Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis. Multicenter, Randomized Stepped-wedge Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 416
- 试验地点
- 12
- 主要终点
- Duration of untreated psychosis (DUP)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients already treated and followed for FPE
- •Brief psychotic state not requiring specific management
结局指标
主要结局
Duration of untreated psychosis (DUP)
时间窗: Baseline
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
次要结局
- Number of patients still in care(Week 4)
- Customer satisfaction(Week 4)
- Caregiver Burden(Baseline and week 4)
- Assessment of the context(before the start and after the end of the PRESTO program)
- Engagement in care(Week 4)
- treatment adherence(Week 4)
- therapeutic alliance(Week 4)