Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement (DUP)
Primary Purpose
Psychotic Disorders
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Screen + Education (Phase 1)
Targeted Provider Education (Phase 1)
Community Mobile Engagement (Phase 2)
Clinic based Engagement (Phase 2)
Sponsored by
About this trial
This is an interventional screening trial for Psychotic Disorders
Eligibility Criteria
Inclusion criteria:
Meet DSM-IV criteria for a diagnosis of affective or nonaffective psychosis.
Exclusion criteria:
- Duration of psychosis > 2 years
- Current substance dependence
- Neurological illness or injury leading to psychotic symptoms
- Only substance induced psychotic symptoms
- Documented IQ < 70
- Lack of English fluency
Sites / Locations
- University of California Davis Early Diagnosis and Preventative Treatment (EDAPT) Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Electronic Screen + Education (Phase 1)
Targeted Provider Education (Phase 1)
Community Mobile Engagement (Phase 2)
Clinic based Engagement (Phase 2)
Arm Description
Electronic screening of participants and targeted education of providers according to standard EDAPT model.
Targeted education of providers according to standard EDAPT model.
Clinical intake interviews take place via videoconference at a location in the community convenient for the participant.
Clinical intake interviews take place at the EDAPT clinic.
Outcomes
Primary Outcome Measures
Days of active psychosis between onset of illness and identification for care (Duration of untreated psychosis)
Secondary Outcome Measures
Rates of patient enrollment in first episode psychosis care
Full Information
NCT ID
NCT02841956
First Posted
June 29, 2016
Last Updated
June 22, 2021
Sponsor
University of California, Davis
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02841956
Brief Title
Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement
Acronym
DUP
Official Title
Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Reducing Duration of Untreated Psychosis (DUP) is a primary goal for improving long-term outcomes in young people with a first episode of psychosis (FEP). The "standard of FEP care" within the US focuses on targeted provider education regarding signs and symptoms of early psychosis to motivate patient referrals to FEP services, followed by initiation of services within largely clinic-based settings Experience at the Early Diagnosis and Preventive Treatment (EDAPT) FEP specialty program at U.C. Davis in Sacramento has identified two important bottlenecks to reducing DUP, consistent with reports in the literature from other FEP clinics. These are 1) delays in the identification of psychotic symptoms by referral sources, and 2) delays or disruptions of patient engagement in specialty FEP care. Building upon a comprehensive and established referral network of 20 sites across the Sacramento area (schools/universities, ER/inpatient hospitals, outpatient mental health, primary care), the investigators will address delays in patient identification and engagement using a two-phase, cluster randomized design. The investigators will consecutively test the impact of two interventions to reduce DUP, defined in this RFA as time from first onset of psychotic symptoms to engagement in FEP specialty care. To address identification delays, the investigators will examine the use of standard targeted provider education plus novel technology-enhanced screening compared to standard targeted provider education alone, testing the hypothesis that the education plus technology-enhanced screening will identify more patients, earlier in their illness. To address engagement delays, the investigators will compare the use of a mobile community-based, telepsychiatry-enhanced engagement team to standard clinic-based procedures for intake, engagement and initiation of treatment, to test the hypothesis that the mobile approach facilitates earlier and more stable engagement, thereby reducing DUP. The proposed work will provide new specific evidence-based practices for reducing DUP and improving outcomes through specialty care of individuals with a first episode of psychosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
427 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electronic Screen + Education (Phase 1)
Arm Type
Experimental
Arm Description
Electronic screening of participants and targeted education of providers according to standard EDAPT model.
Arm Title
Targeted Provider Education (Phase 1)
Arm Type
Active Comparator
Arm Description
Targeted education of providers according to standard EDAPT model.
Arm Title
Community Mobile Engagement (Phase 2)
Arm Type
Experimental
Arm Description
Clinical intake interviews take place via videoconference at a location in the community convenient for the participant.
Arm Title
Clinic based Engagement (Phase 2)
Arm Type
Active Comparator
Arm Description
Clinical intake interviews take place at the EDAPT clinic.
Intervention Type
Other
Intervention Name(s)
Electronic Screen + Education (Phase 1)
Intervention Description
PHASE 1 Electronic Screening Arm + Targeted Education: Referral sources will receive the same standard targeted education as active comparator. In addition, the PQ-B (a 21 item screening questionnaire) will be administered to all patients at their first visit to the referral sites (e.g. intake) via an android tablet provided to the site for ease of administration and scoring. The investigators will provide multiple tablets per site so that the screening is available for more than one individual simultaneously and can be completed in any appropriate location. The investigators will allow paper-and-pencil administration for situations where it is more appropriate (e.g. emergency room).
Intervention Type
Other
Intervention Name(s)
Targeted Provider Education (Phase 1)
Intervention Description
PHASE 1 Targeted Education Intervention: EDAPT standard targeted provider education1 focuses on increasing awareness about the signs of early psychosis & building collaborative relationships with community members so community members see EDAPT as a rapid, effective source of help. It consists of a 2-hour workshop describing: 1) how to identify specific early symptoms & changes associated with the onset of psychotic illness, 2) the benefits of early intervention on treatment outcomes in psychosis, 3) the structure, philosophy & treatment model of the EDAPT Clinic, and 4) procedures for expeditious referral to our program. Case-based vignettes are reviewed to ensure understanding of the key symptoms.
Intervention Type
Other
Intervention Name(s)
Community Mobile Engagement (Phase 2)
Intervention Description
PHASE 2 Community-based Mobile Engagement: Clinical assessment appointments will take place at the EDAPT clinic or within the community, wherever the individual would prefer. With patients deemed eligible for EDAPT services, the EDAPT clinician will obtain vitals and contact the EDAPT psychiatrist with a telemedicine-enabled laptop to complete the psychiatric evaluation remotely. The psychiatrist will prescribe medications and order labs, as indicated. The EDAPT clinician will follow up with the individual within 5 days to determine if the prescribed medication regimen has started.
Intervention Type
Other
Intervention Name(s)
Clinic based Engagement (Phase 2)
Intervention Description
PHASE 2 Clinic-based Engagement: The clinical assessment appointment will be completed within the EDAPT clinic. If deemed eligible for EDAPT services, the individual will be scheduled for a clinic-based appointment with the EDAPT psychiatrist within 5 days, who will prescribe medications and order labs as indicated. The EDAPT clinician will follow up with the individual within 5 days of the psychiatric evaluation (by phone or in the clinic) to determine if the prescribed medication regimen has started.
Primary Outcome Measure Information:
Title
Days of active psychosis between onset of illness and identification for care (Duration of untreated psychosis)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Rates of patient enrollment in first episode psychosis care
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Meet DSM-IV criteria for a diagnosis of affective or nonaffective psychosis.
Exclusion criteria:
Duration of psychosis > 2 years
Current substance dependence
Neurological illness or injury leading to psychotic symptoms
Only substance induced psychotic symptoms
Documented IQ < 70
Lack of English fluency
Facility Information:
Facility Name
University of California Davis Early Diagnosis and Preventative Treatment (EDAPT) Clinic
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://earlypsychosis.ucdavis.edu
Description
UC Davis Early Psychosis Programs
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Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement
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