NCT05343793

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. 1.Enhanced Monitoring and Feedback
  2. 2.NIATx/MAT Academy
  3. 3.Randomization to either NIATx Internal Facilitation or NIATx External Facilitation
  4. 4.Assignment to NIATx External Facilitation if outcome targets are not achieved in the NIATx Internal Facilitation arm
  5. 5.Reach - At least 75% of patients with opioid use disorder (OUD) receiving MOUD for three consecutive months
  6. 6.Adoption - At least 1 integrated MOUD prescriber actively prescribing MOUD
  7. 7.Implementation - a total score ≥ 4 on the Integrating Medications for Addiction Treatment (IMAT) Index.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Mar 2022Jun 2026

Study Start

First participant enrolled

March 14, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

4.3 years

First QC Date

April 6, 2022

Last Update Submit

November 21, 2024

Conditions

Addiction, Opioid

Keywords

Implementation strategiesMedications for opioid use disorder

Outcome Measures

Primary Outcomes (4)

  • 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

Other Outcomes (6)

  • Contextual determinants

    Months 1,7,14,24,34,46

  • Engagement in implementation

    Monthly ; Months 1 to 46

  • Cost of implementation

    Monthly ; Months 1 to 46

  • +3 more other outcomes

Study Arms (5)

Path 1

EXPERIMENTAL

Enhanced Monitoring and Feedback

Other: Enhanced Monitoring and Feedback (EMF)

Path 2

EXPERIMENTAL

Enhanced Monitoring and Feedback + NIATx/MAT Academy

Other: Enhanced Monitoring and Feedback (EMF)Other: NIATx/MAT Academy

Path 3

EXPERIMENTAL

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx External Facilitation

Other: Enhanced Monitoring and Feedback (EMF)Other: NIATx/MAT AcademyOther: NIATx-External Facilitation (NIATx-EF)

Path 4

EXPERIMENTAL

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation

Other: Enhanced Monitoring and Feedback (EMF)Other: NIATx/MAT AcademyOther: NIATx-Internal Facilitation (NIATx-IF)

Path 5

EXPERIMENTAL

Enhanced Monitoring and Feedback + NIATx/MAT Academy + NIATx Internal Facilitation + NIATx External Facilitation

Other: Enhanced Monitoring and Feedback (EMF)Other: NIATx/MAT AcademyOther: NIATx-Internal Facilitation (NIATx-IF)Other: NIATx-External Facilitation (NIATx-EF)

Interventions

Enhanced Monitoring and Feedback (EMF)OTHER

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.

Path 1Path 2Path 3Path 4Path 5
NIATx/MAT AcademyOTHER

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).

Path 2Path 3Path 4Path 5
NIATx-Internal Facilitation (NIATx-IF)OTHER

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.

Path 4Path 5
NIATx-External Facilitation (NIATx-EF)OTHER

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.

Path 3Path 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Opioid treatment programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State Healthcare Authority

Olympia, Washington, 98501, United States

Location

Related Publications (3)

  • Jaros S, Magid MA, Cheng H, Gassman M, Garneau HC, Ford Ii JH, McGovern M. A mixed methods analysis of clinics' perspectives on community factors influencing access to medications for opioid use disorder. Addict Sci Clin Pract. 2026 Jan 8. doi: 10.1186/s13722-025-00643-1. Online ahead of print.

    PMID: 41508111DERIVED

  • Cheng H, Abdel Magid M, McGovern MP, Ford JH 2nd, Manja V, Chokron Garneau H, Wagner TH. A pragmatic approach to estimating the cost to deliver and participate in implementation strategies. Implement Sci. 2025 Oct 17;20(1):44. doi: 10.1186/s13012-025-01459-y.

    PMID: 41107954DERIVED

  • Ford JH 2nd, Cheng H, Gassman M, Fontaine H, Garneau HC, Keith R, Michael E, McGovern MP. Stepped implementation-to-target: a study protocol of an adaptive trial to expand access to addiction medications. Implement Sci. 2022 Sep 29;17(1):64. doi: 10.1186/s13012-022-01239-y.

    PMID: 36175963DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Mark McGovern, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • James H Ford II, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 25, 2022

Study Start

March 14, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)