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. 2020 Dec 1:217:108335.
doi: 10.1016/j.drugalcdep.2020.108335. Epub 2020 Oct 17.

The HEALing (Helping to End Addiction Long-term SM) Communities Study: Protocol for a cluster randomized trial at the community level to reduce opioid overdose deaths through implementation of an integrated set of evidence-based practices

HEALing Communities Study Consortium
Collaborators, Affiliations

The HEALing (Helping to End Addiction Long-term SM) Communities Study: Protocol for a cluster randomized trial at the community level to reduce opioid overdose deaths through implementation of an integrated set of evidence-based practices

HEALing Communities Study Consortium. Drug Alcohol Depend. .

Abstract

Background: Opioid overdose deaths remain high in the U.S. Despite having effective interventions to prevent overdose deaths, there are numerous barriers that impede their adoption. The primary aim of the HEALing Communities Study (HCS) is to determine the impact of an intervention consisting of community-engaged, data-driven selection, and implementation of an integrated set of evidence-based practices (EBPs) on reducing opioid overdose deaths.

Methods: The HCS is a four year multi-site, parallel-group, cluster randomized wait-list controlled trial. Communities (n = 67) in Kentucky, Massachusetts, New York and Ohio are randomized to active intervention (Wave 1), which starts the intervention in Year 1 or the wait-list control (Wave 2), which starts the intervention in Year 3. The HCS will test a conceptually driven framework to assist communities in selecting and adopting EBPs with three components: 1) a community engagement strategy with local coalitions to guide and implement the intervention; 2) a compendium of EBPs coupled with technical assistance; and 3) a series of communication campaigns to increase awareness and demand for EBPs and reduce stigma. An implementation science framework guides the intervention and allows for examination of the multilevel contexts that promote or impede adoption and expansion of EBPs. The primary outcome, number of opioid overdose deaths, will be compared between Wave 1 and Wave 2 communities during Year 2 of the intervention for Wave 1. Numerous secondary outcomes will be examined.

Discussion: The HCS is the largest community-based implementation study in the field of addiction with an ambitious goal of significantly reducing fatal opioid overdoses.

Keywords: Community engagement; HEALing Communities Study; Helping to End Addiction Long-term; Medications for opioid use disorder (MOUD); Naloxone; Opioid prescribing; Opioid use disorder (OUD); Overdose.

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Conflict of interest statement

Competing interest disclosures include the following: DMC Serves on Data Safety Monitoring Boards for Janssen Research & Development; the studies have no relation to HCS work. MRL (MA) has research funds paid to their institution from OptumLabs for research on OUD treatment pathways. RS has received medication at no charge from Alkermes in support of a study testing naltrexone for alcohol use disorder. MDS (MA) reviewed grants for Alkermes in 2019. EN is an investigator on a study sponsored and funded by Braeburn-Camurus, served as a consultant without compensation to Alkermes, Braeburn-Camurus, and Pear Therapeutics, and has been an investigator on studies receiving in kind medication from Alkermes and Indivior, and in kind digital therapeutic from Pear Therapeutics. FL receives grant support from the NIDA, SAMHSA and US World Meds, consults for Major League Baseball, serves as an unpaid member of a Scientific Advisory Board for Alkermes, Novartis and US WorldMeds. KK has been compensated for providing consultation and reports for ongoing opioid litigation. SLW serves as a scientific advisor to Opiant and has served as a scientific consultant to Otsuka, Brainsway Therapeutics, Astra Zeneca and Biosciences Summit. All other authors have no conflicts to declare.

Figures

Fig. 1
Fig. 1
Map of rural and urban communities participating in the HEALing Communities Study. Communities (n = 67) from the four participating states are shown with gray shading representing urban communities and black shading representing rural communities.
Fig. 2
Fig. 2
The Communities That Heal intervention core components.
Fig. 3
Fig. 3
The seven phases of the Communities That Heal community-engagement strategy.
Fig. 4
Fig. 4
Opioid-overdose Reduction Continuum of Care Approach (ORCCA) Menu.
Fig. 5
Fig. 5
HEALing Communities Study implementation science framework. This figure is adapted from the revised, enhanced RE-AIM/PRISM 2019 model (Glasgow et al., 2019, p. 6).
See this image and copyright information in PMC

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