NCT04958798

Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities

Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities.

Detailed description

This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder (MOUD) in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities. The study design is a cluster randomized stepped wedge implementation trial with two steps, and two sites per step (N=4 sites). Study design and methods are informed by the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The primary outcome of the trial is the number of consumers with OUD initiated onto MOUD (i.e., buprenorphine, extended-release naltrexone, or methadone) in the 6 months after intervention delivery (compared to the 6 months before intervention delivery) - capturing implementation intervention Reach. The primary outcome will be measured at the end of the six-month implementation stage and compared to the pre-intervention observation phase (prior to delivery of the implementation intervention). Primary data collection will use de-identified data from the electronic medical records (EMR) at each site beginning with data from the six months prior to intervention delivery for Step 1 sites and 12 months prior for Step 2 sites. For Step 1 sites, some secondary outcomes will also be assessed during the sustainment stage (the six months following implementation). As part of the study, consumers with OUD will be asked to participate in additional assessments and provide informed consent. Enrolled consumer participants will be asked to complete four assessment visits (baseline, week 4, week 8, and week 12) to collect comprehensive information about mental health, cultural connectedness and spirituality, social functioning, and experiences with and acceptability of OUD treatment. Providers at each clinical site will also be asked to complete surveys at three time points to assess attitudes, knowledge, and readiness related to MOUD.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Culturally Centered MOUD Implementation Intervention	Support clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs

Timeline

• Start date: 2021-12-20
• Primary completion: 2024-12-13
• Completion: 2025-01-16
• First posted: 2021-07-12
• Last updated: 2025-06-29

Locations

3 sites across 1 country: United States