Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities
- Conditions
- Opioid-use Disorder
- Interventions
- Behavioral: Culturally Centered MOUD Implementation Intervention
- Registration Number
- NCT04958798
- Lead Sponsor
- New York State Psychiatric Institute
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Willing and able to provide informed consent
- English comprehension and proficiency
- Receiving services at a participating study site
- Meet criteria for a current opioid use disorder
- Self-identify as American Indian or Alaska Native
- Willing to have program data linked to assessment data
- 18 years or older
- participation in research assessments contraindicated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Culturally Centered MOUD Implementation Culturally Centered MOUD Implementation Intervention Culturally centered program-level implementation intervention to increase the use of medications for opioid use disorder in healthcare and treatment settings serving AI/AN communities
- Primary Outcome Measures
Name Time Method # consumers with OUD initiated onto MOUD 6 months number of consumers with OUD initiated onto MOUD in the 6 months after intervention delivery compared to pre-intervention
- Secondary Outcome Measures
Name Time Method # consumers with OUD retained in care for at least three months 6 months number of consumers with OUD retained in care for at least three months in the 6 months after intervention delivery compared to pre-intervention
# consumers screened for OUD of the overall # of new consumers 6 months number of consumers screened for OUD of the overall number of new consumers in the 6 months after intervention delivery compared to pre-intervention
# consumers with OUD offered MOUD 6 months number of consumers with OUD offered MOUD in the 6 months after intervention delivery compared to pre-intervention
Trial Locations
- Locations (3)
Southcentral Foundation
🇺🇸Anchorage, Alaska, United States
Missouri Breaks
🇺🇸Eagle Butte, South Dakota, United States
Native American Community Clinic
🇺🇸Minneapolis, Minnesota, United States