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Randomized Controlled Trial Multicenter Study
Community-Based Cluster-Randomized Trial to Reduce Opioid Overdose Deaths.
- HEALing Communities Study Consortium, Jeffrey H Samet, Nabila El-Bassel, T John Winhusen, Rebecca D Jackson, Emmanuel A Oga, Redonna K Chandler, Jennifer Villani, Bridget Freisthler, Joella Adams, Arnie Aldridge, Angelo Angerame, Denise C Babineau, Sarah M Bagley, Trevor J Baker, Peter Balvanz, Carolina Barbosa, Joshua Barocas, Tracy A Battaglia, Dacia D Beard, Donna Beers, Derek Blevins, Nicholas Bove, Carly Bridden, Jennifer L Brown, Heather M Bush, Joshua L Bush, Ryan Caldwell, Katherine Calver, Deirdre Calvert, CampbellAimee N CANCThe authors' affiliations are as follows: Boston Medical Center, Boston University Chobanian and Avedisian School of Medicine, Department of Medicine, Section of General Internal Medicine, and Boston University School of Public Health , Jane Carpenter, Rachel Caspar, Deborah Chassler, Joan Chaya, Debbie M Cheng, Chinazo O Cunningham, Anindita Dasgupta, James L David, Alissa Davis, Tammy Dean, Mari-Lynn Drainoni, Barry Eggleston, Laura C Fanucchi, Daniel J Feaster, Soledad Fernandez, Wilson Figueroa, Darcy A Freedman, Patricia R Freeman, Caroline E Freiermuth, Eric Friedlander, Kitty H Gelberg, Erin B Gibson, Louisa Gilbert, LaShawn Glasgow, Dawn A Goddard-Eckrich, Stephen Gomori, Dawn E Gruss, Jennifer Gulley, Damara Gutnick, Megan E Hall, Nicole Harger Dykes, Sarah L Hargrove, Kristin Harlow, Aumani Harris, Daniel Harris, Donald W Helme, JaNae Holloway, Juanita Hotchkiss, Terry Huang, Timothy R Huerta, Timothy Hunt, Ayaz Hyder, Van L Ingram, Tim Ingram, Emily Kauffman, Jennifer L Kimball, Elizabeth N Kinnard, Charles Knott, Hannah K Knudsen, Michael W Konstan, Sarah Kosakowski, Marc R Larochelle, Hannah M Leaver, Patricia A LeBaron, R Craig Lefebvre, Frances R Levin, Nikki Lewis, Nicky Lewis, Michelle R Lofwall, David W Lounsbury, Jamie E Luster, Michael S Lyons, Aimee Mack, Katherine R Marks, Stephanie Marquesano, Rachel Mauk, Ann Scheck McAlearney, Kristin McConnell, Margaret L McGladrey, Jason McMullan, Jennifer Miles, Rosie Munoz Lopez, Alisha Nelson, Jessica L Neufeld, Lisa Newman, Trang Q Nguyen, Edward V Nunes, Devin A Oller, Carrie B Oser, Douglas R Oyler, Sharon Pagnano, Theodore V Parran, Joshua Powell, Kim Powers, William Ralston, Kelly Ramsey, Bruce D Rapkin, Jennifer G Reynolds, Monica F Roberts, Will Robertson, Peter Rock, Emma Rodgers, Sandra Rodriguez, Maria Rudorf, Shawn Ryan, Pamela Salsberry, Monika Salvage, Nasim Sabounchi, Merielle Saucier, Caroline Savitzky, Bruce Schackman, Elizabeth Schady, Eric E Seiber, Aimee Shadwick, Abigail Shoben, Michael D Slater, Svetla Slavova, Drew Speer, Joel Sprunger, StarbirdLaura ELEThe authors' affiliations are as follows: Boston Medical Center, Boston University Chobanian and Avedisian School of Medicine, Department of Medicine, Section of General Internal Medicine, and Boston University School of Public Health (J., Michele Staton, Michael D Stein, Danelle J Stevens-Watkins, Thomas J Stopka, Ann Sullivan, Hilary L Surratt, Rachel Sword Cruz, Jeffery C Talbert, Jessica L Taylor, Katherine L Thompson, Nathan Vandergrift, Rachel A Vickers-Smith, Deanna J Vietze, Daniel M Walker, Alexander Y Walley, Scott T Walters, Roger Weiss, Philip M Westgate, Elwin Wu, April M Young, Gary A Zarkin, and Sharon L Walsh.
- The authors' affiliations are as follows: Boston Medical Center, Boston University Chobanian and Avedisian School of Medicine, Department of Medicine, Section of General Internal Medicine, and Boston University School of Public Health (J.H.S.), Boston Medical Center and Boston University Chobanian and Avedisian School of Medicine, Departments of Medicine and Pediatrics (S.M.B.), Boston Medical Center, Section of General Internal Medicine (T.J.B., P.B., D. Beers, C. Bridden, K.C., J. Carpenter, E.B.G., A. Harris, S.K., Nikki Lewis, R.M.L., M.R., M. Saucier, R.S.C.), Boston University Chobanian and Avedisian School of Medicine (T.A.B.), Boston University School of Public Health, Department of Health Law, Policy and Management (D.D.B., M.D. Stein), Massachusetts Department of Public Health, Bureau of Substance Addiction Services (D. Calvert), Boston University School of Social Work (D. Chassler), Boston University School of Public Health, Department of Biostatistics (D.M.C.), Boston University Chobanian and Avedisian School of Medicine, Department of Medicine, Section of Infectious Diseases, and Boston University School of Public Health, Department of Health Law, Policy and Management (M.-L.D.), Massachusetts HCS Community Advisory Board (J.L.K., K.P.), Boston Medical Center, Section of Infectious Diseases (E.N.K., C.S.), Boston Medical Center and Boston University Chobanian and Avedisian School of Medicine, Department of Medicine, Section of General Internal Medicine (M.R. Larochelle, J.L.T., A.Y.W.), Boston Medical Center, Department of Medicine (H.M.L.), Massachusetts Department of Public Health, Registry of Vital Records and Statistics (S.P.), Tufts University School of Medicine, Department of Public Health and Community Medicine (T.J.S.), and McLean Hospital, Division of Alcohol, Drugs, and Addiction, and Harvard Medical School, Department of Psychiatry (R.W.) - all in Boston; the Social Intervention Group, School of Social Work, Columbia University (N.E.-B., A. Dasgupta, J.L.D., A. Davis, K.H.G., L. Gilbert, D.A.G.-E., D.E.G., J. Hotchkiss, T. Hunt, J.L.N., E.R., S. Rodriguez, E.W.), New York HCS Community Advisory Board (A. Angerame, R. Caldwell, S.M., K.M., J.P., K.R., W.R., M. Salvage), Columbia University Irving Medical Center, Department of Psychiatry (D. Blevins, A.N.C.C., F.R.L., E.V.N.), Albert Einstein College of Medicine, Department of Epidemiology and Population Health (N.B., D.G., D.W.L., B.D.R.), Montefiore Medical Center (J. Chaya), New York State Office of Addiction Services and Supports (C.O.C.), City University of New York (T. Huang, N.S.), Weill Cornell Medicine, Department of Population Health Sciences (B.S.), and the New York Office of Mental Health (A. Sullivan), New York, and the New York State Department of Health, Albany (T.Q.N., E.S.) - all in New York; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine (T.J.W.), University of Cincinnati Corrections Institute (T.D.), University of Cincinnati College of Medicine, Department of Emergency Medicine (C.E.F., J. McMullan), University of Cincinnati Medical Center, Emergency Medicine (N.H.D.), University of Cincinnati College of Medicine, Department of Environmental and Public Health Sciences (T.I.), Case Western Reserve University School of Medicine, Department of Family Medicine and Community Health (T.V.P.), Brightview Health (S. Ryan), and University of Cincinnati College of Medicine, Department of Psychiatry and Behavioral Neuroscience (J.S.), Cincinnati, the College of Medicine (R.D.J., S.F., K.H., J.E.L., M.S.L.) and the College of Social Work (B.F.), Center of Health Outcomes and Policy Evaluation Studies (W.F.), Department of Family and Community Medicine (T.R.H., A.S.M., D.M.W.), College of Public Health and Translational Data Analytics Institute (A. Hyder), Department of Emergency Medicine (E.K.), Ohio Colleges of Medicine Government Resource Center (A.M., R.M.), One Ohio Foundation (A.N.), College of Public Health (P.S., E.E.S., A. Shoben), Recovery Ohio (A. Shadwick), and the School of Communication (M.D. Slater), Ohio State University, Columbus, Case Western Reserve University School of Medicine, Department of Population and Quantitative Health Sciences (D.A.F.), and Case Western Reserve University School of Medicine, Clinical and Translational Science Institute (M.W.K.), Cleveland, and Brown County Mental Health and Addiction Services, Georgetown (D.J.V.) - all in Ohio; RTI International, Research Triangle Park, NC (E.A.O., J.A., A. Aldridge, D. Babineau, C. Barbosa, R. Caspar, B.E., L. Glasgow, S.G., M.E.H., J. Holloway, C.K., P.A.L., R.C.L., L.N., N.V., G.A.Z.); the National Institute on Drug Abuse, Bethesda, MD (R.K.C., J.V.); University of Colorado School of Medicine, Divisions of General Internal Medicine and Infectious Diseases, Aurora (J.B.); University of North Texas Health Science Center, Fort Worth (S.T.W.); Kentucky Office of Drug Control Policy, Frankfort (V.L.I.), University of Kentucky, College of Public Health (H.M.B.), University of Kentucky, Kentucky Injury Prevention Research Center (J.L. Bush, S.L.H ), University of Kentucky College of Medicine, Department of Medicine, Division of Infectious Diseases, Center on Drug and Alcohol Research (L.C.F.), University of Kentucky, Department of Pharmacy Practice and Science (P.R.F., D.H., D.R.O.), Commonwealth of Kentucky, Cabinet for Health and Family Services (E.F., K.R.M.), University of Kentucky, Department of Communication (D.W.H., Nicky Lewis), University of Kentucky, Department of Behavioral Science (H.K.K.), University of Kentucky College of Medicine, Center on Drug and Alcohol Research (M.R. Lofwall, S.L.W.), University of Kentucky, Department of Health Management and Policy and Center for Innovation in Population Health (M.L.M.), University of Kentucky, Substance Use Research Priority Area (J. Miles, M.F.R., P.R., D.S.), University of Kentucky College of Medicine, Internal Medicine (D.A.O.), University of Kentucky, Department of Sociology (C.B.O.), University of Kentucky (B.D.R.), University of Kentucky, Department of Biostatistics (S.S., P.M.W.), University of Kentucky, Dr. Bing Zhang Department of Statistics (K.L.T.), University of Kentucky, Department of Behavioral Science (M. Staton, H.L.S.), University of Kentucky, Center for Health Equity Transformation (D.J.S.-W.), University of Kentucky College of Medicine, Institute for Biomedical Informatics (J.C.T.), and University of Kentucky, Department of Epidemiology and Environmental Health (R.A.V.-S., A.M.Y.), Lexington, and the Commonwealth of Kentucky, Clark County Health Department, Winchester (J.G.) - all in Kentucky; Purdue University, Department of Psychological Sciences, Lafayette, IN (J.L. Brown); University of Miami Miller School of Medicine, Department of Public Health Sciences, Miami (D.J.F.); Oak Ridge Associated Universities (ORAU), Health Communications, Marketing, and Promotion Program, Oak Ridge, TN (J.G.R.); and University of Pennsylvania School of Nursing, Department of Family and Community Health, Philadelphia (L.E.S.).
- N. Engl. J. Med. 2024 Sep 19; 391 (11): 9891001989-1001.
BackgroundEvidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices.MethodsIn this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults.ResultsDuring the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year.ConclusionsIn this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.).Copyright © 2024 Massachusetts Medical Society.
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