HEALing Communities Study

HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis

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%.

Study Overview

• Status: Active, not recruiting
• Conditions: Opioid Use Disorder (OUD)
• Intervention / Treatment: Other: Communities That HEAL; Other: Wait-list control

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • University of Kentucky
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New York
    • New York, New York, United States, 10027
      • Columbia University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wave 1 - Intervention; Communities in Wave 1 will receive the CTH intervention during the first 30 months of the trial. 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.	Other: Communities That HEAL; The Communities That HEAL (CTH) intervention is a community-engaged intervention designed to increase the adoption of an integrated set of evidence-based practices delivered across healthcare, behavioral health, justice, and other community-based settings. It includes 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.; Other Names: CTH
Other: Wave 2 - Wait-list comparison; Communities in Wave 2 will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention.	Other: Wait-list control; Communities in the wait-list control condition will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of opioid overdose deaths	Count of HCS community resident overdose deaths (i.e. deaths with an underlying cause of drug poisoning) where opioids were determined to be contributing (alone or in combination with other drugs) to the drug poisoning.	Months 19-30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of naloxone units distributed in communities	Count of naloxone units distributed in the HCS communities during the measurement period as captured by the following submeasures: 1) count of naloxone units distributed by the state health agency (secondary data from state health agencies) and HCS study logs for naloxone distributed by the study and 2) the count of naloxone units sold by pharmacies (IQVIA pharmacy data)	Months 19-30
Number of individuals receiving buprenorphine products that are approved by the Food and Drug Administration (FDA) for treatment of OUD	Count of number of unique individuals receiving buprenorphine MOUD during the measurement period.	Months 19-30
Incidents of high-risk opioid prescribing	Count of individuals with one or more of the following during the twelve month study period (months 19-30), and not in a prior specified time window (3 months): risk of continued opioid use (new opioid episode lasting at least 31 days); initiating opioid treatment with extended-release or long-acting opioid; incident high dosage (average ≥ 90 mg morphine per day); and/or incident overlapping opioid and benzodiazepine for ≥ 30 days.	Months 19-30

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: National Institute on Drug Abuse (NIDA); Columbia University; Boston Medical Center; Ohio State University; University of Kentucky; Substance Abuse and Mental Health Services Administration (SAMHSA)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Drug Alcohol Depend. 2021 Jul 1;224:108742.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: addiction; opioid; methadone; Opioid Use Disorder (OUD); overdose; Naloxone; Buprenorphine; evidence-based practices; community engagement
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 38088; 1UM1DA049394 (U.S. NIH Grant/Contract); 1UM1DA049415 (U.S. NIH Grant/Contract); 1UM1DA049417 (U.S. NIH Grant/Contract); 1UM1DA049412 (U.S. NIH Grant/Contract); 1UM1DA049406 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

We plan to make study methods, data, and results available to anyone interested in reducing the burden of the opioid crisis. The data sharing plan will comply with the NIH HEAL Initiative ClinicalTrials.govSM Public Access and Data Sharing Policy, the NIH Data Sharing Policy, and the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, and the NIH Clinical Trial Registration and Results Information Submission rule.

The data sharing plan will follow NIH requirements for sharing data via the creation of public-use data sets. A structured process will be used to evaluate the risk of re-identification based on guidance documents from the US DHHS and HIPAA. The risk of re-identification will also be quantitatively evaluated using accepted statistical methods. Study data deposited into a repository selected by NIDA, such as the National Addiction & HIV Data Archive Program, will be de-identified or masked to minimize risks to study participant privacy.

• IPD Sharing Time Frame: The HEALing Communities Study period of performance ends March 2025. We expect data archival in February 2025.
• IPD Sharing Access Criteria: The DCC will provide a statistical system file and limit administrative data to the study measures as outlined in the common data model (CDM). We will mask HCS geography and provide five flag variables (Research Site, Intervention Arm, Geography, Community, Time Frequency) in addition to the CDM outcomes. The DCC will suppress or statistically mask individual variables as required in each applicable data use agreement governing HCS administrative data release. The repository disseminates data to users based on its Access Policy Framework. HCS datasets are freely available to the public through the HCS thematic collection. Users download datasets and analyze them on their own computers. Access to data requires submission of username, institution, and analytic purpose and aim. There is no formal approval process initially planned by NIDA. Data users are expected to adhere to norms for responsible use.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No