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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01176929
First received: August 5, 2010
Last updated: April 10, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:

  • 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 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176929

Locations
France
Assistance Publique - Hôpitaux de Paris : BICETRE Hospital
Le Kremlin Bicetre, France, 94275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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 April 16, 2014