Culturally Centered MOUD Implementation Intervention
BehavioralSupport clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs
NCT Number: NCT04958798
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Southcentral Foundation, Anchorage, Alaska, United States
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) but this will be exploratory. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Support clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs
Time frame: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)
The primary outcome is comprised of de-identified EMR data comparing MOUD initiation pre-intervention to post-intervention time periods with offset terms for time and clinic size.
Time frame: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)
Retention is operationalized as the number of clients at each site during each period who had at least one visit for care in three or more months within that period using de-identified data from the EMR comparing pre-intervention to post-intervention time periods.
Time frame: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)
Screening was operationalized as the number of clients screened for OUD of the number of clients with documented OUD and a visit from the de-identified EMR comparing pre-intervention to post-intervention time periods.
New York State Psychiatric Institute
Other
Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska
Acronym: CTN-0096
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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