Grand Rounds January 24, 2025: The HEALing Communities Study – 10 Million People, 67 Communities: A Community-Based Cluster Randomized Trial to Reduce Opioid Overdose Deaths (Jeffrey H. Samet, MD, MA, MPH)

Speaker

Jeffrey H. Samet, MD, MA, MPH
John Noble Professor in General Internal Medicine & Professor of Public Health
Boston University Chobanian and Avedisian School of Medicine and School of Public Health
Boston Medical Center

Keywords

Opioid Epidemic; Evidence-Based Practices; NIH HEAL Initiative; MOUD; OEND; Harm Reduction

Key Points

  • Over roughly 20 years, opioid overdose (OD) mortality in the U.S. increased tenfold: from a little over 8,000 in 1999 to over 80,000 in 2022. Health authorities urged medical professionals to address the crisis through stigma reduction, uptake of opioid use disorder (OUD) treatment, and other evidence-based practices (EBPs).
  • The goal of the HEALing Communities Study (HCS) was to reduce opioid OD through implementation of EBPs, including overdose education and naloxone distribution (OEND); access to medications for OUD (MOUD); and safer opioid prescribing and dispensing practices.
  • The research team conducted the cluster randomized trial in 67 communities across Ohio, Kentucky, New York, and Massachusetts – a total study population of about 10 million. HCS is the largest implementation science study funded by NIDA.
  • The primary objective of HCS was to compare the number of opioid OD deaths in adults during the comparison period (July 2021 – June 2022) between the intervention and control communities. Secondary outcomes included the rates of naloxone distribution; access to or utilization of MOUD; opioid + stimulant OD deaths; and non-fatal overdose events.
  • The intervention involved 3 pathways for implementing OUD EBPs: community engagement; the Opioid Reduction Continuum of Care Approach (ORCCA), consisting of a menu of strategies to support implementation of EBPs; and community-based health communications campaigns. Multi-level partnerships, Dr. Samet noted, are critical to the success of community-engaged research.
  • Between the intervention group and the control group, there was no difference in the number of opioid OD deaths. OD deaths involving opioids and psychostimulants (excluding cocaine) decreased by 37% in the intervention group, and there was a 15% reduction in nonfatal overdoses.
  • Factors that may have impacted results included the complex array of strategies; a limited period of time in which to achieve full benefits from the implementation of EBPs; COVID-19-related demands on coalition members and healthcare personnel; increasing rates of fentanyl in the drug supply with stimulant contamination; and statistical power.
  • Limitations included the fact that control communities could still access non-HCS funds to address the opioid epidemic and a variation in the affected population size within each community.

Discussion Themes

The research team had 18 months to get the intervention up and running; when the comparison period began, they were at 35% implementation – lower than their goal. This was partially a product of the stakes; the death toll of the opioid epidemic was high and the team was motivated to make quick progress. The COVID-19 pandemic also slowed things down.

Dr. Samet emphasized that the HCS team wasn’t testing whether MOUD and OEND worked; there is significant evidence demonstrating that these strategies are effective. Rather, the team was testing whether communities adopted them and if they had an effect on OD reduction.

When the team shared the results back with community partners, they heard anecdotal reports about the positive effects their partners had witnessed in their communities.

Engagement coalitions formed across communities. Ohio and Kentucky utilized existing coalitions while New York and Massachusetts built new ones. Dr. Samet noted that each of the four states performed well in different realms.