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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Le Kremlin Bicetre, Frankrike, 94275
- Assistance Publique - Hôpitaux de Paris : BICETRE Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Interventional group
Usual treatment + prevention program of recurrent suicidal acts
|
Prevention program of recurrent suicidal acts includes three interventions:
Andra namn:
|
|
Aktiv komparator: Control group
Usual treatment
|
Usual Treatment
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
suicidal act frequency
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
suicide attempts frequency
Tidsram: 12 months
|
Number of occurrence of suicide attempts.
|
12 months
|
|
Adherence to health care
Tidsram: 12 months
|
Adherence to health care: Defined by:
|
12 months
|
|
Number of eligibles persons
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Arnaud MARCHAND, MD, Assistance Publique - Hôpitaux de Paris
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OST08017
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