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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00787-34 | Other Identifier | ANSM |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRESTO program | Experimental | 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:
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| Usual Care | No Intervention | No change in the conditions of referral of First Episod Psychosis (emergencies, hospitalizations, consultations) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRESTO Early Identification Program | Other | The program combines :
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients still in care | measurement of the number of patients continuing care | Week 4 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric FAKRA, MD PhD | Contact | (0)477127885 | +33 | eric.fakra@chu-st-etienne.fr |
| Amandine BAUDOT, CRA | Contact | (0)477829450 | +33 | amandine.baudot@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Eric FAKRA, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Recruiting | Bron | 69500 | France |
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| Week 4 |
| 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. | Week 4 |
| 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. | Week 4 |
| 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. | Week 4 |
| 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. | Baseline and week 4 |
| 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. | before the start and after the end of the PRESTO program |
| Chu Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
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| Chu Grenoble | Recruiting | Grenoble | 38000 | France |
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| CHU de Montpellier | Recruiting | Montpellier | 34090 | France |
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| CHU de Nîmes | Recruiting | Nîmes | 30900 | France |
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| Chu Saint Etienne | Recruiting | Saint-Etienne | 42100 | France |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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