Randomized controlled trial of enhanced coordinated specialty care (CSC 2.0)

增强协调专业护理的随机对照试验（CSC 2.0）

• 批准号: 10623805
• 负责人: Dost Ongur
• 金额: $ 102.66万
• 依托单位: MCLEAN HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-15 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10623805
• 关键词: Adherence; Appointment; Blinded; Caring; Case Management; Clinic; Clinical; Clinical Trials; Cognitive remediation; Collaborations; Complement; Coordinated Specialty Care; Data; Data Collection; Dedications; Drops; Early Intervention; Education; Effectiveness; Electronic Health Record; Face; Family; Feedback; Funding; Future; Individual; Inpatients; Intervention; Laboratories; Laboratory Research; Lead; Massachusetts; Mental Health; Methods; Modeling; National Institute of Mental Health; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Policy Maker; Process; Provider; Psychotherapy; Randomized; Randomized, Controlled Trials; Registries; Research; Sampling; Scheme; Services; Social Workers; Standard Model; Strategic Planning; Sum; Supported Employment; System; Testing; Time; Training; United States Substance Abuse and Mental Health Services Administration; Visit; arm; blind; care delivery; care outcomes; care systems; data registry; design; digital; early psychosis; experience; falls; first episode psychosis; follow-up; improved; improved outcome; intervention program; outreach; patient engagement; patient retention; patient subsets; peer; personalized intervention; primary outcome; randomized, clinical trials; remote health care; scale up; secondary analysis; treatment arm; treatment as usual; virtual; web site

1. Abstract Trial and meta-analytic evidence support early intervention after a first episode of psychosis (e.g., through coordinated specialty care [CSC]) to improve patient outcomes, but clinics often face real-world challenges in delivering components of this care and have difficulty retaining patients in treatment. This disconnect between the evidence suggesting CSC efficacy and the real-world challenges lead to worse outcomes for patients that one might expect given the trial data, i.e., effectiveness falls below efficacy. The challenges include staffing shortages and allocation inefficiency, particularly with smaller scale clinics. Moreover, some patients need additional services, e.g., cognitive remediation. The LEAP Center “signature project” will be a cluster-randomized controlled trial (RCT) of enhanced coordinated specialty care (CSC 2.0) compared to standard, real-world CSC in a network of clinics in Massachusetts which together will serve as a “research laboratory” for testing improvements to CSC. The CSC 2.0 intervention includes peer providers, digital outreach, family groups, coordination with ED/inpatient providers/PCPs, and cognitive remediation, all organized using a centrally managed hub-and-spoke design. We selected these components based on clinic feedback about existing fidelity challenges and patient needs and because of their promise to improve patient engagement/retention in CSC, a critical mechanism for improving outcomes. The trial will randomize 350 patients by clinic*month using a scheme that both will split evenly the sample and blind clinic staff to the randomization process. The control arm consists of usual care within the clinics, which we will track. The intervention arm uses a hub-and-spoke model deploying the intervention to all clinics, often delivering care remotely for both clinician and patient. Because follow-up losses are most pronounced during the first year of care, our primary outcome will be the number of months (0-12) during which the patient attended the expected number of CSC appointments. The trial will leverage existing electronic health record data and EPINET registry data, maximizing data collection efficiency. We have developed and refined these types of data during the first funding period. The trial will leverage the efforts of the Administrative and Methods Cores as well as the other projects, which in turn will complement and extend the trial capabilities. In sum, this project will provide clinicians, patients, and policy makers rigorous experimental data on the impact of an enhanced CSC delivery approach compared with the usual care offered by CSC clinics with all of their real-world challenges.

1。摘要 试验和荟萃分析证据支持精神病第一集后的早期干预（例如，通过协调 专业护理[CSC]）以改善患者的结果，但是诊所经常在交付组件方面面临现实世界中的挑战 在这种护理中，很难保留患者治疗。暗示CSC的证据之间的这种断开连接 疗效和现实世界中的挑战会导致患者的结果较差，因为鉴于试验数据， 有效性低于效率。挑战包括人员短缺和分配效率低下，尤其是 规模较小的诊所。此外，有些患者需要其他服务，例如认知补救。跳跃中心 “签名项目”将是增强协调专业护理（CSC 2.0）的集群随机对照试验（RCT） 与马萨诸塞州诊所网络中的标准现实世界CSC相比 用于测试CSC的实验室”。CSC2.0干预措施包括同行提供商，数字外展，家庭 组，与ED/住院提供者/PCP的协调以及认知补救，所有这些都使用中心组织 托管轮毂和辐条设计。我们根据有关现有保真度的诊所反馈选择了这些组件 挑战和患者的需求，并且由于他们承诺改善CSC的患者参与/保留率，这是一个关键 改善结果的机制。该试验将使用诊所*一个月随机对350名患者进行随机，使用两者都将 将样本和盲目诊所人员均匀分配到随机化过程中。控制臂包括通常的护理 我们将跟踪的诊所。干预部门使用将干预措施部署到所有诊所的轮毂和辐条模型， 通常为临床和患者提供远程护理。因为后续损失最为明显 护理的第一年，我们的主要结果将是患者参加预期的月数（0-12） CSC约会数量。该试验将利用现有的电子健康记录数据和Epiwet注册表数据， 最大化数据收集效率。在第一个资金期间，我们已经开发并完善了这些类型的数据。 该试验将利用行政和方法核心以及其他项目的努力，而这些项目又将 补充和扩展试验能力。总而言之，该项目将为临床医生，患者和政策制定者提供 与加强CSC交付方法的影响相比，严格的实验数据与提供的通常护理相比 CSC诊所都面临着所有现实世界的挑战。