Clinical trial NCT05343793: Stagewise Implementation-To-Target- Medications for Addiction Treatment (SITT-MAT)
Official title: Stagewise Implementation-To-Target- Medications for Addiction Treatment (SITT-MAT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Addiction, Opioid
Keywords: Implementation strategies
Medications for opioid use disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
name: National Institute on Drug Abuse (NIDA)
name: Washington State Health Care Authority
First posted: 2022-04-25
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reach
timeFrame: Quarterly ; Months 1 to 46
measure: Adoption
timeFrame: Quarterly ; Months 1 to 46
measure: Effectiveness
timeFrame: Quarterly ; Months 1 to 46
measure: Implementation - Integrating Medications for Addiction Treatment (IMAT) Index
timeFrame: Months 1,7,14,24,34,46
Secondary outcomes:
Other outcomes:
measure: Contextual determinants
timeFrame: Months 1,7,14,24,34,46
measure: Engagement in implementation
timeFrame: Monthly ; Months 1 to 46
measure: Cost of implementation
timeFrame: Monthly ; Months 1 to 46
measure: Fidelity
timeFrame: Months 7,14,24,34,46
measure: Implementation climate
timeFrame: Months 1,7,14,24,34,46
measure: Implementation Leadership
timeFrame: Months 1,7,14,24,34,46
Locations:
city: Olympia
country: United States
facility: Washington State Healthcare Authority
state: Washington
Study officials:
affiliation: Stanford University
name: Mark McGovern, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: James H Ford II, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.