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Opioid-use DisorderNCT04363320

Fostering MAT Use in Justice Populations

A study testing NIATx Coaching and ECHO in people with Opioid-use Disorder and Recidivism, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid-use Disorder, Recidivism
What is being tested?
NIATx Coaching and ECHO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteUnited States
Study dates
30 Jul 2020to 28 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin-Madison

    Madison, Wisconsin, 53706

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
NIATx Coaching, ECHO
Keywords
MOUD, OUD, Justice Populations, Jails, ECHO, NIATx, Inter-agency
Medical subject headings
Opioid-Related Disorders, Recidivism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIATx CoachingBehavioural

    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.

  • ECHOBehavioural

    Also called Extension for Community Healthcare Outcomes

    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.

Study groups in NCT04363320
Study groupRoleWhat they receive
High-Dose NIATx Coaching & ECHOExperimental* 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
Receives: Behavioral: NIATx Coaching; Behavioral: ECHO
Low-Dose NIATx Coaching & ECHOExperimental* 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
Receives: Behavioral: NIATx Coaching; Behavioral: ECHO
High-Dose NIATx Coaching & No ECHOExperimental* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team
Receives: Behavioral: NIATx Coaching
Low-Dose NIATx Coaching & No ECHOExperimental* 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
Receives: Behavioral: NIATx Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: baseline to 12 months

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

    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.

    Measured: 13 months, 24 months

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

    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.

    Measured: baseline to 12 months

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

    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.

    Measured: 13 months to 24 months

  5. 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.

    Measured: baseline, 12 months, 24 months

Secondary outcomes (1)
  1. MOUD Sustainability Measured Using the Program Sustainability Assessment Tool

    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.

    Measured: baseline, 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2020
  2. Study start30 Jul 2020
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
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)
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04363320
Sponsor's protocol ID
2019-1473
Other IDs
3U2CDA050097-01S1, 20200548, A195010, ENGR/CHESS PROGRAM
Status last verified
May 2025
First submitted
23 Apr 2020
Last updated
28 May 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39901259

Questions about this trial

What is this clinical trial studying?

A study testing NIATx Coaching and ECHO in people with Opioid-use Disorder and Recidivism, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase (time frame: baseline to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04363320, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

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