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

NCT05343793 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-11-25

No results posted yet for this study

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.

Conditions

  • Addiction, Opioid

Interventions

OTHER

Enhanced Monitoring and Feedback (EMF)

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.

OTHER

NIATx/MAT Academy

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).

OTHER

NIATx-Internal Facilitation (NIATx-IF)

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.

OTHER

NIATx-External Facilitation (NIATx-EF)

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.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    collaborator OTHER
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Washington State Health Care Authority

    collaborator UNKNOWN
  • Stanford University

    lead OTHER

Principal Investigators

  • Mark McGovern, PhD · Stanford University

  • James H Ford II, PhD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05343793 on ClinicalTrials.gov