Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt (OSTA)
Primary Purpose
Suicide, Attempted
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Usual treatment and Prevention program
Usual Treatment
Sponsored by
About this trial
This is an interventional prevention trial for Suicide, Attempted focused on measuring Suicide, Attempted, prevention suicidal act, telephone contact, professional coordination
Eligibility 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.
Sites / Locations
- Assistance Publique - Hôpitaux de Paris : BICETRE Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interventional group
Control group
Arm Description
Usual treatment + prevention program of recurrent suicidal acts
Usual treatment
Outcomes
Primary Outcome Measures
suicidal act frequency
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
Number of occurrence of suicide attempts.
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.
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.
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.
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.
Full Information
NCT ID
NCT01176929
First Posted
August 5, 2010
Last Updated
April 10, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01176929
Brief Title
Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt
Acronym
OSTA
Official Title
Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
Suicide, Attempted, prevention suicidal act, telephone contact, professional coordination
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Usual treatment + prevention program of recurrent suicidal acts
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Usual treatment
Intervention Type
Other
Intervention Name(s)
Usual treatment and Prevention program
Other Intervention Name(s)
Prevention program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Treatment
Intervention Description
Usual Treatment
Primary Outcome Measure Information:
Title
suicidal act frequency
Description
The primary endpoint is the occurrence of a suicidal act (occurrence or not). The suicidal act includes suicide and suicide attempt.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
suicide attempts frequency
Description
Number of occurrence of suicide attempts.
Time Frame
12 months
Title
Adherence to health care
Description
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.
Time Frame
12 months
Title
Number of eligibles persons
Description
Number of eligibles persons:
Number of people (among all people admitted to the emergency department fo a suicide attempt) meeting the criteria of selection.
Time Frame
12 months
Title
Number of participants responding to telephone calls
Description
Number of participants responding to telephone calls:
We consider the failure to call after three unsuccessful telephone calls to three different days.
Time Frame
12 months
Title
Number of people lost sight of
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud MARCHAND, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Paris : BICETRE Hospital
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33884617
Citation
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.
Results Reference
derived
Learn more about this trial
Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt
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