Comparative Effectiveness Review Number 177 Nonpharmacologic Interventions for Agitation and Aggression in Dementia Comparative Effectiveness Review Number 177 Nonpharmacologic Interventions for Agitation and Aggression in Dementia Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. 290-2012-00016-I Prepared by: Minnesota Evidence-based Practice Center Minneapolis, MN Investigators: Michelle Brasure, Ph.D., M.S.P.H., M.L.I.S. Eric Jutkowitz, B.A. Erika Fuchs, M.P.H., Ph.D. Victoria A. Nelson, M.Sc. Rosalie A. Kane, Ph.D. Tetyana Shippee, Ph.D. Howard A. Fink, M.D., M.P.H. Tonye Sylvanus, M.D., M.P.H. Jeannine Ouellette Mary Butler, Ph.D. Robert L. Kane, M.D. AHRQ Publication No. 16-EHC019-EF March 2016 This report is based on research conducted by the Minnesota Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00016-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. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. 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 is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders. AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied. This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report. Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. Suggested citation: Brasure M, Jutkowitz E, Fuchs E, Nelson VA, Kane RA, Shippee T, Fink HA, Sylvanus T, Ouellette J, Butler M, Kane RL. Nonpharmacologic Interventions for Agitation and Aggression in Dementia. Comparative Effectiveness Review No. 177. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-2012-00016-I.) AHRQ Publication No.16-EHC019-EF. Rockville, MD: Agency for Healthcare Research and Quality; March 2016. 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 systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new health care technologies and strategies. Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews can help clarify whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about AHRQ EPC systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm. AHRQ expects that these systematic reviews will be helpful to health plans, providers, purchasers, government programs, and the health care system as a whole. Transparency and stakeholder input are essential to the Effective Health Care Program. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an email list to learn about new program products and opportunities for input. If you have comments on this systematic review, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to [email protected]. Richard G. Kronick, Ph.D. Arlene S. Bierman, M.D., M.S. Director Director Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Director Kim Wittenberg, M.A. Evidence-based Practice Center Program Task Order Officer Center for Evidence and Practice Improvement Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality iii Acknowledgments We thank Marilyn Eells and Cheryl Cole-Hill for their editorial help bringing the report to completion. We also thank Kim Wittenberg and Kathleen Lohr for their helpful editorial comments. Key Informants In designing the study questions, the EPC consulted several Key Informants who represent the end-users of research. The EPC sought the Key Informant input on the priority areas for research and synthesis. Key Informants are not involved in the analysis of the evidence or the writing of the report. Therefore, in the end, study questions, design, methodological approaches, and/or conclusions do not necessarily represent the views of individual Key Informants. Key Informants must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their role as end-users, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any conflicts of interest. The list of Key Informants who provided input to this report follows: Alice Bonner, Ph.D., M.S.N. Katie Maslow, M.S.W. Bouve College of Health Sciences National Academy of Sciences Northeastern University Institute of Medicine Burlington, MA Washington, DC Richard H. Fortinsky, Ph.D. Bruce E. Robinson, M.D., M.P.H. Center on Aging Medical Education and Palliative Care University of Connecticut Health Center Services Farmington, CT Sarasota Memorial Hospital Sarasota, FL Delores Gallagher-Thompson, Ph.D. Center for Longevity Glenn Smith, Ph.D. Stanford University School of Medicine College of Public Health and Health Stanford, CA Professions University of Florida Laura Gitlin, Ph.D., M.A. Gainesville, FL Center for Innovative Care in Aging Johns Hopkins University Peter Whitehouse, M.D., Ph.D. Baltimore, MD Brain Health and Memory Center Case Western Reserve University Michele Laughman Cleveland, OH Division of Nursing Homes Centers for Medicare & Medicaid Services Baltimore, MD iv Technical Expert Panel In designing the study questions and methodology at the outset of this report, the EPC consulted several technical and content experts. Broad expertise and perspectives were sought. Divergent and conflicted opinions are common and perceived as healthy scientific discourse that results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design, methodologic approaches, and/or conclusions do not necessarily represent the views of individual technical and content experts. Technical Experts must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified. The list of Technical Experts who provided input to this report follows: Cornelia Beck, Ph.D., R.N. Kathleen Kelly, M.P.A. University of Arkansas for Medical Sciences Family Caregiver Alliance Little Rock, AR National Center on Caregiving San Francisco, CA Alice Bonner, Ph.D., M.S.N.* Bouve College of Health Sciences Katie Maslow, M.S.W.* Northeastern University National Academy of Sciences Boston, MA Institute of Medicine Washington, DC Joseph Gaugler, Ph.D.* School of Nursing Laurie Ryan, Ph.D.* University of Minnesota National Institute on Aging Minneapolis, MN National Institutes of Health Bethesda, MD Laura Gitlin, Ph.D., M.A. Center for Innovative Care in Aging Glenn Smith, Ph.D.* Johns Hopkins University College of Public Health and Health Baltimore, MD Professions University of Florida Gainesville, FL *Provided input on Draft Report. Peer Reviewers Prior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report do not necessarily represent the views of individual reviewers. v Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential nonfinancial conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts of interest identified. The list of Peer Reviewers follows: Cameron J. Camp, Ph.D. Director of Research and Development Mark E. Kunik, M.D., M.P.H. Center for Applied Research in Dementia Houston Center for Quality of Care & Solon, OH Utilization Studies Health Services Research and Development Roderick Corriveau, Ph.D. Services National Institute of Neurological Disorders Houston, TX and Stroke National Institutes of Health Rockville, MD vi Nonpharmacologic Interventions for Agitation and Aggression in Dementia Structured Abstract Objective. To assess the efficacy, comparative effectiveness, and adverse effects of nonpharmacologic interventions for agitation and aggression in individuals with dementia. Data sources. Ovid MEDLINE®, Ovid Embase®, and the Cochrane Central Register of Controlled Trials bibliographic databases; hand searches of references of relevant studies. Review methods. Two investigators screened abstracts and full-text articles of identified references for eligibility. Eligible studies included randomized controlled trials evaluating nonpharmacologic interventions to manage agitation/aggression in individuals with dementia in nursing home, assisted living, or community settings. We analyzed outcomes of agitation/ aggression, general behavior, patient quality of life, admission to long-term care, and staff and caregiver outcomes related to patient behavior and care burden. We assessed risk of bias, extracted data, and evaluated strength of evidence for each comparison and outcome. We analyzed pooled estimates to assess efficacy and comparative effectiveness. We conducted a qualitative analysis when data could not be pooled. Results. We identified 126 unique randomized controlled trials as of July 2015. Patient-level interventions involving music, aromatherapy with lavender, and bright light were similar to usual treatment or attention control at managing agitation/aggression in people with dementia (low- strength evidence); interventions tailored to recipients’ skills, interests, or both were similar to usual care in managing agitation/aggression in people with dementia (low-strength evidence). Care delivery–level interventions (dementia care mapping and person-centered care) were similar to usual care in managing agitation/aggression in people with dementia (low-strength evidence). Evidence was insufficient to draw conclusions on the effectiveness of most caregiver- level interventions in managing agitation/aggression in people with dementia; caregiver interventions targeting caregiver skills and behavior were similar to attention control in managing agitation/aggression (low-strength evidence). However, these interventions show benefits in caregiver confidence in caregiving and caregiver distress. Adverse effects were rarely reported. Conclusions. Although many trials have been conducted to determine effective nonpharmacologic interventions for agitation/aggression in dementia, which is a critical topic, the evidence base is weak because of the variety of comparisons, measurement issues, and other methodological limitations. When evidence was sufficient to draw conclusions about effectiveness for a group of interventions, agitation/aggression outcomes were typically similar to those of control groups. Future research is needed to guide providers and informal caregivers toward effective interventions for agitation/aggression in dementia. vii Contents Executive Summary .................................................................................................................ES-1 Introduction ....................................................................................................................................1 Background and Objectives .......................................................................................................1 Key Questions ............................................................................................................................8 Analytical Framework ...............................................................................................................8 Populations, Interventions, Comparisons, Outcomes, Timing, and Setting (PICOTS) .............9 Methods .........................................................................................................................................10 Criteria for Inclusion/Exclusion of Studies in the Review .....................................................10 Searching for the Evidence: Literature Search Strategies for Identification of Relevant Studies To Answer the Key Questions .................................................................................10 Data Abstraction and Data Management .................................................................................10 Assessment of Methodological Risk of Bias of Individual Studies .........................................11 Data Synthesis ..........................................................................................................................11 Grading the Strength of Evidence for Major Comparisons and Outcomes .............................11 Assessing Applicability ...........................................................................................................12 Results ...........................................................................................................................................13 Literature Search and Screening ..............................................................................................13 Patient-Level Nonpharmacologic Interventions for Agitation/Aggression in Individuals With Dementia in Nursing Homes and Assisted Living Facilities .......................................14 Key Points ..........................................................................................................................14 Overview ............................................................................................................................14 Care Delivery-Level Nonpharmacologic Interventions for Agitation/Aggression in Individuals With Dementia in Long-Term Care Settings .....................................................53 Key Points ..........................................................................................................................53 Overview ............................................................................................................................53 Patient-Level Interventions for Community-Dwelling Individuals With Dementia ...............89 Key Points ..........................................................................................................................89 Overview ............................................................................................................................89 Caregiver-Level Interventions for Community-Dwelling Individuals With Dementia ...........92 Key Points ..........................................................................................................................92 Overview ............................................................................................................................92 Discussion....................................................................................................................................115 Limitations of Available Studies ...........................................................................................115 Applicability ..........................................................................................................................119 Future Research Needs ..........................................................................................................120 Conclusions ............................................................................................................................123 References ...................................................................................................................................124 Abbreviations .............................................................................................................................133 Tables Table A. Types of interventions addressing agitation/aggression in dementia ........................ES-3 Table B. Populations, interventions, comparisons, outcomes, timing, and setting (PICOTS)...................................................................................................................ES-5 Table C. Study inclusion criteria ..............................................................................................ES-6 viii Table D. Patient-level interventions in nursing home and assisted living facility residents with dementia ..........................................................................................................ES-12 Table E. Care delivery–level interventions in nursing home and assisted living facility residents with dementia ...........................................................................................ES-15 Table F. Patient-level interventions in community-dwelling individuals with dementia ......ES-16 Table G. Caregiver-level interventions: evidence summary ..................................................ES-18 Table H. Future research needs ..............................................................................................ES-27 Table 1. Types of interventions addressing agitation/aggression in dementia ..............................4 Table 2. Instruments measuring intermediate, primary, and secondary outcomes .......................5 Table 3. Populations, interventions, comparisons, outcomes, timing, and setting (PICOTS).........................................................................................................................9 Table 4. Study inclusion criteria ..................................................................................................10 Table 5. Patient-level interventions for agitation/aggression in nursing home and assisted living facility residents with dementia ..........................................................................34 Table 6. Efficacy and comparative effectiveness of patient-level interventions for agitation/aggression in nursing home and assisted living facility residents with dementia ........................................................................................................................36 Table 7. Care delivery-level interventions for agitation/aggression in nursing home and assisted living facility residents with dementia .............................................................67 Table 8. Efficacy and comparative effectiveness of care delivery interventions for agitation/aggression in nursing home and assisted living facility residents with dementia ........................................................................................................................68 Table 9. Patient-level interventions for agitation/aggression in community-dwelling individuals with dementia .............................................................................................90 Table 10. Efficacy and comparative effectiveness of interventions delivered directly to caregivers of community-dwelling individuals with dementia .....................................91 Table 11. Caregiver-level interventions: evidence summary ......................................................102 Table 12. Efficacy and comparative effectiveness of caregiver-level interventions for community-dwelling individuals with dementia .........................................................105 Table 13. Future research needs ..................................................................................................121 Figures Figure A. Analytic framework for nonpharmacologic interventions to manage agitation/aggression in dementia ...............................................................................ES-4 Figure B. Literature flow diagram .............................................................................................ES-8 Figure 1. Analytic framework for nonpharmacologic interventions to manage agitation/aggression in dementia .....................................................................................8 Figure 2. Literature flow diagram .................................................................................................13 Figure 3. Music therapy versus control (impact of treatment on agitation/aggression) ...............33 Figure 4. Bright light versus standard light (impact of treatment on agitation/aggression) .........33 Figure 5. Random effects meta-analysis for the effect of dementia care mapping on agitation/aggression .......................................................................................................86 Figure 6. Random effects meta-analysis for the effect of person-centered care on agitation/aggression .......................................................................................................86 Figure 7. Random effects meta-analysis for the effect of clinical protocols on dose of antipsychotics ................................................................................................................87 ix