Community-based cluster-randomized trial to reduce opioid overdose deaths

Gary A. Zarkin; Rachel A. Caspar; Arnie P. Aldridge; Patricia Ann LeBaron; LaShawn Marie Glasgow; Richard Craig Lefebvre; Carolina Pinto Pereira Barbosa; Barry Swanson Eggleston; Charles Edward Knott; Lisa T. Newman; Stephen Gregory Gomori; Nathan Alexander Vandergrift; Emmanuel Aja Oga; Megan Elizabeth Hall; Joella Wabine Irene Adams; Denise C. Babineau; JaNae Logan Holloway; Jeffrey H. Samet; Nabila El-Bassel; T John Winhusen; Rebecca D. Jackson; Emmanuel Aja Oga; Redonna K. Chandler; Jennifer Villani; Bridget Freisthler; Joella Wabine Irene Adams; Arnie P. Aldridge; Angelo Angerame; Denise C. Babineau; Sarah M. Bagley; Trevor J. Rivers; Peter Balvanz; Carolina Barbosa; Joshua A Barocas; Tracy A. Battaglia; Dacia Beard; Donna Beers; Derek Blevins; Nicholas Rove; Carly Bridden; Jennifer L Brown; Heather M. Bush; Joshua L Bush; Ryan Caldwell; Katherine Calvin; Deirdre Calvert; Aimee N.c. Campbell; Jane Carpenter; Rachel A. Caspar; Deborah Chassler; Joan Chaya; Debbie M. Cheng; Chinazo Cunningham; Anindita Dasgupta; James L. David; Alissa Davis; Barry Swanson Eggleston; LaShawn Marie Glasgow; Stephen Gregory Gomori; Megan Hall; JaNae Logan Holloway; Charles Edward Knott; Patty LeBaron; Richard Craig Lefebvre; Lisa T. Newman; Nathan Alexander Vandergrift; Gary A. Zarkin

Community-based cluster-randomized trial to reduce opioid overdose deaths

The HEALing Communities Study Consortium (2024). Community-based cluster-randomized trial to reduce opioid overdose deaths. New England Journal of Medicine, 391(11), 989-1001. https://doi.org/10.1056/NEJMoa2401177

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Abstract

BACKGROUND: Evidence-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.

METHODS: In 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.

RESULTS: During 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.

CONCLUSIONS: In 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.).