California Collaborative Network to Promote Data Driven Care and Improve Outcomes in Early Psychosis
Part of paid clinical trials in Sacramento, California.
- Sponsor
- University of California, Davis
- Study ID
- NCT04007510
- Status
- Enrolling By Invitation
Conditions
- First Episode Psychosis (FEP)
Eligibility Criteria
- Sex
- ALL
- Age
- 8 Years - 40 Years
- Healthy Volunteers
- Not accepted
Interventions
- EPI-CAL data network — COMBINATION_PRODUCTThis mobile, app-based platform was designed to: 1) enable outcomes data collection from clients and family members/support person who are receiving care at an early psychosis program, 2) summarize the data visually for clients and providers on a secure web-based dashboard, and 3) allow download of de-identified data for program or research analysis.
- Community DUP Assessment Tool — DIAGNOSTIC_TESTA tool will be developed to enable measurement of the duration of untreated psychosis (DUP) for FEP individuals based on 1) data other assessments that are typically completed during the intake process (e.g. SIPS, SCID) or 2) specific questions, prompts, a rating scale, and anchor points to enable rating of the DUP. Participants would have their DUP rated on the new tool and also complete a second assessment of DUP by research evaluators using the Symptom Onset in Schizophrenia Inventory (SOS) to determine reliability and validity of the new tool.
Study Details
The proposed project seeks to create a California early psychosis network using a core assessment battery of valid, low burden measures and mHealth technology platform to collect client-level data, visualize data via clinician dashboard for treatment planning, and integrate across clinics to provide de-identified data to the national coordinating hub. Research capacity for the network will be tested via development and validation of a measure of the Duration of Untreated Psychosis (DUP) that is feasible for use in community settings. The proposed California network will contribute systematically collected outcomes data on over 100 FEP clients per year, from 12 community and university EP clinics, to enhance the development of a national EP network, supported by the NIMH EPINET program.
Key Dates
- Start date
- Sep 10, 2019
- Status verified
- Sep 2025
- Primary completion
- Mar 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 1,329 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: EPI-CAL mHealth data networkThis arm of the study involves the use of the mobile health technology ("app") to measure outcomes within an early psychosis (EP) program.
- Experimental: DUP EvaluationA subset of individuals will participate in interviews to validate a tool to determine the duration of untreated psychosis in community settings
Primary Outcome Measure
Enrollment [ Time Frame: end of study, maximum of 5 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Imaging Research Center | Sacramento | California | 95817 | - |
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Related Studies
- Reducing the Duration of Untreated Psychosis in the United States: The Impact of Screening and Systematic CommunicationEnrolling By Invitation · Icahn School of Medicine at Mount Sinai · New York, New York