PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment.
PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment.
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DOI：
10.1186/s13722-021-00218-w
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发表时间：
2021-01-31
影响因子：
3.7
通讯作者：
Bradley KA
中科院分区：
文献类型：
--
作者：
Campbell CI;Saxon AJ;Boudreau DM;Wartko PD;Bobb JF;Lee AK;Matthews AG;McCormack J;Liu DS;Addis M;Altschuler A;Samet JH;LaBelle CT;Arnsten J;Caldeiro RM;Borst DT;Stotts AL;Braciszewski JM;Szapocznik J;Bart G;Schwartz RP;McNeely J;Liebschutz JM;Tsui JI;Merrill JO;Glass JE;Lapham GT;Murphy SM;Weinstein ZM;Yarborough BJH;Bradley KA
大多数阿片类药物使用障碍(OUD)患者从未接受过治疗。建议将初级保健中的药物治疗作为增加获得保健的机会的一种方法。初级保健阿片类药物使用障碍治疗(PROAD)试验测试使用护士护理经理(NCM)支持初级保健中OUD的药物治疗的协作护理模式(马萨诸塞州模型)的实施是否增加OUD治疗并改善结果。具体地说，它测试了与通常的初级保健相比，实施协作护理是否增加了OUD的用药天数(实施目标)，并减少了急性卫生保健利用(有效性目标)。这里介绍了骄傲试验的方案。PROAD是一项在六个医疗保健系统中进行的混合型III型群组随机实施试验。干预措施包括三个实施战略：全职NCM的工资，NCM的培训和技术援助，以及要求三个初级保健提供者拥有DEA豁免才能开丁丙诺啡。在每个卫生系统内，两个初级保健诊所是随机的：一个接受干预，另一个接受普通初级保健。样本包括在随机初级保健诊所就诊的16-90岁的所有患者，从随机前3年到随机后2年(预计为 >； 170,000人)。量化数据来自现有的卫生系统管理数据、电子病历和/或医保索赔(“电子健康记录”[EHR])。匿名工作人员调查、利益攸关方汇报以及来自现场访问、培训和技术援助的意见为评估执行障碍和促进者提供了定性数据。实施目标的结果(主要结果)是随机化后两年内OUD药物治疗患者天数的临床水平测量。有效性目标的患者级结果(次要结果)是在随机化之前记录在案的OUD患者随机后2年多的急性护理利用天数[例如紧急护理、急诊科(ED)和/或住院]。这项值得骄傲的试验为临床领导者和政策制定者提供了有关初级保健中OUD管理的协作护理模式对患者和卫生系统的潜在好处的信息，并在现实世界中进行了多样化的初级保健环境测试。试用注册号：NCT03407638(2018年2月28日)；CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1
Most people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here. PROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16–90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be > 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims (“electronic health records,” [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2 years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and/or hospitalizations] over 2 years post-randomization among patients with documented OUD prior to randomization. The PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings. Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1
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影响因子：
12.7
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