California Collaborative Network to Promote Data Driven Care and Improve Outcomes in Early Psychosis

NCT04007510 | Enrolling By Invitation DMC

• 1 other identifier: 1403828
• Study Type: interventional
• Target: 1,329
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

First Episode Psychosis (FEP)

Keywords

Psychosis; first episode; clinical high risk; outcomes; mobile health; data driven care; learning healthcare network

Outcome Measures

Primary Outcomes (9)

• Enrollment

  Show adequate reach of enrollment using descriptive statistics showing 70% of eligible FEP participants, who are representative of the target population based on current program demographics, and 50% of their available family members, across the network were enrolled and complete baseline

  end of study, maximum of 5 years

• Colorado Symptom Index (CSI) - Symptom severity

  Efficacy of measurement-based care, comparing adjusted mean differences in baseline to 12-month change in psychotic symptom severity on the Colorado Symptom Index (CSI), between groups defined by clinician metrics from mHealth app assessed during this 12-month period. The CSI is a 14-item, self-report scale designed to assess frequency of positive mood and cognitive symptoms. Each item is scored on a 0-4 Likert-style scale and added together to give a score between 0 and 56, with higher scores indicating greater emotional distress. Reduction in score over time is considered clinical improvement. Maintenance of measurement-based care, based on adjusted mean differences in baseline to 24-month change in psychotic symptom severity between groups defined by clinician metrics from mHealth app aggregated over the 6-, 12- and 18-month assessment period, with the primary analysis based on a composite indicator for any endorsement of "impact on treatment plan" across these three periods.

  end of study, maximum of 5 years

• Provider use of data in care

  Compared to pre-implementation period, providers will report a change in the use of data to determine treatment choices after training and using the app for 6 months (Adoption). Adoption of data in care is measure by pre- and post-surveys of randomly sampled client sessions)

  end of study, maximum of 5 years

• Provider use of mHealth app

  Over 12 months, EP providers will use mHealth app in direct care to FEP clients for at least 50% of completed assessments (Implementation) as measured by metrics gathered in mHealth app.

  end of study, maximum of 5 years

• DUP tool reliability

  New DUP tool will show inter-rater reliability (IRR) between CSC providers and a MA-level assessor with an intra-class coefficient (ICC) of at least .80 for days from initial assessment to DUP start point, days from assessment to DUP end point, and days from start point to end point DUP (total DUP).

  end of study, maximum of 5 years

• DUP Tool convergent validity

  New DUP tool will show convergent validity, with ICCs of at least .80 between CSC providers and centralized study team assessors using the Symptom Onset in Schizophrenia Inventory (SOS) (reference standard).

  end of study, maximum of 5 years

• DUP Tool predictive validity - Functioning

  New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in functioning (Global Social and Role Functioning scales) at 6 and 12 months - shown by regression coefficients between DUP and change from baseline to 6 and 12 months in functioning.

  end of study, maximum of 5 years

• DUP Tool predictive validity - Quality of Life

  New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in quality of life (Lehman Quality of Life scale) at 6 and 12 months - shown by regression coefficients between DUP and change from baseline to 6 and 12 months in quality of life.

  end of study, maximum of 5 years

• DUP Tool feasibility and Acceptability

  Feasibility and acceptability to EP providers and clients, with a mean administration time of less than 40 minutes for the brief and full versions of the new DUP Tool

  end of study, maximum of 5 years

Secondary Outcomes (2)

• Satisfaction with care

  end of study, maximum of 5 years

• Provider level factors

  end of study, maximum of 5 years

Study Arms (2)

EPI-CAL mHealth data network

EXPERIMENTAL

This arm of the study involves the use of the mobile health technology ("app") to measure outcomes within an early psychosis (EP) program.

Combination Product: EPI-CAL data network

DUP Evaluation

EXPERIMENTAL

A subset of individuals will participate in interviews to validate a tool to determine the duration of untreated psychosis in community settings

Diagnostic Test: Community DUP Assessment Tool

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.

Also known as: mHealth App

EPI-CAL mHealth data network

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.

DUP Evaluation

Eligibility Criteria

• Age: 8 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• FEP individuals, ages 12-30, who have experienced the onset of an affective (bipolar or major depression with psychotic features) or non-affective psychotic disorder (schizophrenia, schizoaffective, schizophreniform, brief psychotic, other specified or unspecified schizophrenia spectrum disorders) within the past 5 years and are receiving early psychosis services at one of the study sites.
• Family members/support persons, over age 18, of the participating FEP (or CHR) individuals are receiving early psychosis services at one of the study sites
• Early psychosis (EP) care providers (e.g. clinicians, physicians, nurses, support staff) who are providing care at one of the study sites.
• Additional stakeholders from the communities served by the study sites, including EP program and county administrators, state representatives, and local community groups as well as researchers and other experts in relevant domains.
• Clinical high risk (CHR) individuals, ages 12-30, who have no history of psychosis and will demonstrate attenuated psychotic symptoms consistent with the Structured Interview for Prodromal Syndromes (SIPS), or genetic risk (first-degree relative with psychosis) in conjunction with a substantial drop in functioning over the past year.

You may not qualify if:

• neurological illness or injury leading to psychotic symptoms
• reported diagnosis of intellectual disability or estimated IQ below 70 according to the Pennsylvania Computerized Neuropsychological Test Battery.

Sponsors & Collaborators

• University of California, Davis: lead
• University of California, San Francisco: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Washington University School of Medicine: collaborator

Study Sites (1)

Imaging Research Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• Tryon VL, Nye KE, Savill M, Loewy R, Miles MJ, Tully LM, Padovani AJ, Tancredi DJ, Melnikow J, Ereshefsky S, Sharma N, McNamara AP, Kado-Walton M, Hakusui CK, Miller C, Nguyen KLH, Safdar M, Padilla VE, Smith L, Wilcox AB, Banks LM, Hayes SL, Pierce KM, Muro K, Shapiro DI, Bolden-Thompson KA, Botello RM, Grattan RE, Zhang Y, Hotz B, Dixon L, Carter CS, Niendam TA. The California collaborative network to promote data driven care and improve outcomes in early psychosis (EPI-CAL) project: rationale, background, design and methodology. BMC Psychiatry. 2024 Nov 14;24(1):800. doi: 10.1186/s12888-024-06245-6.

  PMID: 39543502 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 5, 2019
• Study Start: September 10, 2019
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)