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Completed

NCT Number: NCT04363320

Fostering MAT Use in Justice Populations

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.

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Key information

Conditions

Opioid-use Disorder Behavior Chemically-Induced Disorders Criminal Behavior Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Recidivism Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIATx Coaching

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

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.

Other names: Extension for Community Healthcare Outcomes

Primary outcomes

  1. Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase

    Time frame: baseline to 12 months

    The intervention reach will be measured using data gathered through organization monthly tracking sheets 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.

  2. Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase

    Time frame: 13 months, 24 months

    The intervention reach will be measured using data gathered through organization monthly tracking sheets 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.

  3. Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase

    Time frame: baseline to 12 months

    The intervention reach will be measured using data gathered through organization monthly tracking sheets 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.

  4. Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase

    Time frame: 13 months to 24 months

    The intervention reach will be measured using data gathered through organization monthly tracking sheets 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.

  5. Change in Number of Prescribers Using MOUD

    Time frame: baseline, 12 months, 24 months

    The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point.

Secondary outcomes

  1. MOUD Sustainability Measured Using the Program Sustainability Assessment Tool

    Time frame: baseline, 12 months, 24 months

    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.

Other outcomes

  1. NIATx Fidelity

    Time frame: 12 months, 24 months

    Assess fidelity to the NIATx implementation strategies at two points during the study using a 10-item measure with scores ranging from 0-40 with higher scores indicating stronger fidelity of the intervention.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • George Mason University
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2020
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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