- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03134885
Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters (EVAL-VIGILANS)
Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters in the North-Pas de Calais Region of France
VigilanS is an innovative healthcare program. Participants of this program are all patients leaving in the Nord-Pas de Calais region who survived a suicide attempt.
General goals of the post hospitalization monitoring system for suicidal attempters are:
- Standardize general healthcare's practices by offering alert networks and innovative response procedures in case of suicidal crisis.
- Coordinate the various health partners' actions around the patient (GP, psychiatrist, psychologist).
- Contribute to reducing mortality and morbidity by suicide (subsequent suicide) in determined territories.
The evaluation of VigilanS will be quantitative and qualitative.
Study Overview
Status
Conditions
Detailed Description
Every patient who is discharged after a suicidal gesture will be proposed to enter the program. He will be handed a "green card" with a toll-free and unique phone number and an information letter which explains the program and his rights as a patient.
Phone calls Calling team is composed of 4 psychologists and 3 psychiatric nurses especially trained to detect and manage suicidal crises. Monday to Friday, from 9 AM until 6 PM, there is two callers located in the emergencies' calling center. They will give calls to patients after their entry in the program and they will also receive incoming calls at the number available on "green cards" handed to patients.
Calls 10 days after discharge
Subjects who did at least two suicidal attempts before entering the VigilanS program will be call 10 to 20 days after their discharge from the hospital.
After every call, a short report is sent to the patient psychiatrist or his GP. 6 months calls
For every suicide attempters included in the program, a call is planned at the end of the sixth month after discharge from the hospital. This call aims to make a clinical review of patient and propose the end of the monitoring. If needed, the monitoring program can be reset for a 6 months period. In order to structure the call and gather data on the program evaluation, the six months call includes a psychological assessment by Mini International Neuropsychiatric Interview / MINI DSM V (Sheehan et al. 1998) and by the Columbia Suicide Severity rating Scale C-SSRS (Posner et al. 2011) as well as a global satisfactory survey on the program. If a contacted subject represents a high suicide risk, callers can trigger various actions like in a 10 days call.
If patient is unreachable a unique postcard will be sent to remind him of VigilanS coordinates. After every call, a short report is sent to the patient psychiatrist or his GP.
Postcards After every contact, but mostly after a 10 days call, the caller can decide to send 4 personalized post cards to a patient. One postcard is sent by month on a period of four months. Cards are embodied by patient name, logo of the structure which included him and coordinates of including department.
Quantitative evaluation will assess:
- Profiles of patients with good respond to the program or not (who had or not attempted suicide within 6 months)
- Development of partnership within the program (number of facilities sharing the system, number of patients in the program compared to overall number of suicide attempters addressed to one centre…).
Program efficiency "in real life" on reduction of suicidal conducts. Using four comparator tools :
- Evolution of suicidal conducts since the implementation of VigilanS in a specific center (comparison "before / after").
- Evolution of suicidal conducts between a region implementing VigilanS and a region which doesn't, upon the same period of time (comparison "here/there").
- Comparison of subsequent suicide attempts rate between patients in VigilanS and patients benefiting of "treatment as usual", within a year.
- Comparison of mortality by suicide rate.
- The impact of VigilanS on a patient's care pathway based on data from CNAMTS' database (National health insurance system).
Qualitative evaluation will assess the system acceptability by patients and professionals and also the variation of representations of suicide by different professionals which are in contact with suicidal patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Armentieres, France
- General Hospital, Armentieres
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Arras, France
- General Hospital, Arras
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Bethune, France
- General Hospital, Bethune
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Boulogne sur Mer, France
- General Hospital, Boulogne sur Mer
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Calais, France
- General Hospital, Calais
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Cambrai, France
- General Hospital, Cambrai
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Denain, France
- General Hospital, Denain
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Douai, France
- General Hospital, Douai
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Dunkerque, France
- General Hospital, Dunkerque
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Fourmies, France
- General Hospital, Fourmies
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Hazebrouck, France
- General Hospital, Hazebrouck
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Henin-Beaumont, France
- Clinic Fleury, Hénin Beaumont
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Henin-Beaumont, France
- Polyclinic, Henin-Beaumont
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Lens, France
- General Hospital, Lens
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Lievin, France
- Riaumont's Polyclinic, Liévin
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Lille, France
- University Hospital, Lille
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Lille, France
- St Vincent's Hospital, Lille
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Lomme, France
- St Philibert's Hospital, Lomme
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Maubeuge, France
- Genral Hospital, Maubeuge
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Montreuil sur Mer, France
- General Hospital, Montreuil sur Mer
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Roubaix, France
- General Hospital, Roubaix
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Roubaix, France
- Lucien Bonnafé Hospital, Roubaix
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Saint Omer, France
- General Hospital, St Omer
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Saint Venant, France
- EPSM, St Venant
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Seclin, France
- General Hospital, Seclin
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Tourcoing, France
- General Hospital, Tourcoing
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Tourcoing, France
- EPSM, Tourcoing
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Valenciennes, France
- General Hospital, Valenciennes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- leaving in the Nord-Pas de Calais region
- entering in the VigilanS program after a suicide attempt
Exclusion Criteria:
- refusal to enter in the program
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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VigilanS Nord-Pas de Calais cohort
All patients leaving in the Nord-Pas de Calais region and entering in the VigilanS program after a suicide attempt
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
If patients had or not attempted suicide
Time Frame: 6 months
|
Yes or no
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6 months
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Sex
Time Frame: 6 months
|
6 months
|
|
Age
Time Frame: inclusion
|
inclusion
|
|
Marital status
Time Frame: inclusion
|
inclusion
|
|
Means of suicide attempts
Time Frame: 6 months
|
6 months
|
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Reason of suicide attempts
Time Frame: 6 months
|
6 months
|
|
Length of the hospital stay at inclusion
Time Frame: inclusion
|
inclusion
|
|
Presence of accompanying people
Time Frame: inclusion
|
inclusion
|
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MINI (Mini International Neuropsychiatric Interview) lifetime 5.5.0
Time Frame: 6 months
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psychopathological evaluation
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6 months
|
Columbia Suicide Severity Rating Scale C-SSRS
Time Frame: 6 months
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review of suicidal behaviours and thoughts
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6 months
|
Number of emergency calls
Time Frame: 6 months
|
6 months
|
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Number of subsequent suicide attempts
Time Frame: 6 months
|
6 months
|
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Number of hospitalization after a suicide attempt
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of suicidal attempts in Nord-Pas de Calais region
Time Frame: each year during 3 years
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each year during 3 years
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Local mortality by suicide
Time Frame: each year during 3 years
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each year during 3 years
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Number of suicidal conducts in Picardie region
Time Frame: 1 year
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1 year
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Number of hospital stays after a suicide attempt
Time Frame: each year during 3 years
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Obtained from PMSI's data (French register of hospitals economics management)
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each year during 3 years
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Care pathway
Time Frame: 1 year
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GP or psychiatrist appointments, medical treatment, and hospitalization in psychiatric facility : with CNAM (National health insurance system) data
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1 year
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Number of "green cards" distributed
Time Frame: each year during 3 years
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each year during 3 years
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Number of incoming and outgoing calls
Time Frame: each year during 3 years
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each year during 3 years
|
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Number of phone intervention and of calls leading to triggering of emergency department
Time Frame: each year during 3 years
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each year during 3 years
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Number of postcards sent
Time Frame: each year during 3 years
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each year during 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillaume Vaiva, MD, PhD, University Hospital, Lille
Publications and helpful links
General Publications
- Fossi LD, Debien C, Demarty AL, Vaiva G, Messiah A. Suicide reattempt in a population-wide brief contact intervention to prevent suicide attempts: The VigilanS program, France. Eur Psychiatry. 2021 Jul 16;64(1):e57. doi: 10.1192/j.eurpsy.2021.2221.
- Duhem S, Berrouiguet S, Debien C, Ducrocq F, Demarty AL, Messiah A, Courtet P, Jehel L, Thomas P, Deplanque D, Danel T, Walter M, Notredame CE, Vaiva G. Combining brief contact interventions (BCI) into a decision-making algorithm to reduce suicide reattempt: the VigilanS study protocol. BMJ Open. 2018 Oct 23;8(10):e022762. doi: 10.1136/bmjopen-2018-022762.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015_52
- 2015-A01984-45 (Other Identifier: ID-RCB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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