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| Name | Class |
|---|---|
| University of Maryland, College Park | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer-delivered Behavioral Activation | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation (BA) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| MOUD Retention Rate | Average number of days a participant missed an MOUD appointment between receiving the intervention and completing the follow-up assessment (approximately 8-12 weeks following the intervention date), averaged across all participants with available data. | Measured between participants' completion of baseline assessment and completion of the follow-up assessment (approximately 8-12 weeks following the intervention date). |
| Intervention Fidelity: Proportion of Intervention Components Delivered as Intended | Defined as the proportion of all 24 intervention components in the total intervention that were delivered with fidelity by the interventionist (ranging from 0 to 1.0 with higher proportion reflecting more fidelity). | The number of days between starting the intervention and completing the intervention (approximately 8-10 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Acceptability: Percentage of Patients Enrolled Who Attend ≥75% Sessions | Defined as the percentage of participants who started the intervention who then finish the intervention (defined as completing 8 total sessions) | The number of days between starting the intervention and completing the intervention (approximately 8-10 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Julia Felton, PhD. | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Detroit Recovery Project | Detroit | Michigan | 48203 | United States |
After all primary analyses are complete, de-identified data will be available per request of outside individual
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Participants were enrolled via flyers and word-of-mouth at a community-based substance use treatment setting from December 2021 through April 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MOUD Retention Rate | Average number of days a participant missed an MOUD appointment between receiving the intervention and completing the follow-up assessment (approximately 8-12 weeks following the intervention date), averaged across all participants with available data. | We were able to get data on MOUD visits from 18 participants from the total sample. | Posted | Mean | Standard Deviation | number of days missed MOUD appointment | Measured between participants' completion of baseline assessment and completion of the follow-up assessment (approximately 8-12 weeks following the intervention date). |
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Over the course of the intervention delivery, approximately one year.
No differences in how adverse events are described
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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None noted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julia Felton | Henry Ford Health | 313-598-0841 | jfelton4@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2022 | Aug 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2024 | Aug 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Intervention Feasibility: Percentage of Patients Who Consents Who Started BA | Defined as the percentage of participants who started BA sessions relative to those who enrolled in the program | The number of days between starting providing consent and starting BA (approximately 1-5 weeks). |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Intervention Fidelity: Proportion of Intervention Components Delivered as Intended | Defined as the proportion of all 24 intervention components in the total intervention that were delivered with fidelity by the interventionist (ranging from 0 to 1.0 with higher proportion reflecting more fidelity). | Fidelity was examined among participants who took part in at least one BA session. | Posted | Mean | Standard Deviation | proportion of elements delivered | The number of days between starting the intervention and completing the intervention (approximately 8-10 weeks). |
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| Secondary | Intervention Acceptability: Percentage of Patients Enrolled Who Attend ≥75% Sessions | Defined as the percentage of participants who started the intervention who then finish the intervention (defined as completing 8 total sessions) | We examined the percentage of all participants who started the intervention who then completed the intervention (defined as taking part in 8 sessions) | Posted | Number | percentage of participants | The number of days between starting the intervention and completing the intervention (approximately 8-10 weeks). |
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| Secondary | Intervention Feasibility: Percentage of Patients Who Consents Who Started BA | Defined as the percentage of participants who started BA sessions relative to those who enrolled in the program | We examined the percentage of participants who took part in at least one BA session relative to those who enrolled. | Posted | Count of Participants | Participants | The number of days between starting providing consent and starting BA (approximately 1-5 weeks). |
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