Opioid Treatment and Peer Recovery Support

Not Applicable

Recruiting

• Conditions: Opioid-use Disorder

• Registration Number: NCT04978168
• Lead Sponsor: Brown University

Brief Summary

Determine whether a facilitated local change team intervention improves a probation organization's client-level medication for opioid use disorder (MOUD) outcomes and implementation outcomes relative to baseline across multiple sites. Determine whether client-level outcomes are further enhanced by the introduction of Peer Support Services.

Detailed Description

Background: The purpose is to determine whether a facilitated local change team (LCT) intervention improves linkage to medication for opioid use disorder (MOUD) and implementation outcomes, and whether participant-level outcomes are further enhanced by the use of Peer Support Specialists (PSS).

Methods/Design: This Type 1 hybrid implementation-effectiveness study involves a pre-post design (implementation study) followed by a randomized trail of PSS (effectiveness study). The study is conducted at 7 performance sites in 3 states.

Phase 1 (Core Implementation Study): The Exploration, Preparation, Implementation, Sustainability (EPIS) framework is used to guide system-change through facilitated LCTs consisting of probation and community treatment staff who are given a core set of implementation strategies which are used to conduct a needs assessment and set goals. The overall objective is to improve linkage to the continuum of evidence-based care for justice-involved individuals with opioid use disorder (OUD). Organizational (program-level) and staff survey are collected at the end of each EPIS stage (baseline Exploration, end of Preparation, end of Implementation, and 12 months \[Sustainability\]). Implementation outcomes: Organizational engagement in MOUD (primary), plus changes in staff knowledge/attitudes and organizational outcomes (secondary).

Phase 2 (Effectiveness Study of PSS): After completing implementation, 450 adults on probation are randomized to receive PSS vs. treatment as usual (TAU), with assessments at baseline, 3, and 6 months. This trial tests whether having a trained peer improves clinical outcomes beyond effects of Core Implementation. Implementation program-level outcomes include organizational engagement in MOUD use (primary outcome); changes in staff knowledge and attitudes about MOUD, commitment and efficacy, readiness for change; organizational attitudes for change, commitment and efficacy (secondary outcomes). Client-level effectiveness outcomes include participant engagement in MOUD (primary outcome), probation revocation, illicit opioid use, and overdoses (secondary outcomes). Other aims include identifying barriers and facilitators, and cost-benefit analysis of PSS.

Primary Research Questions:

The primary aim is to test the effectiveness of PSS compared to TAU (agency approach after implementation) on outcomes of individuals on probation: Engagement in MOUD (primary effectiveness outcome), probation revocation (secondary), illicit opioid use (secondary), and overdose (tertiary).

The second aim is to test the effectiveness of EPIS-based Core Implementation Intervention relative to baseline on engagement in MOUD (primary implementation outcome).

The third aim is to test the effects of the EPIS implementation strategies relative to baseline on program-level (organizational and staff-level) outcomes.

The fourth aim is to conduct a cost-benefit analysis of implementing PSS compared to TAU.

The fifth aim is to identify organizational and staff barriers and facilitators to intervention implementation by conducting qualitative interviews with key probation and community treatment stakeholders who are managing and delivering the MOUD program.

Study Timeline

• Study Start: 2021-03-02
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-12-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Community Provider Staff: Any front-line treatment provider at an agency participating in this study who: (a) provides support to MOUD clients, (b) has an active caseload including some individuals on probation, and (c) willing to commit to 12 months to the project.
• Probation/Parole Staff: Any probation officer (PO) at an agency participating in this study who (a) has an active caseload, and (b) is willing to commit to 12 months to the project.
• Individuals on Probation: (a) 18 years or older, (b) committed to probation within 90 days prior to study enrollment, (c) English speaking, (d) diagnosed with OUD, (e) have stable method of contact in community

Exclusion Criteria

• Individuals on Probation: Currently incarcerated or in a court-mandated inpatient treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD	26 weeks	Calculated from self-report survey of being enrolled in MOUD (yes or no) at each assessment.
Program-Level Implementation Outcome: Engagement in MOUD	26 weeks	MOUD engagement (primary implementation outcome) is defined as enrollment in MOUD treatment program, or filling a prescription for buprenorphine from a provider (in not on MOUD at time of recruitment), or remaining in MOUD treatment (if already on MOUD when recruited or at previous follow-up), coded dichotomously. Number of clients in probation enrolled in MOUD is tracked via medical and probation records.

Secondary Outcome Measures

Name	Time	Method
Non-Fatal Overdose Events (Individual-Level Experimental (Period 2) Outcome)	26 weeks	Calculated from treatment agency records: number of reports of medical treatment or death due to overdose events.
Staff MOUD Knowledge and Attitudes (Program-Level Implementation Outcome)	26 weeks	Extent of staff knowledge about and attitudes towards MOUD, commitment and efficacy, readiness for change, using Medications Opinion Survey.
Outcome Costs (Program-Level Implementation Outcome)	26 weeks	Participant surveys will be used to record number of days in jail during the follow-up period. Analyses will convert these to dollar costs using government information.
Opioid Use (Individual-Level Experimental (Period 2) Outcome)	26 weeks	Calculated from self-report surveys and urine screens: any opioid use
Input Costs: PSS time (Program-Level Implementation Outcome)	26 weeks	PSS logs will be used to record the time PSSs spend with each participant (hours and minutes). Data analyses will convert these to dollar costs per participant using information from the Bureau of Labor Statistics.
Input Costs: Medical Usage (Program-Level Implementation Outcome)	26 weeks	Participant surveys will be sued to record number of visits to each type of medical provider during the study. Data analyses will convert these to dollar costs using Medicare fee-for-service information.
Detainment during Assessment Period (Individual-Level Experimental (Period 2) Outcome)	26 weeks	Calculated from probation records: Number of days detained during the assessment period
Organizational Readiness for Change (Program-Level Implementation Outcome)	26 weeks	Measures of organizational climate, functioning, innovation support, leadership, and staff attributes were adapted from the Evidence-Based Practices Attitudes Scale (Aarons, 2004), Survey of Organizational Functioning (IBR, 2005), and Organizational Readiness for Change (IBR, 2009). Organizational linkages for collaboration and coordination between correctional and treatment agency dyads, using the Inter-Organizational Relationships (IOR) Survey.

Trial Locations

Locations (3)

Duke University; 🇺🇸 Durham, North Carolina, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States