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

Study Overview
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Brief Summary
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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: Enhanced Monitoring and Feedback NIATx/MAT Academy Randomization to either NIATx Internal Facilitation or NIATx External Facilitation Assignment to NIATx External Facilitation if outcome targets are not achieved in the NIATx Internal Facilitation arm Implementation targets are: Reach - At least 75% of patients with opioid use disorder (OUD) receiving MOUD for three consecutive months Adoption - At least 1 integrated MOUD prescriber actively prescribing MOUD 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.

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

Conditions
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Addiction, Opioid

Intervention / Treatment
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* Other: Enhanced Monitoring and Feedback (EMF)
* Other: NIATx/MAT Academy
* Other: NIATx-Internal Facilitation (NIATx-IF)
* Other: NIATx-External Facilitation (NIATx-EF)


Participation Criteria
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Eligibility Criteria
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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) Exclusion Criteria: Opioid treatment programs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Path 1<br>Enhanced Monitoring and Feedback | Other: Enhanced Monitoring and Feedback (EMF)<br>* Enhanced Monitoring and Feedback consists of performance data (reach, adoption, effectiveness, implementation) gathered and reported by the program on a quarterly basis. Data summaries for each program and in comparison to the entire sample, will be reflected back to participants, via dashboards, within one-month of data submission.<br>|
| Experimental: Path 2<br>Enhanced Monitoring and Feedback + NIATx/MAT Academy | Other: Enhanced Monitoring and Feedback (EMF)<br>* Enhanced Monitoring and Feedback consists of performance data (reach, adoption, effectiveness, implementation) gathered and reported by the program on a quarterly basis. Data summaries for each program and in comparison to the entire sample, will be reflected back to participants, via dashboards, within one-month of data submission.<br>Other: NIATx/MAT Academy<br>* This two-day workshop will provide participating clinics with rationale, clinical practice and program integration with MOUD (Day 1), and an overview of NIATx principles and tools (Day 2).<br>|
| Experimental: Path 3<br>Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation | Other: Enhanced Monitoring and Feedback (EMF)<br>* Enhanced Monitoring and Feedback consists of performance data (reach, adoption, effectiveness, implementation) gathered and reported by the program on a quarterly basis. Data summaries for each program and in comparison to the entire sample, will be reflected back to participants, via dashboards, within one-month of data submission.<br>Other: NIATx/MAT Academy<br>* This two-day workshop will provide participating clinics with rationale, clinical practice and program integration with MOUD (Day 1), and an overview of NIATx principles and tools (Day 2).<br>Other: NIATx-External Facilitation (NIATx-EF)<br>* For 9-months, organizations in the NIATx-EF study arm will work with one of 4 experienced consultant NIATx External Facilitators (EFs). The EF meets with clinic staff to plan change projects, review ongoing change efforts, discuss successes, and offer guidance on planning future change projects using PDSA cycles. The EF makes a 1-day site visit during the 1st quarter of the implementation period and leads monthly 1-hour phone calls.<br>|
| Experimental: Path 4<br>Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation | Other: Enhanced Monitoring and Feedback (EMF)<br>* Enhanced Monitoring and Feedback consists of performance data (reach, adoption, effectiveness, implementation) gathered and reported by the program on a quarterly basis. Data summaries for each program and in comparison to the entire sample, will be reflected back to participants, via dashboards, within one-month of data submission.<br>Other: NIATx/MAT Academy<br>* This two-day workshop will provide participating clinics with rationale, clinical practice and program integration with MOUD (Day 1), and an overview of NIATx principles and tools (Day 2).<br>Other: NIATx-Internal Facilitation (NIATx-IF)<br>* Internal facilitators will receive training (in-person or online) on how to provide coaching within their organization. For 9-months, Internal Facilitators (IFs) will: a) support teams to harness resources toward systemic change and improvement; b) employ a range of concepts and tools to provide individualized support to teams; c) help teams to practice and hone their skills to optimize performance, and d) focus on team relationships and communications.<br>|
| Experimental: Path 5<br>Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation | Other: Enhanced Monitoring and Feedback (EMF)<br>* Enhanced Monitoring and Feedback consists of performance data (reach, adoption, effectiveness, implementation) gathered and reported by the program on a quarterly basis. Data summaries for each program and in comparison to the entire sample, will be reflected back to participants, via dashboards, within one-month of data submission.<br>Other: NIATx/MAT Academy<br>* This two-day workshop will provide participating clinics with rationale, clinical practice and program integration with MOUD (Day 1), and an overview of NIATx principles and tools (Day 2).<br>Other: NIATx-Internal Facilitation (NIATx-IF)<br>* Internal facilitators will receive training (in-person or online) on how to provide coaching within their organization. For 9-months, Internal Facilitators (IFs) will: a) support teams to harness resources toward systemic change and improvement; b) employ a range of concepts and tools to provide individualized support to teams; c) help teams to practice and hone their skills to optimize performance, and d) focus on team relationships and communications.<br>Other: NIATx-External Facilitation (NIATx-EF)<br>* For 9-months, organizations in the NIATx-EF study arm will work with one of 4 experienced consultant NIATx External Facilitators (EFs). The EF meets with clinic staff to plan change projects, review ongoing change efforts, discuss successes, and offer guidance on planning future change projects using PDSA cycles. The EF makes a 1-day site visit during the 1st quarter of the implementation period and leads monthly 1-hour phone calls.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach | The proportion of program patients with OUD and receiving MOUD (buprenorphine, naltrexone) within the index quarter. | Quarterly ; Months 1 to 46 | 
| Adoption | The number of integrated prescribers of buprenorphine and/or naltrexone, who are actively prescribing MOUD. | Quarterly ; Months 1 to 46 | 
| Effectiveness | 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. | Quarterly ; Months 1 to 46 | 
| Implementation - Integrating Medications for Addiction Treatment (IMAT) Index | 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. | Months 1,7,14,24,34,46 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation strategies, Medications for opioid use disorder