfamily Brumley, 2003 7 Brumley, 2007 Casarett, 2005 9 Cohen, 2010 10 Dudgeon, 2008 Engelhardt , 11 2006 12 Hughes, 2000 13 Jordhoy, 2000 , 14 Jordhoy, 2001 , 15 Ringdal, 2001 , 16 Ringdal, 2002 17 Luhrs, 2005 18 McMillan, 2011 19 Mitchell, 2008 20 Moore, 2002 21 Pantilat, 2010 22 Rabow, 2004 23 Reymond, 2011 Temel, 2010 24 Integrative Integrative Consultative: interacts with patientfamily Integrative Combined: Interacts with both Combined: interacts with both Integrative Integrative Integrative Consultative: interacts with both Consultative: interacts with both Consultative: interacts with both Integrative Consultative: interacts with both Target of intervention Case management, interdisciplinary assessment, symptom management, advanced care planning, overutilization Communication, coordination, advanced care planning, over-utilization, symptom management Symptom management, coordination, interdisciplinary assessment, comfort care, over-utilization Case management, interdisciplinary assessment, transition, communication Interdisciplinary teams, communication, symptom management, support for families, case management Case management, interdisciplinary assessments, family support, communication, coordination Case management, interdisciplinary assessments, family support, communication, coordination, spiritual Transition, communication Transition Pain, care giving, interdisciplinary assessment, coordination, documentation Psychosocial support, communication, coordination, family support and care giving, advanced care planning, case management Transition, case management, interdisciplinary assessment Interdisciplinary team, symptom management, support for caregivers who had died from advanced cancer Transition, case management, interdisciplinary assessment Interdisciplinary assessment Interdisciplinary teams Case management, coordination, documentation Interdisciplinary assessments, communication, documentation Case management, communication, interdisciplinary teams, interdisciplinary assessments, psychosocialspiritual support, physical symptoms Coordination, care planning, symptom management Physical and psychosocial symptoms, goals of care, treatment decision making and coordinating care E-21 Evidence Table 2. Description of interventions for studies addressing continuity, coordination of care, and transitions Author, year Integrative vs. consultative Van der Heide, Integrative 25 2010 26 Woo, 2011 Integrative Evidence Table 2 Reference List 1. 2. Target of intervention Interdisciplinary assessment, communication, symptom management, transition Communication, coordination, documentation Aiken LS, Butner J, Lockhart CA, Volk-Craft BE, Hamilton G, Williams FG. Outcome evaluation of a randomized trial of the PhoenixCare intervention: program of case management and coordinated care for the seriously chronically ill. J Palliat Med 2006; 9(1):111-26. 12. Badger F, Clifford C, Hewison A, Thomas K. An evaluation of the implementation of a programme to improve end-of-life care in nursing homes. Palliat Med 2009; 23(6):502-11. Hughes SL, Weaver FM, Giobbie-Hurder A et al. Effectiveness of teammanaged home-based primary care: a randomized multicenter trial. JAMA: the Journal of the American Medical Association 2000; 284(22):2877-85. 13. - Jordhoy MS, - Fayers P, - Saltnes T, - Ahlner-Elmqvist M, - Jannert M, Kaasa S. - A Palliative-Care Intervention and Death at Home: a Cluster Randomised Trial. - Lancet - 200009092000 Sep 9; - 356(- 9233):- 888, 893. patients, surrogates, and healthcare costs: a randomized trial. Am J Manag Care 2006; 12(2):93-100. 3. Bailey FA, Burgio KL, Woodby LL et al. Improving processes of hospital care during the last hours of life. Arch Intern Med 2005; 165(15):1722-7. 4. Bakitas M, Lyons KD, Hegel MT et al. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA 2009; 302(7):741-9. 14. Jordhoy MS, Fayers P, Loge JH, Ahlner-Elmqvist M, Kaasa S. Quality of life in palliative cancer care: results from a cluster randomized trial. J Clin Oncol 2001; 19(18):3884-94. 5. Bookbinder M, Blank AE, Arney E et al. Improving end-of-life care: development and pilot-test of a clinical pathway. J Pain Symptom Manage 2005; 29(6):529-43. 15. - Ringdal GI, - Jordhoy MS, - Ringdal K, - Kaasa S. - The First Year of Grief and Bereavement in Close Family Members to Individuals Who Have Died of Cancer. - Palliative Medicine - 200103; - 15(- 2):- 91, - 105. 6. Brumley RD, Enguidanos S, Cherin DA. Effectiveness of a home-based palliative care program for end-of-life. J Palliat Med 2003; 6(5):715-24. 16. 7. Brumley R, Enguidanos S, Jamison P et al. Increased satisfaction with care and lower costs: results of a randomized trial of in-home palliative care. J Am Geriatr Soc 2007; 55(7):993-1000. - Ringdal GI, - Jordhoy MS, - Kaasa S. - Family Satisfaction With End-ofLife Care for Cancer Patients in a Cluster Randomized Trial. - Journal of Pain & Symptom Management - 200207; - 24(- 1):- 53, - 63. 17. Casarett D, Karlawish J, Morales K, Crowley R, Mirsch T, Asch DA. Improving the use of hospice services in nursing homes: a randomized controlled trial. JAMA 2005; 294(2):211-7. Luhrs CA, Meghani S, Homel P et al. Pilot of a pathway to improve the care of imminently dying oncology inpatients in a Veterans Affairs Medical Center. J Pain Symptom Manage 2005; 29(6):544-51. 18. McMillan SC, Small BJ, Haley WE. Improving hospice outcomes through systematic assessment: a clinical trial. Cancer Nurs 2011; 34(2):89-97. 19. Mitchell GK, Del Mar CB, O'Rourke PK, Clavarino AM. Do case conferences between general practitioners and specialist palliative care services improve quality of life? A randomised controlled trial (ISRCTN 52269003). Palliative Medicine 2008; 22(8):904-12. 20. Moore S, Corner J, Haviland J et al. Nurse led follow up and conventional medical follow up in management of patients with lung cancer: randomised trial. BMJ 2002; 325(7373):1145. 8. 9. 10. 11. Cohen LM, Ruthazer R, Germain MJ. Increasing hospice services for elderly patients maintained with hemodialysis. J Palliat Med 2010; 13(7):847-54. Dudgeon DJ, Knott C, Eichholz M et al. Palliative Care Integration Project (PCIP) quality improvement strategy evaluation. J Pain Symptom Manage 2008; 35(6):573-82. Engelhardt JB, McClive-Reed KP, Toseland RW, Smith TL, Larson DG, Tobin DR. Effects of a program for coordinated care of advanced illness on E-22 21. Pantilat SZ, O'Riordan DL, Dibble SL, Landefeld CS. Hospital-based palliative medicine consultation: a randomized controlled trial. Arch Intern Med 2010; 170(22):2038-40. 24. Temel JS, Greer JA, Muzikansky A et al. Early palliative care for patients with metastatic non-small-cell lung cancer. The New England Journal of Medicine 2010; 363(8):733-42. 22. Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med 2004; 164(1):83-91. 25. 23. Reymond L, Israel FJ, Charles MA. A residential aged care end-of-life care pathway (RAC EoLCP) for Australian aged care facilities. Aust Health Rev 2011; 35(3):350-6. van der Heide A, Veerbeek L, Swart S, van der Rijt C, van der Maas PJ, van Zuylen L. End-of-life decision making for cancer patients in different clinical settings and the impact of the LCP. J Pain Symptom Manage 2010; 39(1):33-43. 26. Woo J, Cheng JO, Lee J et al. Evaluation of a continuous quality improvement initiative for end-of-life care for older noncancer patients. J Am Med Dir Assoc 2011; 12(2):105-13. E-23 Evidence Table 3. Description of quality improvement elements in studies addressing continuity, coordination of care, and transitions Provider reminder system? No Facilitated relay of clinical data to providers? Yes Audit and feedback? No Badger, 2 2009 Yes Yes Bailey, 3 2005 Yes Bakitas, 4 2009 Provider education? No Coaching collaborative skills training? No Patient family caregiver education? Yes Promotion of selfManagement? Yes Organizational change? Yes Other? No Yes Yes Yes No No Yes No Yes No Yes Yes No No No No No No No No No Yes Yes Yes No Bookbinder, 5 2005 Yes Yes No Yes Yes No No No No Brumley, 6 2003 No No No Yes No Yes Yes Yes No Brumley, 7 2007 Casarett, 8 2005 No No No Yes No Yes Yes Yes No No Yes No No No No No No No Cohen, 9 2010 No No No No No No No Yes No Dudgeon, 10 2008 Yes Yes No Yes No No No No No Engelhardt, 11 2006 No Yes No No No Yes Yes Yes No Hughes, 12 2000 No No No No No No Yes Yes No Author, year 1 Aiken, 2006 E-24 Evidence Table 3. Description of quality improvement elements in studies addressing continuity, coordination of care, and transitions (continued) Provider reminder system? No Facilitated relay of clinical data to providers? No Audit and feedback? No Luhrs, 17 2005 No No McMillan, 18 2011 Yes Mitchell, 19 2008 Provider education? Yes Coaching collaborative skills training? No Patient family caregiver education? Yes Promotion of selfManagement? Yes Organizational change? Yes Other? No No No No No Yes Yes No Yes No No No No No Yes No No Yes No No No No No Yes No Moore, 20 2002 No Yes No No No No No Yes No Pantilat, 21 2010 Yes Yes No No No No No Yes No Rabow, 22 2004 No Yes No No No Yes No Yes No Reymond, 23 2011 Yes No N Yes N No No No No Temel, 24 2010 No No No No No Yes Yes No Yes Author, year Jordhoy, 13 2000 , Jordhoy, 14 2001 , Ringdal, 15 2001 , Ringdal, 16 2002 E-25 Evidence Table 3. Description of quality improvement elements in studies addressing continuity, coordination of care, and transitions (continued) Author, year Van der Heide, 25 2010 Woo, 2011 26 Provider reminder system? Yes Facilitated relay of clinical data to providers? No Audit and feedback? No Yes Yes No Provider education? No Coaching collaborative skills training? No Patient family caregiver education? No Promotion of selfManagement? No Organizational change? No Other? No Yes Yes Yes No No No Evidence Table 3 Reference List 1. Aiken LS, Butner J, Lockhart CA, Volk-Craft BE, Hamilton G, Williams FG. Outcome evaluation of a randomized trial of the PhoenixCare intervention: program of case management and coordinated care for the seriously chronically ill. J Palliat Med 2006; 9(1):111-26. controlled trial. JAMA 2005; 294(2):211-7. 9. Cohen LM, Ruthazer R, Germain MJ. Increasing hospice services for elderly patients maintained with hemodialysis. J Palliat Med 2010; 13(7):847-54. 2. Badger F, Clifford C, Hewison A, Thomas K. An evaluation of the implementation of a programme to improve end-of-life care in nursing homes. Palliat Med 2009; 23(6):502-11. 10. Dudgeon DJ, Knott C, Eichholz M et al. Palliative Care Integration Project (PCIP) quality improvement strategy evaluation. J Pain Symptom Manage 2008; 35(6):573-82. 3. Bailey FA, Burgio KL, Woodby LL et al. Improving processes of hospital care during the last hours of life. Arch Intern Med 2005; 165(15):1722-7. 11. 4. Bakitas M, Lyons KD, Hegel MT et al. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA 2009; 302(7):741-9. Engelhardt JB, McClive-Reed KP, Toseland RW, Smith TL, Larson DG, Tobin DR. Effects of a program for coordinated care of advanced illness on patients, surrogates, and healthcare costs: a randomized trial. Am J Manag Care 2006; 12(2):93-100. 12. Bookbinder M, Blank AE, Arney E et al. Improving end-of-life care: development and pilot-test of a clinical pathway. J Pain Symptom Manage 2005; 29(6):529-43. Hughes SL, Weaver FM, Giobbie-Hurder A et al. Effectiveness of teammanaged home-based primary care: a randomized multicenter trial. JAMA: the Journal of the American Medical Association 2000; 284(22):2877-85. 13. - Jordhoy MS, - Fayers P, - Saltnes T, - Ahlner-Elmqvist M, - Jannert M, Kaasa S. - A Palliative-Care Intervention and Death at Home: a Cluster Randomised Trial. - Lancet - 200009092000 Sep 9; - 356(- 9233):- 888, 893. 5. 6. Brumley RD, Enguidanos S, Cherin DA. Effectiveness of a home-based palliative care program for end-of-life. J Palliat Med 2003; 6(5):715-24. 7. Brumley R, Enguidanos S, Jamison P et al. Increased satisfaction with care and lower costs: results of a randomized trial of in-home palliative care. J Am Geriatr Soc 2007; 55(7):993-1000. 14. Jordhoy MS, Fayers P, Loge JH, Ahlner-Elmqvist M, Kaasa S. Quality of life in palliative cancer care: results from a cluster randomized trial. J Clin Oncol 2001; 19(18):3884-94. 8. Casarett D, Karlawish J, Morales K, Crowley R, Mirsch T, Asch DA. Improving the use of hospice services in nursing homes: a randomized 15. - Ringdal GI, - Jordhoy MS, - Ringdal K, - Kaasa S. - The First Year of Grief and Bereavement in Close Family Members to Individuals Who Have Died E-26 of Cancer. - Palliative Medicine - 200103; - 15(- 2):- 91, - 105. 16. 17. 18. 19. 20. 21. palliative medicine consultation: a randomized controlled trial. Arch Intern Med 2010; 170(22):2038-40. - Ringdal GI, - Jordhoy MS, - Kaasa S. - Family Satisfaction With End-ofLife Care for Cancer Patients in a Cluster Randomized Trial. - Journal of Pain & Symptom Management - 200207; - 24(- 1):- 53, - 63. 22. Luhrs CA, Meghani S, Homel P et al. Pilot of a pathway to improve the care of imminently dying oncology inpatients in a Veterans Affairs Medical Center. J Pain Symptom Manage 2005; 29(6):544-51. Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med 2004; 164(1):83-91. 23. Reymond L, Israel FJ, Charles MA. A residential aged care end-of-life care pathway (RAC EoLCP) for Australian aged care facilities. Aust Health Rev 2011; 35(3):350-6. 24. Temel JS, Greer JA, Muzikansky A et al. Early palliative care for patients with metastatic non-small-cell lung cancer. The New England Journal of Medicine 2010; 363(8):733-42. 25. van der Heide A, Veerbeek L, Swart S, van der Rijt C, van der Maas PJ, van Zuylen L. End-of-life decision making for cancer patients in different clinical settings and the impact of the LCP. J Pain Symptom Manage 2010; 39(1):33-43. 26. Woo J, Cheng JO, Lee J et al. Evaluation of a continuous quality improvement initiative for end-of-life care for older noncancer patients. J Am Med Dir Assoc 2011; 12(2):105-13. McMillan SC, Small BJ, Haley WE. Improving hospice outcomes through systematic assessment: a clinical trial. Cancer Nurs 2011; 34(2):89-97. Mitchell GK, Del Mar CB, O'Rourke PK, Clavarino AM. Do case conferences between general practitioners and specialist palliative care services improve quality of life? A randomised controlled trial (ISRCTN 52269003). Palliative Medicine 2008; 22(8):904-12. Moore S, Corner J, Haviland J et al. Nurse led follow up and conventional medical follow up in management of patients with lung cancer: randomised trial. BMJ 2002; 325(7373):1145. Pantilat SZ, O'Riordan DL, Dibble SL, Landefeld CS. Hospital-based E-27 Evidence Table 4. Risk of bias assessment of studies addressing continuity, coordination of care, and transitions Author, year 1 Aiken, 2006 2 Badger, 2009 3 Bailey, 2005 Bakitas, 4 2009 Bookbinder, 5 2005 Brumley, 6 2003 Brumley, 7 2007 Casarett, 8 2005 9 Cohen, 2010 Dudgeon, 10 2008 Engelhardt , 11 2006 Hughes, 12 2000 Jordhoy, 13 2000 , 14 2001 , Ringdal, 15 2001 , 16 2002 17 Luhrs, 2005 McMillan, 18 2011 Mitchell, 19 2008 20 Moore, 2002 Pantilat, 21 2010 Rabow, 22 2004 Sequence generation Yes No No Yes Allocation concealment Yes No No Unclear Binding of personnel (shortterm outcomes) Yes No No No Blinding of outcome assessors (short-term outcomes) Yes No No Unclear Binding of personnel (long-term outcomes) Yes No No No Blinding of outcome assessors (long-term outcomes) Yes No No Unclear Incomplete outcome data (shortterm outcomes) Yes No Yes Yes Incomplete outcome data (longterm outcomes) Yes No Yes Yes Selective outcome reporting Unclear Unclear Yes Yes Other sources of bias Yes Yes Yes Yes No No No No No No Yes Yes No No No No No Yes No Yes Unclear Unclear Yes Yes Yes Yes No Yes No Yes Yes Yes No No Yes Yes No No No No Yes Yes Yes Yes No No No No No No No No No No No No Unclear Unclear Unclear Unclear Yes Yes Yes Yes Yes Unclear No No No No No No Yes Yes Unclear No No No No Yes Yes Yes Yes Unclear Unclear No No No No Yes No Yes Yes No Unclear No No No No No No No No No Yes Unclear Yes Unclear Yes Yes Yes Yes Yes Yes No No No No Yes Yes No No Yes Unclear Yes No No No No Yes No No No Yes Unclear Unclear Unclear Unclear Yes Yes Yes No No No No No No Yes Yes Yes Yes Yes E-28 Evidence Table 4. Risk of bias assessment of studies addressing continuity, coordination of care, and transitions Sequence generation No Allocation concealment No Author, year Reymond, 23 2011 24 Temel, 2010 Unclear Unclear Van der No No 25 Heide, 2010 26 Woo, 2011 No No Evidence Table 4 Reference List 1. Binding of personnel (shortterm outcomes) No Blinding of outcome assessors (short-term outcomes) No Binding of personnel (long-term outcomes) No Blinding of outcome assessors (long-term outcomes) No Incomplete outcome data (shortterm outcomes) Y Incomplete outcome data (longterm outcomes) Yes Selective outcome reporting No Other sources of bias No No No No No No No No No Yes Unclear Yes Unclear No Yes Yes Yes No No No No Unclear Unclear No Yes Aiken LS, Butner J, Lockhart CA, Volk-Craft BE, Hamilton G, Williams FG. Outcome evaluation of a randomized trial of the PhoenixCare intervention: program of case management and coordinated care for the seriously chronically ill. J Palliat Med 2006; 9(1):111-26. 10. Dudgeon DJ, Knott C, Eichholz M et al. Palliative Care Integration Project (PCIP) quality improvement strategy evaluation. J Pain Symptom Manage 2008; 35(6):573-82. 2. Badger F, Clifford C, Hewison A, Thomas K. An evaluation of the implementation of a programme to improve end-of-life care in nursing homes. Palliat Med 2009; 23(6):502-11. 11. 3. Bailey FA, Burgio KL, Woodby LL et al. Improving processes of hospital care during the last hours of life. Arch Intern Med 2005; 165(15):1722-7. Engelhardt JB, McClive-Reed KP, Toseland RW, Smith TL, Larson DG, Tobin DR. Effects of a program for coordinated care of advanced illness on patients, surrogates, and healthcare costs: a randomized trial. Am J Manag Care 2006; 12(2):93-100. 12. 4. Bakitas M, Lyons KD, Hegel MT et al. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA 2009; 302(7):741-9. Hughes SL, Weaver FM, Giobbie-Hurder A et al. Effectiveness of teammanaged home-based primary care: a randomized multicenter trial. JAMA: the Journal of the American Medical Association 2000; 284(22):2877-85. 13. 5. Bookbinder M, Blank AE, Arney E et al. Improving end-of-life care: development and pilot-test of a clinical pathway. J Pain Symptom Manage 2005; 29(6):529-43. - Jordhoy MS, - Fayers P, - Saltnes T, - Ahlner-Elmqvist M, - Jannert M, Kaasa S. - A Palliative-Care Intervention and Death at Home: a Cluster Randomised Trial. - Lancet - 200009092000 Sep 9; - 356(- 9233):- 888, 893. 6. Brumley RD, Enguidanos S, Cherin DA. Effectiveness of a home-based palliative care program for end-of-life. J Palliat Med 2003; 6(5):715-24. 14. 7. Brumley R, Enguidanos S, Jamison P et al. Increased satisfaction with care and lower costs: results of a randomized trial of in-home palliative care. J Am Geriatr Soc 2007; 55(7):993-1000. Jordhoy MS, Fayers P, Loge JH, Ahlner-Elmqvist M, Kaasa S. Quality of life in palliative cancer care: results from a cluster randomized trial. J Clin Oncol 2001; 19(18):3884-94. 15. Casarett D, Karlawish J, Morales K, Crowley R, Mirsch T, Asch DA. Improving the use of hospice services in nursing homes: a randomized controlled trial. JAMA 2005; 294(2):211-7. - Ringdal GI, - Jordhoy MS, - Ringdal K, - Kaasa S. - The First Year of Grief and Bereavement in Close Family Members to Individuals Who Have Died of Cancer. - Palliative Medicine - 200103; - 15(- 2):- 91, - 105. 16. - Ringdal GI, - Jordhoy MS, - Kaasa S. - Family Satisfaction With End-ofLife Care for Cancer Patients in a Cluster Randomized Trial. - Journal of Pain & Symptom Management - 200207; - 24(- 1):- 53, - 63. 8. 9. patients maintained with hemodialysis. J Palliat Med 2010; 13(7):847-54. Cohen LM, Ruthazer R, Germain MJ. Increasing hospice services for elderly E-29 17. Luhrs CA, Meghani S, Homel P et al. Pilot of a pathway to improve the care of imminently dying oncology inpatients in a Veterans Affairs Medical Center. J Pain Symptom Manage 2005; 29(6):544-51. 22. Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med 2004; 164(1):83-91. 18. McMillan SC, Small BJ, Haley WE. Improving hospice outcomes through systematic assessment: a clinical trial. Cancer Nurs 2011; 34(2):89-97. 23. 19. Mitchell GK, Del Mar CB, O'Rourke PK, Clavarino AM. Do case conferences between general practitioners and specialist palliative care services improve quality of life? A randomised controlled trial (ISRCTN 52269003). Palliative Medicine 2008; 22(8):904-12. Reymond L, Israel FJ, Charles MA. A residential aged care end-of-life care pathway (RAC EoLCP) for Australian aged care facilities. Aust Health Rev 2011; 35(3):350-6. 24. Temel JS, Greer JA, Muzikansky A et al. Early palliative care for patients with metastatic non-small-cell lung cancer. The New England Journal of Medicine 2010; 363(8):733-42. 25. van der Heide A, Veerbeek L, Swart S, van der Rijt C, van der Maas PJ, van Zuylen L. End-of-life decision making for cancer patients in different clinical settings and the impact of the LCP. J Pain Symptom Manage 2010; 39(1):33-43. 26. Woo J, Cheng JO, Lee J et al. Evaluation of a continuous quality improvement initiative for end-of-life care for older noncancer patients. J Am Med Dir Assoc 2011; 12(2):105-13. 20. Moore S, Corner J, Haviland J et al. Nurse led follow up and conventional medical follow up in management of patients with lung cancer: randomised trial. BMJ 2002; 325(7373):1145. 21. Pantilat SZ, O'Riordan DL, Dibble SL, Landefeld CS. Hospital-based palliative medicine consultation: a randomized controlled trial. Arch Intern Med 2010; 170(22):2038-40. E-30 Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions Outcome measures QOL Author, Year 1 Aiken, 2006 Patient symptoms LOS Other Badger, 2009 2 Measures SF 36 Sample size 192 Disparities None Outcomes: Benefits. Significantly improved Memorial Symptom Assessment Scale Outcomes: Benefits. Not Outcomes: significantly improved Harms 68 measurements=NS Other key information Difficulties with recruitment led to smaller enrollment than planned; Significant attrition (13 died or went to hospice in 1st 3 months) (only 25% of control group still participating at end of data collection); reported that COPD showed stronger response Frequency and severity=NS LOS=NS AD Quality of care measures Other Self management and knowledge Death in the care home Other Crisis hospitalization 71% vs. 65% p =0.05, OR 4.47, [CI: 1.10, 18.18] Statistics not reported at time 6 where it would be NS 46 and 36 measurements at all time point=NS 437 None 81% before vs. 88.5% after, p<0.001 38% vs. 26% after, p=0.001 E-31 Evidence that the GSF was implemented in the care homes; Crisis events, advanced care plan in place, access to as required medications, last days of life care pathway, written information to family all significantly Improved Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Outcome measures Other Author, Year 3 Bailey, 2005 Other Other Other 4 Bakitas, 1077 Quality of care measures QOL Patient symptoms Resource use Psychosocial symptoms and support Measures DNR orders Sample size 203 Disparities None Location of death Opioid orders at death Outcomes: Benefits. Not significantly improved 57.1% vs. 83.2% (P=฀.001). NS 322 None 1.7 (SD 2.1) vs. 4.4 (SD 2.7) (P=฀.001) Intervention: higher QOL (mean [SE], 4.6 [2]; P=.02); None Symptom intensity Hospital LOS, ICU LOS, # ER visits; survival CES-D Outcomes: Harms Significant increase in documented use of restraints Patients dying in ICU Nasogastric tube at death Symptom documentation Functional Assessment of Chronic Illness Therapy for Palliative Care ESAS Outcomes: Benefits. Significantly improved 61.9% vs. 85.1% (P=฀.001) Mood: CES-D score, (mean[SE], -1.8 [0.81]; p=0.02) E-32 Other key information This intervention went beyond ordinary education to facilitate change in staff practice patterns by providing tools (pocket card reminders, supportive policy changes, and a structured order set) to reinforce and guide care plans; concurrent implementation of other restraint policies may have caused restraint finding; also significant increase in documentation of care plans Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Outcome measures Symptoms assessed, problematic symptoms identified, # interventions, # inpatient consultations Author, Year Bookbinder, 5 2005 6 Brumley, 2003 Satisfaction Sample Measures size 257 Chart Abstraction Tool (CAT) - indices on admission Referral data, end-of-life decision making, symptom assessment management, death, and resource utilization data Reid-Gundlach satisfaction of service 300 Disparities None None Service use Cost Satisfaction Reid-Gundlach satisfaction of service 297 Outcomes: Benefits. Significantly improved None Outcomes: Benefits. Not significantly Outcomes: improved Harms Number of symptoms assessed increased significantly in both comparison and study units.(Only within group comparisons) Within-group comparison= useless F=13.953; p = 0.001 $7,990 vs.$14,570 p<.001 At 30 days At 60 days OR=3.37, 95% CI=1.42–8.10; P=.006 and 90 days,(OR=3.37, 95% CI=0.65– 4.96; P=.03) E-33 Other key information Pilot testing. Some CAT indices increased significantly on all units - possible indication of diffusion of educationcultural change despite not implementing the pathway; other changes were significant in the inpatient palliative care unit but not in the geriatrics or oncology units - 100% of patients in the inpatient palliative care unit but only 33% of patients in the latter 2 units were placed on the pathway; non-VA setting Lowered service use and costs while maintaining satisfaction. Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Outcome Author, Year measures 6 Brumley, 2003 Service use (continued) Cost 7 Casarett, 2005 Hospice enrollment Quality of care measures Hospice enrollment LOS Location of death 8 Cohen, 2010 Use of hospice services Measures Sample size Disparities Overall costs Enrollment within 30 days 205 None reported in results Toolkit After death Survey Outcomes: Benefits. Significantly improved ED visits: 20% vs. 33% p=0.01, hospitalizations : 36% vs. 59% p<.001. LOS p<.001 P=.03; 95% CI= $12,411 to $780 21107 [20%] vs. 198 [1%]; P= .001; 95% confidence interval [CI], 1.345.19)(number needed to treat [NNT]=5). 4.3(SD 1.01) vs. 2.2 (1.47), p=0.01 At time of death Outcomes: Benefits. Not significantly improved Outcomes: Harms Other key information Also significantly different hospice enrollment within 6 months, # of acute care admissions, and days spent in an acute care setting Enrolled in hospice at time of death LOS 133 The resident died where heshe would have wanted Use of hospice None services None Discontinuati on of dialysis Discontinuation of dialysis E-34 In a subgroup of patients >65 the primary outcome of utilization of hospice services improved significantly (p<0.05) Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Author, Year Dudgeon, 9 2008 Outcome measures Patient symptoms Satisfaction Frequency and duration of hospital stay Measures Edmonton Symptom assessment scale , FAMCARE Scale, Chart Audits, PsychoCare-giver social assessment symptoms and support; Caregiver burden Quality of care measures; Location of death, Sample size 200 Disparities None Outcomes: Benefits. Significantly improved Outcomes: Benefits. Not significantly Outcomes: improved Harms ESAS(NS),Sympto None m score(NS) FAMCARE(NS), AC admission Death(NS), Chart Audits (35=NS), (p<0.001) 476513 patients (92.8%) in 2001 vs 497570 (87.2%) in 2002, 498579 in 2003 (86.0%) CRA(NS) Location of death (NS), E-35 Other key information The study showed minimal improvements. Challenge: conducted during SARS. Lessons: takes longer to implement projects than anticipated, standardized documentation should be in place prior to initiating such a project Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Outcome measures Satisfaction Author, Year Engelhardt, 10 2006 Hughes, 2000 11 Sample Measures size 275 EOL Family interview, Likert scale, Quality of care measures; Documentati on, AD and DNR , cost QOL MOS SF-36 Satisfaction; Ware patient Satisfaction with Care scales Functional Barthel score status Psychosocial Montgomery symptoms scale, and support; Caregiver burden Readmission Satisfaction; Caregiver Disparities None 188 None patients, 289 caregiver s Outcomes: Benefits. Significantly improved Patient satisfaction (p=0.03, effect size=0.18), Problems reported by surrogates(p=0. 03, effect size=0.39), AD (p=0.01) Outcomes: Benefits. Not significantly Outcomes: improved Harms Attitudes about None participation in treatment decisions (NS), Cost, DNR 68 scales improved for both patients and caregivers Abstracted the results for the terminally ill group only; utilization not reported separately for this group; Intervention is not described in detail 66 outcomes=NS NS NS NS 56 scales improved E-36 Other key information Don't report all caregiver outcomes Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Author, Year 12 Luhrs, 2005 Jordhoy, 13 14 2000 , 2000 , 15 Ringdal 2002 , 16 2001 Outcome measures Quality of care measures Quality of care measures; Place of death Quality of care measures; % of nursing home deaths Measures EOL-CAT Home or institution Sample size 39 434 Disparities None Not addressed Outcomes: Benefits. Significantly improved 35 Interventions on last day decreased significantly, more patients were identified as dying and comfort care plan increased significantly, significantly more symptoms assessed and managed (0.5 comparison vs. 1.0 intervention, p=.02) More frequently home for intervention group (25%) than control group (15%), p=0.02 adjusted Less frequent in intervention group (9%) than control group (21) p=0.01 E-37 Outcomes: Benefits. Not significantly improved No difference in survival Outcomes: Harms Increased LOS in PCAD group Other key information Same intervention in a VA setting acute care oncology unit. QI interdisciplinary team and education of staff assisted in implementation; commitment of leadership and involvement of attending physicians, as well as discussion at monthly staff meetings; 64.7% of patients in the intervention period who died were placed on PCAD. No change in practice in a concurrently measured group on another unit. Family satisfaction was collected but response rate too low for analysis PC intervention allowed more pts to die at home, however no increase in overall proportion of time spent at home. PC led to less use of nursing homes, but in Norway nursing home beds are sometimes used as substitutes for inpatient hospital beds Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Author, Year Jordhoy, 13 14 2000 , 2000 , 15 Ringdal 2002 , 16 2001 (continued) Outcome Sample measures Measures size Days spent in Days in hospital hospital in the last month of life Disparities Outcomes: Benefits. Significantly improved % of hospital deaths Outcomes: Benefits. Not significantly improved NS NS QOL European Organization for Research and Treatment of Cancer Quality of Life-C30 EORTC QLQC30 NS Other Impact of Event Scales IESmeasures how pts react to stressful events like having cancer NS for psychological distress, pain, physical and emotional functioning p>.1 E-38 Outcomes: Harms Other key information Significantly less time spent in NH but % of admissions not different Possible reasons - conventional care is generally good for only marginal improvements (some control groups also focused on palliative care); also trial started just after the PMU was opened so may not have been optimally skilled; strongly based on community service with limited palliative care competence; study in Norway Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Outcome Author, Year measures 15 Ringdal, 2002 Family members satisfaction with care Ringdal, 2001 Mcmillan, 17 2011 16 Sample Measures size FAMCARE 182 scale-looks at close family members satisfaction with care Grief Texas Revised Inventory of F=Grief-TRIG QOL HQLI 14 Patient symptoms MSAS CES-D 183 Disparities Not addressed Outcomes: Benefits. Significantly improved Intervention group "reported lowest scores, that is highest satisfaction with care on all items except item 6 "availability of hospital bed, and item 14 times required to make diagnosis. In total 11 of 18 items were significant Outcomes: Benefits. Not significantly improved Not addressed NS differences in grief reactions between the family members of the two groups at any point in time. None NS NS Estimate -0.03, SE 0.01, p=0.02 CES-D NS E-39 Outcomes: Harms Other key information Children of the deceased were least satisfied with care p<.001, males were more satisfied with care than females p<.015, "results should be interpreted with caution. Most close family members were aware that the trial was connected to the PMU and may have been reluctant to give criticism." More pts in the intervention group died at home than in the control group. "Attrition caused by refusal and withdrawal findings may not be representative for the two groups (intervention and control) and should be interpreted with caution" Attrition rate was higher in the control group Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Outcome Author, Year measures 18 Mitchell, 2008 QOL; At 3 weeks Career burden Moore, 2002 19 QOL Satisfaction; Patient Survival Cost Use of service Sample Measures size Assessment of 159 Quality of life at the End of Life Mcgill Quality of Life Questionnaire Subjective Wellbeing Scale Caregiver Reaction Assessment European 202 Organization for Research and Treatment of Cancer's core questionnaire Disparities None Outcomes: Benefits. Significantly improved Outcomes: Benefits. Not significantly improved NS NS NS Most time points =NS None 1314 items are NS 55 items p>0.05 Fewer admission to hospitals, more died at home E-40 NS NS 1116 items are NS Outcomes: Harms Other key information Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Outcome Author, Year measures 20 Pantilat, 2010 Pain scores Rabow, 2004 21 Measures Scoring from 110 Sample size 107 Disparities None Outcomes: Benefits. Significantly improved Outcomes: Benefits. Not significantly improved NS Patient symptoms; Anxiety Patient symptoms; Dyspnea Quality of care measures; Care, Preferences, Prognosis, and Spiritual Care QOL Scoring from 110 NS Scoring from 110 NS Pain scores Brief Pain Inventory CES-DProfile of Mood States Outcomes: Harms Other key information Reasons for ineffectiveness may have included - physician onlybased intervention rather than multidisciplinary, and intervening on chronically ill patients not otherwise referred for palliative care NS Multidimensional 90 Quality of Life Scale– Cancer Version Patient symptoms; DepressionA nxiety Other Spiritual WellBeing Scale None NS NS NS Improved 7.5 vs. 1.5: p=0.05 E-41 Most effective in improving outcomes that the team could influence directly, via provision of services, education, and support. Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Outcome Author, Year measures 21 Rabow, 2004 Satisfaction (continued) Measures Group Health Association of America Consumer Satisfaction Survey Sample size Disparities Patient symptoms; Dyspnea Reymond, 22 2011 Outcomes: Benefits. Significantly improved Outcomes: Harms Other key information Reporting of any Dyspnea: OR=6.07; 95% CI= 1.04-35.56 Costs Total hospital days Quality of Utilization Care NS NS 299 NR 298 None Transfer to hospital: 12% (31253) postvs 21.7% (1046) pre-; no statistics given Bereaved families evaluations of care no significant change DNR agreements, options of last resort discussed Satisfaction V.d. Heide, 23 2010 Outcomes: Benefits. Not significantly improved NS E-42 Only 47% of dying residents were placed on the pathway during the implementation period Differences in end-of-life medication use with use of the LCP Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Author, Year 24 Woo, 2011 Outcome measures Patient symptoms Measures Symptom checklist QOL; Cost of care Caregiver Index QOL; Patient Mc Gill QOL Questionnaire Satisfaction; 10 point scale Patient (caregiverreported) QOL; SF-12 Caregiver Service use ER admissions, LOS, X-rays, Blood tests Satisfaction; 10 point scale Caregiver Distress Chinese Death Anxiety Inventory Sample size 169 Disparities None Outcomes: Benefits. Significantly improved Pain improved OR=0.25, CI=0,13-0.52, p<0.001 Outcomes: Benefits. Not significantly improved 1820Symptoms =NS NS Not reported 7.54pre vs. 8.24 post, p=0.029 NS Significantly ER admissions, less acute care Non acute care admissions, admissions LOS, X-rays, blood tests 7.8 pre vs. 8.56 post, p=0.017 Not reported for patients E-43 Outcomes: Harms Other key information Hong Kong; used PDSA, developed own care pathway and other forms; communication skills workshops in addition to extensive seminars; revision of intervention based on feedback Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Author, Year 25 Temel, 2010 Outcome measures QOL Sample Measures size Trial Outcome 151 Index (TOI)-sum of scores on the Lung Cancer Subscale and the physical well-being and functional wellbeing subscales of the Functional Assessment of Cancer Therapy–Lung Scale Disparities African American (4%), Asian (1%), Hispanic (1%) Outcomes: Benefits. Significantly improved TOI Control 53.0+ 11.5- vs. intervention 59.0 +- 11.6 (P = 0.009) 95%CI 1.5-10.4). Effect size 0.52; FACT-L and LCS also statistically significantly different E-44 Outcomes: Benefits. Not significantly improved Outcomes: Harms None Other key information Average # of palliative care visits was 4;14% in control group had palliative care - all 12 visits; duration, 11 days in intervention group vs. 4 days in control group (P = 0.09) insufficient sample size for statistics on other indicators, such as chemotherapy, but rates were lower in intervention group Highly-specialized academic center and advanced palliative care program. Evidence Table 5. Outcomes reported in studies addressing continuity, coordination of care, and transitions (continued) Outcomes: Outcomes: Benefits. Benefits. Not Significantly significantly Outcome Sample Outcomes: Author, Year measures Measures size Disparities improved improved Harms Other key information 25 Fewer Hospital Anxiety Temel, 2010 Distress; depressive Mood, patient and Depression (continued) depressive symptoms in Scale and the symptoms Intervention Patient Health Questionnaire 9 16% vs control 38%,(P = 0.01) on HADS-D; also statistically significant for PHQ-9 Fewer received All: chemotherapy, Health care Overall for those overall use who died, all: ER visits, any aggressive chemo-therapy, admissions until end-of-life care death ER visits, any in intervention admissions until group 33% vs. death Control 54% (P =0.05) Survival Longer median survival in intervention group 11.6 months vs. Control 8.9 months (P = 0.02) Abbreviations: AD=Advanced Directives; AQEL=Assessment of Quality of life at the End of Life; CAT=Chart Abstraction Toll; CCCI=Cost of care Index ; CES-D=Center for Epidemiologic Studies Depression Scale; COPD=Chronic Obstructive Pulmonary Airway Disease; CRA=Care Giver Assessment; DNR=Do Not Resuscitate; EOL=End of Life; EORTC=European Organization for Research and Treatment of Cancer's core; ER=Emergency Room; ESAS=Edmonton Symptom assessment scale; FACT-L=Functional Assessment of Cancer Therapy–Lung; GSF=Gold Standard Framework; HADS-D=Hospital Anxiety and Depression Scale; ICU=Intensive Care Unit; LCS=Lung Cancer Scale; LOS=Length of Stay; NS=Not Significant; PHQ=Patient Health Questionnaire; PHQ-9=Patient Health Questionnaire 9; QOL=Quality of Life; SCL=Symptom Checklist; SE=Standard Error; SF=Significant Finding Evidence Table 5 Reference List 1. Aiken LS, Butner J, Lockhart CA, Volk-Craft BE, Hamilton G, Williams FG. Outcome evaluation of a randomized trial of the PhoenixCare intervention: program of case management and coordinated care for the seriously chronically ill. J Palliat Med 2006; 9(1):111-26. 2. E-45 Badger F, Clifford C, Hewison A, Thomas K. An evaluation of the implementation of a programme to improve end-of-life care in nursing homes. Palliat Med 2009; 23(6):502-11. 3. 4. 5. Bailey FA, Burgio KL, Woodby LL et al. Improving processes of hospital care during the last hours of life. Arch Intern Med 2005; 165(15):1722-7. Geiger TM, Miedema BW, Geana MV, Thaler K, Rangnekar NJ, Cameron GT. Improving rates for screening colonoscopy: Analysis of the health information national trends survey (HINTS I) data. Surg Endosc 2008; 22(2):527-33. Bookbinder M, Blank AE, Arney E et al. Improving end-of-life care: development and pilot-test of a clinical pathway. J Pain Symptom Manage 2005; 29(6):529-43. 6. Brumley RD, Enguidanos S, Cherin DA. Effectiveness of a home-based palliative care program for end-of-life. J Palliat Med 2003; 6(5):715-24. 7. Casarett D, Karlawish J, Morales K, Crowley R, Mirsch T, Asch DA. Improving the use of hospice services in nursing homes: a randomized controlled trial. JAMA 2005; 294(2):211-7. 8. Cohen LM, Ruthazer R, Germain MJ. Increasing hospice services for elderly patients maintained with hemodialysis. J Palliat Med 2010; 13(7):847-54. 9. Dudgeon DJ, Knott C, Eichholz M et al. Palliative Care Integration Project (PCIP) quality improvement strategy evaluation. J Pain Symptom Manage 2008; 35(6):573-82. 10. Engelhardt JB, McClive-Reed KP, Toseland RW, Smith TL, Larson DG, Tobin DR. Effects of a program for coordinated care of advanced illness on patients, surrogates, and healthcare costs: a randomized trial. Am J Manag Care 2006; 12(2):93-100. 11. Hughes SL, Weaver FM, Giobbie-Hurder A et al. Effectiveness of teammanaged home-based primary care: a randomized multicenter trial. JAMA: the Journal of the American Medical Association 2000; 284(22):2877-85. 12. Luhrs CA, Meghani S, Homel P et al. Pilot of a pathway to improve the care of imminently dying oncology inpatients in a Veterans Affairs Medical Center. J Pain Symptom Manage 2005; 29(6):544-51. 13. - Jordhoy MS, - Fayers P, - Saltnes T, - Ahlner-Elmqvist M, - Jannert M, Kaasa S. - A Palliative-Care Intervention and Death at Home: a Cluster Randomised Trial. - Lancet - 200009092000 Sep 9; - 356(- 9233):- 888, 893. 14. life in palliative cancer care: results from a cluster randomized trial. J Clin Oncol 2001; 19(18):3884-94. Jordhoy MS, Fayers P, Loge JH, Ahlner-Elmqvist M, Kaasa S. Quality of E-46 15. - Ringdal GI, - Jordhoy MS, - Kaasa S. - Family Satisfaction With End-ofLife Care for Cancer Patients in a Cluster Randomized Trial. - Journal of Pain & Symptom Management - 200207; - 24(- 1):- 53, - 63. 16. - Ringdal GI, - Jordhoy MS, - Ringdal K, - Kaasa S. - The First Year of Grief and Bereavement in Close Family Members to Individuals Who Have Died of Cancer. - Palliative Medicine - 200103; - 15(- 2):- 91, - 105. 17. McMillan SC, Small BJ, Haley WE. Improving hospice outcomes through systematic assessment: a clinical trial. Cancer Nurs 2011; 34(2):89-97. 18. Mitchell GK, Del Mar CB, O'Rourke PK, Clavarino AM. Do case conferences between general practitioners and specialist palliative care services improve quality of life? A randomised controlled trial (ISRCTN 52269003). Palliative Medicine 2008; 22(8):904-12. 19. Moore S, Corner J, Haviland J et al. Nurse led follow up and conventional medical follow up in management of patients with lung cancer: randomised trial. BMJ 2002; 325(7373):1145. 20. Pantilat SZ, O'Riordan DL, Dibble SL, Landefeld CS. Hospital-based palliative medicine consultation: a randomized controlled trial. Arch Intern Med 2010; 170(22):2038-40. 21. Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med 2004; 164(1):83-91. 22. Reymond L, Israel FJ, Charles MA. A residential aged care end-of-life care pathway (RAC EoLCP) for Australian aged care facilities. Aust Health Rev 2011; 35(3):350-6. 23. van der Heide A, Veerbeek L, Swart S, van der Rijt C, van der Maas PJ, van Zuylen L. End-of-life decision making for cancer patients in different clinical settings and the impact of the LCP. J Pain Symptom Manage 2010; 39(1):33-43. 24. Woo J, Cheng JO, Lee J et al. Evaluation of a continuous quality improvement initiative for end-of-life care for older noncancer patients. J Am Med Dir Assoc 2011; 12(2):105-13. 25. Temel JS, Greer JA, Muzikansky A et al. Early palliative care for patients with metastatic non-small-cell lung cancer. The New England Journal of Medicine 2010; 363(8):733-42. Evidence Table 6. Description of interventions for studies addressing pain Author, year 1 Anderson, 2004 2 Aubin, 2006 3 Borneman, 2008 4 Borneman2010 5 Dalton, 2004 6 Du Pen, 2000 7 Fuchs-Lacelle, 2008 8 Given, 2002 9 Keefe, 2005 Kovach 2006 30572 10 Lovell, 2010 11 Marinangeli, 2004 12 13 Miaskowski, 2004 , Miaskowski 2007 Oldenmenger, 2011{#40373} 14 15 Oliver, 2001 ; Kalauokalani, 2007 16 Syrjala, 2008 17 Van der Peet, 2004 18 Ward, 2000 19 Ward, 2008 20 Wells, 2003 21 Wilkie, 2010 Evidence Table 6 Reference List Integrative vs. consultative consultative Integrative: interacts with both Combined: interacts with both Integrative Consultative: interacts with patientfamily Combined: interacts with both Integrative Integrative: interacts with patientfamily Consultative: interacts with patientfamily Combined: interacts with both Otherneither Integrative Consultative: interacts with patientfamily consultative Consultative: interacts with patientfamily Integrative Consultative: interacts with both Integrative Consultative: interacts with patientfamily Combined: interacts with both Consultative: interacts with patientfamily 1. Anderson KO, Mendoza TR, Payne R et al. Pain education for underserved minority cancer patients: a randomized controlled trial. J Clin Oncol 2004; 22(24):4918-25. cancer pain algorithm for ambulatory care. Pain Manag Nurs 2000; 1(4):11628. 7. - Fuchs-Lacelle S, - Hadjistavropoulos T, - Lix L. - Pain Assessment as Intervention: a Study of Older Adults With Severe Dementia. - Clinical Journal of Pain - 200810; - 24(- 8):- 697, - 707. 2. Aubin M, Vezina L, Parent R et al. Impact of an educational program on pain management in patients with cancer living at home. Oncol Nurs Forum 2006; 33(6):1183-8. 8. Given B, Given CW, McCorkle R et al. Pain and fatigue management: results of a nursing randomized clinical trial. Oncol Nurs Forum 2002; 29(6):949-56. 3. Borneman T, Koczywas M, Cristea M, Reckamp K, Sun V, Ferrell B. An interdisciplinary care approach for integration of palliative care in lung cancer. Clin Lung Cancer 2008; 9(6):352-60. 9. Keefe FJ, Ahles TA, Sutton L et al. Partner-guided cancer pain management at the end of life: a preliminary study. J Pain Symptom Manage 2005; 29(3):263-72. 4. Borneman T, Koczywas M, Sun VC, Piper BF, Uman G, Ferrell B. Reducing patient barriers to pain and fatigue management. J Pain Symptom Manage 2010; 39(3):486-501. 10. Lovell MR, Forder PM, Stockler MR et al. A randomized controlled trial of a standardized educational intervention for patients with cancer pain. J Pain Symptom Manage 2010; 40(1):49-59. 5. Dalton JA, Keefe FJ, Carlson J, Youngblood R. Tailoring cognitive-behavioral treatment for cancer pain. Pain Manag Nurs 2004; 5(1):3-18. 11. Marinangeli F, Ciccozzi A, Leonardis M et al. Use of strong opioids in advanced cancer pain: a randomized trial. J Pain Symptom Manage 2004; 27(5):409- 6. Du Pen AR, Du Pen S, Hansberry J et al. An educational implementation of a E-47 16. 17. van der Peet EH, van den Beuken-van Everdingen MH, Patijn J, Schouten HC, van Kleef M, Courtens AM. Randomized clinical trial of an intensive nursing-based pain education program for cancer outpatients suffering from pain. Support Care Cancer 2008. 12. Miaskowski C, Dodd M, West C et al. Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. J Clin Oncol 2004; 22(9):1713-20. 13. Miaskowski C, Dodd M, West C et al. The use of a responder analysis to identify differences in patient outcomes following a self-care intervention to improve cancer pain management. Pain 2007; 129(1-2):55-63. 18. Ward S, Donovan HS, Owen B, Grosen E, Serlin R. An individualized intervention to overcome patient-related barriers to pain management in women with gynecologic cancers. Research in Nursing & Health 2000; 23(5):393-405. 14. Oliver JW, Kravitz RL, Kaplan SH, Meyers FJ. Individualized patient education and coaching to improve pain control among cancer outpatients. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 2001; 19(8):2206-12. 19. Ward S, Donovan H, Gunnarsdottir S, Serlin RC, Shapiro GR, Hughes S. A randomized trial of a representational intervention to decrease cancer pain (RIDcancerPain). Health Psychol 2008; 27(1):59-67. 20. Wells N, Hepworth JT, Murphy BA, Wujcik D, Johnson R. Improving cancer pain management through patient and family education. J Pain Symptom Manage 2003; 25(4):344-56. 15. Kalauokalani D, Franks P, Oliver JW, Meyers FJ, Kravitz RL. Can patient coaching reduce racialethnic disparities in cancer pain control? Secondary analysis of a randomized controlled trial. Pain Med 2007; 8(1):17-24. 21. Wilkie D, Berry D, Cain K et al. Effects of coaching patients with lung cancer to report cancer pain. Western Journal of Nursing Research 2010; 32(1):23-46. 16. Syrjala KL, Abrams JR, Polissar NL et al. Patient training in cancer pain management using integrated print and video materials: a multisite randomized controlled trial. Pain 2008; 135(1-2):175-86. E-48 Evidence Table 7. Description of quality improvement elements in studies addressing pain Author, year 1 Anderson, 2004 2 Facilitated Audit and relay of clinical feedback? data to providers? No No Aubin, 2006 No 3 Borneman, 2008 Yes 4 Borneman, 2010 No 5 Dalton, 2004 No 6 Du Pen, 2000 No 7 Fuchs-Lacelle, 2008 Yes 8 Given, 2002 No 9 Keefe, 2005 No 10 Kovach, 2006 Yes 11 Lovell, 2010 No 12 Marinangeli, 2004 Yes 13 Miaskowski, 2004 , Yes 14 Miaskowski 2007 15 Oldenmenger, 2011 No 16 Oliver, 2001 , No 17 Kalauokalani, 2007 18 Syrjala, 2008 No 19 Van der Peet, 2004 Yes 20 Ward, 2000 No 21 Ward, 2008 No 22 Wells, 2003 No 23 Wilkie, 2010 No Evidence Table 7 Reference List 1. Provider education? Patient family caregiver education? Promotion of selfmanagement? Organizational change? Other? Yes Patient caregiver reminder system? No No Yes No No No Yes No No No No No No No No No No Yes Yes No No Yes No No No Yes No No No Yes Yes Yes Yes No No Yes Yes No Yes No Yes Yes Yes Yes Yes No No Yes Yes No Yes No Yes No No No No No No No No No No No No No Yes No No No No No No No No No No No No No No No Yes No No No No No No No No No No Yes Yes Yes Yes No No No No Yes No No No No No No No No No No No No No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No No No No No Yes No No No No No No No Yes No No No No Anderson KO, Mendoza TR, Payne R et al. Pain education for underserved minority cancer patients: a randomized controlled trial. J Clin Oncol 2004; 22(24):4918-25. 2010; 39(3):486-501. 5. Dalton JA, Keefe FJ, Carlson J, Youngblood R. Tailoring cognitivebehavioral treatment for cancer pain. Pain Manag Nurs 2004; 5(1):3-18. 2. Aubin M, Vezina L, Parent R et al. Impact of an educational program on pain management in patients with cancer living at home. Oncol Nurs Forum 2006; 33(6):1183-8. 6. Du Pen AR, Du Pen S, Hansberry J et al. An educational implementation of a cancer pain algorithm for ambulatory care. Pain Manag Nurs 2000; 1(4):116-28. 3. Borneman T, Koczywas M, Cristea M, Reckamp K, Sun V, Ferrell B. An interdisciplinary care approach for integration of palliative care in lung cancer. Clin Lung Cancer 2008; 9(6):352-60. 7. - Fuchs-Lacelle S, - Hadjistavropoulos T, - Lix L. - Pain Assessment as Intervention: a Study of Older Adults With Severe Dementia. - Clinical Journal of Pain - 200810; - 24(- 8):- 697, - 707. 4. Borneman T, Koczywas M, Sun VC, Piper BF, Uman G, Ferrell B. Reducing patient barriers to pain and fatigue management. J Pain Symptom Manage 8. Given B, Given CW, McCorkle R et al. Pain and fatigue management: E-49 results of a nursing randomized clinical trial. Oncol Nurs Forum 2002; 29(6):949-56. 9. 10. 11. 12. Keefe FJ, Ahles TA, Sutton L et al. Partner-guided cancer pain management at the end of life: a preliminary study. J Pain Symptom Manage 2005; 29(3):263-72. Kovach CR, Logan BR, Noonan PE et al. Effects of the Serial Trial Intervention on discomfort and behavior of nursing home residents with dementia. American Journal of Alzheimer's Disease and Other Dementias 2006; 21(3):147-55. Lovell MR, Forder PM, Stockler MR et al. A randomized controlled trial of a standardized educational intervention for patients with cancer pain. J Pain Symptom Manage 2010; 40(1):49-59. Marinangeli F, Ciccozzi A, Leonardis M et al. Use of strong opioids in advanced cancer pain: a randomized trial. J Pain Symptom Manage 2004; 27(5):409-16. 13. Miaskowski C, Dodd M, West C et al. Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. J Clin Oncol 2004; 22(9):1713-20. 14. Miaskowski C, Dodd M, West C et al. The use of a responder analysis to identify differences in patient outcomes following a self-care intervention to improve cancer pain management. Pain 2007; 129(1-2):55-63. 15. Oldenmenger WH, Sillevis Smitt PA, van Montfort CA, de Raaf PJ, van der Rijt CC. A combined pain consultation and pain education program decreases average and current pain and decreases interference in daily life by pain in oncology outpatients: a randomized controlled trial. Pain 2011; 152(11):2632-9. E-50 16. Oliver JW, Kravitz RL, Kaplan SH, Meyers FJ. Individualized patient education and coaching to improve pain control among cancer outpatients. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 2001; 19(8):2206-12. 17. Kalauokalani D, Franks P, Oliver JW, Meyers FJ, Kravitz RL. Can patient coaching reduce racialethnic disparities in cancer pain control? Secondary analysis of a randomized controlled trial. Pain Med 2007; 8(1):17-24. 18. Syrjala KL, Abrams JR, Polissar NL et al. Patient training in cancer pain management using integrated print and video materials: a multisite randomized controlled trial. Pain 2008; 135(1-2):175-86. 19. van der Peet EH, van den Beuken-van Everdingen MH, Patijn J, Schouten HC, van Kleef M, Courtens AM. Randomized clinical trial of an intensive nursing-based pain education program for cancer outpatients suffering from pain. Support Care Cancer 2008. 20. Ward S, Donovan HS, Owen B, Grosen E, Serlin R. An individualized intervention to overcome patient-related barriers to pain management in women with gynecologic cancers. Research in Nursing & Health 2000; 23(5):393-405. 21. Ward S, Donovan H, Gunnarsdottir S, Serlin RC, Shapiro GR, Hughes S. A randomized trial of a representational intervention to decrease cancer pain (RIDcancerPain). Health Psychol 2008; 27(1):59-67. 22. Wells N, Hepworth JT, Murphy BA, Wujcik D, Johnson R. Improving cancer pain management through patient and family education. J Pain Symptom Manage 2003; 25(4):344-56. 23. Wilkie D, Berry D, Cain K et al. Effects of coaching patients with lung cancer to report cancer pain. Western Journal of Nursing Research 2010; 32(1):23-46. Evidence Table 8. Risk of bias assessment of studies addressing pain Author, year Sequence Allocation Binding of generation concealment personnel (short-term outcomes) 1 Blinding of outcome assessors (short-term outcomes) No No No No No No No Yes Yes Unclear No Yes Yes Yes Yes Anderson, 2004 Unclear Unclear No 2 Aubin, 2006 No No No 3 Borneman, 2008 No No No Borneman 2010{741} No No No 4 Dalton, 2004 Unclear Unclear No 5 Du Pen, 2000 Unclear No No 6 Given, 2002 Unclear No No 7 Keefe, 2005 Yes Yes Yes 8 Kovach, 2006 Yes Yes Yes 9 Lovell, 2010 Unclear Yes No 10 Marinangeli, 2004 Unclear Unclear No 11 Miaskowski, 2004 Yes Yes Yes 12 Miaskowski, 2007 Yes Yes Yes 13 Oldenmenger, 2011 Yes Unclear No 14 Oliver, 2001 , Unclear Yes No 15 Kalauokalani, 2007 16 Syrjala, 2008 Unclear No No No 17 Van der Peet, 2004 Yes Yes No No 18 Ward, 2000 Unclear No No No 19 Ward, 2008 Unclear No No No 20 Wells, 2003 Unclear No No No 21 Wilkie, 2010 Yes Yes No No Evidence Table 8 Reference List 1. Anderson KO, Mendoza TR, Payne R et al. Pain education for underserved minority cancer patients: a randomized controlled trial. J Clin Oncol 2004; 22(24):4918-25. 2. Aubin M, Vezina L, Parent R et al. Impact of an educational program on pain management in patients with cancer living at home. Oncol Nurs Forum 2006; 33(6):1183-8. 3. Borneman T, Koczywas M, Cristea M, Reckamp K, Sun V, Ferrell B. An interdisciplinary care approach for integration of palliative care in lung cancer. Clin Lung Cancer 2008; 9(6):352-60. 4. Dalton JA, Keefe FJ, Carlson J, Youngblood R. Tailoring cognitivebehavioral treatment for cancer pain. Pain Manag Nurs 2004; 5(1):3-18. 5. Du Pen AR, Du Pen S, Hansberry J et al. An educational implementation of a cancer pain algorithm for ambulatory care. Pain Manag Nurs 2000; Binding of personnel (long-term outcomes) Incomplete outcome data (shortterm outcomes) Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes Incomplete outcome data (longterm outcomes) Yes Yes Yes Yes Yes No No Yes Yes Unclear Yes Yes Yes Yes Yes Selective Other outcome sources reporting of bias No No No No No No No Yes Yes No No Yes Yes No No Blinding of outcome assessors (long-term outcomes) No No No No No No No Yes Yes No No Yes Yes Yes Yes Yes Yes Yes Yes Yes No No Yes Yes Unclear Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes Yes Yes Yes No No No No No No No Yes No No No No No Yes No Yes No Yes No Yes No Yes No Yes No Yes No No No Yes No Yes No No No Yes 6. 7. 8. 9. E-51 1(4):116-28. Given B, Given CW, McCorkle R et al. Pain and fatigue management: results of a nursing randomized clinical trial. Oncol Nurs Forum 2002; 29(6):949-56. Keefe FJ, Ahles TA, Sutton L et al. Partner-guided cancer pain management at the end of life: a preliminary study. J Pain Symptom Manage 2005; 29(3):263-72. Kovach CR, Logan BR, Noonan PE et al. Effects of the Serial Trial Intervention on discomfort and behavior of nursing home residents with dementia. American Journal of Alzheimer's Disease and Other Dementias 2006; 21(3):147-55. Lovell MR, Forder PM, Stockler MR et al. A randomized controlled trial of a standardized educational intervention for patients with cancer pain. J Pain 10. 11. 12. 13. 14. 15. Symptom Manage 2010; 40(1):49-59. Marinangeli F, Ciccozzi A, Leonardis M et al. Use of strong opioids in advanced cancer pain: a randomized trial. J Pain Symptom Manage 2004; 27(5):409-16. Miaskowski C, Dodd M, West C et al. Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. J Clin Oncol 2004; 22(9):1713-20. Miaskowski C, Dodd M, West C et al. The use of a responder analysis to identify differences in patient outcomes following a self-care intervention to improve cancer pain management. Pain 2007; 129(1-2):55-63. Oldenmenger WH, Sillevis Smitt PA, van Montfort CA, de Raaf PJ, van der Rijt CC. A combined pain consultation and pain education program decreases average and current pain and decreases interference in daily life by pain in oncology outpatients: a randomized controlled trial. Pain 2011; 152(11):2632-9. Oliver JW, Kravitz RL, Kaplan SH, Meyers FJ. Individualized patient education and coaching to improve pain control among cancer outpatients. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 2001; 19(8):2206-12. Kalauokalani D, Franks P, Oliver JW, Meyers FJ, Kravitz RL. Can patient coaching reduce racialethnic disparities in cancer pain control? Secondary 16. 17. 18. 19. 20. 21. E-52 analysis of a randomized controlled trial. Pain Med 2007; 8(1):17-24. Syrjala KL, Abrams JR, Polissar NL et al. Patient training in cancer pain management using integrated print and video materials: a multisite randomized controlled trial. Pain 2008; 135(1-2):175-86. van der Peet EH, van den Beuken-van Everdingen MH, Patijn J, Schouten HC, van Kleef M, Courtens AM. Randomized clinical trial of an intensive nursing-based pain education program for cancer outpatients suffering from pain. Support Care Cancer 2008. Ward S, Donovan HS, Owen B, Grosen E, Serlin R. An individualized intervention to overcome patient-related barriers to pain management in women with gynecologic cancers. Research in Nursing & Health 2000; 23(5):393-405. Ward S, Donovan H, Gunnarsdottir S, Serlin RC, Shapiro GR, Hughes S. A randomized trial of a representational intervention to decrease cancer pain (RIDcancerPain). Health Psychol 2008; 27(1):59-67. Wells N, Hepworth JT, Murphy BA, Wujcik D, Johnson R. Improving cancer pain management through patient and family education. J Pain Symptom Manage 2003; 25(4):344-56. Wilkie D, Berry D, Cain K et al. Effects of coaching patients with lung cancer to report cancer pain. Western Journal of Nursing Research 2010; 32(1):23-46. Evidence Table 9. Outcomes reported in studies addressing pain Outcome measures Measures Author, year 1 Anderson, 2004 pain BPI (intensity and interference) QOL Sample size 97 Disparities specifically looking at underserved populations (black and hispanic only) Physical and Mental Health Summary Scales of the Short Form (SF) -12 Health Survey E-53 Outcomes: benefits. Significantly improved Outcomes: benefits. Not Other key significantly improved information NS At the 8-10 week assessmen only (of 3 different assessment time points), the control group reported a lower mean pain worst rating than the education group (P ฀ <.05) AA Patients only: analysis of the pain worst item revealed a significant group-bytime interaction (P< .01). For pain interference: significant group-bytime interaction for the Af- rican American patients (P<.04) but not for Hispanic patients (P =.41); recruitment was challenging in this population NS Evidence Table 9. Outcomes reported in studies addressing pain (continued) Outcome measures Measures Pain scores BPI Author, year 2 Aubin, 2006 3 Borneman, 2008 Pain scores QOL scalecancer patient tool, Fatigue 46 patients, 18 in control, 28 in intervention Outcomes: benefits. Significantly improved Average pain scores at baseline, two weeks and four weeks between the experimental (3.0, 2.1, 1.7) and control groups (2.4, 3.3, 2.4) were significantly different (p = 0.01) No statistically significant effects on outcomes of interest between experimental and control Piper fatigue scale 4 Borneman, 2010 Pain scores Treatment data Fatigue Sample size Disparities 80 patients, control: 27, intervention: 53 187 patients, 83 Sample in control; 104 included 35% in intervention ethnic minorities Piper fatigue scale, barriers questionnaire, fatigue barriers scale, fatigue knowledge tool Sensory fatigue dropped significantly at one and three months for the intervention group (baseline: 6.4; 1 month: 5.4; 3 months: 4.4), it did not change over time for the usual care group (baseline: 6.4; 1 month: 6.2; 3 months: 5.5), and this difference was statistically significant (p=0.025) E-54 Outcomes: benefits. Not Other key significantly improved information Maximum pain scores were not significantly different over time for the experimental and control groups Overall QOL, physical QOL, psychological QOL, spiritual QOL, social QOL, fatigue-related QOL, painrelated QOL all ns Sensory fatigue, overall fatigue NS Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year 5 Dalton, 2004 Du pen, 2000 6 Outcome measures Measures Pain scores BPI Distress Symptom distress scale Psychosocia l symptoms QOL Karnofsky performance status, pain goals Pain scores Profile of mood states Sf-12 BPI Sample size Disparities 127 patients, standard cbt=43, profile tailored cbt (intervention) = 50, usual care = 34 Outcomes: benefits. Significantly improved Outcomes: benefits. Not significantly improved 6 month follow-up: of 10 components of BPI, only 1 statistically significant in each arm vs. usual care at p=0.04 6 months: 36 symptoms statistically significant for tailored intervention 6 months: ns for tailored, 12 significant for standard 6 months: ns Ns 20 oncologists and 38 oncology nurses; 105 patients - 54 in intervention, 51 in control Intervention group experienced a decrease in their mean level of usual pain on a scale of 0 to 10 from a baseline mean score of 3.6 (standard deviation [sd] =1.9) to a mean score of 2.8 (sd =1.9); patients treated by untrained physicians nurses experienced a relatively flat trajectory in their level of usual pain over the 4 months of their treatment (mean =3.0, sd =2.0). The difference between the 2 groups was statistically significant(t = 2.0, p = .05) E-55 Other key information High level of attrition; unable to abstract 1-month outcomes from study due to table formatting issue, despite contact with authors Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year 6 Du pen, 2000 (continued) Fuchs-lacelle, 7 2008 Outcome measures Opioid provider adherence scores (0 to 3 scale), neuropathic co-analgesic prescribing Overall adherence Measures Chart abstraction Sample size Disparities Chart abstraction aggregate score (tpa) Outcomes: benefits. Significantly improved Outcomes: benefits. Not Other key significantly improved information NS Statistically significant improvement in tpa in the trained group versus control group, as measured by slope scores (t = 2.1, p = .04). NursePain assessment 173, 89 in assessed checklist for intervention, 84 pain scores seniors with limited in control ability to communicate Longitudinal outcome: systematic pain assessment statistically changed the log expected rate of observable pain behaviors. More specifically, pain scores, as measured by the pacslac, showed a statistically significant decrease at the rate of 0.01 for each unit of time. E-56 Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year Fuchs-lacelle, 7 2008 (continued) Given, 2002 8 Outcome measures Increased use of underused pain management medication Pain scores Fatigue 9 Keefe, 2005 Kovach, 2006 Pain scores 10 QOL,, caregiver strain, caregiver mood, Patient symptoms; discomfort Measures (medication quantification scale) Sample size Disparities Outcomes: benefits. Significantly improved The symptom 113 patients 53 experience scale in intervention, 60 in control The symptom experience scale BPI - usual pain 78 patients, 41 and worst pain in intervention, 37 in control i Outcomes: benefits. Not Other key significantly improved information Longitudinal outcome: baseline (0.64, sd=2.07) for the experimental condition and (0.44, sd=1.65) for the control condition. At the end of the intervention, (0.98 (sd=2.12) for the experimental condition and (0.16, sd=0.82) for the control condition. (p=0.00) Ns Ns Ns Ns Behave-ad 114 patients; 57 each in intervention and control Ns Discomfort-data Significant intervention x time effect on discomfortad scores (p<0.001) E-57 Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year 11 Lovell, 2010 11 Lovell, 2010 Marinangeli, 12 2004 Outcome measures Measures Pain scores Wisconsin brief pain inventory Sample size Disparities 185 patients, 40 in standard care, 37 in booklet only group, 36 in video only group, 45 in booklet plus video group Anxietydepr Hospital anxiety ession, QOL and depression scale, uni-scale for global quality of life Pain scores Vas 92 patients, 44 in intervention, 48 in control Outcomes: benefits. Significantly improved There was a significant difference in the change in average pain score between the standard care group (mean: 0.02) and the booklet and video group (mean: 1.19; difference: 1.17 with 95% ci: 0.17, 2.17, p = 0.0214). Reductions in worst pain scores were significantly greater in the booklet and video group than in the standard care group ( 1.53 vs. 0.41; difference: 1.12 with 95% CI: 0.00, 2.23, p = 0.05). Outcomes: benefits. Not significantly improved Booklet versus standard care ns video versus standard care ns no significant differences for pain interference between the groups Ns Intervention group significantly better than control group on pain scores (control - 4.98 +1.26 vs. Intervention 4.23 +- 1.36; p 0.007) and with greater decrease in pain from baseline (intervention -2.61, control -1.92, p=0.041). E-58 Other key information There were marginal differences between standard care and booklet alone (p = 0.07) and standard care and video alone (p = 0.09) for average pain the presence of a partner increased the effect of any educational intervention on average pain and worst pain scores compared to those without partners (significant) Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year Marinangeli, 12 2004 (continued) Outcome measures QOL, performance status Measures Sample size Multidimensional questionnaire. Karnovsky performance status Disparities Side effects Satisfaction Miaskowski, 13 2004 and Miaskowski, 14 2007 Pain scores; BPI pain intensity 174 patients, intervention=93, control=81 (2004), 167; intervention=89, control=78 (2007) Pain BPI interference Outcomes: benefits. Significantly improved Outcomes: benefits. Not Other key significantly improved information NS Nausea as a side effect was significantly lower in the intervention group (315 episodes versus 437 episodes; p = 0.0001). Intervention group significantly more satisfied with pain management (intervention 85.6% vs. Control 80.5%, p = 0.041), For least pain, a significant group x time interaction (p< 0.0001) was found. For average pain, a significant group x time interaction (p<0.0001) and significant main effects by group (p=0.026) for worst pain, a significant group x time interaction (p< 0.0001) as well as significant main effects of group (p =.033) were found. Vomiting, constipation, gastro-enteric bleeding, periods of mental confusion No significant difference for least pain scores between groups. Ns E-59 Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year Miaskowski, 13 2004 and Miaskowski, 14 2007 (continued) 15 Oliver, 2001 Kalauokalani, 16 2007 Outcome measures Opioid intake, appropriate analgesia, mood state QOL Measures Nurse recorded analgesic intake and prescriptions, profile of mood states SF-36 Pain scores; BPI average pain Sample size Disparities Outcomes: benefits. Significantly improved Only significant difference is on subscale for body pain, intervention = 39.6, control=46.8 (p=0.005) Controlling for pain at baseline average pain differed by -8.96 points on a 100 point scale between control and experimental groups (p<0.05) 67 patients, 34 in intervention, 33 in control Outcomes: benefits. Not Other key significantly improved information Ns When social factors are added to the model, this association fails to meet significance Functional impairment due to pain and pain frequency - no significant differences Impairment Pain effects due to pain subscale of the mos-paq and pain frequency E-60 Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year Oldenmenger, 17 2011 Outcome measures Pain intensity Measures Sample size BPI (current, 72 average, and worst in past 24 hours) Disparities Pain BPI interference interference questions (7 items, averaged) Pain knowledge Ferrell Patient Pain Questionnaire adequacy of PMI (Pain analgesia Management Index) E-61 Outcomes: benefits. Significantly improved For average pain intensity, the mean difference in pain intensity (mDPI) was 1.13 for SC and 1.95 for PCPEP (20% vs 31%; P = .03). For current pain intensity, the mDPI was 0.67 for SC and 1.50 for PC-PEP (16% vs 30%; P = .016). For daily interference, the mean reduction was 0.11 for SC and 0.91 for PCPEP (2.5% vs 20%; P = .01) At week 2, the level of pain knowledge (0 to 100) was significantly better after randomization to PC-PEP (71, SD = 13) than to SC (64,SD=10;P=.002) Outcomes: benefits. Not significantly improved No significant difference was found between SC and PC-PEP groups for worst pain (1.16 vs 1.28). Other key information Higher adherence to analgesics in intervention group (p=0.03); results were sustained over study period; most patients had multiple visits with pain consult service Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year 15 Oliver, 2001 Kalauokalani, 16 2007 (continued) Outcome measures Measures Sample size Minority patients: 8 in intervention, 7 in control Outcomes: benefits. Significantly improved Disparities Regression analysis, adjusting for baseline pain, revealed a significant interaction between minority status (Latinos, Asians, blacks, other) and study group for BPI, indicating a greater effect of the intervention in minorities (interaction effect = −1.73,95% ci = −0.06,−3.41,p = 0.043); E-62 Outcomes: benefits. Not Other key significantly improved information Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year 18 Syrjala, 2008 Outcome measures Measures Pain scores BPI Increased use of opioids Van der peet, 19 2004 Sample size Disparities 78 patients, 43 in intervention, 35 in control Patient interview and viewing medications by research nurses Patient Memorial symptom symptoms assessment scale Pain scores BPI 120 patients, 58 in intervention, 62 in control Outcomes: benefits. Significantly improved Intervention group with better control of usual pain - differed by -.81 with intervention group having greater decrease in pain from baseline (p=0.03)) Significant difference in opioid dose between intervention and control group (<0.001) with intervention group taking more morphine (0.31 in log10 of daily morphine dose) Outcomes: benefits. Not Other key significantly improved information Group comparisons were not significant at 6month time point. The pain training effect on opioid use differed significantly, also, between those whose pain was due to treatment versus those whose pain was due to other etiology, primarily due to disease (p = .009) NS Present pain score intervention group = 3.78 versus control group = 4.84 (p=0.02) at 4 weeks follow up E-63 Difference between intervention and control group ns at 8 weeks follow up Patients in the most pain (BPI -7 or higher) had the greatest benefit from the intervention significant differences in pain were found between the intervention and control groups at t1 (p=0.00) and t2 (p=0.00) in patients with a baseline score of 7–10. Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year Van der peet, 19 2004 Ward, 2000 Ward, 2008 20 21 Outcome measures Depression anxiety; Quality of Life, and non-pain symptoms Pain scores; pain intensity Pain scores; pain interference Measures HADS Sample size BPI 43 patients, 21 in intervention, 22 in control BPI interference scale, plus one additional item about caring for others Analgesic Medication side side effects effect checklist. scores, PMI, fact-g adequacy of analgesia, QOL Pain scores; BPI - worst, least, pain severity and pain now aggregated to single score, also used one question from the total pain management quality dataset for "usual severity" Pain BPI interference, analgesic use, QOL Disparities Outcomes: benefits. Significantly improved Outcomes: benefits. Not Other key significantly improved information Not reported NS NS NS 176 total patients, 92 in intervention, 84 in control NS NS E-64 Evidence Table 9. Outcomes reported in studies addressing pain (continued) Author, year 22 Wells, 2003 23 Wilkie, 2010 Outcome measures Measures Pain scores; BPI-SF worst pain, average pain, pain interference, pain relief Analgesic PMI use Pain scores Mcgill pain questionnaire, Sample size Disparities 64 patients, 24 in standard care, 21 in hot line intervention, and 19 in weekly call intervention Outcomes: benefits. Significantly improved Outcomes: benefits. Not Other key significantly improved information NS NS 151 patients, 76 in intervention, 75 in control NS except for 1 subscale This intervention did statistically significantly improve pain communication by patients to providers (audio taped data): intervention improved reporting, but more than this is needed to change provider and patient behavior and improve pain NS Anxiety, State trait anxiety depression, inventory, CES-D pain coping, coping strategies pain questionnaire, PMI prescriptions Abbreviations: BPI=Blood Pressure Index; MQS=Michigan Quality System; PMI=Pain Management Index; QOL=Quality of Life; SF=Significant Finding; HADS=The Hospital Anxiety and Depression Scale; NS=Not Significant; Evidence Table 9 Reference List 1. Anderson KO, Mendoza TR, Payne R et al. Pain education for underserved minority cancer patients: a randomized controlled trial. J Clin Oncol 2004; 22(24):4918-25. 3. Borneman T, Koczywas M, Cristea M, Reckamp K, Sun V, Ferrell B. An interdisciplinary care approach for integration of palliative care in lung cancer. Clin Lung Cancer 2008; 9(6):352-60. 2. Aubin M, Vezina L, Parent R et al. Impact of an educational program on pain management in patients with cancer living at home. Oncol Nurs Forum 2006; 33(6):1183-8. 4. Borneman T, Koczywas M, Sun VC, Piper BF, Uman G, Ferrell B. Reducing patient barriers to pain and fatigue management. J Pain Symptom Manage 2010; 39(3):486-501. E-65 5. Dalton JA, Keefe FJ, Carlson J, Youngblood R. Tailoring cognitive-behavioral treatment for cancer pain. Pain Manag Nurs 2004; 5(1):3-18. and coaching to improve pain control among cancer outpatients. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 2001; 19(8):2206-12. 6. Du Pen AR, Du Pen S, Hansberry J et al. An educational implementation of a cancer pain algorithm for ambulatory care. Pain Manag Nurs 2000; 1(4):11628. 16. Kalauokalani D, Franks P, Oliver JW, Meyers FJ, Kravitz RL. Can patient coaching reduce racialethnic disparities in cancer pain control? Secondary analysis of a randomized controlled trial. Pain Med 2007; 8(1):17-24. 7. Fuchs-Lacelle S, Hadjistavropoulos T, Lix L. Pain Assessment as Intervention: a Study of Older Adults With Severe Dementia. Clinical Journal of Pain 200810; 24(8):697, 707. 8. Given B, Given CW, McCorkle R et al. Pain and fatigue management: results of a nursing randomized clinical trial. Oncol Nurs Forum 2002; 29(6):949-56. 17. Oldenmenger WH, Sillevis Smitt PA, van Montfort CA, de Raaf PJ, van der Rijt CC. A combined pain consultation and pain education program decreases average and current pain and decreases interference in daily life by pain in oncology outpatients: a randomized controlled trial. Pain 2011; 152(11):2632-9. 9. Keefe FJ, Ahles TA, Sutton L et al. Partner-guided cancer pain management at the end of life: a preliminary study. J Pain Symptom Manage 2005; 29(3):263-72. 18. Syrjala KL, Abrams JR, Polissar NL et al. Patient training in cancer pain management using integrated print and video materials: a multisite randomized controlled trial. Pain 2008; 135(1-2):175-86. 10. Kovach CR, Logan BR, Noonan PE et al. Effects of the Serial Trial Intervention on discomfort and behavior of nursing home residents with dementia. American Journal of Alzheimer's Disease and Other Dementias 2006; 21(3):147-55. 19. van der Peet EH, van den Beuken-van Everdingen MH, Patijn J, Schouten HC, van Kleef M, Courtens AM. Randomized clinical trial of an intensive nursing-based pain education program for cancer outpatients suffering from pain. Support Care Cancer 2008. 11. Lovell MR, Forder PM, Stockler MR et al. A randomized controlled trial of a standardized educational intervention for patients with cancer pain. J Pain Symptom Manage 2010; 40(1):49-59. 20. Ward S, Donovan HS, Owen B, Grosen E, Serlin R. An individualized intervention to overcome patient-related barriers to pain management in women with gynecologic cancers. Research in Nursing & Health 2000; 23(5):393-405. 12. Marinangeli F, Ciccozzi A, Leonardis M et al. Use of strong opioids in advanced cancer pain: a randomized trial. J Pain Symptom Manage 2004; 27(5):40916. 21. Ward S, Donovan H, Gunnarsdottir S, Serlin RC, Shapiro GR, Hughes S. A randomized trial of a representational intervention to decrease cancer pain (RIDcancerPain). Health Psychol 2008; 27(1):59-67. 13. Miaskowski C, Dodd M, West C et al. Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. J Clin Oncol 2004; 22(9):1713-20. 22. Wells N, Hepworth JT, Murphy BA, Wujcik D, Johnson R. Improving cancer pain management through patient and family education. J Pain Symptom Manage 2003; 25(4):344-56. 14. Miaskowski C, Dodd M, West C et al. The use of a responder analysis to identify differences in patient outcomes following a self-care intervention to improve cancer pain management. Pain 2007; 129(1-2):55-63. 23. Wilkie D, Berry D, Cain K et al. Effects of coaching patients with lung cancer to report cancer pain. Western Journal of Nursing Research 2010; 32(1):23-46. 15. Oliver JW, Kravitz RL, Kaplan SH, Meyers FJ. Individualized patient education E-66 Evidence Table 10. Description of interventions for studies addressing distress Author, year 1 Aranda, 2006 2 Blumenthal, 2006 3 Carlson, 2010 4 Hudson, 2005 5 Porter, 2011 Integrative vs. consultative Combined: interacts with both Consultative: interacts with family Consultative: interacts with family Consultative: interacts with family Consultative: interacts with patientfamily 6 Steel, 2007 Consultative: interacts with patientfamily 7 Walsh, 2007 Consultative: interacts with patientfamily Evidence Table 10 Reference List Target of intervention Psychosocial needs Distress, coping Distress, depression, anxiety Support for family Patient pain, psychological distress, quality of life measure, and self-efficacy. Caregiver mood, strain, and self-efficacy in symptom management. Interdisciplinary assessments Care giver distress, needs 1. Aranda S, Schofield P, Weih L, Milne D, Yates P, Faulkner R. Meeting the support and information needs of women with advanced breast cancer: a randomized controlled trial. Br J Cancer 2006; 95(6):667-73. 5. Porter LS, Keefe FJ, Garst J et al. Caregiver-Assisted Coping Skills Training for Lung Cancer: Results of a Randomized Clinical Trial. J Pain Symptom Manage 2010. 2. Blumenthal JA, Babyak MA, Keefe FJ et al. Telephone-based coping skills training for patients awaiting lung transplantation. Journal of Consulting and Clinical Psychology 2006; 74(3):535-44. 6. Steel JL, Nadeau K, Olek M, Carr BI. Preliminary results of an individually tailored psychosocial intervention for patients with advanced hepatobiliary carcinoma. J Psychosocial Oncology 2007; 25(3):19-42. 3. Carlson LE, Groff SL, Maciejewski O, Bultz BD. Screening for distress in lung and breast cancer outpatients: a randomized controlled trial. J Clinical Oncology 2010; 28(33):4884-91. 7. Walsh K, Jones L, Tookman A et al. Reducing emotional distress in people caring for patients receiving specialist palliative care. Randomized trial. Br J Psychiatry 2007; 190:142-7. 4. Hudson PL, Aranda S, Hayman-White K. A psycho-educational intervention for family caregivers of patients receiving palliative care: a randomized controlled trial. J Pain Symptom Manage 2005; 30(4):329-41. E-67 Evidence Table 11. Description of quality improvement elements in studies addressing distress Facilitated relay of clinical Author, year data to providers? 1 Aranda, 2006 Yes Blumenthal, No 2 2006 Carlson, No 3 2010 Hudson, No 4 2005 5 Porter, 2011 No 6 Steel, 2007 No 7 Walsh, 2007 No Evidence Table 11 Reference List Provider education? Yes No Patient family caregiver education? Yes Yes Promotion of selfmanagement? Yes Yes Patient caregiver reminder system? No No Organizational change? No No Other? No No No No No No Yes No No Yes Yes Yes No No No No No Yes Yes Yes Yes Yes Yes No No No No No No No Yes No 1. Aranda S, Schofield P, Weih L, Milne D, Yates P, Faulkner R. Meeting the support and information needs of women with advanced breast cancer: a randomized controlled trial. Br J Cancer 2006; 95(6):667-73. 5. Porter LS, Keefe FJ, Garst J et al. Caregiver-Assisted Coping Skills Training for Lung Cancer: Results of a Randomized Clinical Trial. J Pain Symptom Manage 2010. 2. Blumenthal JA, Babyak MA, Keefe FJ et al. Telephone-based coping skills training for patients awaiting lung transplantation. Journal of Consulting and Clinical Psychology 2006; 74(3):535-44. 6. Steel JL, Nadeau K, Olek M, Carr BI. Preliminary results of an individually tailored psychosocial intervention for patients with advanced hepatobiliary carcinoma. J Psychosocial Oncology 2007; 25(3):19-42. 3. Carlson LE, Groff SL, Maciejewski O, Bultz BD. Screening for distress in lung and breast cancer outpatients: a randomized controlled trial. J Clinical Oncology 2010; 28(33):4884-91. 7. Walsh K, Jones L, Tookman A et al. Reducing emotional distress in people caring for patients receiving specialist palliative care. Randomized trial. Br J Psychiatry 2007; 190:142-7. 4. Hudson PL, Aranda S, Hayman-White K. A psycho-educational intervention for family caregivers of patients receiving palliative care: a randomized controlled trial. J Pain Symptom Manage 2005; 30(4):329-41. E-68 Evidence Table 12. Risk of bias assessment of studies addressing distress Binding of personnel Sequence Allocation (short-term Author, year generation concealment outcomes) 1 Aranda, 2006 Yes Yes Unclear 2 Blumenthal, 2006 Yes Yes No 3 Carlson, 2010 Yes Yes Yes 4 Hudson, 2005 Yes Yes Yes 5 Porter, 2011 Yes Yes No 6 Steel, 2007 Unclear Unclear No 7 Walsh, 2007 Yes Yes No Evidence Table 12 Reference List Blinding of outcome assessors (short-term outcomes) Unclear Yes Unclear Yes Yes Yes No Binding of personnel (long-term outcomes) Unclear No Yes Yes Yes No No Blinding of outcome assessors (long-term outcomes) Unclear Yes Unclear Yes Yes Yes No Incomplete outcome data (short-term outcomes) Yes Yes Yes Yes Yes Yes Yes Incomplete outcome data (long-term outcomes) Yes Yes Yes Yes Yes Yes Yes Selective outcome reporting Yes Yes Yes Yes Yes Yes Yes Other sources of bias Yes Yes Yes Yes Yes Yes Yes 1. Aranda S, Schofield P, Weih L, Milne D, Yates P, Faulkner R. Meeting the support and information needs of women with advanced breast cancer: a randomized controlled trial. Br J Cancer 2006; 95(6):667-73. 5. Porter LS, Keefe FJ, Garst J et al. Caregiver-Assisted Coping Skills Training for Lung Cancer: Results of a Randomized Clinical Trial. J Pain Symptom Manage 2010. 2. Blumenthal JA, Babyak MA, Keefe FJ et al. Telephone-based coping skills training for patients awaiting lung transplantation. Journal of Consulting and Clinical Psychology 2006; 74(3):535-44. 6. Steel JL, Nadeau K, Olek M, Carr BI. Preliminary results of an individually tailored psychosocial intervention for patients with advanced hepatobiliary carcinoma. J Psychosocial Oncology 2007; 25(3):19-42. 3. Carlson LE, Groff SL, Maciejewski O, Bultz BD. Screening for distress in lung and breast cancer outpatients: a randomized controlled trial. J Clinical Oncology 2010; 28(33):4884-91. 7. Walsh K, Jones L, Tookman A et al. Reducing emotional distress in people caring for patients receiving specialist palliative care. Randomized trial. Br J Psychiatry 2007; 190:142-7. 4. Hudson PL, Aranda S, Hayman-White K. A psycho-educational intervention for family caregivers of patients receiving palliative care: a randomized controlled trial. J Pain Symptom Manage 2005; 30(4):329-41. E-69 Evidence Table 13. Outcomes reported in studies addressing distress Outcomes: Benefits. Sample AuthorYear Outcome Significantly Refid measures Measures Disparities improved size Distress; Carlson, Canadian; White; All patients: Triage Minimal Distress 1134 1 Impact of thermometer; European; Asian; group lower distress 2010 Full Psychological First Nations; referrals than minimal group African; Arabic; (p=0.031); Over Scan for Cancer CentralSouth (Triage (full distress cutoff (DT American screen and score>=4): 36% in offered referral to triage, 46% full psychosocial screen, 48.7% in services) minimal screen 2 (X =10.55, p=0.005) E-70 Outcomes: Benefits. Not significantly improved All patients: overall lower distress at follow-up (F=2.37, p=0.094) Outcomes: Harms All patients: Referral linked to less improvement on DT (t=4.43, p<0.001); higher baseline stress predicted greater decrease on DT (t=-3.69, p<0.001); High baseline distress improved more if lower levels of education (t=2.05, p=0.041) and without chemo (t=2.16, p=0.031) Other key information Distress scores in breast lower at followup in full and triage groups. Triage group in lung with high baseline distress showed 20% reduction in distress at follow-up showing benefit of psycho social intervention. Evidence Table 13. Outcomes reported in studies addressing distress (continued) AuthorYear Refid 1 Carlson, 2010 (continued) Outcome measures Measures Psychosocial symptoms and support Sample size Outcomes: Benefits. Significantly improved Lung: DT scores: No change; Over distress cutoff: 30.7% triage, 50.9% full screen, 51.3% minimal screen 2 (X =14.51 p=0.001) Disparities Other Breast: Study condition associated with DT scores (F=3.27, p=0.039); Triage and full screen had lower DT scores than minimal screen (p=<0.05) E-71 Outcomes: Benefits. Not significantly improved Men with higher baseline depression improved more than women (t=1.97, p=047) Outcomes: Harms Higher baseline anxiety levels predicted greater improvement (t=4.91, p<0.016); higher anxiety in lung improved more than higher anxiety in breast (t=2.68, p=0.008); higher anxiety among those receiving hormone therapy improved less than those who did not (t=-2.60, p=0.01) Predictor of depression (PSSCAN depression) improvement: Greater baseline depression (t=4.72, p<0.001) Other key information Referral to psychosocial resources improved anxiety and depression but DT scores were higher. Study highly feasible; 90% recruitment and 84.47% (breast) and 64.7% (lung) retention. Evidence Table 13. Outcomes reported in studies addressing distress (continued) AuthorYear Refid 1 Carlson, 2010 (continued) Walsh, 2007 2 Outcome measures Measures Distress; Bereavement General Health Questionnaire Sample size 271 Disparities 14% non-white (not further stratified) QOL Satisfaction Other E-72 Outcomes: Benefits. Significantly improved No difference in anxiety and depression scores at follow-up Predictor of depression improvement: referral (t=2.229, p=0.03); lower income (t=2.01, p=0.036) and lower income with higher baseline depression (t=3.48, p=0.001); male (t=2.14, p=0.033) and male with higher baseline depression (t=1.97, p=0.047) None Outcomes: Benefits. Not significantly improved Reduction in career distress Outcomes: Harms Other key information Quality of life decreased over time in both arms Need larger sample size and longer, ongoing intervention. Evidence Table 13. Outcomes reported in studies addressing distress (continued) AuthorYear Refid 3 Aranda, 2006 Outcome measures Psychosocial symptoms and support Needs Blumenthal, 4 2006 Depression Measures EORTC QLQ-30 Supportive care needs survey Beck Depression Inventory Distress General Health Questionnaire Anxiety State-Trait Anxiety Inventory-State Form QOL PulmonarySpecific Quality of Life Scale PQLS Sample size 105 Disparities Not reported Outcomes: Benefits. Significantly improved Outcomes: Benefits. Not significantly improved NS on any of 5 scales Outcomes: Harms Other key information For group with lower baseline needs only: 19-point vs. 14-point decrease in psychological needs in intervention group vs. Control (p=0.026) Need larger sample size and greater follow-up time and subsequent intervention sessions. No harms listed CST was effective for pts with poor PQOL at beginning of treatment but little difference if PQOL was good already at beg of treatment NS 328 Mostly Caucasian pop 11.1 to 9.8 vs. 12.6 to 8.8 (treatment), p=0.003 45.2 to 43.2 vs. 48.1 to 39.7 (treatment), p=0.035 36.1 to 35.0 vs. 38.1 to 33.9 (treatment), p=0.045 NS E-73 Evidence Table 13. Outcomes reported in studies addressing distress (continued) AuthorYear Refid Blumenthal, 4 2006 (continued) Hudson, 2005 5 Outcome measures Secondary listed as stress, mental health, social support, vitality and optimism; also SF-36 somatic outcomes and survival Psychosocial symptoms and support Rewards Measures SF-36 HADS Rewards of care giving Scale Sample size 106 Outcomes: Benefits. Significantly improved Disparities Not addressed other than 74.3% Australian born and 74.3% identified as Christians Preparedness for Care giving Scale Outcomes: Benefits. Not significantly improved No differences in somatic QOL outcomes or survival NS P=0.036 Time 1-Time 2 not sig but Time to Time 3 sig NS E-74 Outcomes: Harms Other key information Assessment tools not validated previously for this population Only 15 standard care participants and 12 intervention participants completed assessments at all three time points Caregivers in this study were highly functioning making it difficult to improve intervention effects The impact of participants' pre palliative care characteristics on the success of the intervention remains unknown Evidence Table 13. Outcomes reported in studies addressing distress (continued) AuthorYear Refid 5 Hudson, 2005 (continued) Porter, 2011 6 Outcome measures Measures Caregiver Competence Scale QOL; three way dichotomizing patient's and caregivers based on Satisfaction; cancer stage of I, II or III For patients-pain Basic Pain Inventory Scale, distress-Beck Depression Inventory Anxiety-State trait anxiety inventory Pain scores Self efficacyused some questions from the chronic pain self efficacy scale Sample size 233 Outcomes: Benefits. Significantly improved Disparities 11% African American Outcomes: Benefits. Not significantly improved NS No outcomes significantly improved over time Outcomes: Harms None Other key information Gate keeping at access was a potential influence on sample representativeness A set of questions specific to the intervention aims and tested within the study might have assisted interpretation of the results No control group with no intervention Future studies could include using a stepped approach, early stage pts could benefit from shorter interventions, design future study to examine efficacy of various interventions Only 54% of pts asked choose to participate E-75 Evidence Table 13. Outcomes reported in studies addressing distress (continued) AuthorYear Refid 6 Porter, 2011 (continued) Outcome measures Measures QOL-Functional Assessment of Cancer therapy lung cancer Sample size Outcomes: Benefits. Significantly improved Disparities For caregiverscaregiver moodProfile of Mood States-B Caregiver strainCaregiver Strain Index Caregiver self efficacy in symptom managementused modified version of self efficacy scale as patients used E-76 Outcomes: Benefits. Not significantly improved Outcomes: Harms Other key information Attrition rate at 27% post test and 40% at four month mostly due to deaths Pts predominantly Caucasian Evidence Table 13. Outcomes reported in studies addressing distress (continued) AuthorYear Refid 7 Steel, 2007 Outcome measures QOL Anxiety Measures Functional Assessment of Cancer TherapyHepatobiliary State Trait Anxiety Index Other Center for Epidemiological StudiesDepression Scale Other Date of diagnosis to death Sample size 28 Disparities African American (1), Native American (1) HispanicLatino (2) Other? (1) Outcomes: Benefits. Significantly improved Outcomes: Benefits. Not significantly improved QOL via FACTdid not use p values to describe Reported decrease in anxiety from beginning assessment to end assessment comparing control group and intervention group Reported reduction in depressive symptoms between control and intervention group between beg and end assessment Intervention group had longer survival by 20days but not statistically significant Outcomes: Harms None None None Other key information Looked at mean change in scores during assessment times for analysis Need further research with a larger sample size (this is underway) Although difference bet control and intervention group was not statistically significant, they were clinically significant. None Other QI - structured patient assessment and intervention; Abbreviations: CCS=Care giver Competence Scale; CES-D=Center for Epidemiological Studies-Depression Scale ; DT=Minimal Distress thermometer ; FACT-Hep=Functional Assessment of Cancer Therapy-Hepatobiliary ; GHQ=General Health Questionnaire; HADS=Hospital Anxiety and Depression Scale; NS=Not Significant; PQOL=Patient Recorded Outcome and Quality of Life Scale; PSSCAN=Full Psychological Scan for Cancer ; QI=QMQI; Pain Tracking Tool; QOL=Quality of Life; STAI=State Trait Anxiety Index E-77 Evidence Table 13 Reference List 1. Carlson LE, Groff SL, Maciejewski O, Bultz BD. Screening for distress in lung and breast cancer outpatients: a randomized controlled trial. J Clinical Oncology 2010; 28(33):4884-91. 5. Hudson PL, Aranda S, Hayman-White K. A psycho-educational intervention for family caregivers of patients receiving palliative care: a randomized controlled trial. J Pain Symptom Manage 2005; 30(4):329-41. 2. Walsh K, Jones L, Tookman A et al. Reducing emotional distress in people caring for patients receiving specialist palliative care. Randomized trial. Br J Psychiatry 2007; 190:142-7. 6. Porter LS, Keefe FJ, Garst J et al. Caregiver-Assisted Coping Skills Training for Lung Cancer: Results of a Randomized Clinical Trial. J Pain Symptom Manage 2010. 3. Aranda S, Schofield P, Weih L, Milne D, Yates P, Faulkner R. Meeting the support and information needs of women with advanced breast cancer: a randomized controlled trial. Br J Cancer 2006; 95(6):667-73. 7. Steel JL, Nadeau K, Olek M, Carr BI. Preliminary results of an individually tailored psychosocial intervention for patients with advanced hepatobiliary carcinoma. J Psychosocial Oncology 2007; 25(3):19-42. 4. Blumenthal JA, Babyak MA, Keefe FJ et al. Telephone-based coping skills training for patients awaiting lung transplantation. Journal of Consulting and Clinical Psychology 2006; 74(3):535-44. E-78 Evidence Table 14. Description of interventions for studies addressing communication Author, year 1 Ahrens, 2003 Campbell, 2003 3 Clayton, 2007 4 Cowan, 2003 Gade, 2008 2 5 Hanks, 2002 6 7 Jacobsen, 2011 8 Kaufer, 2008 9 Lautrette, 2007 10 Lilly, 2000 11 Lilly, 2003 12 Molloy, 2000 13 Mosenthal, 2008 14 Muir, 2010 15 Norton, 2007 16 Penticuff, 2005 17 Sampson, 2011 Schneiderman, 18 2000 Schneiderman, 19 2003 20 Tulsky, 2011 Integrative vs. consultative Combined: interacts with both Consultative: interacts with both Integrative Consultative: interacts with both Consultative: interacts with both Consultative: interacts with both Integrative Consultative: interacts with both Combined: interacts with provider Integrative Integrative Integrative Combined: interacts with patientfamily Integrative Consultative: interacts with both Integrative Mixed Consultative: interacts with both Consultative: interacts with both integrative Target of intervention Communication Communication Patient participation during oncology consultations, psychosocial support. Provider-patient family communication, information giving, understanding and making decisions with families. Interdisciplinary teams, symptom management, psychosocial and spiritual support, end-of-life planning, and post-hospital care. Interdisciplinary teams, patients symptoms control and quality of life Interdisciplinary teams, advance care planning, provider-patient communication Provider-patient family communication, decision making, quality of care, family satisfaction and minority patient population Patient family and providers Interdisciplinary teams, patients goals and expectations of care, critical care use and advanced supportive technology Dying patients directed care goals, patients and family centered care plan, interdisciplinary team Advance care planning, patient and provider education, decision making Prognosis, advance directives, family needs, family support, and surrogate decision maker, and pain and symptoms Provider-patient family communication and decision making. Provider-patient communication, decision making on goals of care and potential treatment limitations. Care planning, parent -professional collaboration Advance care planning, provider and carer communication, carer distress, patients pain and distress Interdisciplinary teams, ethical issues: cardiopulmonary resuscitation; do-not-attempt resuscitation; tracheotomy, gastrostomy, and transfusion; artificial nutritionhydration, and ventilation. Provider-patient and family communication (sharing information, dealing with emotional discomfort and grieving, correcting misunderstandings) Provider education, patient centered care, and provider-patient communication. E-79 Evidence Table 14 Reference List 1. Ahrens T, Yancey V, Kollef M. Improving family communications at the end of life: implications for length of stay in the intensive care unit and resource use. Am J Crit Care 2003; 12(4):317-23; discussion 324. 11. Lilly CM, Sonna LA, Haley KJ, Massaro AF. Intensive communication: four-year follow-up from a clinical practice study. Crit Care Med 2003; 31(5 Suppl):S394-9. 2. Campbell ML, Guzman JA. Impact of a proactive approach to improve endof-life care in a medical ICU. Chest 2003; 123(1):266-71. 12. 3. Clayton JM, Butow PN, Tattersall MH et al. Randomized controlled trial of a prompt list to help advanced cancer patients and their caregivers to ask questions about prognosis and end-of-life care. J Clin Oncol 2007; 25(6):715-23. Molloy DW, Guyatt GH, Russo R et al. Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial. JAMA 2000; 283(11):1437-44. 13. Mosenthal AC, Murphy PA, Barker LK, Lavery R, Retano A, Livingston DH. Changing the culture around end-of-life care in the trauma intensive care unit. J Trauma 2008; 64(6):1587-93. 4. Cowan JD, Burns D, Palmer TW, Scott J, Feeback E. A palliative medicine program in a community setting: 12 points from the first 12 months. Am J Hosp Palliat Care 2003; 20(6):415-33. 14. Muir JC, Daly F, Davis MS et al. Integrating palliative care into the outpatient, private practice oncology setting. J Pain Symptom Manage 2010; 40(1):126-35. 5. Gade G, Venohr I, Conner D et al. Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med 2008; 11(2):180-90. 15. 6. Hanks GW, Robbins M, Sharp D et al. The imPaCT study: a randomised controlled trial to evaluate a hospital palliative care team. British Journal of Cancer 2002; 87(7):733-9. Norton SA, Hogan LA, Holloway RG, Temkin-Greener H, Buckley MJ, Quill TE. Proactive palliative care in the medical intensive care unit: effects on length of stay for selected high-risk patients. Crit Care Med 2007; 35(6):1530-5. 16. Ritchie L. Planning end-of-life care. Nurs N Z 2011; 17(9):23. 17. Sampson EL, Jones L, Thune-Boyle IC et al. Palliative assessment and advance care planning in severe dementia: an exploratory randomized controlled trial of a complex intervention. Palliat Med 2011; 25(3):197-209. 18. Schneiderman LJ, Gilmer T, Teetzel HD. Impact of ethics consultations in the intensive care setting: a randomized, controlled trial. Crit Care Med 2000; 28(12):3920-4. 19. Schneiderman LJ, Gilmer T, Teetzel HD et al. Effect of ethics consultations on nonbeneficial life-sustaining treatments in the intensive care setting: a randomized controlled trial. JAMA 2003; 290(9):1166-72. 20. Tulsky J, Arnold R, Alexander S et al. Enhancing communication between oncologists and patients with a computer-based training program: a randomized trial. Annals of Internal Medicine 2011; 155(9):593-601. 7. Jacobsen Juliet, Robinson Ellen, Jackson VA, Meigs JB, Billings J Andrew. Development of a Cognitive Model for Advance Care Planning Discussions: Results From a Quality Improvement Initiative. Journal of Palliative Medicine - 201103; 14(3): 331, 336. 8. Kaufer M, Murphy P, Barker K, Mosenthal A. Family satisfaction following the death of a loved one in an inner city MICU. Am J Hosp Palliat Care 2008; 25(4):318-25. 9. Lautrette A, Darmon M, Megarbane B et al. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med 2007; 356(5):469-78. 10. Lilly CM, De Meo DL, Sonna LA et al. An intensive communication intervention for the critically ill. Am J Med 2000; 109(6):469-75. E-80 Evidence Table 15. Description of quality improvement elements in studies addressing communication Author, year Ahrens, 1 2003 Campbell, 2 2003 Clayton, 3 2007 Cowan, 4 2003 Gade, 5 2008 Hanks, 6 2002 Jacobsen, 7 2011 Kaufer, 8 2008 Lautrette, 9 2007 Lilly, 10 2000 Lilly, 11 2003 Molloy, 12 2000 Mosenthal, 13 2008 Muir, 14 2010 Norton, 15 2007 Penticuff, 16 2005 Provider reminder system? No Facilitated relay of clinical data to providers? Yes Audit and feedback? No Yes Yes No Provider education? Yes Coaching collaborative skills training? No Patient family caregiver education? No Promotion of selfmanagement? No Patient Caregiver reminder system? No Organizational change? No Other? No No No Yes Yes No No Yes No Yes No No No Yes Yes No No No No Yes Yes No No Yes Yes No No No No Yes Yes No No Yes Yes No Yes No No Yes No No No Yes Yes Yes No No No No No Yes Yes Yes Yes No No No No Yes Yes Yes Yes Yes Yes No No No No No No Yes Yes Yes No No No No No Yes No No No Yes Yes No No No No No No No No Yes Yes No No No No No No Yes Yes Yes Yes No No No No No No No No Yes Yes No No No No Yes Yes Yes Yes Yes Yes No No No No Yes Yes No No Yes Yes No No No No No No Yes No Yes Yes No No Yes E-81 Evidence Table 15. Description of quality improvement elements in studies addressing communication (continued) Author, year Sampson, 17 2011 Schneiderman, 18 2000 Schneiderman, 19 2003 Tulsky, 20 2011 Provider reminder system? No Facilitated relay of clinical data to providers? No Audit and feedback? No No Yes No No Provider education? No Coaching collaborative skills training? No Patient family caregiver education? Yes Promotion of selfmanagement? Yes Patient Caregiver reminder system? No Organizational change? No Other? No No Yes Yes Yes Yes No No No Yes No Yes Yes Yes Yes No No No No Yes Yes No No No No No No Evidence Table 15 Reference List 1. Ahrens T, Yancey V, Kollef M. Improving family communications at the end of life: implications for length of stay in the intensive care unit and resource use. Am J Crit Care 2003; 12(4):317-23; discussion 324. 7. - Jacobsen Juliet, - Robinson Ellen, - Jackson VA, - Meigs JB, Billings J Andrew. - Development of a Cognitive Model for Advance Care Planning Discussions: Results From a Quality Improvement Initiative. - Journal of Palliative Medicine - 201103; - 14(- 3):- 331, 336. 2. Campbell ML, Guzman JA. Impact of a proactive approach to improve end-of-life care in a medical ICU. Chest 2003; 123(1):26671. 8. Kaufer M, Murphy P, Barker K, Mosenthal A. Family satisfaction following the death of a loved one in an inner city MICU. Am J Hosp Palliat Care 2008; 25(4):318-25. 3. Clayton JM, Butow PN, Tattersall MH et al. Randomized controlled trial of a prompt list to help advanced cancer patients and their caregivers to ask questions about prognosis and end-of-life care. J Clin Oncol 2007; 25(6):715-23. 9. Lautrette A, Darmon M, Megarbane B et al. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med 2007; 356(5):469-78. 4. Cowan JD, Burns D, Palmer TW, Scott J, Feeback E. A palliative medicine program in a community setting: 12 points from the first 12 months. Am J Hosp Palliat Care 2003; 20(6):415-33. 10. Lilly CM, De Meo DL, Sonna LA et al. An intensive communication intervention for the critically ill. Am J Med 2000; 109(6):469-75. 11. Lilly CM, Sonna LA, Haley KJ, Massaro AF. Intensive communication: four-year follow-up from a clinical practice study. Crit Care Med 2003; 31(5 Suppl):S394-9. 5. Gade G, Venohr I, Conner D et al. Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med 2008; 11(2):18090. 12. Molloy DW, Guyatt GH, Russo R et al. Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial. JAMA 2000; 283(11):1437-44. 6. Hanks GW, Robbins M, Sharp D et al. The imPaCT study: a randomised controlled trial to evaluate a hospital palliative care team. British Journal of Cancer 2002; 87(7):733-9. E-82 13. Mosenthal AC, Murphy PA, Barker LK, Lavery R, Retano A, Livingston DH. Changing the culture around end-of-life care in the trauma intensive care unit. J Trauma 2008; 64(6):1587-93. randomized controlled trial of a complex intervention. Palliat Med 2011; 25(3):197-209. 18. Schneiderman LJ, Gilmer T, Teetzel HD. Impact of ethics consultations in the intensive care setting: a randomized, controlled trial. Crit Care Med 2000; 28(12):3920-4. 14. Muir JC, Daly F, Davis MS et al. Integrating palliative care into the outpatient, private practice oncology setting. J Pain Symptom Manage 2010; 40(1):126-35. 19. Schneiderman LJ, Gilmer T, Teetzel HD et al. Effect of ethics consultations on nonbeneficial life-sustaining treatments in the intensive care setting: a randomized controlled trial. JAMA 2003; 290(9):1166-72. 15. Norton SA, Hogan LA, Holloway RG, Temkin-Greener H, Buckley MJ, Quill TE. Proactive palliative care in the medical intensive care unit: effects on length of stay for selected high-risk patients. Crit Care Med 2007; 35(6):1530-5. 20. Tulsky J, Arnold R, Alexander S et al. Enhancing communication between oncologists and patients with a computer-based training program: a randomized trial. Annals of Internal Medicine 2011; 155(9):593-601. 16. Ritchie L. Planning end-of-life care. Nurs N Z 2011; 17(9):23. 17. Sampson EL, Jones L, Thune-Boyle IC et al. Palliative assessment and advance care planning in severe dementia: an exploratory E-83 Evidence Table 16. Risk of bias assessment of studies addressing communication Author, year 1 Ahrens, 2003 2 Campbell, 2003 3 Clayton, 2007 4 Cowan, 2003 5 Gade, 2008 6 Hanks, 2002 7 Jacobsen, 2011 8 Kaufer, 2008 9 Lautrette, 2007 10 Lilly, 2000 11 Lilly, 2003 12 Molloy, 2000 13 Mosenthal, 2008 14 Muir, 2010 15 Norton, 2007 16 Penticuff, 2005 17 Sampson, 2011 Schneiderman, 18 2000 Schneiderman, 19 2003 20 Tulsky, 2011 Sequence generation Allocation concealment Binding of personnel (short-term outcomes) Blinding of outcome assessors (short-term outcomes) Binding of personnel (long-term outcomes) Incomplete outcome data (shortterm outcomes) Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Incomplete outcome data (longterm outcomes) Selective outcome reporting Other sources of bias No No No No No No No No No No No No No No No No No No Blinding of outcome assessors (long-term outcomes) No No Yes No No No No No Yes No No No No No No No No No Yes No Yes No Yes No No No Yes No No No No No No No No No No No No No Yes No No No Yes No No No No No No No No No Yes No No No No Yes No No No No No No No No No No No No Yes No Yes No No Yes No No Yes No No No No No No No No No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No No No No Yes Yes Yes Yes Evidence Table 16 Reference List 1. Ahrens T, Yancey V, Kollef M. Improving family communications at the end of life: implications for length of stay in the intensive care unit and resource use. Am J Crit Care 2003; 12(4):317-23; discussion 324. 4. Cowan JD, Burns D, Palmer TW, Scott J, Feeback E. A palliative medicine program in a community setting: 12 points from the first 12 months. Am J Hosp Palliat Care 2003; 20(6):415-33. 5. Gade G, Venohr I, Conner D et al. Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med 2008; 11(2):180-90. 2. Campbell ML, Guzman JA. Impact of a proactive approach to improve end-of-life care in a medical ICU. Chest 2003; 123(1):266-71. 6. Hanks GW, Robbins M, Sharp D et al. The imPaCT study: a randomised controlled trial to evaluate a hospital palliative care team. British Journal of Cancer 2002; 87(7):733-9. 3. Clayton JM, Butow PN, Tattersall MH et al. Randomized controlled trial of a prompt list to help advanced cancer patients and their caregivers to ask questions about prognosis and end-of-life care. J Clin Oncol 2007; 25(6):715-23. 7. Jacobsen Juliet, - Robinson Ellen, - Jackson VA, - Meigs JB, - Billings J E-84 Andrew. - Development of a Cognitive Model for Advance Care Planning Discussions: Results From a Quality Improvement Initiative. - Journal of Palliative Medicine - 201103; - 14(- 3):- 331, 336. outpatient, private practice oncology setting. J Pain Symptom Manage 2010; 40(1):126-35. 15. Norton SA, Hogan LA, Holloway RG, Temkin-Greener H, Buckley MJ, Quill TE. Proactive palliative care in the medical intensive care unit: effects on length of stay for selected high-risk patients. Crit Care Med 2007; 35(6):1530-5. 8. Kaufer M, Murphy P, Barker K, Mosenthal A. Family satisfaction following the death of a loved one in an inner city MICU. Am J Hosp Palliat Care 2008; 25(4):318-25. 16. Ritchie L. Planning end-of-life care. Nurs N Z 2011; 17(9):23. 9. Lautrette A, Darmon M, Megarbane B et al. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med 2007; 356(5):469-78. 17. Sampson EL, Jones L, Thune-Boyle IC et al. Palliative assessment and advance care planning in severe dementia: an exploratory randomized controlled trial of a complex intervention. Palliat Med 2011; 25(3):197-209. 10. Lilly CM, De Meo DL, Sonna LA et al. An intensive communication intervention for the critically ill. Am J Med 2000; 109(6):469-75. 18. Schneiderman LJ, Gilmer T, Teetzel HD. Impact of ethics consultations in the intensive care setting: a randomized, controlled trial. Crit Care Med 2000; 28(12):3920-4. 11. Lilly CM, Sonna LA, Haley KJ, Massaro AF. Intensive communication: four-year follow-up from a clinical practice study. Crit Care Med 2003; 31(5 Suppl):S394-9. 19. Schneiderman LJ, Gilmer T, Teetzel HD et al. Effect of ethics consultations on nonbeneficial life-sustaining treatments in the intensive care setting: a randomized controlled trial. JAMA 2003; 290(9):1166-72. 12. Molloy DW, Guyatt GH, Russo R et al. Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial. JAMA 2000; 283(11):1437-44. 13. Mosenthal AC, Murphy PA, Barker LK, Lavery R, Retano A, Livingston DH. Changing the culture around end-of-life care in the trauma intensive care unit. J Trauma 2008; 64(6):1587-93. 20. Tulsky J, Arnold R, Alexander S et al. Enhancing communication between oncologists and patients with a computer-based training program: a randomized trial. Annals of Internal Medicine 2011; 155(9):593-601. 14. Muir JC, Daly F, Davis MS et al. Integrating palliative care into the E-85 Evidence Table 17. Outcomes reported in studies addressing communication Author, year Ahrens et al, 1 2003 Cowan, 2003 Outcomes: Benefits. Outcomes: Benefits. Not significantly Measures Sample size Disparities Significantly improved improved Hospital LOS 151 patients (108 39-40% African Control 16.4 days, in standard American, 58- intervention 11.3 days; p = practice, 43 in 60% white, 1- 0.03 intervention) 2% Asian LOS ICU LOS Control 9.5 days, intervention 6.1 days; p=0.009 Mortality Hospital Control 93%, Mortality Intervention 74%; p =0.14 Cost Hospital variable direct charge per case: control $24,080, intervention $15,559; p=0.01; Hospital Varian indirect charge per case: control $8035, intervention $5087; p=0.07; Fixed chargecase: Control $8485, Intervention $5320; p=0.006; 873 6% African Receiving the intervention Decision to forgo Resuscitation Americans increased the average predicted probability of deciding to forgo resuscitation by about 50%, from 18% to 28%. (OR 1.81, p=0.017) Decision to give Receiving the intervention comfort care only increased the average predicted probability of choosing comfort care by 59%, from 14% to 22%. (OR 1.94, p= 0.018) Outcome measures LOS 2 E-86 Outcomes: Other key Harms information None None None None Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year 2 Cowan, 2003 (continued) Outcome measures Measures Decision to treat aggressively Satisfaction; Overall satisfaction with care Satisfaction with information provided Satisfaction Satisfaction; Satisfaction with involvement in decision making Campbell & LOS Hospital los 3 Guzman, 2003 (days in means) LOS LOS ICU LOS (days in means) DNR status (days in means) Sample size Disparities Outcomes: Benefits. Outcomes: Benefits. Not significantly Outcomes: Other key Harms Significantly improved improved information Receiving the intervention None increased the average predicted probability of choosing aggressive care by almost 90%, from 10% to nearly 20%. (OR 2.30, p=0.002). Intervention vs. Control None (OR 0.68, p=0.14) Intervention vs. Control None (OR 0.86, p=0.44) Intervention vs. Control None (OR 0.84, p=0.54) Total 81; retrospective control 40, intervention 41 None noted. Global cerebral ischemia patients: control 8.6 days, intervention 4.7 days; p < 0.001 GCI: control 7.1 days, Intervention 3.7 days; p < 0.01 MOSF to DNR: control 4.7 days, intervention 1.5 days; p < 0.05; E-87 Multi-system organ None failure patients: control 20.6 days, intervention 15.1 days; p = 0.063 MOSF: control 10.7 days, intervention 10.4 days; p = 0.735 MOSF admission to DNR: control 10.7 days, intervention 10.4 days; p = 0.735; GCI admission to DNR: control 3.5 days, intervention 2.8 days; p = 0.063 None Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year Campbell & 3 Guzman, 2003 (continued) Outcome measures LOS LOS Use of hospital resources Measures CMO status (days in means) MOSF to death (days in means) Therapeutic Intervention Scoring System - after withhold support Therapeutic Intervention Scoring System - after make patient CMO Sample size Disparities Outcomes: Benefits. Outcomes: Benefits. Not significantly Outcomes: Other key Harms Significantly improved improved information MOSF to CMO: control 7.3 days, intervention 2.2 days, p< 0.05; GCI hosp admission to CMO: control 6.3 days, intervention 3.5 days; p < 0.05 Control 5.8 days, intervention 2.1 days; p<0.05 MOSF: Decrease of: Control 1.8, intervention 4.1; p=0.37, GCI: Decrease of: Control 3.8, intervention 4.3; p=0.41 MOSF: Decrease of: GCI: Decrease of: control 12, intervention control 19.4, 25.6; p < 0.05 intervention 15.4; p=0.34 E-88 Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year 4 Clayton, 2007 Outcome measures Measures Sample size Primary outcome: Spiel-Berger 174 patients total number of State Anxiety patient questions Inventory during the consultation and patient preference for information Disparities None Satisfaction, Patient satisfaction with the consultation Other Patient anxiety E-89 Outcomes: Benefits. Outcomes: Benefits. Not significantly Outcomes: Other key Harms Significantly improved improved information Patients in the QPL group Thespis a 16asked 2.31 times (95% CI, page A5 1.68 to 3.18 booklet times) more questions (Appendix, directly requesting for online only) information during the containing consultation than controls 112 questions grouped into (P .0001). 23% (95% CI, nine topics 11% to 37%) more items encompasswere discussed during ing issues consultations with QPL that may be patients than controls (P discussed .0001). with a physician or another health professional. Unmet patient information need, was reduced by the QPL. Patients were highly satisfied with the consultation in both groups (mean score out of 125: QPL, 110.1 v control, 110.3; 95% CI for difference, 3.4 to 2.9) Patient anxiety scores were similar in both groups (mean, 40.3 in both groups; 95% CI for difference, 2.7 to 2.7). Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year 5 Muir, 2010 Outcome measures LOS Measures Sample size 480 Disparities None LOS; ICU stay Presence of Living will DNAR order Number of Tracheotomy ICU Mortality Post-discharge Mortality E-90 Outcomes: Benefits. Significantly improved Outcomes: Benefits. Not significantly Outcomes: Other key Harms improved information Control 22.84 (13.36) None vs. Intervention 24.86 (13.04), P=0.07 Control 13.44 (9.18) vs. None Intervention 14.41 (9.85), P=0.16 Control 30 (22.2) vs. None Intervention 53 (15.3), P=0.07 Control 46 (34.1)vs. None Intervention 107 (30.9), P=0.51 Control 74 (55.6) vs. None Intervention 169 (49.3), P=0.21 Control 26 (19.3) vs. None Intervention 67 (19.4), P=0.98 Control 19 (21.6) vs. None Intervention 38 (15.9), P=0.03 Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year 6 Gade, 2008 Outcome measures Patient symptoms; Primary study outcomes: symptom control Measures Sample size Physical Area 517 patients scale of the Modified City of Hope Patient Questionnaires, Emotional Relationship Area and Spiritual Area scales, Place of Care Environment scale and the Doctors, Nurses Other Care Providers Communication scale, Eastern Cooperative Oncology Group performance scale. Disparities None Satisfaction; Primary study outcomes: patient satisfaction Outcomes: Benefits. Significantly improved Outcomes: Benefits. Not significantly Outcomes: Other key Harms improved information No difference between None This study IPCS and UC groups provides for patient symptom evidence for control. the positive impact of IPCS consultations on satisfaction with care and decreased health care costs. It also contributes new information on the impact of this service on ICU admissions and hospice utilization. IPCS group reported higher mean satisfaction for both the Place of Care Environment scale (IPCS: 6.8; UC: 6.4, p 001.) QOL; Primary study outcomes No difference between IPCS and UC groups for quality of life. E-91 Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year 6 Gade, 2008 (continued) Outcome measures Measures Psychosocial symptoms and support; levels of emotional Primary study outcomes: spiritual support Primary study outcomes: total health services costs at 6 months post index hospitalization Secondary measures: survival Secondary measures: number of advance directives (ads) at discharge Secondary measures: hospice utilization within the 6 months post index hospitalization. Secondary measures: ICU admissions Sample size Disparities Outcomes: Benefits. Significantly improved Outcomes: Benefits. Not significantly Outcomes: Other key Harms improved information No difference between IPCS and UC groups for emotional and spiritual support. Total mean health costs for the IPCS group were lower by $6,766 per patient compared to UC patients (IPCS: $14,486; UC: $21, 252, p 0.001). No difference between IPCS and UC groups for survival. IPCS patients completed significantly more ADS at hospital discharge than UC patients (91.1% vs. 77.8%; p0.001), IPCS patients had significantly longer median hospice stays than UC participants (IPCS: 24 days; UC: 12days, p0.04) Fewer ICU admissions IPCS 12 vs. UC 21 (P=0.04) E-92 Evidence Table 17. Outcomes reported in studies addressing communication (continued) Outcome measures Symptom Author, year 7 Hanks, 2002 Satisfaction Measures Sample size VAS, mood 261 (Memorial Pain Assessment Card), emotional (WONCA scale) Macadam’s 261 Assessment of Suffering Questionnaire , FAMCARE scale, the Hospital Anxiety and Depression scale Disparities None Outcomes: Benefits. Significantly improved None 8 899 None This study didn’t show a significant difference between the ‘full-PCT’ and ‘telephonePCT’ in respect of the primary outcome measures, and particularly symptoms and HRQOL No p values given but no apparent differences. QOL, HealthEORTC QLQrelated quality of C30 life questionnaire, LOS Jacobsen, 2011 Advance care plan discussion Presence of an order at the time of discharge to limit lifesustaining treatment Outcomes: Benefits. Not significantly Outcomes: Other key Harms improved information No diff; Symptom severity (p=0.48), Mood (p=0.45), emotional problems (0.58) 33.8% intervention vs. 21.2% control, p<0.001 19.1% intervention vs. 13.9% control, p<0.044 E-93 No significant diff between groups (p = 0.45). Full PCT 14.7 (9.4) days vs. Telephone PCT 13.2 (9.6) days. P value not given None None None None Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year 9 Kaufer, 2008 Outcome measures Overall satisfaction with hospital experience; Satisfaction Satisfaction with amount of treatment received Satisfaction; Patient life not prolonged or shortened unnecessarily Satisfaction Satisfaction with understanding of information Distress Emotional support Measures Sample size Family 88 Satisfaction with Care Questionnaire Disparities 67% African American Outcomes: Benefits. Significantly improved Outcomes: Benefits. Not significantly Outcomes: Other key Harms improved information No significant change None Family Satisfaction with Care Questionnaire Family Satisfaction with Care Questionnaire Increased from 44% to 75%(P = .03) None Increased from 47% preintervention to 73% postintervention (P =0.016) None Family Satisfaction with Care Questionnaire Family Satisfaction with Care Questionnaire Patient Symptom Family Satisfaction management with Care symptoms Questionnaire Other Family Involvement in Satisfaction decision making with Care Questionnaire Increased from 44% to 73% (P=0.005) postintervention None Increased from 76% to 86% (P<0.05) None No significant change None Increased from 40% to 70% (P = .004). E-94 None Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year Kaufer, 2008 (continued) Lautrette et al, 10 2007 Outcome measures Satisfaction with frequency of communication Other Measures Sample size Family Satisfaction with Care Questionnaire Disparities Distress; Caregiver distress Impact of Event Scale Score 86 (intervention) or 88% (control) of patients were of French descent Control group 63 patients, Intervention group 63 patients. Outcomes: Benefits. Outcomes: Benefits. Not significantly Significantly improved improved Communication from doctors (44% to 76%, p=0.003), from nurses (72% to 91%, p=0.021) of information, honesty of information, and completeness of information increased from 44% to 73%, 56% to 80%, and 49% to 78%, respectively (P =0.005, 0.015, and 0.005 respectively). Intervention IES score median 27 (IQR 18-42) vs. Control IES score 39 (IQR 25-48); p=0.02; 45% of families in intervention group at risk for PTSD and 69% of families in control group at risk for PTSD E-95 Outcomes: Other key Harms information None None noted. Symptoms of anxiety & depression also significantly different; most measures of effectiveness of overall information provided were not statistically significantly different; use of nonbeneficial interventions (ventilation, others) not significantly different Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year Lautrette et al, 10 2007 Outcome measures Psychosocial symptoms and Caregiver distress support LOS Discussion of goals of care by physicians on rounds Measures Sample size Hospital Anxiety and Depression Scale Number of days in ICU from admission to decision to forgo lifesustaining treatments Disparities Outcomes: Benefits. Outcomes: Benefits. Not significantly Outcomes: Other key Harms Significantly improved improved information Intervention HADS score median 11 (IQR 8-18) vs. Control HADS 17 (IQR 1125); p=0.004; Intervention 2 days (IQR 2-14), Control 5 days (IQR 2-10), p=0.38 Discussion of goals of care by physicians on rounds increased from 4% to 36% of patientdays. Do not resuscitate and Withdrawal of life support Mortality rate DNR (43%) and WD (24%) were unchanged. During intervention, rates of mortality (14%), E-96 Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year 11 Lilly, 2003 Outcome measures Length of stay (primary vs. Secondary not stated) Measures ICU LOS Mortality Mortality LOS Adjustment for acute physiology and chronic health evaluation 3 score Sample size 2495 Patients Disparities None 530 African Americans, Hispanics, Asians Outcomes: Benefits. Outcomes: Benefits. Not significantly Outcomes: Other key Harms Significantly improved improved information Length of stay in the ICU None None Intensive communication was reduced from 4 [2–11] to 3days [2–6 days, is a process interquartile range; n based 2361] intervention that encourages the use of advanced supportive technology when it is effective for accomplishing patientdirected goals and facilitates acceptance of a comfortfocused care plan for dying patients. ICU mortality rate in follow-up study was 18.0% and lower than the rate of 31.3% observed for our pre-intervention group (chi-square p .001) 4 days (2 to 11days) to 3 None None days (2 to 6 days) P= 0.01. APACHE 3 score [risk ratio- 0.81, 95% confidence interval (CI), 0.66 to 0.99, P- 0.04 E-97 Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year 12 Lilly, 2000 Outcome measures Mortality Measures Sample size Disparities Rate of family non-consensus Rate of provider non-consensus Molloy, 2000 13 Satisfaction Satisfaction 1133 questionnaire s None Outcomes: Benefits. Outcomes: Benefits. Not significantly Significantly improved improved 7 of 35patients (20%) died None in the pre-intervention period, and 5 of 102 patients (5%) died in the intensive communication period (P - 0.02). 171 days per 1,000 None patient-days to 16days per 1,000 patient-days (1.7 to 0.09 days per patient) after the intervention (P0.001) 65 days per 1,000 patient None days to 4 days per 1,000 patient-days, (0.56 to 0.02 days per patient) Mean diff -0.16 [-0.410.1], P=0.24 Hospital cost Risk of hospitalization and # hosp days Outcomes: Other key Harms information None None None None Hosp cost: intervention Can$1772, control Can$3869, (p=0.003); total health care & implement cost intervention Can$3490, control Can$5239 (p=0.01) Risk of hosp: Intervention 0.27, control 0.48 (p=0.001); # hosp days: intervention 2.61, control 5.86 (p=0.01) Mortality rate None Intervention and control homes (24% vs. 28%; P = .20). E-98 None Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year Mosenthal, 14 2008 Norton, 2007{ #16225} Outcome measures LOS; Hospital LOS LOS; MICU LOS LOS Mortality rate Measures Sample size Glasgow 367 Coma Scale, severe head injury, Injury Severity Score. 191 Outcomes: Benefits. Outcomes: Benefits. Not significantly Outcomes: Other key Harms Disparities Significantly improved improved information None In baseline patients ICU None LOS mean 7.6, median 3, hospital LOS mean 14.4, median 3.5, In intervention patients ICU LOS mean 6.1, median 1, hospital LOS mean 6.5, median 1.5 The proactive PC None African intervention group was American 8.96 days compared with (19.4%), Hispanic (3%) 16.28 days for the usual care group, a statistically significant difference of 7.32 days (p=0.0001) The usual care group: None 41.40 days compared with 35.8 days for the proactive PC intervention group (p=0.5011) In hospital mortality - None 55.4% control vs. 59.5% intervention - no change the MICU death rate was 25 of 65 (38.5%) in the usual care group and 46 of 126 (36.5%) in the proactive PC intervention group. (p=0.6128). E-99 Evidence Table 17. Outcomes reported in studies addressing communication (continued) Outcome Author, year measures Measures Sample size 15 Penticuff, 2005 Parental Collaboration 154 satisfaction with and participation, care Satisfaction and relationship About Care ;Satisfaction Questionnaire Subscale of Parent's comprehension Parents’ Understandin of medical g of Infant information Care and Outcomes Questionnaire Five-point Parent's understanding of Likert scale of 30 items. infant care Decision conflicts Decision Conflict Scale Amount of shared decision making Disparities African American (15%), Hispanic (34%) Outcomes: Benefits. Significantly improved Had fewer unrealistic concerns 4.32 vs. 8.56 (p=0.018) Less uncertainty about infant care intervention vs. Control mean 1.92 vs. 3.82 (p=0.003) Intervention vs. Control; mean 45.88 vs. 59.10 (p<0.001) Intervention vs. Control 139 vs. 122.69 (p=0.010) E-100 Outcomes: Benefits. Not significantly Outcomes: Other key Harms improved information Intervention vs. Control None with care 64.98 vs. 65.69 (p<0.610), with relationship 193.11 vs. 193.35 (p <0.960) None None None None Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, year Sampson, 16 2011 Outcome measures Measures Number of carers making Advanced care planning Sample size 32 Disparities Outcomes: Benefits. Significantly improved Carer satisfaction Life satisfaction scale LSQ carer distress Kessler distress scale KD10 Patient pain visual analogue scale VAS visual analogue scale VAS Patient distress Outcomes: Benefits. Not significantly Outcomes: Other key Harms improved information Only seven carers none Attrition made ACPs. The care precluded planning discussion statistical was well received, comparison but few carers wrote an of control and ACP, despite intensive intervention support from an groups, but experienced nurse some trends specialist. are suggested by the data. Intervention vs Control at baseline: 4.5(1.1) vs 4.6(1.2), at 6months 5.4(0.9) vs 5.5(0.6) Intervention vs Control at baseline; 20.7(6.8) vs 22.7(10.3), at 6months 14.6(3.4) vs 15.0(4.4). Improvement in the months following the patient’s index admission no observable trends in the carer ratings of patients’ pain. no observable trends in the carer ratings of patients’ distress. E-101 Evidence Table 17. Outcomes reported in studies addressing communication (continued) Outcome Author, year measures Schneiderman, LOS; Hospital 17 2003 days Measures Sample size 546 Disparities African Americans, Hispanics, Asians Days receiving ventilation Days receiving artificial nutrition hydration Days receiving artificial nutrition and hydration Days receiving ventilation % of patients receiving CPR, DNAR, gastrostomy, tracheotomy, transfusion, ventilator Overall mortality Schneiderman, LOS; ICU days 18 2000 Outcomes: Benefits. Outcomes: Benefits. Not significantly Outcomes: Other key Harms Significantly improved improved information Intervention (n=173) vs. None This study Control patients (n=156) showed that hospital days (−2.95 days, ethics P=.01) consultations in the ICU were helpful in addressing treatment conflicts. Intervention vs. Control None patients (−1.7 days, P=.03) Days receiving None nutritionhydration (1.03days, P=.14) Control 12.0 vs. None Intervention 4.1(p 0.05) Control 11.4 vs. Intervention 3.7 (p 0.05) None No difference. 70 African Americans, Hispanics, Asians There was a reduction in ICU days: control13.2 days vs. Intervention 4.2 days (p 0.03) E-102 There were no None differences - p=1.0 - in overall mortality between the control patients and patients receiving ethics consultations. None Evidence Table 17. Outcomes reported in studies addressing communication (continued) Author, Sample year Outcome measures Measures size Disparities Tulsky, Audio recordings to 264 10% Black, 19 2011 measure the emotion4% handling skills outcomes Hispanic of providers Outcomes: Benefits. Significantly improved The mean number of empathic statements per conversation increased (mean, 0.8 [SD, 1.3] in the intervention group vs. 0.4 [SD, 0.8] in the control group). This value increased more among oncologists in the intervention group (adjusted rate ratio, 1.9 [CI, 1.1 to3.3]; P 0.024) Trust scale: intervention versus control; 4.7 (4.6-4.8) vs 4.6 (4.5-4.7), mean difference 0.1 90.00.2), p value= 0.036. Outcomes: Benefits. Not significantly improved Outcomes: Harms Other key information Perceived empathy scale p none Patient perceptions; In this study, the control value= 0.058, Therapeutic trust, perceieved oncologists performed slightly alliance scale pvalue= 0.27, empathy, therapeutic worse in the postintervention phase. To improve the quality of perceieved knowledge of alliance, perceived communication in medical patient p value= 0.28, knowledge of patient, encounters, more physicians perceived belief that provider perceieved belief that cares p value= 0.63, should receive communication provider cares, perceived belief that skills training that includes perceived belief that oncologist understood individualized, reflective provider understood patient as a whole pvalue= feedback. patient as a whole person 0.093 Abbreviations: Can $=Canadian dollar; CMO=Comfort measures only; CPR=Cardiopulmonary resuscitation; DNARDNR=Do not attempt resuscitation; EORTC QLQ C30=European organization for research and treatment of cancer quality of life questionnaire; GCI=Global cerebral ischemia; HADS=Hospital anxiety and depression scale; HRQOL=Health related quality of life; ICU=Intensive care unit; IPCS=Interdisciplinary palliative care service; IES=Impact of event scale; IQR=Interquantile range; LOS=Length of stay; MICU=Medical intensive care unit; MOSF=Multi-organ systems failure; PC=Palliative care; PCT=Palliative care team; PTSD=Post-traumatic stress disorder; QOL=Quality of life; QPL=Question prompts lists; UC=Usual care; WD=Withdrawal of life support; VAS=Visual analog scale; WONCA=World Organization of National Colleges and Academic Evidence Table 17 Reference List 1. Ahrens T, Yancey V, Kollef M. Improving family communications at the end of life: implications for length of stay in the intensive care unit and resource use. Am J Crit Care 2003; 12(4):317-23; discussion 324. 2. Cowan JD, Burns D, Palmer TW, Scott J, Feeback E. A palliative medicine program in a community setting: 12 points from the first 12 months. Am J Hosp Palliat Care 2003; 20(6):415-33. 3. Campbell ML, Guzman JA. Impact of a proactive approach to E-103 improve end-of-life care in a medical ICU. Chest 2003; 123(1):26671. communication: four-year follow-up from a clinical practice study. Crit Care Med 2003; 31(5 Suppl):S394-9. 4. Clayton JM, Butow PN, Tattersall MH et al. Randomized controlled trial of a prompt list to help advanced cancer patients and their caregivers to ask questions about prognosis and end-of-life care. J Clin Oncol 2007; 25(6):715-23. 12. Lilly CM, De Meo DL, Sonna LA et al. An intensive communication intervention for the critically ill. Am J Med 2000; 109(6):469-75. 13. Molloy DW, Guyatt GH, Russo R et al. Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial. JAMA 2000; 283(11):1437-44. 5. Muir JC, Daly F, Davis MS et al. Integrating palliative care into the outpatient, private practice oncology setting. J Pain Symptom Manage 2010; 40(1):126-35. 14. Mosenthal AC, Murphy PA, Barker LK, Lavery R, Retano A, Livingston DH. Changing the culture around end-of-life care in the trauma intensive care unit. J Trauma 2008; 64(6):1587-93. 6. Gade G, Venohr I, Conner D et al. Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med 2008; 11(2):18090. 15. Ritchie L. Planning end-of-life care. Nurs N Z 2011; 17(9):23. 7. Hanks GW, Robbins M, Sharp D et al. The imPaCT study: a randomised controlled trial to evaluate a hospital palliative care team. British Journal of Cancer 2002; 87(7):733-9. 16. Sampson EL, Jones L, Thune-Boyle IC et al. Palliative assessment and advance care planning in severe dementia: an exploratory randomized controlled trial of a complex intervention. Palliat Med 2011; 25(3):197-209. 8. - Jacobsen Juliet, - Robinson Ellen, - Jackson VA, - Meigs JB, Billings J Andrew. - Development of a Cognitive Model for Advance Care Planning Discussions: Results From a Quality Improvement Initiative. - Journal of Palliative Medicine - 201103; - 14(- 3):- 331, 336. 17. Schneiderman LJ, Gilmer T, Teetzel HD et al. Effect of ethics consultations on nonbeneficial life-sustaining treatments in the intensive care setting: a randomized controlled trial. JAMA 2003; 290(9):1166-72. 18. Schneiderman LJ, Gilmer T, Teetzel HD. Impact of ethics consultations in the intensive care setting: a randomized, controlled trial. Crit Care Med 2000; 28(12):3920-4. 9. Kaufer M, Murphy P, Barker K, Mosenthal A. Family satisfaction following the death of a loved one in an inner city MICU. Am J Hosp Palliat Care 2008; 25(4):318-25. 19. Tulsky J, Arnold R, Alexander S et al. Enhancing communication between oncologists and patients with a computer-based training program: a randomized trial. Annals of Internal Medicine 2011; 155(9):593-601. 10. Lautrette A, Darmon M, Megarbane B et al. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med 2007; 356(5):469-78. 11. Lilly CM, Sonna LA, Haley KJ, Massaro AF. Intensive E-104 Evidence Table 18. Description of interventions for studies addressing quality improvement Author, year 1 Campion, 2011 2 Detmar, 2002 3 Meyers, 2011 4 Mills, 2009 Rosenbloom, 5 2007 6 Taenzer, 2000 7 Velikova, 2004 , 8 Velikova 2010 Integrative vs. consultative Consultative: interacts with providers Other neither Consultative: Interacts with patients and families Other neither Consultative: Interacts with both Target of intervention Symptom Assessment and Use of Hospice Assessments Quality of Life, Problem Solving Other neither Integrative Quality of life assessment Case management Assessments Assessments Evidence Table 18 Reference List 1. Campion FX, Larson LR, Kadlubek PJ, Earle CC, Neuss MN. Advancing performance measurement in oncology. Am J Manag Care 2011; 17 Suppl 5 Developing:SP32-6. 2. Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA 2002; 288(23):3027-34. 3. 4. Meyers FJ, Carducci M, Loscalzo MJ, Linder J, Greasby T, Beckett LA. Effects of a problem-solving intervention (COPE) on quality of life for patients with advanced cancer on clinical trials and their caregivers: simultaneous care educational intervention (SCEI): linking palliation and clinical trials. (1557-7740 (Electronic). 1557-7740 (Linking)). Mills ME, Murray LJ, Johnston BT, Cardwell C, Donnelly M. Does a patient-held quality-of-life diary benefit patients with inoperable lung cancer? J Clin Oncol 2009; 27(1):70-7. E-105 5. - Rosenbloom SK, - Victorson DE, - Hahn EA, - Peterman AH, - Cella David. - Assessment Is Not Enough: a Randomized Controlled Trial of the Effects of Hqrl Assessment on Quality of Life and Satisfaction in Oncology Clinical Practice. - Psycho-Oncology - 200712; - 16(- 12):1069, - 1079. 6. Taenzer P, Bultz BD, Carlson LE et al. Impact of computerized quality of life screening on physician behaviour and patient satisfaction in lung cancer outpatients. Psychooncology 2000; 9(3):203-13. 7. Velikova G, Booth L, Smith AB et al. Measuring quality of life in routine oncology practice improves communication and patient wellbeing: a randomized controlled trial. J Clin Oncol 2004; 22(4):714-24. 8. Velikova G, Keding A, Harley C et al. Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. Eur J Cancer 2010; 46(13):2381-8. Evidence Table 19. Description of quality improvement elements in studies addressing quality improvement Author, year 1 Campion, 2011 2 Detmar, 2002 3 Meyers, 2011 4 Mills, 2009 Rosenbloom, 5 2007 6 Taenzer, 2000 7 Velikova, 2004 , 8 Velikova 2010 Facilitated relay of clinical data to providers? Provider education? Organizational change? No Yes No Yes No Patient family caregiver education? No Yes Yes No No No Yes No Yes Yes Yes Yes Yes Yes No No No Yes No No No No No Evidence Table 19 Reference List 1. Campion FX, Larson LR, Kadlubek PJ, Earle CC, Neuss MN. Advancing performance measurement in oncology. Am J Manag Care 2011; 17 Suppl 5 Developing:SP32-6. 2. Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA 2002; 288(23):3027-34. 3. 4. Meyers FJ, Carducci M, Loscalzo MJ, Linder J, Greasby T, Beckett LA. Effects of a problem-solving intervention (COPE) on quality of life for patients with advanced cancer on clinical trials and their caregivers: simultaneous care educational intervention (SCEI): linking palliation and clinical trials. (1557-7740 (Electronic). 1557-7740 (Linking)). Mills ME, Murray LJ, Johnston BT, Cardwell C, Donnelly M. Does a patient-held quality-of-life diary benefit patients with inoperable lung cancer? J Clin Oncol 2009; 27(1):70-7. E-106 5. - Rosenbloom SK, - Victorson DE, - Hahn EA, - Peterman AH, - Cella David. - Assessment Is Not Enough: a Randomized Controlled Trial of the Effects of Hqrl Assessment on Quality of Life and Satisfaction in Oncology Clinical Practice. - Psycho-Oncology - 200712; - 16(12):- 1069, - 1079. 6. Taenzer P, Bultz BD, Carlson LE et al. Impact of computerized quality of life screening on physician behaviour and patient satisfaction in lung cancer outpatients. Psychooncology 2000; 9(3):203-13. 7. Velikova G, Booth L, Smith AB et al. Measuring quality of life in routine oncology practice improves communication and patient wellbeing: a randomized controlled trial. J Clin Oncol 2004; 22(4):714-24. 8. Velikova G, Keding A, Harley C et al. Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. Eur J Cancer 2010; 46(13):2381-8. Evidence Table 20. Risk of bias assessment of studies addressing quality improvement Author, year Sequence generation Allocation concealment Blinding of outcome assessors (short-term outcomes) No Binding of personnel (long-term outcomes) No Binding of personnel (shortterm outcomes) No Incomplete outcome data (shortterm outcomes) Yes Incomplete outcome data (longterm outcomes) Yes Selective outcome reporting Other sources of bias No Blinding of outcome assessors (long-term outcomes) No Campion, 1 2011 Detmar, 2 2002 Meyers, 3 2011 4 Mills, 2009 Rosenbloom, 5 2007 Taenzer, 6 2000 Velikova, 7 2004 , Velikova, 8 2010 No Yes No Unclear No No Unclear No Unclear Yes Yes Yes No Yes Unclear No Unclear Unclear Unclear Yes Yes Yes No Yes Unclear Unclear Unclear No No No No No No No No Yes Yes Yes Yes Yes Yes Yes Yes No No No No No No No Yes Yes No Unclear Unclear Unclear Unclear Unclear Unclear No No No Unclear Evidence Table 20 Reference List 1. Campion FX, Larson LR, Kadlubek PJ, Earle CC, Neuss MN. Advancing performance measurement in oncology. Am J Manag Care 2011; 17 Suppl 5 Developing:SP32-6. 2. Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA 2002; 288(23):3027-34. 3. 4. Meyers FJ, Carducci M, Loscalzo MJ, Linder J, Greasby T, Beckett LA. Effects of a problem-solving intervention (COPE) on quality of life for patients with advanced cancer on clinical trials and their caregivers: simultaneous care educational intervention (SCEI): linking palliation and clinical trials. (1557-7740 (Electronic). 1557-7740 (Linking)). Mills ME, Murray LJ, Johnston BT, Cardwell C, Donnelly M. Does a patient-held quality-of-life diary benefit patients with inoperable lung cancer? J Clin Oncol 2009; 27(1):70-7. E-107 5. - Rosenbloom SK, - Victorson DE, - Hahn EA, - Peterman AH, - Cella David. - Assessment Is Not Enough: a Randomized Controlled Trial of the Effects of Hqrl Assessment on Quality of Life and Satisfaction in Oncology Clinical Practice. - Psycho-Oncology - 200712; - 16(12):- 1069, - 1079. 6. Taenzer P, Bultz BD, Carlson LE et al. Impact of computerized quality of life screening on physician behaviour and patient satisfaction in lung cancer outpatients. Psychooncology 2000; 9(3):203-13. 7. Velikova G, Booth L, Smith AB et al. Measuring quality of life in routine oncology practice improves communication and patient wellbeing: a randomized controlled trial. J Clin Oncol 2004; 22(4):714-24. 8. Velikova G, Keding A, Harley C et al. Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. Eur J Cancer 2010; 46(13):2381-8. Evidence Table 21. Outcomes reported in studies addressing quality improvement Author, year Campion, 1 2011 Outcome measures Quality of Care Measures Sample size Disparities Pain assessed appropriately before death 644 sites NR Dyspnea 644 sites addressed appropriate before death Hospice or palliative care discussed 641 sites Hospicepalliative care addressed appropriately 633 sites Outcomes: Benefits. Significantly improved Sites reporting in multiple periods vs. sites reporting only in Fall 2010 (65.84% vs. 46.89%, p<0.001) Outcomes: Benefits. Not significantly improved Sites reporting in multiple periods vs. sites reporting only in Fall 2010 (71.37% vs. 60.82%, p=0.005) Sites reporting in multiple periods vs. sites reporting only in Fall 2010 (21.54% vs. 17.00%, p=0.152) Sites reporting in multiple periods vs. sites reporting only in Fall 2010 (65.60% vs. 54.65%, p=0.005) Sites reporting in multiple periods vs. sites reporting only in Fall 2010 (52.92% vs. 50.01%, p=0.046) Sites reporting in multiple periods vs. sites reporting only in Fall 2010 (40.95% vs. 31.45%, p=0.015) Hospice or 644 sites palliative care used Hospice enrollment 628 sites more than 3 days before death E-108 Outcomes: Harms Other key information Evidence Table 21. Outcomes reported in studies addressing quality improvement (continued) Author, year Detmar, 2 2002 Outcome measures Other Satisfaction QOL Physician awareness of patient's QOL, QOL-related medications and counseling referrals Measures Composite communication score calculated by summing all HRQL-related topics that were discussed Patient Satisfaction Questionnaire C SF-36 Sample size 214 Disparities Not reported Outcomes: Benefits. Significantly improved Composite score 4.7 (SD 2.3) intervention group, 3.7(1.9) control group (p=0.01) Outcomes: Benefits. Not significantly improved Physical functioning Not significantly improved Not significantly improved E-109 Outcomes: Harms None Other key information Physician-level randomization Evidence Table 21. Outcomes reported in studies addressing quality improvement (continued) Author, year Meyers, 3 2011 Outcome measures Quality of Life Measures City of Hope Quality of Life Instruments for Patients of Caregivers Sample size 476 Disparities AA: 43 Problem Solving Social Problem Solving InventoryRevised AsianPI: 61 Quality of Life: Psychological City of Hope Quality of Life Instruments for Patients of Caregivers City of Hope Quality of Life Instruments for Patients of Caregivers City of Hope Quality of Life Instruments for Patients of Caregivers White: 719 Quality of Life: Social Quality of Life: Physical Quality of Life: Spiritual Outcomes: Benefits. Significantly improved Caregiver QOL scores in the intervention arm declined at less than half the rate of the control arm (p=0.02) Neither patients (p=0.86) nor caregivers (p=0.21) showed any change in problem solving skills There was no change in psychological wellbeing among patients (p=0.82) SCEI caregivers scored higher in the social subdomain ( p=0.09) Native American: 8 There was no change in phsycial well-being among patients (p=0.97) and caregivers (p=0.61) Hispanic: 72 City of Hope Quality of Life Instruments for Patients of Caregivers Spiritual well-being among caregivers improved in the SCEI group relative to control (p<0.001) E-110 Outcomes: Benefits. Not significantly improved No difference for patients Outcomes: Harms Other key information Effect size: 0.3 standard deviation Evidence Table 21. Outcomes reported in studies addressing quality improvement (continued) Author, year 4 Mills, 2009 Rosenbloom, 5 2007 Taenzer, 6 2000 Outcome measures QOL Diary utilization, communication, satisfaction, discussion of problems Clinical treatment changes QOL Satisfaction Measures EORTC QLQ c30 Sample size 115 53 Disparities None None discussed PDIS-pt satisfaction questionnaire Outcomes: Benefits. Significantly improved Palliative Care QOL Index (communication, discussion) Outcomes: Benefits. Not significantly improved QOL(primary outcome), 45 QOL measurements, satisfaction, Significantly different in 3 of 15 function and symptom scales experimental group better only for dyspnea Not significantly improved Other EORTC items addressed during the visit significantly higher for experimental group; no significant difference in medical record audit for number of EORTC categories charted E-111 Outcomes: Harms Clinical deterioration Other key information Most patients gave no feedback to providers- no chance for intervention None noted "Clinic staff behavior may have changed since they were aware of the purpose of the study, even before the introduction of the QOL screening reports."; pre-post study, small sample size Evidence Table 21. Outcomes reported in studies addressing quality improvement (continued) Author, year Velikova, 7 2004 ; Velikova, 8 2010 Outcome measures Quality of care measures Quality of life Measures Sample size 286 Disparities Not reported Functional assessment of cancer therapygeneral questionnaire score Outcomes: Benefits. Significantly improved Symptom communication: 3.3(SD 1.63) vs. 2.7 (1.53) (p=0.03 ) (# of symptoms in the questionnaire mentioned during encounter) Estimate effect: 8.01 (SE 2.84), p=0.006 (intervention vs. Control) E-112 Outcomes: Benefits. Not significantly improved Communication about other symptoms, issues not significantly improved Outcomes: Harms Other key information In general, significant differences with control group but not with the group that had HRQOL measured but no feedback to physicians; attrition rate of 30%; randomized at patient level Evidence Table 21. Outcomes reported in studies addressing quality improvement (continued) Author, year Outcome measures Measures Sample size Disparities Outcomes: Benefits. Significantly improved Outcomes: Benefits. Not significantly improved Satisfaction Likert scale (2 questions) Other: patient perceptions of communication, continuity and coordination Medical care Significantly Coordination not Questionnaire Different for 23 subscales estimate effect - ; communication, 4.51 (p=0.03 ); preferences 3.32, p=0.027 (intervention vs. Control) significantly improved Outcomes: Harms Other key information Not significantly improved Abbreviations: EORTC-QLQ=European organization for research and treatment of cancer quality of life questionnaire; HRQOL=Health related quality of life; PDIS=Patientdoctor interaction scale; QOL=Quality of life; SF-36=Short form health survey with 36 questions Evidence Table 21 Reference List 1. Campion FX, Larson LR, Kadlubek PJ, Earle CC, Neuss MN. Advancing performance measurement in oncology. Am J Manag Care 2011; 17 Suppl 5 Developing:SP32-6. 2. Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA 2002; 288(23):3027-34. 3. Meyers FJ, Carducci M, Loscalzo MJ, Linder J, Greasby T, Beckett LA. Effects of a problem-solving intervention (COPE) on quality of life for patients with advanced cancer on clinical trials and their caregivers: simultaneous care educational intervention (SCEI): linking palliation and clinical trials. (1557-7740 (Electronic). 1557-7740 (Linking)). 4. Mills ME, Murray LJ, Johnston BT, Cardwell C, Donnelly M. Does a patient-held quality-of-life diary benefit patients with inoperable lung cancer? J Clin Oncol 2009; 27(1):70-7. 5. - Rosenbloom SK, - Victorson DE, - Hahn EA, - Peterman AH, - Cella David. - Assessment Is Not Enough: a Randomized Controlled Trial of 6. 7. 8. E-113 the Effects of Hqrl Assessment on Quality of Life and Satisfaction in Oncology Clinical Practice. - Psycho-Oncology - 200712; - 16(- 12):1069, - 1079. Taenzer P, Bultz BD, Carlson LE et al. Impact of computerized quality of life screening on physician behaviour and patient satisfaction in lung cancer outpatients. Psychooncology 2000; 9(3):203-13. Velikova G, Booth L, Smith AB et al. Measuring quality of life in routine oncology practice improves communication and patient wellbeing: a randomized controlled trial. J Clin Oncol 2004; 22(4):714-24. Velikova G, Keding A, Harley C et al. Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. Eur J Cancer 2010; 46(13):2381-8. Appendix F. Evidence Grading: Hospice and Nursing Homes Table 1. Evidence grading for hospice and nursing home settings Number of studies; subjects Domains pertaining to strength of evidence Risk of bias: 4;1675 RCTmedium 1; 176 NonRCTmedium 2;1338 RCTmedium 2;895 NonRCTmedium Consistency Directness for outcome Patient symptoms Inconsistent Direct Inconsistent Direct Utilization Consistent Indirect Consistent Indirect F-1 Magnitude of effect and strength of evidence Precision; Study heterogeneity Not applicable; medium Not applicable; medium Not applicable; medium Not applicable; medium Absolute risk difference per 100 patients Low SOE Improvement with intervention; low Improvement with intervention; low Low SOE Improvement with intervention; low Improvement with intervention; low