HEALing Communities Study

RTI International

Status: Active, not recruiting

Conditions: Opioid Use Disorder (OUD)

Treatments: Other: Wait-list control; Other: Communities That HEAL

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04111939

1UM1DA049415 (U.S. NIH Grant/Contract)

1UM1DA049412 (U.S. NIH Grant/Contract)

1UM1DA049417 (U.S. NIH Grant/Contract)

1UM1DA049394 (U.S. NIH Grant/Contract)

1UM1DA049406 (U.S. NIH Grant/Contract)

38088

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 67 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Wave 1 - Intervention

Experimental group

Description:

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.

Treatment:

Other: Communities That HEAL

Wave 2 - Wait-list comparison

Other group

Description:

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.

Treatment:

Other: Wait-list control