Clinical trial NCT04363320: Fostering MAT Use in Justice Populations
Official title: Fostering MAT Use in Justice Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Recidivism
Keywords: MOUD
OUD
Justice Populations
Jails
ECHO
NIATx
Inter-agency
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: George Mason University
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-04-27
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase
timeFrame: baseline to 12 months
measure: Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase
timeFrame: 13 months, 24 months
measure: Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase
timeFrame: baseline to 12 months
measure: Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase
timeFrame: 13 months to 24 months
measure: Change in Number of Prescribers Using MOUD
timeFrame: baseline, 12 months, 24 months
Secondary outcomes:
measure: MOUD Sustainability Measured Using the Program Sustainability Assessment Tool
timeFrame: baseline, 12 months, 24 months
Other outcomes:
measure: NIATx Fidelity
timeFrame: 12 months, 24 months
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Todd Molfenter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Mason University
name: Faye Taxman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.