Opioid Treatment and Peer Recovery Support

Opioid-use Disorder Clinical Trial

— JCOIN  

Official title:

Using Implementation Interventions and Peer Recovery Support to Improve Opioid Treatment Outcomes in Community Supervision

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04978168
• Other study ID #: 2002002636
• Secondary ID: U01DA050442-01
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: April 30, 2026

Study information

• Verified date: April 2024
• Source: Brown University
• Contact: Rosemarie A Martin, PhD
• Phone: 401-863-6656
• Email: Rosemarie_Martin[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• Core Intervention
Staff are provided with a core set of implementation strategies to facilitate interorganizational linkages between probation agencies and local community treatment providers.
• Peer Support Specialists (PSS)
Participants randomized to PSS will meet with a PSS for 6 months. Contact scheduled is flexible and based on the participant's needs and wants, plus written guidance for PSS-participant interactions.
• Treatment as Usual (TAU)
Participants randomized to TAU will receive the services that will be offered at the time the Core Implementation intervention is completed.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Temple University	Philadelphia	Pennsylvania
United States	Brown University	Providence	Rhode Island

Sponsors (8)

Lead Sponsor	Collaborator
Brown University	CODAC Behavioral Healthcare, Duke University, National Institute on Drug Abuse (NIDA), Temple University, The Miriam Hospital, University of North Carolina, Chapel Hill, University of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD	Calculated from self-report survey of being enrolled in MOUD (yes or no) at each assessment.	26 weeks
Primary	Program-Level Implementation Outcome: Engagement in MOUD	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.	26 weeks
Secondary	Detainment during Assessment Period (Individual-Level Experimental (Period 2) Outcome)	Calculated from probation records: Number of days detained during the assessment period	26 weeks
Secondary	Opioid Use (Individual-Level Experimental (Period 2) Outcome)	Calculated from self-report surveys and urine screens: any opioid use	26 weeks
Secondary	Non-Fatal Overdose Events (Individual-Level Experimental (Period 2) Outcome)	Calculated from treatment agency records: number of reports of medical treatment or death due to overdose events.	26 weeks
Secondary	Staff MOUD Knowledge and Attitudes (Program-Level Implementation Outcome)	Extent of staff knowledge about and attitudes towards MOUD, commitment and efficacy, readiness for change, using Medications Opinion Survey.	26 weeks
Secondary	Organizational Readiness for Change (Program-Level Implementation Outcome)	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.	26 weeks
Secondary	Input Costs: PSS time (Program-Level Implementation Outcome)	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.	26 weeks
Secondary	Input Costs: Medical Usage (Program-Level Implementation Outcome)	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.	26 weeks
Secondary	Outcome Costs (Program-Level Implementation Outcome)	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.	26 weeks