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

1.摘要 试验和元分析证据支持精神病第一次发作后的早期干预(例如，通过协调 专科护理[CSC])，以改善患者的预后，但诊所在提供组件方面往往面临现实挑战 在这种护理下，患者很难留住治疗。这与证据表明CSC 有效性和现实世界的挑战导致患者的结果比人们可能预期的更差，即， 有效性低于有效性。挑战包括人员短缺和分配效率低下，特别是在 规模较小的诊所。此外，一些患者需要额外的服务，例如认知补救。飞跃中心 “标志性项目”将是增强型协同专科护理(CSC 2.0)的整群随机对照试验(RCT) 与马萨诸塞州诊所网络中的标准、真实世界的CSC相比，这些诊所一起将成为一项“研究” 实验室“用于测试对CSC的改进。CSC 2.0干预包括同伴提供者、数字外展、家庭 小组、与急诊室/住院提供者/初级保健医生的协调以及认知补救，所有这些都使用集中的 托管轴辐式设计。我们根据临床对现有保真度的反馈选择了这些组件 挑战和患者需求，并因为他们承诺提高患者在CSC中的参与度/保留率，这是一个关键的 改善结果的机制。这项试验将按临床*月随机抽取350名患者，采用的方案是 将样本和临床工作人员平均分配到随机过程中。控制臂由内部的常规护理组成 诊所，我们将追踪这些诊所。干预部门使用轴辐式模式，将干预部署到所有诊所， 通常为临床医生和患者提供远程护理。因为后续损失最明显的是在 第一年的护理，我们的主要结果将是患者接受预期治疗的月数(0-12个月) CSC任命的数量。该试验将利用现有的电子健康记录数据和EPINET注册数据， 最大限度地提高数据收集效率。我们在第一个资助期内开发和完善了这些类型的数据。 审判将利用行政和方法核心以及其他项目的努力，这反过来又将 补充和扩展试验能力。总之，该项目将为临床医生、患者和政策制定者 关于增强的CSC交付方法与通常提供的护理的影响的严格实验数据 CSC诊所与他们所有现实世界的挑战。

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.