Clinical trial NCT04958798: Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities
Official title: Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: American Indian
Alaska Native
Medications for Opioid-use Disorder
Implementation
Cultural centering
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: University of New Mexico
First posted: 2021-07-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: # consumers with OUD initiated onto MOUD
timeFrame: 6 months
Secondary outcomes:
measure: # consumers with OUD offered MOUD
timeFrame: 6 months
measure: # consumers screened for OUD of the overall # of new consumers
timeFrame: 6 months
measure: # consumers with OUD retained in care for at least three months
timeFrame: 6 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Southcentral Foundation
state: Alaska
city: Minneapolis
country: United States
facility: Native American Community Clinic
state: Minnesota
city: Eagle Butte
country: United States
facility: Missouri Breaks
state: South Dakota
Study officials:
References:
citation: 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.