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 : November 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Psychotic Disorders||Other: Electronic Screen + Education (Phase 1) Other: Targeted Provider Education (Phase 1) Other: Community Mobile Engagement (Phase 2) Other: Clinic based Engagement (Phase 2)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Experimental: Electronic Screen + Education (Phase 1)
Electronic screening of participants and targeted education of providers according to standard EDAPT model.
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).
Active Comparator: Targeted Provider Education (Phase 1)
Targeted education of providers according to standard EDAPT model.
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.
Experimental: Community Mobile Engagement (Phase 2)
Clinical intake interviews take place via videoconference at a location in the community convenient for the participant.
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.
Active Comparator: Clinic based Engagement (Phase 2)
Clinical intake interviews take place at the EDAPT clinic.
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.
- Days of active psychosis between onset of illness and identification for care (Duration of untreated psychosis) [ Time Frame: Day 1 ]
- Rates of patient enrollment in first episode psychosis care [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841956
|United States, California|
|University of California Davis Early Diagnosis and Preventative Treatment (EDAPT) Clinic||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Tara Niendam, PhD 916-734-3090|
|Principal Investigator: Cameron S Carter, MD|