Randomized Controlled Trial (RCT) of...
Communities that Heal (CTH) to Reduce Opioid Overdose Deaths
Reviewed
New England Journal of Medicine (June 2024) published an RCT of Communities that Heal, a data-driven program that engaged communities in four states to rapidly deploy evidence-based practices to reduce opioid overdose deaths. This large, high-quality RCT found no discernible impact on opioid overdose deaths over 1 year.
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,
We have no suggested revisions to the published abstract.
No-Spin’s Study Overview
Large, high-quality RCT of Communities that Heal (CTH) – a community-engaged, data-driven program to reduce opioid overdose deaths – finds no discernible impact on opioid overdose death rates over one year.
Program:
- Communities participating in CTH received federal grants averaging $1.25M to adopt and deploy evidence-based practices, including promotion of opioid overdose education and naloxone distribution, the use of medications for opioid use disorder, and media messages to reduce stigma.
Study Design:
- The study sample comprised 67 communities in NY, OH, KY, and MA with high rates of overdose deaths, randomized to CTH versus control (usual services). Based on careful review, this was a high-quality RCT (e.g., baseline balance, negligible attrition, preregistered analyses).
Findings:
- The study found that CTH led to strong community uptake of evidence-based practices. But it had no discernible impact on opioid overdose deaths over 1 year: There were 47.2 such deaths per 100K people in the CTH group versus 51.7 in the control group, a difference that slightly favored the treatment group but wasn't statistically significant (p=.30).
Comment:
- The researchers offer possible reasons for the null results (e.g., CTH may need more time to produce effects).
- One possibility we’d add is that most of CTH's "evidence-based practices" have only preliminary (not yet reliable) evidence of effectiveness. For example, the studies of naloxone distribution are observational (non-RCTs), and opioid medication RCTs are almost all short duration (typically several weeks). More rigorous research is needed to build a body of proven practices.
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