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

November 27, 2023 updated by: Julia Felton, Henry Ford Health System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48203
        • The Detroit Recovery Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer-delivered Behavioral Activation
Adults 18 years or older on MOUD or referred to MOUD will receive Behavioral Activation (BA) an evidence-based intervention (EBI) by trained Peer Recovery Coaches (PRC)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MOUD Retention Rate
Time Frame: Measured daily through study completion; up to 24 weeks
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
Intervention Feasibility: percentage of patients who agree to participate in the intervention
Time Frame: Measured at study completion; up to 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Acceptability: percentage of patients enrolled who attend ≥75% sessions
Time Frame: Measured at study completion; up to 24 weeks
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
Intervention Fidelity: percentage of intervention components delivered as intended
Time Frame: Measured through study completion; up to 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

University of Maryland, College Park

Investigators

  • Principal Investigator: Julia Felton, PhD., Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Actual)

August 14, 2023

Study Completion (Actual)

August 14, 2023

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEP: 14920-29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After all primary analyses are complete, de-identified data will be available per request of outside individual

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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