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Fostering MAT Use in Justice Populations

Primary Purpose

Opioid-use Disorder, Recidivism

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIATx Coaching
ECHO
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid-use Disorder focused on measuring MOUD, OUD, Justice Populations, Jails, ECHO, NIATx, Inter-agency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

High-Dose NIATx Coaching & ECHO

Low-Dose NIATx Coaching & ECHO

High-Dose NIATx Coaching & No ECHO

Low-Dose NIATx Coaching & No ECHO

Arm Description

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

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

Attend an in-person Kick-Off Meeting with Study Team & Coaches 4-hour onsite visit 11 monthly (one-hour) NIATx coaching calls

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 23, 2020
Last Updated
July 17, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
George Mason University, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04363320
Brief Title
Fostering MAT Use in Justice Populations
Official Title
Fostering MAT Use in Justice Populations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
George Mason University, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Recidivism
Keywords
MOUD, OUD, Justice Populations, Jails, ECHO, NIATx, Inter-agency

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-Dose NIATx Coaching & ECHO
Arm Type
Experimental
Arm Description
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
Arm Title
Low-Dose NIATx Coaching & ECHO
Arm Type
Experimental
Arm Description
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
Arm Title
High-Dose NIATx Coaching & No ECHO
Arm Type
Experimental
Arm Description
Attend an in-person Kick-Off Meeting with Study Team & Coaches 4-hour onsite visit 11 monthly (one-hour) NIATx coaching calls
Arm Title
Low-Dose NIATx Coaching & No ECHO
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
NIATx Coaching
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ECHO
Other Intervention Name(s)
Extension for Community Healthcare Outcomes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of Eligible Justice Involved Persons initiated and on MOUD
Description
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.
Time Frame
24 months
Title
Change in Number of Prescribers using MOUD
Description
The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point.
Time Frame
baseline, 12-months, 24-months
Secondary Outcome Measure Information:
Title
Percent of sites that continue to use MOUD post intervention
Description
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.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
NIATx Fidelity
Description
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.
Time Frame
12 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Molfenter, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Faye Taxman, PhD
Organizational Affiliation
George Mason University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Fostering MAT Use in Justice Populations

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