Clinical trial NCT03134885: Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters
Official title: Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters in the North-Pas de Calais Region of France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide, Attempted
Keywords: suicide
suicidal conducts
post discharge monitoring system
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Regional Agency of Sante Nord Pas-de-Calais
name: Région Nord-Pas de Calais, France
First posted: 2017-05-01
Enrollment: 12989
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: If patients had or not attempted suicide
timeFrame: 6 months
measure: Sex
timeFrame: 6 months
measure: Age
timeFrame: inclusion
measure: Marital status
timeFrame: inclusion
measure: Means of suicide attempts
timeFrame: 6 months
measure: Reason of suicide attempts
timeFrame: 6 months
measure: Length of the hospital stay at inclusion
timeFrame: inclusion
measure: Presence of accompanying people
timeFrame: inclusion
measure: MINI (Mini International Neuropsychiatric Interview) lifetime 5.5.0
timeFrame: 6 months
measure: Columbia Suicide Severity Rating Scale C-SSRS
timeFrame: 6 months
measure: Number of emergency calls
timeFrame: 6 months
measure: Number of subsequent suicide attempts
timeFrame: 6 months
measure: Number of hospitalization after a suicide attempt
timeFrame: 6 months
Secondary outcomes:
measure: Number of suicidal attempts in Nord-Pas de Calais region
timeFrame: each year during 3 years
measure: Local mortality by suicide
timeFrame: each year during 3 years
measure: Number of suicidal conducts in Picardie region
timeFrame: 1 year
measure: Number of hospital stays after a suicide attempt
timeFrame: each year during 3 years
measure: Care pathway
timeFrame: 1 year
measure: Number of "green cards" distributed
timeFrame: each year during 3 years
measure: Number of incoming and outgoing calls
timeFrame: each year during 3 years
measure: Number of phone intervention and of calls leading to triggering of emergency department
timeFrame: each year during 3 years
measure: Number of postcards sent
timeFrame: each year during 3 years
Other outcomes:
Locations:
city: Armentieres
country: France
facility: General Hospital, Armentieres
city: Arras
country: France
facility: General Hospital, Arras
city: Bethune
country: France
facility: General Hospital, Bethune
city: Boulogne sur Mer
country: France
facility: General Hospital, Boulogne sur Mer
city: Calais
country: France
facility: General Hospital, Calais
city: Cambrai
country: France
facility: General Hospital, Cambrai
city: Denain
country: France
facility: General Hospital, Denain
city: Douai
country: France
facility: General Hospital, Douai
city: Dunkerque
country: France
facility: General Hospital, Dunkerque
city: Fourmies
country: France
facility: General Hospital, Fourmies
city: Hazebrouck
country: France
facility: General Hospital, Hazebrouck
city: Henin-Beaumont
country: France
facility: Clinic Fleury, Hénin Beaumont
city: Henin-Beaumont
country: France
facility: Polyclinic, Henin-Beaumont
city: Lens
country: France
facility: General Hospital, Lens
city: Lievin
country: France
facility: Riaumont's Polyclinic, Liévin
city: Lille
country: France
facility: St Vincent's Hospital, Lille
city: Lille
country: France
facility: University Hospital, Lille
city: Lomme
country: France
facility: St Philibert's Hospital, Lomme
city: Maubeuge
country: France
facility: Genral Hospital, Maubeuge
city: Montreuil sur Mer
country: France
facility: General Hospital, Montreuil sur Mer
city: Roubaix
country: France
facility: General Hospital, Roubaix
city: Roubaix
country: France
facility: Lucien Bonnafé Hospital, Roubaix
city: Saint Omer
country: France
facility: General Hospital, St Omer
city: Saint Venant
country: France
facility: EPSM, St Venant
city: Seclin
country: France
facility: General Hospital, Seclin
city: Tourcoing
country: France
facility: EPSM, Tourcoing
city: Tourcoing
country: France
facility: General Hospital, Tourcoing
city: Valenciennes
country: France
facility: General Hospital, Valenciennes
Study officials:
affiliation: University Hospital, Lille
name: Guillaume Vaiva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.