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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

August 5, 2010
April 10, 2013
October 2009
November 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01176929 on ClinicalTrials.gov Archive Site
  • 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.

Same as current
Not Provided
Not Provided
 
Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Suicide, Attempted
  • 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
  • Other: Usual Treatment
    Usual Treatment
    Other Name: Usual Treatment
  • Experimental: Interventional group
    Usual treatment + prevention program of recurrent suicidal acts
    Intervention: Other: Usual treatment and Prevention program
  • Active Comparator: Control group
    Usual treatment
    Intervention: Other: Usual Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01176929
OST08017
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Arnaud MARCHAND, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP