Stagewise Implementation-To-Target- Medications for Addiction Treatment (SITT-MAT)

Not Applicable

Active, not recruiting

• Conditions: Addiction, Opioid
• Interventions: Other: Enhanced Monitoring and Feedback (EMF); Other: NIATx/MAT Academy; Other: NIATx-External Facilitation (NIATx-EF); Other: NIATx-Internal Facilitation (NIATx-IF)

• Registration Number: NCT05343793
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to expand access to medications for opioid use disorder (MOUD) in specialty addiction programs in Washington State. Sixty-four addiction treatment programs will participate in an adaptive implementation strategy trial that uses a stagewise implementation-to-target (stepped "care" type) approach whereby organizations engage in increasingly intensive implementation strategies as needed. Organizations are moved to a follow-up/sustainment arm once they have met the implementation targets described below. The design also includes an external comparator arm, which consists of 510 addiction treatment programs that are not participating in the study and will mimic as study controls.

The sequence of implementation strategies are:

1. Enhanced Monitoring and Feedback

2. NIATx/MAT Academy

3. Randomization to either NIATx Internal Facilitation or NIATx External Facilitation

4. Assignment to NIATx External Facilitation if outcome targets are not achieved in the NIATx Internal Facilitation arm

Implementation targets are:

1. Reach - At least 75% of patients with opioid use disorder (OUD) receiving MOUD for three consecutive months

2. Adoption - At least 1 integrated MOUD prescriber actively prescribing MOUD

3. Implementation - a total score ≥ 4 on the Integrating Medications for Addiction Treatment (IMAT) Index.

Contextual moderators and mediators of performance on target outcomes as a function of the implementation strategy step will be examined, as will the costs associated with participation in the sequence of implementation strategies.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-03-14
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Addiction treatment programs in Washington State
• Residential (detoxification or rehabilitation) or outpatient (intensive outpatient or outpatient) levels of care
• Primary care clinics, including Federally Qualified Health Centers (FQHCs) and Community Health Centers (CHCs)

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Exclusion Criteria

• Opioid treatment programs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Path 3	Enhanced Monitoring and Feedback (EMF)	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation
Path 2	NIATx/MAT Academy	Enhanced Monitoring and Feedback + NIATx/MAT Academy
Path 3	NIATx/MAT Academy	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation
Path 3	NIATx-External Facilitation (NIATx-EF)	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation
Path 4	Enhanced Monitoring and Feedback (EMF)	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation
Path 2	Enhanced Monitoring and Feedback (EMF)	Enhanced Monitoring and Feedback + NIATx/MAT Academy
Path 1	Enhanced Monitoring and Feedback (EMF)	Enhanced Monitoring and Feedback
Path 4	NIATx/MAT Academy	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation
Path 5	NIATx/MAT Academy	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation
Path 4	NIATx-Internal Facilitation (NIATx-IF)	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation
Path 5	Enhanced Monitoring and Feedback (EMF)	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation
Path 5	NIATx-Internal Facilitation (NIATx-IF)	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation
Path 5	NIATx-External Facilitation (NIATx-EF)	Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation

Primary Outcome Measures

Name	Time	Method
Adoption	Quarterly ; Months 1 to 46	The number of integrated prescribers of buprenorphine and/or naltrexone, who are actively prescribing MOUD.
Effectiveness	Quarterly ; Months 1 to 46	Access: The proportion of patients prescribed MOUD who start the medication within 72 hours of diagnosis. For patients requiring detoxification for naltrexone, Access will be operationalized as the proportion of patients who start the medication within 72 hours of when it is safe or indicated by a physician. Retention: The proportion of patients who are retained in continuous care for at least 6-months from the start of medication, or if in time limited care situations (e.g., residential detoxification) for the entire treatment episode.
Reach	Quarterly ; Months 1 to 46	The proportion of program patients with OUD and receiving MOUD (buprenorphine, naltrexone) within the index quarter.
Implementation - Integrating Medications for Addiction Treatment (IMAT) Index	Months 1,7,14,24,34,46	The IMAT integrates MOUD guidelines, expert consensus recommendations, the OUD care cascade, and best practice information into a team-assessment benchmark measure of current and future state MOUD capability and practice. The IMAT is composed of 45 items, rated on a 1 to 5 scale from: 1- Not Integrated, to 3- Partially integrated, to 5- Fully integrated. Intermediate ratings of 2 and 4, are ratings not at either a 3 or 5 level respectively. The benchmark items address policy, practice and workforce factors, and are clustered into seven dimensions of: 1) Infrastructure; 2) Clinic culture and environment; 3) Patient identification and initiating care; 4) Care delivery and treatment response monitoring; 5) Care coordination; 6) Workforce; and, 7) Staff training and development. The IMAT Total Score is a composite rating from 1 to 5 of overall MOUD care quality. It takes between 1 to 2 hours to complete.

Trial Locations

Locations (1)

Washington State Healthcare Authority; 🇺🇸 Olympia, Washington, United States