Community-Based Cluster-Randomized Trial to Reduce Opioid Overdose Deaths.

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.).

Lessons Learned from Developing Tailored Community Communication Campaigns in the HEALing Communities Study.

This paper outlines lessons learned from tailoring communication campaigns to increase demand for, and reduce stigma toward, evidence-based practices to reduce opioid overdose deaths in 66 communities participating in the HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS). We present nine lessons gathered about how to engage local communities in both virtual and in-person opioid messaging and distribution between February 2019 and June 2022. The research team created four communication campaigns and did extensive, tailored marketing and promotion to assist communities in implementing evidence-based clinical activities to reduce opioid overdose mortality. Various strategies and venues were used to amplify HCS messages, using free and paid outlets for message distribution, focusing primarily on social media due to the COVID-19 pandemic. Increasing the availability of medications for opioid use disorder and naloxone, as HCS attempted, is not enough; getting people to accept and use them depends on communication efforts. This paper focuses on the process of preparing communities for communication campaign activities, which we hope can help guide other communities preparing for opioid or substance-related campaigns in the future.

Leveraging local knowledge to contextualize the opioid epidemic within HEALing Communities Study communities: A Photovoice protocol.

Since its inception 30 years ago, Photovoice has gained increasing popularity as a research method and more recently has been incorporated within randomized controlled trial (RCT) designs. Photovoice is a participatory action research method that pairs photography with focus group discussions to record community strengths and concerns, build critical consciousness, and reach policymakers. Adherence of Photovoice implementation to these original tenets of Photovoice varies. This article provides the Photovoice protocol developed by the authors to improve the methodological rigor of Photovoice integration into RCTs and help contextualize the landscape for the HEALing Communities Study (HCS: NCT04111939), a greater than $350 million investment by the National Institute on Drug Abuse along with the Substance Abuse and Mental Health Services Administration to reduce opioid overdose deaths in 67 of the hardest-hit communities in four states (Kentucky, Massachusetts, New York, and Ohio). The product of a cross-state collaboration, this HCS Photovoice protocol provides ethical and methodological tools for incorporating Photovoice into RCT designs to enhance community engagement, communication campaigns, and data-driven decision-making about evidence-based practice selection and implementation.

Health communication campaigns to drive demand for evidence-based practices and reduce stigma in the HEALing communities study.

BACKGROUND: The HEALing Communities Study (HCS) is testing whether the Communities that Heal (CTH) intervention can decrease opioid overdose deaths through the implementation of evidence-based practices (EBPs) in highly impacted communities. One of the CTH intervention components is a series of communications campaigns to promote the implementation of EBPs, increase demand for naloxone and medications for opioid use disorder (MOUD), and decrease stigma toward people with opioid use disorder and the use of EBPs, especially MOUD. This paper describes the approach to developing and executing these campaigns. METHODS: The HCS communication campaigns are developed and implemented through a collaboration between communication experts, research site staff, and community coalitions using a three-stage process. The Prepare phase identifies priority groups to receive campaign messages, develops content for those messages, and identifies a "call to action" that asks people to engage in a specific behavior. In the Plan phase, campaign resources are produced, and community coalitions develop plans to distribute campaign materials. During the Implement stage, these distribution plans guide delivery of content to priority groups. Fidelity measures assess how community coalitions follow their distribution plan as well as barriers and facilitators to implementation. An evaluation of the communication campaigns is planned. CONCLUSIONS: If successful, the Prepare-Plan-Implement process, and the campaign materials, could be adapted and used by other communities to address the opioid crisis. The campaign evaluation will extend the evidence base for how communication campaigns can be developed and implemented through a community-engaged process to effectively address public health crises.