Contemporary clinical trials · 2025
Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations.
СтатьяПротокол клинического исследованияПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Paschen-Wolff Margaret M, Campbell Aimee N C, Vásquez Ángel, Kessler Jill, Jansen Kelley, Arnatt Catherine P, Rosa Carmen, Hebden Hanna M, Radin Sandra, Stately Antony, Shaw Jennifer, Kennedy Favian, Matthews Abigail G, Venner Kamilla L
Аннотация
BACKGROUND: Incorporating American Indian and Alaska Native (AI/AN) traditional practices and knowledge into healthcare can support AI/AN health. Drug overdose deaths disproportionately impact AI/AN communities due to colonization, genocide, historical trauma, discriminatory policies, and under-resourced healthcare. Medications for opioid use disorder (MOUD; e.g., buprenorphine, methadone, naltrexone) are considered the most effective treatment for reducing mortality. Integrating AI/AN cultural practices with MOUD may increase acceptability and uptake of MOUD within AI/AN communities.
METHODS: National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) Protocol #0096 (Tribal MOUD) is a two-phase community-based participatory research (CBPR) trial to develop and evaluate an implementation intervention to culturally center MOUD delivery in AI/AN communities (N = 4 sites). A Collaborative Board (CB) guided intervention development (Phase I completed). A stepped wedge design (two sites/step) allows intervention implementation at all sites and improvements across sites (Phase II ongoing). The primary implementation outcome is the number of consumers with OUD who initiate MOUD in the six months pre-intervention vs. implementation periods; secondary outcomes are MOUD screening and retention (de-identified electronic medical record data). Additional data include organizational predictors (staff surveys) and moderators (consumer assessments) of implementation outcomes; and MOUD intervention acceptability (staff/consumer qualitative interviews).
CONCLUSIONS: This is the first study to develop and evaluate an implementation intervention to culturally center MOUD delivery in AI/AN communities. Implementation science and CBPR are complimentary for co-developing strategies with AI/AN communities to integrate Indigenous and Western best practices, which may ultimately reduce opioid-related mortality among AI/AN peoples and enhance Indigenous community wellness. Clinical Trials NCT Registration Number:NCT04958798.
METHODS: National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) Protocol #0096 (Tribal MOUD) is a two-phase community-based participatory research (CBPR) trial to develop and evaluate an implementation intervention to culturally center MOUD delivery in AI/AN communities (N = 4 sites). A Collaborative Board (CB) guided intervention development (Phase I completed). A stepped wedge design (two sites/step) allows intervention implementation at all sites and improvements across sites (Phase II ongoing). The primary implementation outcome is the number of consumers with OUD who initiate MOUD in the six months pre-intervention vs. implementation periods; secondary outcomes are MOUD screening and retention (de-identified electronic medical record data). Additional data include organizational predictors (staff surveys) and moderators (consumer assessments) of implementation outcomes; and MOUD intervention acceptability (staff/consumer qualitative interviews).
CONCLUSIONS: This is the first study to develop and evaluate an implementation intervention to culturally center MOUD delivery in AI/AN communities. Implementation science and CBPR are complimentary for co-developing strategies with AI/AN communities to integrate Indigenous and Western best practices, which may ultimately reduce opioid-related mortality among AI/AN peoples and enhance Indigenous community wellness. Clinical Trials NCT Registration Number:NCT04958798.