Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt (OSTA)
Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts
The prevention of recurrent suicidal about people who have made a suicide attempt is a major strand in the prevention of suicide. It is estimated that 10-15 % of people who made a suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at one year. Most people who made a suicide attempt receive ambulatory monitoring. On this population, there is a low adherence to care.
The main objective of the study is to test the effectiveness of a prevention program of recurrent suicidal acts for people who made a suicide attempt.
The secondary objectives of this study are the assessment of adherence to care; the identification of sub - populations benefiting most from this program; the evaluation of the possible generalization level of the program (eligibles persons rate) and its feasibility level.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomized, controlled and prospective trial comparing an experimental group (usual treatment + interventions) to a control group (usual treatment only). All participants are evaluated after one year of monitoring. The search duration is 2 years (one inclusion year and one year of follow-up). It is planned to include 330 patients, 165 patients in each group.
The program (experimental group) includes three interventions:
- A series of three telephone calls ( the second week , one month and three months after discharge from hospital )
- A systematic telephone contact with the referring physician
- A telephone helpline for people who made a suicide attempt and referring physicians.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Le Kremlin Bicetre, Francia, 94275
- Assistance Publique - Hôpitaux de Paris : BICETRE Hospital
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults ≥ 18 years.
- Patients admitted to the emergency department for a suicide attempt.
- Patients referred to outpatient care.
- Patients who have given their written consent.
Exclusion Criteria:
- Patients not affiliated to social security.
- Patients do not have the faculties needed to be evaluated (cognitive or delusional disorder).
- Patients hospitalized for longer than 72 hours.
- Patients can not be recalled by phone (no phone, homeless, incarcerated)
- Patients who do not speak French.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Interventional group
Usual treatment + prevention program of recurrent suicidal acts
|
Prevention program of recurrent suicidal acts includes three interventions:
Otros nombres:
|
|
Comparador activo: Control group
Usual treatment
|
Usual Treatment
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
suicidal act frequency
Periodo de tiempo: 12 months
|
The primary endpoint is the occurrence of a suicidal act (occurrence or not).
The suicidal act includes suicide and suicide attempt.
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
suicide attempts frequency
Periodo de tiempo: 12 months
|
Number of occurrence of suicide attempts.
|
12 months
|
|
Adherence to health care
Periodo de tiempo: 12 months
|
Adherence to health care: Defined by:
|
12 months
|
|
Number of eligibles persons
Periodo de tiempo: 12 months
|
Number of eligibles persons: Number of people (among all people admitted to the emergency department fo a suicide attempt) meeting the criteria of selection. |
12 months
|
|
Number of participants responding to telephone calls
Periodo de tiempo: 12 months
|
Number of participants responding to telephone calls: We consider the failure to call after three unsuccessful telephone calls to three different days. |
12 months
|
|
Number of people lost sight of
Periodo de tiempo: 12 months
|
Number of people lost sight of: A person is considered lost sight if no information can be obtained after contact with the person himself, a third (nearest designated), a doctor (general practitioner and / or psychiatrist) and the nearest emergency department. |
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arnaud MARCHAND, MD, Assistance Publique - Hôpitaux de Paris
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OST08017
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