对美国印第安人和阿拉斯加土著社区进行实施干预研究：方法学考虑。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-06-20 DOI:10.1016/j.cct.2025.107992

Margaret M. Paschen-Wolff , Aimee N.C. Campbell , Ángel Vásquez , Jill Kessler , Kelley Jansen , Catherine P. Arnatt , Carmen Rosa , Hanna M. Hebden , Sandra Radin , Antony Stately , Jennifer Shaw , Favian Kennedy , Abigail G. Matthews , Kamilla L. Venner

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引用次数: 0

摘要

背景：将美国印第安人和阿拉斯加原住民（AI/AN）的传统做法和知识纳入医疗保健可以支持AI/AN的健康。由于殖民、种族灭绝、历史创伤、歧视性政策和医疗资源不足，药物过量死亡对AI/AN社区的影响不成比例。阿片类药物使用障碍(mod；例如，丁丙诺啡、美沙酮、纳曲酮)被认为是降低死亡率最有效的治疗方法。将AI/AN文化实践与mod相结合可以提高AI/AN社区对mod的接受度和吸收度。方法：美国国家药物滥用研究所（NIDA）临床试验网络（CTN）协议#0096（部落模式）是一项两阶段社区参与性研究（CBPR）试验，旨在开发和评估AI/ an社区（N = 4个站点）文化中心模式交付的实施干预措施。协作委员会（CB）指导干预发展（第一阶段完成）。阶梯式楔形设计（两个站点/步骤）允许在所有站点实施干预，并跨站点进行改进（第二阶段正在进行中）。主要的实施结果是在干预前6个月与实施期间启动mod的OUD消费者数量；次要结果是mod筛查和保留（去识别的电子病历数据）。其他数据包括实施结果的组织预测因子（工作人员调查）和调节因子（消费者评估）；以及mod干预的可接受性（员工/消费者定性访谈）。结论：这是第一个开发和评估人工智能/人工智能社区文化中心模式交付实施干预的研究。实施科学和CBPR有助于与AI/AN社区共同制定战略，整合土著和西方最佳做法，最终可能降低AI/AN人民与阿片类药物相关的死亡率，并增强土著社区的健康。临床试验注册号：NCT04958798。

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Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations

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

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.