Comparative Effectiveness Review Number 180 Strategies To De-escalate Aggressive Behavior in Psychiatric Patients e Comparative Effectiveness Review Number 180 Strategies To De-escalate Aggressive Behavior in Psychiatric Patients 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. 290-2015-00011-I Prepared by: RTI-UNC Evidence-based Practice Center Research Triangle Park, NC Investigators: Bradley N. Gaynes, M.D., M.P.H. Carrie Brown, M.D., M.P.H. Linda J. Lux, M.P.A. Kimberly Brownley, Ph.D. Richard Van Dorn, Ph.D., M.S.W. Mark Edlund, M.D., Ph.D. Emmanuel Coker-Schwimmer, M.P.H. Theodore Zarzar, M.D. Brian Sheitman, M.D. Rachel Palmieri Weber, Ph.D. Meera Viswanathan, Ph.D. Kathleen N. Lohr, Ph.D. AHRQ Publication No. 16-EHC032-EF July 2016 This report is based on research conducted by the RTI-UNC Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2015-00011-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. Individuals using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. Suggested citation: Gaynes BN, Brown C, Lux LJ, Brownley K, Van Dorn R, Edlund M, Coker-Schwimmer E, Zarzar T, Sheitman B, Palmieri Weber R, Viswanathan M, Lohr KN. Strategies To De-escalate Aggressive Behavior in Psychiatric Patients. Comparative Effectiveness Review No. 180. (Prepared by the RTI-UNC Evidence-based Practice Center under Contract No. 290-2015-00011-I) AHRQ Publication No. 16-EHC032EF. Rockville, MD: Agency for Healthcare Research and Quality. July 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 e- mail 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, 540 Gaither Road, Rockville, MD 20850, or by email to [email protected]. Andrew Bindman, M.D. Arlene 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. Suchitra Iyer, Ph.D. Director Task Order Officer Evidence-based Practice Center Program 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 The authors gratefully acknowledge the continuing support of our AHRQ Task Order Officer, Suchitra Iyer, Ph.D., to this project. We thank our Associate Editor, Mark Helfand, M.D., M.S., M.P.H., for his helpful comments on a draft version of the report. The authors gratefully acknowledge the following RTI-UNC EPC staff for their contributions to this project and deeply appreciate their considerable support and commitment: Loraine Monroe, our publications specialist; Sharon Barrell, M.A., our editor; Claire Baker, who provided assistance retrieving publications and with manually searching reference lists of pertinent reviews; Charli Randolph, B.A., who provided assistance with preparing our Appendices; Catherine A. Grodensky, M.P.H., who helped record Key Informant discussion notes during the project’s Topic Refinement phase; and Lynn Whitener, Dr.P.H., M.S.L.S. who provided library services. Additionally, the authors gratefully acknowledge and deeply appreciate the contributions of Atlas Research staff during the process of abstracting data from this project’s eligible studies. We express our gratitude to the following individuals: Reva Stidd, M.S., M.B.A., the primary data abstractor at Atlas; Jason Ormsby, Ph.D., M.B.A., M.H.S.A., who assisted Ms. Stidd with data abstractions; and Abby Friedman, the Atlas project manager. iv 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: Les Citrome, M.D., M.P.H.• Larke N. Huang, Ph.D. New York Medical College Substance Abuse and Mental Health Valhalla, NY Services Administration Rockville, MD Sarah Desmarais, Ph.D. North Carolina State University Janice LeBel, E.D., Ph.D. Raleigh, NC Massachusetts Department of Mental Health Boston, MA Ken Duckworth, M.D. National Alliance on Mental Illness Kathleen McCann, R.N., Ph.D.• Cambridge, MA National Association of Psychiatric Health Systems Susan Hardesty, M.D.* Washington, DC The Menninger Clinic Houston, TX Michael Rice, PhD, APN, FAAN • University of Colorado College of Nursing Don Howard, M.S.W. Anschutz Medical Center Centers for Medicare and Medicaid Services Aurora, CO Baltimore, MD Joyce B. Wale, L.C.S.W. UnitedHealthcare Community Plan NY New York, NY • This Key Informant also reviewed and commented on the draft report. *Also represented the American Psychiatric Association v 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: Les Citrome, M.D., M.P.H.• Kim J. Masters, M.D.*• New York Medical College Three Rivers Residential Treatment Valhalla, NY Midlands Campus Columbia, SC Lisa Dixon, M.D., M.P.H.• New York State Psychiatric Institute Michael Rice, PhD, APN, FAAN • New York, NY University of Colorado College of Nursing Anschutz Medical Center Joan Gillece, Ph.D. Aurora, CO National Association of State Mental Health Program Eric Schmidt, Ph.D.• Directors and Substance Abuse and Mental Stanford University Health Services Administration Stanford, CA Alexandria, VA Jennifer P. Wisdom, Ph.D., M.P.H. George Washington University Washington, DC • This member of the Technical Expert Panel also reviewed and commented on the draft report. *Also represented the American Psychiatric Association vi 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 does not necessarily represent the views of individual reviewers. 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 non-financial conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential non-financial conflicts of interest identified. The list of Peer Reviewers follows: Kevin Ann Huckshorn, Ph.D., M.S.N., R.N., Scott Zeller, M.D. C.A.D.C., I.C.R.C. Alameda Health System Behavioral Health Consulting Oakland, CA Chapel Hill, NC vii Strategies To De-escalate Aggressive Behavior in Psychiatric Patients Structured Abstract Objective. To compare the effectiveness of strategies to prevent and de-escalate aggressive behaviors in psychiatric patients in acute care settings, including interventions aimed specifically at reducing use of seclusion and restraint. Data sources. We searched MEDLINE®, Embase®, the Cochrane Library, Academic Search Premier, PsycINFO, and CINAHL from January 1, 1991, through February 3, 2016. We manually searched reference lists of pertinent reviews, included trials, and background articles to identify relevant citations that our searches might have missed. Eligible studies included randomized controlled trials (RCTs), cluster randomized trials (CRTs), and observational and noncontrolled studies with sample sizes greater than 100. Eligible studies were limited to acute care settings and adult patients with psychiatric disorders or severe psychiatric symptomatology (excluding dementia); they had to report on aggression or seclusion and restraint outcomes. Review method. Two investigators independently selected, extracted data from, and rated risk of bias of studies. Risk of bias and strength of evidence (SOE) were assessed only for controlled studies. Twenty-nine primary studies (from 31 articles) met inclusion criteria. Of these, 11 were controlled trials that provided eligible data for SOE grades. Only 4 of these trials took place in the United States. We grouped studies as follows: (1) staff training interventions, (2) risk assessment interventions, (3) multimodal interventions, (4) environmental interventions (including group psychotherapeutic options), and (5) medication protocols versus other medication protocols or alternative strategies. We organized results by three key questions; these covered benefits, harms, and potential modifying characteristics of these strategies. Results. Evidence was limited for benefits and, especially, for harms; information about modifying characteristics was completely absent. No key questions had data supporting SOE grades better than low, indicating limited confidence that the estimate of effect lies close to the true effect for these outcomes. The available evidence comprised primarily pre/post studies whose inherent high risk of bias precludes drawing inferences of causality. Of the 11 trials eligible for SOE assessment, all but 1 had medium (or high) risk of bias. Risk assessment had low SOE for decreasing subsequent aggression and reducing use of seclusion and restraint, but only when applied in a preventive manner (e.g., as unit-wide programs). SOE for all other interventions, whether aimed at preventing aggression or de-escalating aggressive behavior, was insufficient. Conclusions. Given the ethical imperative for treating all patients with dignity, the clinical mandate of finding evidence-based solutions to these mental health challenges, and the legal liability associated with failure to assess and manage violence risk across the treatment continuum, the need for evidence to guide decisionmaking for de-escalating aggressive behavior is critical. The available evidence about relevant strategies is very limited. Only risk assessment decreased subsequent aggression or reduced use of seclusion and restraint (low SOE). Evidence for de-escalating aggressive behavior is even more limited. More research is needed to guide viii clinicians, administrators, and policymakers on how to best prevent and de-escalate aggressive behavior in acute care settings. ix
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