Clinical trial NCT04111939: HEALing Communities Study
Official title: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder (OUD)
Keywords: opioid
Opioid Use Disorder (OUD)
overdose
addiction
Naloxone
Buprenorphine
methadone
evidence-based practices
community engagement
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
name: Columbia University
name: Ohio State University
name: University of Kentucky
name: National Institute on Drug Abuse (NIDA)
name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2019-10-01
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test the impact of implementing the Communities That Helping to End Addiction Long-term (HEAL) intervention on opioid overdose deaths within 67 highly affected communities with the goal of reducing opioid overdose deaths by 40%.

Detailed description: The HEALing Communities Study (HCS) is a multi-site, parallel group, cluster randomized wait-list controlled trial to test the impact of the Communities That HEAL (CTH) intervention, which is designed to increase the adoption of an integrated set of evidence-based practices delivered across healthcare, behavioral health, justice, and other community-based settings. The intervention will include 3 components: community engagement to assist key stakeholders in applying evidence-based practices to addressing their opioid crisis, a menu of evidence-based practices for communities to select and implement, and a communications campaign to build demand for evidence-based practices to address overdose and opioid use disorder. Communities receiving the intervention will be engaged to reach individuals who are at highest risk of overdose death (e.g., out of treatment, leaving jail) and: (1) expand access to and receipt of medication for opioid use disorder (MOUD) and behavioral treatment, (2) increase the number of individuals retained in treatment beyond 6 months, (3) reduce the risk of fatal overdose through expansion of overdose education and naloxone distribution, and (4) improve prescription opioid safety. In addition, the study will determine (1) the factors that contribute to or impede successful implementation of the CTH intervention, (2) the factors that contribute to or impede sustainment of CTH intervention, and (3) the incremental costs and cost effectiveness of the CTH intervention.

Eligibility criteria: Inclusion Criteria:

* The community must be located in one of the four participating states: Kentucky, Ohio, Massachusetts, or New York.
* At least 30% of the communities selected within each state must be rural.
* Across all the HCS communities within each state, there must be a minimum of 150 opioid-related overdose fatalities (with at least 22 opioid-related overdose fatalities experienced by the rural communities) and a rate of at least 25 opioid-related overdose fatalities per 100,000 persons, based on 2016 data.
* The community must express willingness to address in their response strategy the implementation of MOUD, overdose prevention training, and naloxone distribution across their community.
* The community must express willingness to develop partnerships across health care, behavioral health, and justice settings for evidence-based practices to address opioid misuse, OUD, and overdoses.

Exclusion Criteria:

* Communities that did not meet the aforementioned inclusion criteria were excluded from the HCS.

Primary outcomes:
measure: Number of Opioid Overdose Deaths
timeFrame: Months 19-30
Secondary outcomes:
measure: Number of Naloxone Units Distributed in Communities
timeFrame: Months 19-30
measure: Number of Individuals Receiving Buprenorphine Products That Are Approved by the Food and Drug Administration (FDA) for Treatment of OUD
timeFrame: Months 19-30
measure: Incidents of High-risk Opioid Prescribing
timeFrame: Months 19-30
Other outcomes:
measure: Adverse Event Incidence Per 1000 Community Members
timeFrame: 44 months
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References:
citation: Walker DM, Shiu-Yee K, Chen S, DePuccio MJ, Jackson RD, McAlearney AS. Community Coalitions' Perspectives on Engaging with Hospitals in Ohio to Address the Opioid Crisis. Popul Health Manag. 2022 Dec;25(6):729-737. doi: 10.1089/pop.2022.0174. Epub 2022 Oct 28.
citation: Young AM, Brown JL, Hunt T, Sprague Martinez LS, Chandler R, Oga E, Winhusen TJ, Baker T, Battaglia T, Bowers-Sword R, Button A, Fallin-Bennett A, Fanucchi L, Freeman P, Glasgow LM, Gulley J, Kendell C, Lofwall M, Lyons MS, Quinn M, Rapkin BD, Surratt HL, Walsh SL. Protocol for community-driven selection of strategies to implement evidence-based practices to reduce opioid overdoses in the HEALing Communities Study: a trial to evaluate a community-engaged intervention in Kentucky, Massachusetts, New York and Ohio. BMJ Open. 2022 Sep 19;12(9):e059328. doi: 10.1136/bmjopen-2021-059328.
citation: Tang X, Heeren T, Westgate PM, Feaster DJ, Fernandez SA, Vandergrift N, Cheng DM. Performance of model-based vs. permutation tests in the HEALing (Helping to End Addiction Long-termSM) Communities Study, a covariate-constrained cluster randomized trial. Trials. 2022 Sep 8;23(1):762. doi: 10.1186/s13063-022-06708-9.
citation: Walker DM, Childerhose JE, Chen S, Coovert N, Jackson RD, Kurien N, McAlearney AS, Volney J, Alford DP, Bosak J, Oyler DR, Stinson LK, Behrooz M, Christopher MC, Drainoni ML. Exploring perspectives on changing opioid prescribing practices: A qualitative study of community stakeholders in the HEALing Communities Study. Drug Alcohol Depend. 2022 Apr 1;233:109342. doi: 10.1016/j.drugalcdep.2022.109342. Epub 2022 Feb 2.
citation: Westgate PM, Cheng DM, Feaster DJ, Fernandez S, Shoben AB, Vandergrift N. Marginal modeling in community randomized trials with rare events: Utilization of the negative binomial regression model. Clin Trials. 2022 Apr;19(2):162-171. doi: 10.1177/17407745211063479. Epub 2022 Jan 6.
citation: Slavova S, LaRochelle MR, Root ED, Feaster DJ, Villani J, Knott CE, Talbert J, Mack A, Crane D, Bernson D, Booth A, Walsh SL. Operationalizing and selecting outcome measures for the HEALing Communities Study. Drug Alcohol Depend. 2020 Dec 1;217:108328. doi: 10.1016/j.drugalcdep.2020.108328. Epub 2020 Oct 2.
citation: El-Bassel N, Jackson RD, Samet J, Walsh SL. Introduction to the special issue on the HEALing Communities Study. Drug Alcohol Depend. 2020 Dec 1;217:108327. doi: 10.1016/j.drugalcdep.2020.108327. Epub 2020 Oct 1.
citation: Winhusen T, Walley A, Fanucchi LC, Hunt T, Lyons M, Lofwall M, Brown JL, Freeman PR, Nunes E, Beers D, Saitz R, Stambaugh L, Oga EA, Herron N, Baker T, Cook CD, Roberts MF, Alford DP, Starrels JL, Chandler RK. The Opioid-overdose Reduction Continuum of Care Approach (ORCCA): Evidence-based practices in the HEALing Communities Study. Drug Alcohol Depend. 2020 Dec 1;217:108325. doi: 10.1016/j.drugalcdep.2020.108325. Epub 2020 Oct 4.
citation: Knudsen HK, Drainoni ML, Gilbert L, Huerta TR, Oser CB, Aldrich AM, Campbell ANC, Crable EL, Garner BR, Glasgow LM, Goddard-Eckrich D, Marks KR, McAlearney AS, Oga EA, Scalise AL, Walker DM. Model and approach for assessing implementation context and fidelity in the HEALing Communities Study. Drug Alcohol Depend. 2020 Dec 1;217:108330. doi: 10.1016/j.drugalcdep.2020.108330. Epub 2020 Oct 2.
citation: Wu E, Villani J, Davis A, Fareed N, Harris DR, Huerta TR, LaRochelle MR, Miller CC, Oga EA. Community dashboards to support data-informed decision-making in the HEALing communities study. Drug Alcohol Depend. 2020 Dec 1;217:108331. doi: 10.1016/j.drugalcdep.2020.108331. Epub 2020 Oct 1.
citation: Sprague Martinez L, Rapkin BD, Young A, Freisthler B, Glasgow L, Hunt T, Salsberry PJ, Oga EA, Bennet-Fallin A, Plouck TJ, Drainoni ML, Freeman PR, Surratt H, Gulley J, Hamilton GA, Bowman P, Roeber CA, El-Bassel N, Battaglia T. Community engagement to implement evidence-based practices in the HEALing communities study. Drug Alcohol Depend. 2020 Dec 1;217:108326. doi: 10.1016/j.drugalcdep.2020.108326. Epub 2020 Oct 6.