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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder; Recidivism
• Intervention / Treatment: Behavioral: NIATx Coaching; Behavioral: ECHO

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.

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Todd Molfenter, PhD; Phone Number: 608-262-1685; Email: todd.molfenter@wisc.edu
• Study Contact Backup: Name: Jessica Vechinski, MSW; Phone Number: 414-899-4324; Email: jvechinski@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Dose NIATx Coaching & ECHO; 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; 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.; 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.; Other Names: Extension for Community Healthcare Outcomes
Experimental: Low-Dose NIATx Coaching & ECHO; 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; 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.; 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.; Other Names: Extension for Community Healthcare Outcomes
Experimental: High-Dose NIATx Coaching & No ECHO; 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; 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.
Experimental: Low-Dose NIATx Coaching & No ECHO; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIATx Fidelity	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.	12 months, 24 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA); George Mason University
• Investigators: Principal Investigator: Todd Molfenter, PhD, University of Wisconsin, Madison; Principal Investigator: Faye Taxman, PhD, George Mason University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: OUD; ECHO; MOUD; Justice Populations; Jails; NIATx; Inter-agency
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2019-1473; A195010 (Other Identifier: UW Madison); 3U2CDA050097-01S1 (U.S. NIH Grant/Contract); 20200548 (Other Identifier: WIRB protocol number); ENGR/CHESS PROGRAM (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No