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_PRODUCT
    This 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_TEST
    A 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 network
    This arm of the study involves the use of the mobile health technology ("app") to measure outcomes within an early psychosis (EP) program.
  • Experimental: DUP Evaluation
    A 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)

FacilityCityStateZIPSite coordinators
Imaging Research CenterSacramentoCalifornia95817-

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