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

Overview

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.

Full Title of Study: “Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 31, 2024

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Culturally Centered MOUD Implementation
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • # consumers with OUD initiated onto MOUD
    • Time Frame: 6 months
    • number of consumers with OUD initiated onto MOUD in the 6 months after intervention delivery compared to pre-intervention

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • New York State Psychiatric Institute
  • Collaborator
    • University of New Mexico
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aimee Campbell, Research Scientist – New York State Psychiatric Institute
  • Overall Contact(s)
    • Aimee Campbell, PhD, 6467746138, anc2002@cumc.columbia.edu

References

Hirchak KA, Nadeau M, Vasquez A, Hernandez-Vallant A, Smith K, Pham C, Oliver KA, Baukol P, Lizzy K, Shaffer R, Herron J, Campbell ANC, Venner KL; CTN-0096 Collaborative Board. Centering culture in the treatment of opioid use disorder with American Indian and Alaska Native Communities: Contributions from a National Collaborative Board. Am J Community Psychol. 2023 Mar;71(1-2):174-183. doi: 10.1002/ajcp.12620. Epub 2022 Aug 23.

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