Division of Research, Kaiser Permanente Northern California, 2000 Broadway, 3rd Floor, Oakland, CA, 94612, USA.
Center of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System, 1660 S Columbian Way, Seattle, WA, 98108, USA.
Addict Sci Clin Pract. 2021 Jan 31;16(1):9. doi: 10.1186/s13722-021-00218-w.
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.
大多数阿片类药物使用障碍（OUD）患者从未接受过治疗。在初级保健中，药物治疗 OUD 被推荐为增加获得治疗机会的方法。PRimary Care Opioid Use Disorders treatment（PROUD）试验测试了使用护士护理经理（NCM）实施协作护理模式（马萨诸塞州模式）以支持 OUD 的药物治疗是否会增加 OUD 治疗并改善结果。具体而言，它测试了与常规初级保健相比，协作护理的实施是否会增加 OUD 治疗的天数（实施目标）并减少急性医疗保健利用（有效性目标）。这里介绍了 PROUD 试验的方案。
PROUD 是一项在六个医疗系统中进行的混合 III 型聚类随机实施试验。干预措施包括三个实施策略：为全职 NCM 支付工资、为 NCM 提供培训和技术援助，以及要求三名初级保健提供者拥有 DEA 豁免以开具丁丙诺啡。在每个医疗系统中，将两个初级保健诊所随机分为干预组和常规初级保健组。样本包括从随机化初级保健诊所就诊的所有 16-90 岁的患者，时间为随机化前 3 年至随机化后 2 年（预计超过 170,000 人）。定量数据来自现有的医疗系统管理数据、电子病历和/或健康保险索赔（“电子健康记录”[EHRs]）。匿名员工调查、利益相关者汇报、现场访问、培训和技术援助的观察提供定性数据，以评估实施的障碍和促进因素。实施目标（主要结果）的结果是随机化后 2 年内 OUD 药物治疗患者天数的诊所水平衡量标准。有效性目标（次要结果）的患者水平结果是随机化前有记录的 OUD 患者在随机化后 2 年内的急性医疗保健利用天数[例如，紧急护理、急诊部（ED）和/或住院]。
PROUD 试验为临床领导者和政策制定者提供了有关在初级保健中管理 OUD 的协作护理模式为患者和医疗系统带来的潜在益处的信息，该模式在现实世界中各种不同的初级保健环境中进行了测试。试验登记号 #NCT03407638（2018 年 2 月 28 日）；CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1。
