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Suicide Prevention Algorithm in the French Overseas Territories (APSOM)

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ClinicalTrials.gov Identifier: NCT03427190
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborators:
Centre Hospitalier de Monteran, Guadeloupe
Centre Hospitalier Universitaire de Pointe-a-Pitre
Centre Hospitalier de Cayenne
Centre Hospitalier de Ouest Guyanais Franck Joly
Centre d Accueil Psychiatrique Ouest-Centre, La Réunion
Centre d Accueil d Urgences Médico Psychologique, La Réunion
Centre d Accueil Psychiatrique Nord, La Réunion
Etablissement Publique de Santé Mentale de la Réunion
Information provided by (Responsible Party):
University Hospital Center of Martinique

Brief Summary:
In France, suicide behaviours are a major public health concern that triggered the creation in 2013 of a National Observatory of Suicide. In continental France, the "Algos" protocol was found to be effective for the prevention of suicide attempts reiterations. This protocol is based on a procedure that keeps telephone and postal contacts with the suicide attempter and allows, via an algorithm, to assess the risk of suicide attempt recurrence, in order to intervene if necessary. Nevertheless, Algos does not involve primary care health practitioners, who could add a substantial additional efficacy, especially if they intervene downstream and in supplement to Algos. In addition, this kind of protocol has never been evaluated in the French overseas territories.

Condition or disease Intervention/treatment Phase
Suicide Attempt Other: APSOM vs Control Not Applicable

Detailed Description:
Since (1) Algos was never implemented in the French overseas departments (FOD) and does not involve primary care practitioners (PCP), (2) the additional effect of PCP involvement over and beyond Algos alone in unknown, and (3) little research on suicide behaviours has been conducted in the FOD, this proposal has the following main aim: to assess the effectiveness and the efficacy of the intervention, in supplement and downstream to Algos, of a healthcare professional, on the recurrence of suicide attempts in the FOD; the healthcare professional will be the patient's general practitioner, whenever possible.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessment of Preventive Efficacy of an Algorithm Taking Place After Suicide Attempts Among Attempters Admitted to Hospital in the French Overseas Territories
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Phone contact with patient will be made by a professional psychologist within 21 days of hospital discharge. If contact cannot be made after 9 attempts, post-cards will be sent monthly at M2, M3, M4 and M5, asking the participant to establish contact with the designated psychologist. The phone call will determine whether or not the participant is in a state of suicidal crisis. If yes, steps will be taken to attend the crisis within 24 hours.
Other: APSOM vs Control
In complement to actions described in the control arm, the patient's general practitioner (GP) and the patient him/herself will be contacted within 21 days of hospital discharge in order to organize an appointment between them two; this consultation is expected to take place between day 22 and day 45 after hospital discharge. If the patient does not have a GP, a health-care professional (HCP) will be provided. .GP (or HCP) will also be contacted at 6 and 13 months.

APSOM
In complement to actions described in the control arm, the patient's general practitioner (GP) and the patient him/herself will be contacted within 21 days of hospital discharge in order to organize an appointment between them two; this consultation is expected to take place between day 22 and day 45 after hospital discharge. If the patient does not have a GP, a health-care professional (HCP) will be provided. .GP (or HCP) will also be contacted at 6 and 13 months.
Other: APSOM vs Control
In complement to actions described in the control arm, the patient's general practitioner (GP) and the patient him/herself will be contacted within 21 days of hospital discharge in order to organize an appointment between them two; this consultation is expected to take place between day 22 and day 45 after hospital discharge. If the patient does not have a GP, a health-care professional (HCP) will be provided. .GP (or HCP) will also be contacted at 6 and 13 months.




Primary Outcome Measures :
  1. Existence of a suicide [ Time Frame: 6 and 13 months ]
    Reiteration of suicidal attempt after hospital discharge


Secondary Outcome Measures :
  1. Number of suicide attempts [ Time Frame: 6 and 13 months after hospital discharge ]
    To know total number of suicide

  2. Number of deaths by suicide [ Time Frame: 6 and 13 months after hospital discharge ]
    To know number of deaths by suicide

  3. Scores at the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 and 13 months after hospital discharge ]
    Pass the scale HADS

  4. Assessment of suicidal risk by the Sad Persons Scale and the Columbia Suicide Severity Rating Scale (C-SSRS). [ Time Frame: 6 and 13 months after hospital discharge ]
    Pass the scale Columbia



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man or woman over 16 years of age
  • Leaving the hospital within 15 days of the suicide attempt
  • Giving (him/herself or his/her legal representative)an oral consent to participate in the study
  • Having healthcare insurance
  • Reachable by phone, with possibility of confidential conversation, and by mail
  • Resident of Guadeloupe, French Guyana, Martinique, or Reunion Island
  • Able to understand and speak French

Exclusion Criteria:

  • Homeless person
  • Disabled adult, person under judicial/court protection, legally incompetent adult
  • Participant unable to understand the study protocol, its risks and side effects, or declining to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427190


Contacts
Contact: Louis JEHEL, MD-PhD +596596552171 louis.jehel@chu-martinique.fr
Contact: Corine CARPIN, Clinical research associate +596596592696 ext 3382 corine.carpin@chu-martinique.fr

Locations
French Guiana
CH de Cayenne Not yet recruiting
Cayenne, French Guiana, 97306
Contact: Christine LURAT, MD    +594594395164      
CH Ouest Guyanais Not yet recruiting
Saint-Laurent du Maroni, French Guiana, 97393
Contact: Linette TEDONGMO, MD    +595594348888      
Guadeloupe
CHU de Pointe à Pitre Not yet recruiting
Les Abymes, Guadeloupe, 97189
Contact: Jean-Michel GAL, MD    +590590891123      
CH de Monteran Not yet recruiting
Saint-claude, Guadeloupe, 97120
Contact: Geoffrey MARCAGGI, MD    +590590805252      
Réunion
Etablissement Psychiatrique de Santé Mentale Recruiting
Saint-Benoit, Réunion, 97470
Contact: François APPAVOUPOULLE, MD         
Centre d'Accueil Psychiatrique Nord Recruiting
Saint-denis, Réunion, 97405
Contact: Agnès PASQUIER, MD         
Centre d'Accueil Psychiatrique Ouest-Centre Not yet recruiting
Saint-Paul, Réunion, 97863
Contact: Anne-Cécile JANIN, MD         
Centre d'Accueil d'Urgences Médico-Psychologique Recruiting
Saint-Pierre, Réunion, 97448
Contact: Gaël ROHR, MD         
Sponsors and Collaborators
University Hospital Center of Martinique
Centre Hospitalier de Monteran, Guadeloupe
Centre Hospitalier Universitaire de Pointe-a-Pitre
Centre Hospitalier de Cayenne
Centre Hospitalier de Ouest Guyanais Franck Joly
Centre d Accueil Psychiatrique Ouest-Centre, La Réunion
Centre d Accueil d Urgences Médico Psychologique, La Réunion
Centre d Accueil Psychiatrique Nord, La Réunion
Etablissement Publique de Santé Mentale de la Réunion

Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT03427190     History of Changes
Other Study ID Numbers: 15/B/04
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Center of Martinique:
Suicide
Suicide attempted
Secondary Prevention
Relapse prevention
Case Management
Intervention Study

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms