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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014