Fostering MAT Use in Justice Populations

Study Overview
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Brief Summary
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The grant will test two timely and successful evidence-based implementation practices, NIATx Coaching and ECHO, with jail/community-based healthcare providers to increase medication assisted treatment (MAT) use with justice populations.

Detailed Description
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In this trial, the investigators will test two implementation interventions being applied to medications for opioid use disorder (MOUD) dissemination and implementation in justice settings for justice-involved populations: NIATx Coaching and the Extension for Community Healthcare Outcomes (ECHO) model. NIATx Coaches provide expertise in MOUD implementation and organizational change to help treatment organizations and staff make, sustain, and spread MOUD. The ECHO platform focuses only on the provider side by connecting the primary care provider with expert MOUD prescribers to promote high-quality MOUD practices. This will be the first trial that assesses the comparative effectiveness of these approaches overall, and in justice settings. The trial will be conducted with a combination of 48 jails and community-based organizations that treat individuals with opioid use disorders (OUDs) post-incarceration. Sites will be randomly assigned to one of four study arms, with 12 sites in each arm: High-Dose Coaching/ECHO, Low-Dose Coaching/ECHO, High-Dose Coaching/No ECHO, and Low-Dose Coaching/No ECHO. The intervention period will be over a 12-month span with an additional 12-months for sustainability.

Official Title
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Fostering MAT Use in Justice Populations

Conditions
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Opioid-use Disorder, Recidivism

Intervention / Treatment
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* Behavioral: NIATx Coaching
* Behavioral: ECHO


Participation Criteria
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Eligibility Criteria
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Site Inclusion Criteria: Have an interest in embedding or increasing the use of MOUD within their site. Have the funds to pay for medications for the duration of the study (24 months); whether it be from grants, insurance or private pay. Sites agree to implement or continue to use at least one medication, although they will be encouraged to offer more than one medication. Have leadership support at all levels. Agree to provide data described in the MOU or Information Sheet. Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The proposed study will implement a cluster randomized block design where staff are nested within sites. The community-based provider sites and jails will be grouped into homogeneous blocks and then randomly assigned into 2x2 factorial design for each block. The forty-eights sites will be assigned to one of four study arms using a matching strategy within the blocks that groups four jail-clinic combination together prior to randomization. Each jail and cognitive behavioral (CB) treatment provider (or clinic) in these combinations will be treated as a site.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Dose NIATx Coaching & ECHO<br>Attend an in-person Kick-Off Meeting with Study Team & Coaches 4-hour onsite visit (NIATx Training) 11 monthly (one-hour) NIATx coaching calls Prescribers participate in 12 monthly (one-hour) ECHO video conference calls | Behavioral: NIATx Coaching<br>* NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.<br>Behavioral: ECHO<br>* The ECHO model connects MOUD prescribers and experts with primary care providers and medical teams to promote high-quality MOUD practices. ECHO is provided monthly through videoconferences. Experienced MOUD prescribers address topics such as counseling strategies, urine test interpretation, and transitioning from buprenorphine, naltrexone and methadone.<br>* Other names: Extension for Community Healthcare Outcomes;|
| Experimental: Low-Dose NIATx Coaching & ECHO<br>Attend an in-person Kick-Off Meeting with Study Team & Coaches One-hour conference call with Executive Sponsor Two-hour NIATx webinar training with Change Leader/Team Three (one-hour) coaching calls at months 4, 8, and 12 with Change Leader/Team Prescribers participate in 12 monthly (one-hour) ECHO video conference calls | Behavioral: NIATx Coaching<br>* NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.<br>Behavioral: ECHO<br>* The ECHO model connects MOUD prescribers and experts with primary care providers and medical teams to promote high-quality MOUD practices. ECHO is provided monthly through videoconferences. Experienced MOUD prescribers address topics such as counseling strategies, urine test interpretation, and transitioning from buprenorphine, naltrexone and methadone.<br>* Other names: Extension for Community Healthcare Outcomes;|
| Experimental: High-Dose NIATx Coaching & No ECHO<br>Attend an in-person Kick-Off Meeting with Study Team & Coaches 4-hour onsite visit 11 monthly (one-hour) NIATx coaching calls | Behavioral: NIATx Coaching<br>* NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.<br>|
| Experimental: Low-Dose NIATx Coaching & No ECHO<br>Attend an in-person Kick-Off Meeting with Study Team & Coaches One-hour conference call with Executive Sponsor Two-hour NIATx webinar training with Change Leader/Team Three (one-hour) coaching calls at months 4, 8, and 12 with Change Leader/Team | Behavioral: NIATx Coaching<br>* NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Eligible Justice Involved Persons initiated and on MOUD | The intervention reach will be measured using data gathered through organization monthly tracking sheets and state criminal justice databases to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use. | 24 months | 
| Change in Number of Prescribers using MOUD | The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point. | baseline, 12-months, 24-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of sites that continue to use MOUD post intervention | The maintenance of the intervention (MOUD Sustainability) will be measured using the Program Sustainability Assessment Tool included in the Staff Survey at three points during the study (baseline, 12-months & 24-months) to determine if likelihood of sustainability increases as study progresses. This tool has a total possible range of scores from 0-63 with higher scores indicating increased sustainability of the intervention. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MOUD, OUD, Justice Populations, Jails, ECHO, NIATx, Inter-agency