Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis

Official title

Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis. Multicenter, Randomized Stepped-wedge Study

Overview

The First-Episode Psychosis (FPE) is a severe disorder that can include delusions, cognitive disorders and suicidal behavior. In the majority of cases (more than 80%) it evolves into schizophrenia. Numerous studies show that the rapidity of the initial management of FPE would reduce the risk of negative evolution and would have a decisive impact on the short and long term prognosis. The rapidity of this management can be measured by the duration of untreated psychosis, or DUP (Duration of Untreated Psychosis), the time interval between the appearance of the first frank psychotic symptoms and the initiation of adequate psychiatric care. The objective of this study is to show the impact of an intervention facilitating access to specialized care for PEP on the reduction of DUP. This intervention consists of an early identification program for FPE, the PRESTO program, specifically targeting 3 determining steps in the reduction of DUP: * Informing the general population about psychotic disorders * Knowledge of front line actors (APL: general practitioners, school and university medicine, teenager's house, associative networks educators, emergency services, firefighters, etc.) about FPE and its management * Articulation between APL and specialized psychiatric care

Detailed description

The DUP is an easily measurable indicator, closely linked to prognosis and potentially modifiable, which has led to its wide use to guide the development of early identification programs. Great disparities exist across the world, between different countries and even different regions. France is unusually late, with an average DUP of at least 18 months. Several elements may contribute to explain this state in France: absence of a specific care program for FPE in the vast majority of psychiatric centers, significant stigmatization of psychiatric illnesses, the opacity of psychiatric care and of psychiatric care and lack of knowledge of its organization, in particular by the primary care network that receives patients with PEP in the first line. To date, there is no systematic program in France designed to rapidly identify FPE patients and hasten their specialized care. The objective of this study is to show the impact of an intervention facilitating access to specialized care for PEP on the reduction of DUP.

In addition, this study will seek to analyze the implementation factors of such an intervention in view of a possible generalization and perpetuation.

Interventions

• Other PRESTO Early Identification Program
  The program combines : 1. A population-based information component (information campaign aimed at the general population). 2. A training component for the LPAs (Front Line Actors: general practitioners, school and university medicine, pharmacists, teenagers school and university medicine, pharmacists, teenagers' homes, association networks, SAMU, firemen, etc.). 3. Facilitated access to care for FPE patients in the form of a "pivot" mobile team that can directly meet the patient at the request

Primary outcome measures

• Duration of untreated psychosis (DUP) [Time frame: Baseline]

Secondary outcome measures (7)

• Number of patients still in care [Time frame: Week 4]
• Engagement in care [Time frame: Week 4]
• treatment adherence [Time frame: Week 4]
• therapeutic alliance [Time frame: Week 4]
• Customer satisfaction [Time frame: Week 4]
• Caregiver Burden [Time frame: Baseline and week 4]
• Assessment of the context [Time frame: before the start and after the end of the PRESTO program]

Eligibility criteria

Inclusion criteria

• Patients with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or brief psychotic disorder established according to DMS 5
• Never having taken neuroleptic treatment for antipsychotic purposes, except for the current episode and for a duration of < 6 month
• Oral consent of the patient or, for minors, of his/her parents to participate in the study

Exclusion criteria

• Patients already treated and followed for FPE
• Brief psychotic state not requiring specific management

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 6 centers

• Hospices Civils de Lyon — Bron
• Chu Clermont-Ferrand — Clermont-Ferrand
• Chu Grenoble — Grenoble
• CHU de Montpellier — Montpellier
• CHU de Nîmes — Nîmes
• Chu Saint Etienne — Saint-Etienne

Identifiers

NCT: NCT05813457 · 19PH228 · 2021-A00787-34

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗