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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Behavioral: Culturally Centered MOUD Implementation Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: participation in research assessments contraindicated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally Centered MOUD Implementation<br>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 | Behavioral: Culturally Centered MOUD Implementation Intervention<br>* Support clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| # consumers with OUD initiated onto MOUD | number of consumers with OUD initiated onto MOUD in the 6 months after intervention delivery compared to pre-intervention | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| # consumers with OUD offered MOUD | number of consumers with OUD offered MOUD in the 6 months after intervention delivery compared to pre-intervention | 6 months | 
| # consumers screened for OUD of the overall # of new consumers | number of consumers screened for OUD of the overall number of new consumers in the 6 months after intervention delivery compared to pre-intervention | 6 months | 
| # consumers with OUD retained in care for at least three 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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American Indian, Alaska Native, Medications for Opioid-use Disorder, Implementation, Cultural centering