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首次发作后的早期干预（例如，通过协调 专科护理[CSC]），以改善患者的治疗效果，但诊所在提供组件方面往往面临现实挑战 很难留住病人接受治疗。证据表明CSC 有效性和现实世界的挑战导致患者的结果更差，这可能是根据试验数据预期的结果，即， 有效性福尔斯低于功效。挑战包括人员短缺和分配效率低下，特别是 规模较小的诊所此外，一些患者需要额外的服务，例如，认知矫正LEAP中心 “标志性项目”将是一项加强协调专科护理（CSC 2.0）的随机分组对照试验（RCT） 与标准的、真实世界的CSC相比，在马萨诸塞州的诊所网络中，这些诊所将一起作为“研究”。 实验室”，以测试对CSC的改进。CSC 2.0干预措施包括同行提供者，数字外展，家庭 小组，与艾德/住院医生/PCP的协调，以及认知矫正，所有这些都使用集中的 托管的轴辐式设计。我们选择这些组件的基础上，临床反馈现有的保真度 挑战和患者需求，并且由于他们承诺改善CSC中的患者参与/保留， 改善成果的机制。该试验将按诊所 * 月随机分配350名患者， 将样本和盲态诊所工作人员平均分配至随机化过程。对照组包括常规护理， 我们会追踪这些诊所干预部门采用中心辐射模式，将干预部署到所有诊所， 通常为临床医生和患者远程提供护理。因为后续损失在 第一年的护理，我们的主要结果将是月数（0-12），在此期间，病人参加了预期的 CSC任命的人数。该试验将利用现有的电子健康记录数据和EPINET登记数据， 最大限度地提高数据收集效率。我们在第一个供资期内开发和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，这反过来将 补充和扩大审判能力。总之，该项目将为临床医生、患者和政策制定者提供 严格的实验数据的影响，加强CSC提供的方法相比，通常提供的护理 CSC诊所与他们所有的现实世界的挑战。