Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt (OSTA)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Suicide, Attempted |
Other: Usual treatment and Prevention program Other: Usual Treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts |
- suicidal act frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]The primary endpoint is the occurrence of a suicidal act (occurrence or not). The suicidal act includes suicide and suicide attempt.
- suicide attempts frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]Number of occurrence of suicide attempts.
- Adherence to health care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Adherence to health care:
Defined by:
- The Initialization of outpatient care proposed by the suicidology's team at the initial interview or during telephone contacts.
- The number of consultations within 3 months after the first appointment with the referring doctor.
- Number of eligibles persons [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Number of eligibles persons:
Number of people (among all people admitted to the emergency department fo a suicide attempt) meeting the criteria of selection.
- Number of participants responding to telephone calls [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Number of participants responding to telephone calls:
We consider the failure to call after three unsuccessful telephone calls to three different days.
- Number of people lost sight of [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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.
| Enrollment: | 320 |
| Study Start Date: | October 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Interventional group
Usual treatment + prevention program of recurrent suicidal acts
|
Other: Usual treatment and Prevention program
Prevention program of recurrent suicidal acts includes three interventions:
Other Name: Prevention program
|
|
Active Comparator: Control group
Usual treatment
|
Other: Usual Treatment
Usual Treatment
Other Name: Usual Treatment
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| France | |
| Assistance Publique - Hôpitaux de Paris : BICETRE Hospital | |
| Le Kremlin Bicetre, France, 94275 | |
| Principal Investigator: | Arnaud MARCHAND, MD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01176929 History of Changes |
| Other Study ID Numbers: | OST08017 |
| Study First Received: | August 5, 2010 |
| Last Updated: | April 10, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Suicide, Attempted prevention suicidal act telephone contact professional coordination |
Additional relevant MeSH terms:
|
Suicide Suicide, Attempted Self-Injurious Behavior Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013