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.

Study Overview

• Status: Completed
• Conditions: Suicide, Attempted
• Intervention / Treatment: Other: Usual treatment and Prevention program; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Kremlin Bicetre, France, 94275
    • Assistance Publique - Hôpitaux de Paris : BICETRE Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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.; Other Names: Prevention program
Active Comparator: Control group; Usual treatment	Other: Usual Treatment; Usual Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
suicide attempts frequency	Number of occurrence of suicide attempts.	12 months
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Arnaud MARCHAND, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (Estimate): August 6, 2010

Study Record Updates

• Last Update Posted (Estimate): April 11, 2013
• Last Update Submitted That Met QC Criteria: April 10, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Suicide, Attempted; prevention suicidal act; telephone contact; professional coordination
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: OST08017