Fostering MAT Use in Justice Populations

NCT04363320 | Completed Results DMC

• 5 other identifiers: 2019-14733U2CDA050097-01S120200548A195010ENGR/CHESS PROGRAM
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-use Disorder; Recidivism

Keywords

MOUD; OUD; Justice Populations; Jails; ECHO; NIATx; Inter-agency

Outcome Measures

Primary Outcomes (5)

• 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.

  baseline to 12 months

• 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.

  13 months, 24 months

• 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.

  baseline to 12 months

• 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.

  13 months to 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 Outcomes (1)

• MOUD Sustainability Measured Using the Program Sustainability Assessment Tool

  baseline, 12 months, 24 months

Other Outcomes (1)

• NIATx Fidelity

  12 months, 24 months

Study Arms (4)

High-Dose NIATx Coaching & ECHO

EXPERIMENTAL

* 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

Behavioral: NIATx Coaching; Behavioral: ECHO

Low-Dose NIATx Coaching & ECHO

EXPERIMENTAL

* 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

Behavioral: NIATx Coaching; Behavioral: ECHO

High-Dose NIATx Coaching & No ECHO

EXPERIMENTAL

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

Behavioral: NIATx Coaching

Low-Dose NIATx Coaching & No ECHO

EXPERIMENTAL

* 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

Behavioral: NIATx Coaching

Interventions

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.

High-Dose NIATx Coaching & ECHO; High-Dose NIATx Coaching & No ECHO; Low-Dose NIATx Coaching & ECHO; Low-Dose NIATx Coaching & No ECHO

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.

Also known as: Extension for Community Healthcare Outcomes

High-Dose NIATx Coaching & ECHO; Low-Dose NIATx Coaching & ECHO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• George Mason University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location

Related Publications (1)

• 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.

  PMID: 39901259 RESULT

MeSH Terms

Conditions

Opioid-Related Disorders; Recidivism

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Criminal Behavior; Behavior

Results Point of Contact

• Title: Todd Molfenter, PhD
• Organization: University of Wisconsin - Madison

tdmolfenter@wisc.edu

608-262-1685

Study Officials

• Todd Molfenter, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Faye Taxman, PhD

  George Mason University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: July 30, 2020
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)