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| ID | Type | Description | Link |
|---|---|---|---|
| 1UM1DA064515-01 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 10/10/2025 | Other Identifier | UW Madison | |
| SO00004046 | Other Identifier | UW Madison | |
| CHESS | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The goal of this clinical trial is to improve health outcomes for incarcerated individuals by increasing medications for opioid use disorder (MOUD) use, using scalable and cost-effective methods that could be applied more broadly in the criminal justice system.
This trial will evaluate a systems-change approach to scaling medications for opioid use disorder (MOUD) across 120 prisons in 12 U.S. states. Researchers will test two promising, implementation strategies-policy academy and multisite learning collaborative-commonly used in healthcare, education, and community development. The focus on MOUD is driven by strong evidence of its efficacy, low penetration in prisons, significant health inequities among incarcerated populations, and the high risk of overdose deaths during reentry into the community.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substance Abuse and Mental Health Services Administration (SAMHSA) Policy Academy | Experimental | Departments of Corrections (DOCs) which previously completed the SAMHSA Policy Academy will be recruited for the Policy Academy. |
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| Multi-site Learning Collaborative (LC) | Experimental | The LCs will include learning sessions at baseline and monthly coaching sessions thereafter in the 12 month intervention period to provide training and technical assistance on the study protocol, types of MOUD and their clinical effectiveness, strategies to reduce stigma towards MOUD, approaches to overcoming common MOUD implementation barriers, and strategies to increase use and reduce burden of MOUD. |
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| Practice as Usual | No Intervention | This arm will conduct practice as usual, not using the updated MOUD practices. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAMHSA | Behavioral | Implement the scale-up of MOUD |
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| Measure | Description | Time Frame |
|---|---|---|
| Reach of systems-change for scaling medications for MOUD | Using the RE-AIM framework, reach is measured by number of MOUD (buprenorphine, methadone, injectable naltrexone) standardized medication units purchased by prisons in a state | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of systems-change approach for scaling MOUD | Using the RE-AIM framework, effectiveness is measured by the number of disciplinary infractions and individuals participating in SUD programming | 2 years |
| Adoption of systems-change approach for scaling MOUD |
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Inclusion Criteria - Sites:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Vechinski, MSW | Contact | 414-899-4324 | jvechinski@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Todd Molfenter, PhD | University of Wisconsin, Madison | Principal Investigator |
| Rosemarie Martin, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Recruiting | Madison | Wisconsin | 53706 | United States |
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| ID | Term |
|---|---|
| D014482 | United States Substance Abuse and Mental Health Services Administration |
| ID | Term |
|---|---|
| D014492 | United States Public Health Service |
| D014483 | United States Dept. of Health and Human Services |
| D037041 | United States Government Agencies |
| D035082 | Federal Government |
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| Learning Collaborative | Behavioral | The LCs will include learning sessions at baseline and monthly coaching sessions thereafter in the 12 month intervention period to provide training and technical assistance on the study protocol, types of MOUD and their clinical effectiveness, strategies to reduce stigma towards MOUD, approaches to overcoming common MOUD implementation barriers, and strategies to increase use and reduce burden of MOUD. |
|
Using the RE-AIM framework, adoption is measured as the percentage of prisons that use buprenorphine, methadone, and/or naltrexone |
| 2 years |
| Implementation - IMAT Index | Implementation is measured by Integrating Medications for Addiction Treatment (IMAT) Index (prison level). IMAT is a tool for evaluating and improving how primary care and behavioral health programs integrate MOUD. The scoring ranges from "1-Not Integrated" to "5-Fully Integrated", with intermediate scores of 2 and 4 representing in-between stages. The total IMAT score is calculated by averaging all item scores. This results in a composite rating from 1 to 5, which represents the overall implementation quality. | 2 years |
| Implementation - Cascade of Care | Using the RE-AIM framework, implementation is measured by Cascade of Care performance (prison level). Cascade of Care is a framework that tracks progress through different stages of healthcare, from initial contact (like screening or diagnosis) to successful treatment and long-term management. The cascade visualizes how many individuals successfully move from one stage to the next, highlighting points where they are lost from the system. | 2 years |
| Implementation - EBI checklist | Using the RE-AIM framework, implementation is measured by Advancing Recovery Framework Implementation of an EBI Checklist (state level). This measure is structured around the Cascade of Care performance (state level), This model helps states assess and improve their treatment systems by tracking individuals' progress from diagnosis through recovery. | 2 years |
| Implementation - Partnering | Using the RE-AIM framework, implementation is measured by the level of partnering between DOC and prisons. Measure focuses on the strength and consistency of partnerships between the Department of Corrections (DOC) and individual prisons to support the delivery of evidence-based practices for opioid use disorder. | 2 years |
| D006076 | Government |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |