Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness - Recruitment Extension

项目总结/摘要 摘要：尽管面临新冠肺炎大流行的挑战，我们的HEAL资助的临床试验， （合作导致成瘾治疗和从其他压力中恢复）已成功地 招募病人。我们正在寻求额外的资金，以支付额外的8个月的招聘费用。 有了这笔额外的资金，我们很有可能能够实现我们的招聘目标，并完成 在原始研究时间轴内进行研究。完成人类受试者入组对于项目成功至关重要; 在未完成入组的情况下，母研究和竞争性研究的全部试验投资 翻修有风险。 概述：2019年，兰德公司与新墨西哥州大学波士顿医学中心合作， 中心和三个医疗保健系统，根据RFA-MH-19-525资助，以适应，然后测试 阿片类药物使用障碍和并发抑郁症和/或创伤后应激障碍患者的协作护理模式。 协作护理是一种服务提供模式，用于治疗小学生的精神和行为健康状况。 护理机构，但尚未进行测试，以共同发生的精神和物质使用障碍。审判 旨在明确回答该模型在不同的实践环境中实施时， 改善精神健康和药物使用的结果。2020年，兰德通过一项 竞争性修订（CR）。CR使用与母研究相同的程序、方法和措施， 并测试添加专门针对降低自杀和过量风险的成分是否能提供 与最初的CNOO模型相比，这是额外的好处。CR支持招募300名患者， 除了母研究中招募的900名患者之外。 我们招募患者的能力在2019冠状病毒病大流行期间受到影响。这项研究计划， 通过普遍筛查方法招募患者，在初级保健中派驻研究助理 诊所候诊室将对患者进行研究资格筛选。由于大流行，我们的诊所合作伙伴 开始以虚拟方式提供大部分护理，这限制了我们亲自筛选和招募患者的能力。虽然 我们对电子健康记录中确定的患者进行了电话筛查， 入学率大打折扣。母研究的目标样本量为N=900， 对于CR;这两项研究是相关的，因为CR的设计利用了患者的数据 入组母研究，以评估增强版CNOO的增量有效性 与母体研究相比。因此，如果我们无法完成这两项研究， 两项研究的患者入组。到目前为止，我们已经招募了521人，我们提出了1200人。在 2021年秋季，我们被允许再次恢复普遍筛查，尽管我们的几个诊所已经 直到最近，他们仍然在虚拟环境中提供大部分的医疗服务。

PROJECT SUMMARY/ABSTRACT Summary: Despite challenges from the Covid-19 pandemic, our HEAL-funded clinical trial, CLARO (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses) has been successfully recruiting patients. We are seeking additional funding to cover an additional 8 months of recruitment costs. With this additional funding it is highly likely we will be able to meet our recruitment targets and complete the study within the original study timeline. Completion of human subject enrollment is critical for project success; without completion of enrollment the entire investment in the trial for both the parent study and the competitive revision is at-risk. Overview: In 2019, the RAND Corporation, in collaboration with the University of New Mexico, Boston Medical Center and three healthcare systems, was funded under RFA-MH-19-525 to adapt and then test the Collaborative Care model for individuals with opioid use disorders and co-occurring depression and/or PTSD. Collaborative Care is a service delivery model for treating mental and behavioral health conditions in primary care settings but has not been tested for co-occurring mental and substance use disorders. The trial is intended to definitively answer whether the model, when implemented across diverse practice settings, results in improved mental health and substance use outcomes. In 2020, RAND received additional funding through a competitive revision (CR). The CR uses the same procedures, methods and measures as the parent study, and tests whether adding components specifically directed at reducing suicide and overdose risk provides additional benefit compared to the original CLARO model. The CR supports recruiting of 300 patients in addition to the 900 patients to be enrolled in the parent study. Our ability to recruit patients was compromised during the Covid-19 pandemic. The study had planned to recruit patients through a universal screening approach where research assistants stationed in primary care clinic waiting rooms would screen patients for study eligibility. Because of the pandemic, our clinic partners began to provide most care virtually, which limited our ability to screen and recruit patients in-person. Although we pivoted and implemented telephone screening for patients identified in the electronic health record, enrollment was significantly compromised. Our target sample size is N=900 for the parent study, and N=300 for the CR; the two studies are linked because the design of the CR takes advantage of data from patients enrolled into the parent study to estimate the incremental effectiveness of the enhanced version of CLARO compared to the parent study. Thus, investment in both studies is at-risk should we be unable to complete patient enrollment for both studies. To date we have enrolled 521 individuals out of our proposed 1200. In the fall of 2021, we were allowed to resume universal screening again, although several of our clinics have continued until recently to provide most of their care virtually.