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）

基本信息

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
项目类别：
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

项目摘要

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首次精神病发作后的早期干预（例如，通过协调专业护理 [CSC]）以改善患者的治疗效果，但诊所在提供组件方面经常面临现实挑战表明 CSC 的证据之间存在这种脱节。疗效和现实世界的挑战会导致患者的结果比试验数据所预期的更糟糕，即，效率低于功效，挑战包括人员短缺和分配效率低下，尤其是在人员短缺和分配效率低下。此外，一些患者需要额外的服务，例如 LEAP 中心。 “标志性项目”将是强化协调专科护理（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现实世界 CSC 相比，这些诊所网络一起将作为“研究 CSC 2.0 干预措施包括同伴提供者、数字外展、家庭。小组、与 ED/住院提供者/PCP 的协调以及认知补救，所有这些都使用集中组织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，并且由于它们承诺提高患者在 CSC 中的参与度/保留率，这是一个关键该试验将按临床*月对 350 名患者进行随机分组，采用双方都将采用的方案。将样本和盲法诊所工作人员均匀分配到随机化过程中，对照组包括常规护理。我们将跟踪的诊所，干预部门使用中心辐射模型将干预措施部署到所有诊所，经常为临床医生和患者提供远程护理，因为随访期间的损失最为明显。在第一年的护理中，我们的主要结果将是患者参加预期护理的月数（0-12） CSC 预约数量。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间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，这反过来又将总之，该项目将为追随者、患者和政策制定者提供帮助。与 CSC 提供的常规护理相比，关于增强型 CSC 递送方法的影响的严格实验数据 CSC 诊所面临所有现实挑战。