Patient-centered team-based primary care to Treat Opioid Use Disorder, Depression, and Other conditions

总结 背景：美国正处于阿片类药物流行和阿片类药物使用的循证治疗之中 疾病（OUD）需要药物治疗。两种治疗OUD（MOUD）的药物-丁丙诺啡和注射剂 纳洛酮-可在初级保健（PC）中提供。基于团队的PC系统显示出改善的希望 在OUD治疗中的接触和保持。一种这样的模式，协作护理（CC），包括护理经理， 由专家监督，他们支持PC团队为OUD提供基于证据的高质量OUD护理。 然而，许多OUD患者患有精神健康和其他物质使用（MH/SU）障碍， 使OUD接合和保持复杂化的慢性疼痛。虽然CC改善了抑郁症的结果， 其他MH/SU条件和疼痛，目前尚不清楚如何最佳整合CC OUD与CC其他 MH/SU疾病。目的：本实用性试验测试创新的、可扩展的电话CC模型是否 对于OUD和合并症，增加了对MOUD治疗的参与，并改善了抑郁症 OUD和抑郁的PC患者的症状。研究团队：具有专业知识的高级研究者 CC用于OUD、抑郁、焦虑、PTSD、酒精使用障碍和慢性疼痛的实用PC试验， 与OUD和共病条件PC管理的临床专家合作，设计和测试一种新的， 可扩展的CC电话模式。干预：这种电话CC模式包括CC的6个关键要素， 以及关于患者关注的共病状况的共同决策，并将在 第一年的发展阶段。务实的试验样本和设计：第2-4年，拟议的有效性 一项试验将在至少800名患有OUD和抑郁症的PC患者中测试我们的CC模型，随访12个月（ 来自Kaiser Permanente华盛顿和新墨西哥州大学PC诊所的至少各400例）。创新 该试验的实用要素包括：纳入所有符合条件的OUD和活动性抑郁症患者（PHQ-1）， 9 ≥ 10）（两个研究中心常规筛查抑郁症， PHQ-9）; 50%的样本将被随机招募并同意进行CC干预; 将仅使用来自电子健康的次级数据在整个合格样本中测量结果 记录，保险索赔，全州处方监测计划和急诊室 信息交流。这些实用的元素避免只研究有动机的（招募的）病人， 避免激活随机分配到常规护理的患者。主要成果包括：1）6个月的持续MOUD 在12个月随访期间（主要）和2）基于PHQ-9的抑郁症状的解决。一 次要结局，任何重大不良事件，包括：自杀企图、自残、用药过量、住院治疗 或者死亡分析比较了50%的合格患者接受了CC干预（不考虑入组情况 或参与）给那些不打算治疗分析的人。公共卫生影响：作为 根据项目以部署为重点的做法，调查小组将评估执行进程， 积极传播试验结果，以改善全国PC中OUD患者的结局。

SUMMARY Background: The US is in the midst of an opioid epidemic and evidence-based treatment for opioid use disorders (OUD) requires medications. Two medications for OUD (MOUD)—buprenorphine and injectable naltrexone—can be provided in primary care (PC). Systems of team-based PC show promise for improving access and retention in OUD treatment. One such model, collaborative care (CC), includes a care manager, supervised by experts, who supports PC teams in providing evidence-based high-quality OUD care for OUD. However, many patients with OUDs have mental health and other substance use (MH/SU) disorders and chronic pain, which complicate OUD engagement and retention. While CC improves outcomes of depression, other MH/SU conditions and pain, it is unknown how to optimally integrate CC for OUD with CC for other MH/SU disorders. Objective: This pragmatic trial tests whether an innovative, scalable, telephonic model of CC for OUD and comorbid conditions increases engagement in MOUD treatment and improve depression symptoms in PC patients with OUD and depression. Study team: Senior investigators with expertise leading pragmatic PC trials of CC for OUD, depression, anxiety, PTSD, alcohol use disorders, and chronic pain, have partnered with clinical experts in PC management of OUD and comorbid conditions, to design and test a novel, scalable, telephonic model of CC. Intervention: This telephonic CC model includes the 6 key elements of CC, as well as shared decision-making regarding comorbid conditions of concern to patients, and will be refined in a developmental phase in year 1. Pragmatic trial sample and design: Years 2-4, the proposed effectiveness trial will test our CC model in at least 800 PC patients with OUD and depression, followed over 12 months (at least 400 each from Kaiser Permanente Washington and University of New Mexico PC clinics). Innovative pragmatic elements of this trial include: inclusion of all eligible patients with OUD and active depression (PHQ- 9 ≥ 10) seen in participating PC clinics during trial enrollment (both sites routinely screen for depression with the PHQ-9); 50% of the sample will be randomly recruited for and consented for the CC intervention; and main outcomes will be measured in the entire eligible sample using only secondary data from electronic health records, insurance claims, and state-wide prescription monitoring program and emergency department information exchanges. These pragmatic elements avoid studying only motivated (recruited) patients and avoids activating patients randomized to usual care. Main outcomes include 1) 6 months of sustained MOUD during 12-months follow-up (primary) and 2) resolution of depression symptoms based on the PHQ-9. A secondary outcome, any major adverse events, includes: suicide attempt, self-harm, overdose, hospitalization or death. Analyses compare the 50% of eligible patients offered the CC intervention (irrespective of enrollment or engagement) to those who are not, in an intention to treat analysis. Public Health Impact: As part of the project's deployment-focused approach, the investigative team will evaluate implementation processes and actively disseminate trial findings to improve outcomes of patients with OUD seen in PC nationwide.