Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters (EVAL-VIGILANS)

October 24, 2022 updated by: University Hospital, Lille

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

Completed

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

Observational

Enrollment (Actual)

12989

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
6 months
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
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
MINI (Mini International Neuropsychiatric Interview) lifetime 5.5.0
Time Frame: 6 months
psychopathological evaluation
6 months
Columbia Suicide Severity Rating Scale C-SSRS
Time Frame: 6 months
review of suicidal behaviours and thoughts
6 months
Number of emergency calls
Time Frame: 6 months
6 months
Number of subsequent suicide attempts
Time Frame: 6 months
6 months
Number of hospitalization after a suicide attempt
Time Frame: 6 months
6 months

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
each year during 3 years
Local mortality by suicide
Time Frame: each year during 3 years
each year during 3 years
Number of suicidal conducts in Picardie region
Time Frame: 1 year
1 year
Number of hospital stays after a suicide attempt
Time Frame: each year during 3 years
Obtained from PMSI's data (French register of hospitals economics management)
each year during 3 years
Care pathway
Time Frame: 1 year
GP or psychiatrist appointments, medical treatment, and hospitalization in psychiatric facility : with CNAM (National health insurance system) data
1 year
Number of "green cards" distributed
Time Frame: each year during 3 years
each year during 3 years
Number of incoming and outgoing calls
Time Frame: each year during 3 years
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
each year during 3 years
Number of postcards sent
Time Frame: each year during 3 years
each year during 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guillaume Vaiva, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

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)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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