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

> **NIH NIH P50** · MCLEAN HOSPITAL · 2024 · $990,361

## Abstract

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.

## Key facts

- **NIH application ID:** 10918298
- **Project number:** 5P50MH115846-06
- **Recipient organization:** MCLEAN HOSPITAL
- **Principal Investigator:** Dost Ongur
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $990,361
- **Award type:** 5
- **Project period:** 2019-05-15 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10918298

## Citation

> US National Institutes of Health, RePORTER application 10918298, Randomized controlled trial of enhanced coordinated specialty care (CSC 2.0) (5P50MH115846-06). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10918298. Licensed CC0.

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