Fostering MAT Use in Justice Populations

Opioid-use Disorder Clinical Trial

Official title:

Fostering MAT Use in Justice Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363320
• Other study ID #: 2019-1473
• Secondary ID: 3U2CDA050097-01S
• Status: Completed
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Recidivism

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	George Mason University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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