Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters

Suicide, Attempted Clinical Trial

— EVAL-VIGILANS  

Official title:

Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters in the North-Pas de Calais Region of France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134885
• Other study ID #: 2015_52
• Secondary ID: 2015-A01984-45
• Status: Completed
• Start date: September 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12989
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Locations

Country	Name	City	State
France	General Hospital, Armentieres	Armentieres
France	General Hospital, Arras	Arras
France	General Hospital, Bethune	Bethune
France	General Hospital, Boulogne sur Mer	Boulogne sur Mer
France	General Hospital, Calais	Calais
France	General Hospital, Cambrai	Cambrai
France	General Hospital, Denain	Denain
France	General Hospital, Douai	Douai
France	General Hospital, Dunkerque	Dunkerque
France	General Hospital, Fourmies	Fourmies
France	General Hospital, Hazebrouck	Hazebrouck
France	Clinic Fleury, Hénin Beaumont	Henin-Beaumont
France	Polyclinic, Henin-Beaumont	Henin-Beaumont
France	General Hospital, Lens	Lens
France	Riaumont's Polyclinic, Liévin	Lievin
France	St Vincent's Hospital, Lille	Lille
France	University Hospital, Lille	Lille
France	St Philibert's Hospital, Lomme	Lomme
France	Genral Hospital, Maubeuge	Maubeuge
France	General Hospital, Montreuil sur Mer	Montreuil sur Mer
France	General Hospital, Roubaix	Roubaix
France	Lucien Bonnafé Hospital, Roubaix	Roubaix
France	General Hospital, St Omer	Saint Omer
France	EPSM, St Venant	Saint Venant
France	General Hospital, Seclin	Seclin
France	EPSM, Tourcoing	Tourcoing
France	General Hospital, Tourcoing	Tourcoing
France	General Hospital, Valenciennes	Valenciennes

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Région Nord-Pas de Calais, France, Regional Agency of Sante Nord Pas-de-Calais

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	If patients had or not attempted suicide	Yes or no	6 months
Primary	Sex		6 months
Primary	Age		inclusion
Primary	Marital status		inclusion
Primary	Means of suicide attempts		6 months
Primary	Reason of suicide attempts		6 months
Primary	Length of the hospital stay at inclusion		inclusion
Primary	Presence of accompanying people		inclusion
Primary	MINI (Mini International Neuropsychiatric Interview) lifetime 5.5.0	psychopathological evaluation	6 months
Primary	Columbia Suicide Severity Rating Scale C-SSRS	review of suicidal behaviours and thoughts	6 months
Primary	Number of emergency calls		6 months
Primary	Number of subsequent suicide attempts		6 months
Primary	Number of hospitalization after a suicide attempt		6 months
Secondary	Number of suicidal attempts in Nord-Pas de Calais region		each year during 3 years
Secondary	Local mortality by suicide		each year during 3 years
Secondary	Number of suicidal conducts in Picardie region		1 year
Secondary	Number of hospital stays after a suicide attempt	Obtained from PMSI's data (French register of hospitals economics management)	each year during 3 years
Secondary	Care pathway	GP or psychiatrist appointments, medical treatment, and hospitalization in psychiatric facility : with CNAM (National health insurance system) data	1 year
Secondary	Number of "green cards" distributed		each year during 3 years
Secondary	Number of incoming and outgoing calls		each year during 3 years
Secondary	Number of phone intervention and of calls leading to triggering of emergency department		each year during 3 years
Secondary	Number of postcards sent		each year during 3 years