Suicide, AttemptedEVAL-VIGILANSNCT03134885
Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters
An observational study of Suicide, Attempted, run by University Hospital, Lille at 28 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Suicide, Attempted
- How many people
- 12,989 participants
- Where
- 28 sitesFrance
- Study dates
- Sep 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients leaving in the Nord-Pas de Calais region who survived a suicide attempt and entering in the VigilanS program when they discharge from the hospital
Who may be able to join
- leaving in the Nord-Pas de Calais region
- entering in the VigilanS program after a suicide attempt
Who cannot join
- refusal to enter in the program
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
France28 sites
General Hospital, Armentieres
Armentières
General Hospital, Arras
Arras
General Hospital, Bethune
Béthune
General Hospital, Boulogne sur Mer
Boulogne-sur-Mer
General Hospital, Calais
Calais
General Hospital, Cambrai
Cambrai
General Hospital, Denain
Denain
General Hospital, Douai
Douai
General Hospital, Dunkerque
Dunkirk
General Hospital, Fourmies
Fourmies
General Hospital, Hazebrouck
Hazebrouck
Clinic Fleury, Hénin Beaumont
Hénin-Beaumont
Polyclinic, Henin-Beaumont
Hénin-Beaumont
General Hospital, Lens
Lens
Riaumont's Polyclinic, Liévin
Liévin
St Vincent's Hospital, Lille
Lille, Lille
University Hospital, Lille
Lille
St Philibert's Hospital, Lomme
Lomme
Genral Hospital, Maubeuge
Maubeuge
General Hospital, Montreuil sur Mer
Montreuil-sur-Mer
General Hospital, Roubaix
Roubaix
Lucien Bonnafé Hospital, Roubaix
Roubaix
General Hospital, St Omer
Saint-Omer
EPSM, St Venant
Saint-Venant
General Hospital, Seclin
Seclin
EPSM, Tourcoing
Tourcoing
General Hospital, Tourcoing
Tourcoing
General Hospital, Valenciennes
Valenciennes
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide, Attempted
- Keywords
- suicide, suicidal conducts, post discharge monitoring system
- Medical subject headings
- Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
If patients had or not attempted suicide
Yes or no
Measured: 6 months
Sex
Measured: 6 months
Age
Measured: inclusion
Marital status
Measured: inclusion
Means of suicide attempts
Measured: 6 months
Reason of suicide attempts
Measured: 6 months
Length of the hospital stay at inclusion
Measured: inclusion
Presence of accompanying people
Measured: inclusion
MINI (Mini International Neuropsychiatric Interview) lifetime 5.5.0
psychopathological evaluation
Measured: 6 months
Columbia Suicide Severity Rating Scale C-SSRS
review of suicidal behaviours and thoughts
Measured: 6 months
Number of emergency calls
Measured: 6 months
Number of subsequent suicide attempts
Measured: 6 months
Number of hospitalization after a suicide attempt
Measured: 6 months
Secondary outcomes (9)
Number of suicidal attempts in Nord-Pas de Calais region
Measured: each year during 3 years
Local mortality by suicide
Measured: each year during 3 years
Number of suicidal conducts in Picardie region
Measured: 1 year
Number of hospital stays after a suicide attempt
Obtained from PMSI's data (French register of hospitals economics management)
Measured: each year during 3 years
Care pathway
GP or psychiatrist appointments, medical treatment, and hospitalization in psychiatric facility : with CNAM (National health insurance system) data
Measured: 1 year
Number of "green cards" distributed
Measured: each year during 3 years
Number of incoming and outgoing calls
Measured: each year during 3 years
Number of phone intervention and of calls leading to triggering of emergency department
Measured: each year during 3 years
Number of postcards sent
Measured: each year during 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startSep 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,989 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Agency of Sante Nord Pas-de-Calais, Région Nord-Pas de Calais, France
- Responsible party
- Sponsor
- Investigators
- Guillaume Vaiva, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134885
- Sponsor's protocol ID
- 2015_52
- Other IDs
- 2015-A01984-45
- Acronym
- EVAL-VIGILANS
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2017
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 34266505Demesmaeker A, Creupelandt C, Leroy A, Vaiva G, D'Hondt F. Impact of posttraumatic stress disorder and comorbid psychiatric conditions on suicide reattempts. Eur J Psychotraumatol. 2025 Dec;16(1):2461435. doi: 10.1080/20008066.2025.2461435. Epub 2025 Feb 12.
PubMed 39936356Demesmaeker A, Amad A, Chazard E, Demarty AL, Schlienger H, Lehmann E, Debien C, Jardon V, Bounebache K, Rey G, Vaiva G. Suicide and All-Cause Mortality Within 1 Year After a Suicide Attempt in the VigilanS Cohort. J Clin Psychiatry. 2023 Sep 11;84(6):22m14520. doi: 10.4088/JCP.22m14520.
PubMed 37707316Duhem 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.
PubMed 30355792
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters in the North-Pas de Calais Region of France
- ClinicalTrials.gov ID
- NCT03134885
- Acronym / sponsor ID
- EVAL-VIGILANS / 2015_52
- Conditions
- Suicide, Attempted
- Keywords
- suicide, suicidal conducts, post discharge monitoring system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,989 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Regional Agency of Sante Nord Pas-de-Calais, Région Nord-Pas de Calais, France
- Study start
- Sep 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients leaving in the Nord-Pas de Calais region who survived a suicide attempt and entering in the VigilanS program when they discharge from the hospital
Key inclusion criteria (2 listed)
- leaving in the Nord-Pas de Calais region
- entering in the VigilanS program after a suicide attempt
Key exclusion criteria (1 listed)
- refusal to enter in the program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
If patients had or not attempted suicide
Time frame: 6 months
Yes or no
Sex
Time frame: 6 months
Age
Time frame: inclusion
Marital status
Time frame: inclusion
Means of suicide attempts
Time frame: 6 months
Reason of suicide attempts
Time frame: 6 months
Length of the hospital stay at inclusion
Time frame: inclusion
Presence of accompanying people
Time frame: inclusion
MINI (Mini International Neuropsychiatric Interview) lifetime 5.5.0
Time frame: 6 months
psychopathological evaluation
Columbia Suicide Severity Rating Scale C-SSRS
Time frame: 6 months
review of suicidal behaviours and thoughts
Number of emergency calls
Time frame: 6 months
Number of subsequent suicide attempts
Time frame: 6 months
Number of hospitalization after a suicide attempt
Time frame: 6 months
9 secondary outcomes
Number of suicidal attempts in Nord-Pas de Calais region
Time frame: each year during 3 years
Local mortality by suicide
Time frame: each year during 3 years
Number of suicidal conducts in Picardie region
Time frame: 1 year
Number of hospital stays after a suicide attempt
Time frame: each year during 3 years
Care pathway
Time frame: 1 year
Number of "green cards" distributed
Time frame: each year during 3 years
Number of incoming and outgoing calls
Time frame: each year during 3 years
Number of phone intervention and of calls leading to triggering of emergency department
Time frame: each year during 3 years
Number of postcards sent
Time frame: each year during 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 34266505Fossi 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.
- Derived from this study: PubMed 39936356Demesmaeker A, Creupelandt C, Leroy A, Vaiva G, D'Hondt F. Impact of posttraumatic stress disorder and comorbid psychiatric conditions on suicide reattempts. Eur J Psychotraumatol. 2025 Dec;16(1):2461435. doi: 10.1080/20008066.2025.2461435. Epub 2025 Feb 12.
- Derived from this study: PubMed 37707316Demesmaeker A, Amad A, Chazard E, Demarty AL, Schlienger H, Lehmann E, Debien C, Jardon V, Bounebache K, Rey G, Vaiva G. Suicide and All-Cause Mortality Within 1 Year After a Suicide Attempt in the VigilanS Cohort. J Clin Psychiatry. 2023 Sep 11;84(6):22m14520. doi: 10.4088/JCP.22m14520.
- Derived from this study: PubMed 30355792Duhem 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Vaiva, MD, PhD principal investigator
University Hospital, Lille
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide, Attempted, run by University Hospital, Lille at 28 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
If patients had or not attempted suicide (time frame: 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03134885, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.