Fostering MAT Use in Justice Populations

NCT ID: NCT04363320

Last Updated: 2025-05-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2024-02-28

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.

Conditions

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Opioid-use Disorder Recidivism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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High-Dose NIATx Coaching & ECHO

* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches
* 12 monthly (one-hour) coaching calls with Change Leader/Team
* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls

Group Type EXPERIMENTAL

NIATx Coaching

Intervention Type BEHAVIORAL

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.

ECHO

Intervention Type BEHAVIORAL

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.

Low-Dose NIATx Coaching & ECHO

* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches
* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team
* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls

Group Type EXPERIMENTAL

NIATx Coaching

Intervention Type BEHAVIORAL

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.

ECHO

Intervention Type BEHAVIORAL

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.

High-Dose NIATx Coaching & No ECHO

* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches
* 12 monthly (one-hour) coaching calls with Change Leader/Team

Group Type EXPERIMENTAL

NIATx Coaching

Intervention Type BEHAVIORAL

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.

Low-Dose NIATx Coaching & No ECHO

* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches
* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team

Group Type EXPERIMENTAL

NIATx Coaching

Intervention Type BEHAVIORAL

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.

Interventions

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NIATx Coaching

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.

Intervention Type BEHAVIORAL

ECHO

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Extension for Community Healthcare Outcomes

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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George Mason University

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Molfenter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Faye Taxman, PhD

Role: PRINCIPAL_INVESTIGATOR

George Mason University

Locations

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University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Molfenter T, Vechinski J, Kim JS, Zhang J, Meng L, Tveit J, Madden L, Taxman FS. Assessing the comparative effectiveness of ECHO and coaching implementation strategies in a jail/provider MOUD implementation trial. Implement Sci. 2025 Feb 3;20(1):7. doi: 10.1186/s13012-025-01419-6.

Reference Type RESULT
PMID: 39901259 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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3U2CDA050097-01S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20200548

Identifier Type: OTHER

Identifier Source: secondary_id

A195010

Identifier Type: OTHER

Identifier Source: secondary_id

ENGR/CHESS PROGRAM

Identifier Type: OTHER

Identifier Source: secondary_id

2019-1473

Identifier Type: -

Identifier Source: org_study_id

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