FOREward Together: Training Peer Recovery Coaches to Promote Retention and Adherence to MOUD

Opioid Use Clinical Trial

Official title:

Training Peer Recovery Coaches to Promote Retention and Adherence to Medications for Opioid Use Disorder Among Low-Income Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098795
• Other study ID #: FEP: 14920-29
• Status: Completed
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: August 14, 2023

Study information

• Verified date: November 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to implement a peer-led intervention to support retention and adherence to medications for opioid use disorder among low-income adults in Detroit, as well as a training manual for peer recovery coaches serving similar populations. The approach will serve as a guide to coaches in providing positive reinforcement and helping those in treatment to schedule and engage in valued activities. Researchers will examine the effectiveness of the intervention, supervision and training models, and share results with policymakers and treatment programs.

Description:

Low-income and racial/ethnic minorities suffer disproportionately from the opioid use disorder (OUD) crisis, evidencing consistently lower rates of critical treatment outcomes, including medication for OUD (MOUD) engagement and retention. While these individuals exhibited a need for evidence-based care prior to the pandemic, low-income, racial/ethnic minority populations have been disproportionately affected by COVID-19, as have persons with SUDs.

Peer Recovery Coaches (PRC) are individuals with lived-experiences with substance use who have been certified by the state to assist in treatment recovery. Because of similarities between PRCs and substance use clients, PRCs can overcome many of the barriers that clients face to engaging and staying in MOUD treatment, such as stigma. goal of the current project is to conduct an open-label pilot trial to examine the feasibility, acceptability and accessibility of a PRC-led intervention to support retention in MOUD care.

This project proposes to develop a novel and sustainable model for improving retention in MOUD treatment by training PRCs to deliver an evidence-based intervention (EBI), Behavioral Activation (BA). BA seeks to increase the positive reinforcement patients experience from their natural environment by promoting prosocial and valued experiences. BA has been found to improve substance use treatment retention and adherence, as well as medication adherence in low-income individuals with HIV/AIDS. To that end, the following goal is proposed: to evaluate the preliminary feasibility, acceptability, and effectiveness of the PRC- delivered BA approach. An open-label pilot trial (n=40) of the adapted PRC-delivered BA intervention and training protocol in a representative agency in Detroit, MI serving a low-income, predominantly African-American population will be conducted. Findings from this phase of the project will be used to re-adapt the manual and training procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must (1) be receiving or referred to MOUD; and (2) be over the age of 18.

Exclusion Criteria:

• Exclusion criteria will be (1) demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis; or (2) inability to understand the study and give informed consent in English Active, Unstable or Untreated Psychiatric Symptoms: The study team is committed to recruiting a sample that reflects the complexity and likely comorbidity of people with moderate to severe OUD in this setting. Therefore, only people whose concurrent mental health issues preclude ability to participate with the procedures in this study will be excluded. Throughout the study, researchers will monitor for active, unstable or untreated psychiatric symptoms as the presence of these symptoms during study procedures would interfere with participation. Monitoring for exclusionary psychiatric symptoms can include reviewing data in medical chart (per protocol-approved access to medical records), observation during assessments and intervention sessions, and/or current symptoms detected on the MINI modules for psychosis and mania.

Inability to complete informed consent/ study in English. This study/intervention will be implemented in English only. Therefore, the capacity and willingness to give written informed consent in English, to understand the study and inclusion and exclusion criteria in English.

Related Conditions & MeSH terms

• Opioid Use
• Opioid-Related Disorders

Intervention

Behavioral:
• Behavioral Activation (BA)
BA seeks to increase the positive reinforcement patients experience from their natural environment by promoting prosocial and valued experiences. BA has been found to improve substance use treatment retention and adherence, as well as medication adherence in low-income individuals with HIV/AIDS.

Locations

Country	Name	City	State
United States	The Detroit Recovery Project	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	University of Maryland, College Park

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MOUD Retention Rate	The number of days (frequency) a participant visits the clinic for MOUD as indicated by daily clinic records.	Measured daily through study completion; up to 24 weeks
Primary	Intervention Feasibility: percentage of patients who agree to participate in the intervention	Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the percentage of patients who agree to participate in the intervention. Qualitative feedback related to feasibility will be conducted.	Measured at study completion; up to 24 weeks
Secondary	Intervention Acceptability: percentage of patients enrolled who attend =75% sessions	Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, the % of patients enrolled who attend =75% sessions will be measured. Qualitative feedback related to acceptability will be conducted.	Measured at study completion; up to 24 weeks
Secondary	Intervention Fidelity: percentage of intervention components delivered as intended	Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRC adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity, and percentage of intervention components delivered as intended will be assessed.	Measured through study completion; up to 24 weeks