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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Le Kremlin Bicetre, France, 94275
- Assistance Publique - Hôpitaux de Paris : BICETRE Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Interventional group
Usual treatment + prevention program of recurrent suicidal acts
|
Prevention program of recurrent suicidal acts includes three interventions:
Autres noms:
|
|
Comparateur actif: Control group
Usual treatment
|
Usual Treatment
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
suicidal act frequency
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
suicide attempts frequency
Délai: 12 months
|
Number of occurrence of suicide attempts.
|
12 months
|
|
Adherence to health care
Délai: 12 months
|
Adherence to health care: Defined by:
|
12 months
|
|
Number of eligibles persons
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Arnaud MARCHAND, MD, Assistance Publique - Hôpitaux de Paris
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OST08017
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