First Episode Psychosis (FEP) Clinical Trial
Official title:
Early Stage Identification and Engagement to Reduce the Duration of Untreated Psychosis: Evaluating the Impact of Screening and Systematic Communication
The goal of this project is to investigate whether a systematic screening approach enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych) can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. The study team will use a stepped-wedge cluster randomized controlled trial design to compare a systematic screening and communication method (SCM) to systematic screening method (SM) to evaluate whether SCM substantially reduces DUP. The study team hypothesize that: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services. We will also conduct a qualitative study to examine implementation barriers and facilitators of SCM.
Studies find a substantial delay between the onset of psychosis and the initiation of specialty treatment for first episode psychosis (FEP), with the duration of untreated psychosis (DUP) typically over one year in the U.S. Better strategies are needed to improve identification of individuals with FEP and to rapidly engage them in Coordinated Specialty Care (CSC) aimed at restoring functioning. This study will investigate whether a U.S. adaptation of a successful detection approach from the Netherlands enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych), can reduce DUP. Researchers in the Netherlands compared screening of a consecutive help-seeking population entering mental health services to clinician referral from mental health clinics and found that screening captured significantly more individuals at clinical high risk for psychosis (CHR) and with FEP. Based on the Dutch model, within the Mount Sinai Health System in New York, the study team has piloted and established the feasibility of screening help-seeking youth entering mental health services with the aim of improving early identification of FEP cases and rapid referral to specialty care (Early Stage Identification and Engagement to Reduce DUP study (EaSIE), supported by NIMH R34). Individuals entering services are screened with the Prodromal Questionnaire-Brief Version (PQ-B). Those who screen positive are assessed by Structured Interview for Psychosis Risk Syndromes (SIPS) and referred to stage-specific specialty care (FEP or CHR services). To facilitate service engagement the study team developed, piloted, and established feasibility of the ComPsych model, a standardized training program for clinicians in delivering information about schizophrenia, psychosis and CHR to patients and families. The ComPsych model was developed based on qualitative studies with multiple stakeholders, which have shown that family involvement and clear communication about diagnosis are critical components to successful engagement in treatment and adherence to treatment recommendations. ComPsych aims to convey sensitive information in a way that promotes understanding, empathy, and a sense of ongoing support. The objective of this project is to investigate whether a systematic screening approach enhanced by ComPsych can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. This study will use a Hybrid Type 1 randomized controlled trial design (RCT) to test the effectiveness of SCM vs SM and to examine multi-level implementation factors that can inform the identification of implementation strategies for future deployment of SCM in routine practice. This study team will use a stepped-wedge cluster RCT design to compare SCM to SM to evaluate whether SCM substantially reduces DUP. The study hypotheses are: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services; (3) ComPsych targets (understanding of psychosis, stigma, attitudes about treatment) will mediate the impact of SCM on DUP. The study team will also conduct a multi-level qualitative implementation study informed by the Consolidated Framework for Implementation Research (CFIR) to first examine implementation barriers and facilitators and then apply the Expert Recommendations for Implementing Change (ERIC) taxonomy of implementation strategies to these findings to help select potential implementation strategies for SCM and SM. Data will be collected from clinicians and administrators before the implementation of the trial (year 1) and after recruitment for the trial has ended (year 4), and from patients and families throughout the project. The knowledge gathered from this project is of significant public health relevance as it has potential to facilitate more rapid and timely detection and treatment of first episode psychosis (FEP) by evaluating the utility of systematic screening and communication strategies for psychotic symptoms. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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N/A | |
| Completed |
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| Withdrawn |
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N/A |