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

1. 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.