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

Primary Purpose

Psychotic Episode

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PRESTO Early Identification Program
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychotic Episode focused on measuring Schizophrenia, Psychiatric centers, psychiatric illnesses, psychiatric care

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 < 1 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

Sites / Locations

  • Hospices Civils de LyonRecruiting
  • Chu Clermont-FerrandRecruiting
  • Chu GrenobleRecruiting
  • CHU de MontpellierRecruiting
  • CHU de NîmesRecruiting
  • Chu Saint EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PRESTO program

Usual Care

Arm Description

The PRESTO programs consists of an early identification program for First Episod Psychosis, called PRESTO (First Episodes Raise Awareness Treat Referral), including 3 complementary components: Information campaign for the general population Training of front-line actors Facilitating access to specialized care by setting up mobile teams made up of "pivotal" workers who provide the link between front-line actors and specialized psychiatric care

No change in the conditions of referral of First Episod Psychosis (emergencies, hospitalizations, consultations)

Outcomes

Primary Outcome Measures

Duration of untreated psychosis (DUP)
Defines the time interval between the onset of the first frank psychotic signs noted by the patient and his or her entourage and treatment in specialized psychiatric care

Secondary Outcome Measures

Number of patients still in care
measurement of the number of patients continuing care
Engagement in care
Measurement of engagement in care through the Service Engagement Scale. It is a 14-item questionnaire, scored from 0 to 3, divided into four categories: availability, cooperation, help-seeking attitude and therapeutic adherence. The questionnaire is completed by the clinician.
treatment adherence
Medication Adherence Rating Scale (MARS) is a 10-item self-reporting multidimensional instrument describing three dimensions: medication adherence behavior (items 1-4), attitude toward taking medication (items 5-8) and negative side effects and attitudes to psychotropic medication (items 9-10). The total score ranges from 0-10 with a higher score indicating better adherence.
therapeutic alliance
measurement of the therapeutic alliance with the "Working Alliance Inventory" self-questionnaire given to the patient and the clinician. It is a self-administered questionnaire with a 36-item therapist or caregiver component and a 36-item patient component. Each item is rated from 1 to 7 (never to always). The score range is 36 to 252. Higher score reflect a more positive rating of working alliance.
Customer satisfaction
Measurement of Customer satisfaction by self-questionnaire with 8 items applicable to a population with psychotic disorders. The CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction.
Caregiver Burden
Measurement of Caregiver Burden by the Zarit Burden Interview in Caregivers of Patients is a self-questionnaire given to the caregiver. This questionnaire consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0 to 88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
Assessment of the context
Semi-structured interview wera done with stakeholders of PRESTO program to assess contextual factors that increase or limit the effect of the intervention, integration of the intervention into the care organization scheme, collaboration with inpatient, outpatient and non-healthcare sectors, means identified to sustain the intervention.

Full Information

First Posted
April 3, 2023
Last Updated
June 6, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT05813457
Brief Title
Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis
Acronym
PRESTO
Official Title
Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis. Multicenter, Randomized Stepped-wedge Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Episode
Keywords
Schizophrenia, Psychiatric centers, psychiatric illnesses, psychiatric care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
416 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRESTO program
Arm Type
Experimental
Arm Description
The PRESTO programs consists of an early identification program for First Episod Psychosis, called PRESTO (First Episodes Raise Awareness Treat Referral), including 3 complementary components: Information campaign for the general population Training of front-line actors Facilitating access to specialized care by setting up mobile teams made up of "pivotal" workers who provide the link between front-line actors and specialized psychiatric care
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No change in the conditions of referral of First Episod Psychosis (emergencies, hospitalizations, consultations)
Intervention Type
Other
Intervention Name(s)
PRESTO Early Identification Program
Other Intervention Name(s)
PRESTO Program
Intervention Description
The program combines : A population-based information component (information campaign aimed at the general population). 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.). Facilitated access to care for FPE patients in the form of a "pivot" mobile team that can directly meet the patient at the request of the LPA, initiate care and ensure the relay within a the relay within 4 weeks to the existing specialized psychiatric structures on the site (CMP, CATTP (CMP, CATTP, day hospital, hospitalization unit, child and adolescent psychiatry services) adolescent psychiatry services)
Primary Outcome Measure Information:
Title
Duration of untreated psychosis (DUP)
Description
Defines the time interval between the onset of the first frank psychotic signs noted by the patient and his or her entourage and treatment in specialized psychiatric care
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Number of patients still in care
Description
measurement of the number of patients continuing care
Time Frame
Week 4
Title
Engagement in care
Description
Measurement of engagement in care through the Service Engagement Scale. It is a 14-item questionnaire, scored from 0 to 3, divided into four categories: availability, cooperation, help-seeking attitude and therapeutic adherence. The questionnaire is completed by the clinician.
Time Frame
Week 4
Title
treatment adherence
Description
Medication Adherence Rating Scale (MARS) is a 10-item self-reporting multidimensional instrument describing three dimensions: medication adherence behavior (items 1-4), attitude toward taking medication (items 5-8) and negative side effects and attitudes to psychotropic medication (items 9-10). The total score ranges from 0-10 with a higher score indicating better adherence.
Time Frame
Week 4
Title
therapeutic alliance
Description
measurement of the therapeutic alliance with the "Working Alliance Inventory" self-questionnaire given to the patient and the clinician. It is a self-administered questionnaire with a 36-item therapist or caregiver component and a 36-item patient component. Each item is rated from 1 to 7 (never to always). The score range is 36 to 252. Higher score reflect a more positive rating of working alliance.
Time Frame
Week 4
Title
Customer satisfaction
Description
Measurement of Customer satisfaction by self-questionnaire with 8 items applicable to a population with psychotic disorders. The CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction.
Time Frame
Week 4
Title
Caregiver Burden
Description
Measurement of Caregiver Burden by the Zarit Burden Interview in Caregivers of Patients is a self-questionnaire given to the caregiver. This questionnaire consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0 to 88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
Time Frame
Baseline and week 4
Title
Assessment of the context
Description
Semi-structured interview wera done with stakeholders of PRESTO program to assess contextual factors that increase or limit the effect of the intervention, integration of the intervention into the care organization scheme, collaboration with inpatient, outpatient and non-healthcare sectors, means identified to sustain the intervention.
Time Frame
before the start and after the end of the PRESTO program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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 < 1 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric FAKRA, MD PhD
Phone
(0)477127885
Ext
+33
Email
eric.fakra@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine BAUDOT, CRA
Phone
(0)477829450
Ext
+33
Email
amandine.baudot@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric FAKRA, MD PhD
Organizational Affiliation
CHU SAINT ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric HAESEBAERT, MD
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume LEGRAND, MD
Facility Name
Chu Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clément DONDE, MD
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MD
First Name & Middle Initial & Last Name & Degree
Alexandra CARRE, MD
First Name & Middle Initial & Last Name & Degree
Laurie SURIG, MD
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30900
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie SCHANDRIN, MD
Facility Name
Chu Saint Etienne
City
Saint-Étienne
ZIP/Postal Code
42100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric FAKRA, MD PhD
First Name & Middle Initial & Last Name & Degree
Eric FAKRA, MD PhD
First Name & Middle Initial & Last Name & Degree
Maxence RIGON, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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