1. In this cluster-randomized controlled trial, in communities with a high rate of opioid-related overdoses, the implementation of the Communities That HEAL (CTH) intervention did not decrease the occurrence of opioid-related deaths.

2. Intervention effectiveness was hindered by the onset of the coronavirus disease 2019 (COVID-19) pandemic and the developing fentanyl epidemic.

Evidence Rating Level: 3 (Average)

Study Rundown: In recent years, the United States has experienced a sharp rise in opioid-related deaths. While efforts such as overdose education and increased access to naloxone have been made to combat this crisis, these initiatives have frequently fallen short, hindered by both individual and community-level barriers like stigma and transportation challenges. In response, the National Institutes of Health launched the CTH intervention, a program designed to expand evidence-based practices and enhance public communication to prevent opioid-related deaths in Kentucky, Massachusetts, New York, and Ohio. However, during the 12-month comparison period, no significant difference in opioid overdose deaths was observed between communities that received the CTH interventions and those that did not. Despite this, the study highlighted variations in opioid-related deaths across states and between rural and urban areas. Overall, the study encountered several limitations, including the fact that only 38% of the interventions were implemented before the comparison period, complications arising from the COVID-19 pandemic and the fentanyl crisis, difficulties in comparing communities with diverse demographics, the unintentional adoption of intervention techniques by some control communities, and a lack of data on the number of individuals accessing the interventions. As a result, it remains unclear whether the strategies were ineffective or if the study’s design constrained their perceived impact.

Click here to read the study in NEJM

In-Depth [randomized controlled trial]: This cluster-randomized trial examined whether implementing evidence-based interventions could reduce opioid overdose deaths. Communities in Kentucky, Massachusetts, New York, and Ohio were selected based on high baseline rates of opioid-related deaths (over 25 deaths per 100,000 adults). These communities were reported to have demographics reflecting those commonly affected by the opioid crisis in the United States, and 30% were identified as rural. A total of 67 communities were selected, with 34 assigned to the intervention group and 33 to the control group. From January 2020 to June 2022, communities in the intervention group received overdose education, naloxone distribution, and stigma reduction campaigns. The primary outcome measured was the number of opioid overdose deaths between July 2021 and June 2022. During this comparison period, opioid overdose death rates were 47.2 per 100,000 in the intervention group and 51.7 per 100,000 in the control group (rate ratio, 0.91; 95% confidence interval [CI], 0.76 to 1.09; p=0.30). The effect remained consistent when adjusting for state, urban, or rural status and demographic factors such as age, sex, race, and ethnicity. The intervention showed the most impact in state of Massachusetts (rate ratio, 0.86; 95% CI, 0.54-1.37), in rural areas (rate ratio, 0.83; 95% CI, 0.57-1.20), among individuals aged over 55 (rate ratio, 0.86; 95% CI, 0.59-1.23), male participants (rate ratio, 0.88; 95% CI, 0.71-1.08), and those identifying with an ethnicity other than Hispanic, White, or Black (rate ratio, 0.59; 95% CI, 0.20-1.68). The highest rates of opioid overdose deaths were found in males aged 35-54 and in individuals identifying as non-Hispanic Black. Despite the lack of a significant reduction in opioid overdose deaths, the study’s several limitations may have affected the results. Further investigation is needed to assess the efficacy of these community-based interventions in combating the opioid crisis.

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