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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03134885
Other study ID # 2015_52
Secondary ID 2015-A01984-45
Status Completed
Phase
First received
Last updated
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
Health authority
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 centreā€¦). - 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

Study Design


Related Conditions & MeSH terms


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
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