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

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT03134885
Collaborator
Regional Agency of Sante Nord Pas-de-Calais (Other), Région Nord-Pas de Calais, France (Other)
16,000
28
51
571.4
11.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    16000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters in the North-Pas de Calais Region of France
    Actual Study Start Date :
    Sep 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. If patients had or not attempted suicide [6 months]

      Yes or no

    2. Sex [6 months]

    3. Age [inclusion]

    4. Marital status [inclusion]

    5. Means of suicide attempts [6 months]

    6. Reason of suicide attempts [6 months]

    7. Length of the hospital stay at inclusion [inclusion]

    8. Presence of accompanying people [inclusion]

    9. MINI (Mini International Neuropsychiatric Interview) lifetime 5.5.0 [6 months]

      psychopathological evaluation

    10. Columbia Suicide Severity Rating Scale C-SSRS [6 months]

      review of suicidal behaviours and thoughts

    11. Number of emergency calls [6 months]

    12. Number of subsequent suicide attempts [6 months]

    13. Number of hospitalization after a suicide attempt [6 months]

    Secondary Outcome Measures

    1. Number of suicidal attempts in Nord-Pas de Calais region [each year during 3 years]

    2. Local mortality by suicide [each year during 3 years]

    3. Number of suicidal conducts in Picardie region [1 year]

    4. Number of hospital stays after a suicide attempt [each year during 3 years]

      Obtained from PMSI's data (French register of hospitals economics management)

    5. Care pathway [1 year]

      GP or psychiatrist appointments, medical treatment, and hospitalization in psychiatric facility : with CNAM (National health insurance system) data

    6. Number of "green cards" distributed [each year during 3 years]

    7. Number of incoming and outgoing calls [each year during 3 years]

    8. Number of phone intervention and of calls leading to triggering of emergency department [each year during 3 years]

    9. Number of postcards sent [each year during 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital, Armentieres Armentieres France
    2 General Hospital, Arras Arras France
    3 General Hospital, Bethune Bethune France
    4 General Hospital, Boulogne sur Mer Boulogne sur Mer France
    5 General Hospital, Calais Calais France
    6 General Hospital, Cambrai Cambrai France
    7 General Hospital, Denain Denain France
    8 General Hospital, Douai Douai France
    9 General Hospital, Dunkerque Dunkerque France
    10 General Hospital, Fourmies Fourmies France
    11 General Hospital, Hazebrouck Hazebrouck France
    12 Clinic Fleury, Hénin Beaumont Henin-Beaumont France
    13 Polyclinic, Henin-Beaumont Henin-Beaumont France
    14 General Hospital, Lens Lens France
    15 Riaumont's Polyclinic, Liévin Lievin France
    16 St Vincent's Hospital, Lille Lille France
    17 University Hospital, Lille Lille France
    18 St Philibert's Hospital, Lomme Lomme France
    19 Genral Hospital, Maubeuge Maubeuge France
    20 General Hospital, Montreuil sur Mer Montreuil sur Mer France
    21 General Hospital, Roubaix Roubaix France
    22 Lucien Bonnafé Hospital, Roubaix Roubaix France
    23 General Hospital, St Omer Saint Omer France
    24 EPSM, St Venant Saint Venant France
    25 General Hospital, Seclin Seclin France
    26 EPSM, Tourcoing Tourcoing France
    27 General Hospital, Tourcoing Tourcoing France
    28 General Hospital, Valenciennes Valenciennes France

    Sponsors and Collaborators

    • University Hospital, Lille
    • Regional Agency of Sante Nord Pas-de-Calais
    • Région Nord-Pas de Calais, France

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT03134885
    Other Study ID Numbers:
    • 2015_52
    • 2015-A01984-45
    First Posted:
    May 1, 2017
    Last Update Posted:
    Sep 10, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University Hospital, Lille
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 10, 2020