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Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement (DUP)

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ClinicalTrials.gov Identifier: NCT02841956
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE June 29, 2016
First Posted Date  ICMJE July 22, 2016
Last Update Posted Date January 4, 2019
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
Days of active psychosis between onset of illness and identification for care (Duration of untreated psychosis) [ Time Frame: Day 1 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02841956 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
Rates of patient enrollment in first episode psychosis care [ Time Frame: Baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement
Official Title  ICMJE Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Psychotic Disorders
Intervention  ICMJE
  • Other: Electronic Screen + Education (Phase 1)
    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).
  • Other: Targeted Provider Education (Phase 1)
    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.
  • Other: Community Mobile Engagement (Phase 2)
    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.
  • Other: Clinic based Engagement (Phase 2)
    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.
Study Arms  ICMJE
  • Experimental: Electronic Screen + Education (Phase 1)
    Electronic screening of participants and targeted education of providers according to standard EDAPT model.
    Intervention: Other: Electronic Screen + Education (Phase 1)
  • Active Comparator: Targeted Provider Education (Phase 1)
    Targeted education of providers according to standard EDAPT model.
    Intervention: Other: Targeted Provider Education (Phase 1)
  • Experimental: Community Mobile Engagement (Phase 2)
    Clinical intake interviews take place via videoconference at a location in the community convenient for the participant.
    Intervention: Other: Community Mobile Engagement (Phase 2)
  • Active Comparator: Clinic based Engagement (Phase 2)
    Clinical intake interviews take place at the EDAPT clinic.
    Intervention: Other: Clinic based Engagement (Phase 2)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2016)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

Meet DSM-IV criteria for a diagnosis of affective or nonaffective psychosis.

Exclusion criteria:

  1. Duration of psychosis > 2 years
  2. Current substance dependence
  3. Neurological illness or injury leading to psychotic symptoms
  4. Only substance induced psychotic symptoms
  5. Documented IQ < 70
  6. Lack of English fluency
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02841956
Other Study ID Numbers  ICMJE 608950
R01MH104235 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE Not Provided
PRS Account University of California, Davis
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP