Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt

Suicide, Attempted Clinical Trial

— OSTA  

Official title:

Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176929
• Other study ID #: OST08017
• Status: Completed
• Phase: N/A
• First received: August 5, 2010
• Last updated: April 10, 2013
• Start date: October 2009
• Est. completion date: November 2012

Study information

• Verified date: April 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

Other:
• Usual treatment and Prevention program
Prevention program of recurrent suicidal acts 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.
• Usual Treatment
Usual Treatment

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris : BICETRE Hospital	Le Kremlin Bicetre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	suicidal act frequency	The primary endpoint is the occurrence of a suicidal act (occurrence or not). The suicidal act includes suicide and suicide attempt.	12 months	No
Secondary	suicide attempts frequency	Number of occurrence of suicide attempts.	12 months	No
Secondary	Adherence to health care	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.	12 months	No
Secondary	Number of eligibles persons	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	No
Secondary	Number of participants responding to telephone calls	Number of participants responding to telephone calls: We consider the failure to call after three unsuccessful telephone calls to three different days.	12 months	No
Secondary	Number of people lost sight of	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	Yes