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

Primary Purpose

Opioid Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation (BA)
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring Medications for opioid use disorder, Peer recovery coach, Substance use, Behavioral activation, Task sharing, Treatment retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Detroit Recovery Project

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peer-delivered Behavioral Activation

Arm Description

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)

Outcomes

Primary Outcome Measures

MOUD Retention Rate
The number of days (frequency) a participant visits the clinic for MOUD as indicated by daily clinic records.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 7, 2021
Last Updated
September 7, 2023
Sponsor
Henry Ford Health System
Collaborators
University of Maryland, College Park
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1. Study Identification

Unique Protocol Identification Number
NCT05098795
Brief Title
FOREward Together: Training Peer Recovery Coaches to Promote Retention and Adherence to MOUD
Official Title
Training Peer Recovery Coaches to Promote Retention and Adherence to Medications for Opioid Use Disorder Among Low-Income Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
August 14, 2023 (Actual)
Study Completion Date
August 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
University of Maryland, College Park

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use
Keywords
Medications for opioid use disorder, Peer recovery coach, Substance use, Behavioral activation, Task sharing, Treatment retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-delivered Behavioral Activation
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation (BA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
MOUD Retention Rate
Description
The number of days (frequency) a participant visits the clinic for MOUD as indicated by daily clinic records.
Time Frame
Measured daily through study completion; up to 24 weeks
Title
Intervention Feasibility: percentage of patients who agree to participate in the intervention
Description
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.
Time Frame
Measured at study completion; up to 24 weeks
Secondary Outcome Measure Information:
Title
Intervention Acceptability: percentage of patients enrolled who attend ≥75% sessions
Description
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.
Time Frame
Measured at study completion; up to 24 weeks
Title
Intervention Fidelity: percentage of intervention components delivered as intended
Description
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.
Time Frame
Measured through study completion; up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Felton, PhD.
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Detroit Recovery Project
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After all primary analyses are complete, de-identified data will be available per request of outside individual

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

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