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Suicide Prevention Algorithm in the French Overseas Territories (APSOM)

Primary Purpose

Suicide Attempt

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
APSOM vs Control
Sponsored by
University Hospital Center of Martinique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide Attempt focused on measuring Suicide, Suicide attempted, Secondary Prevention, Relapse prevention, Case Management, Intervention Study

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH de Cayenne
  • CH Ouest Guyanais
  • CHU de Pointe à Pitre
  • CH de Monteran
  • CHU Martinique
  • Etablissement Psychiatrique de Santé Mentale
  • Centre d'Accueil Psychiatrique Nord
  • Centre d'Accueil Psychiatrique Ouest-Centre
  • Centre d'Accueil d'Urgences Médico-Psychologique

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Control

APSOM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Existence of a suicide
Reiteration of suicidal attempt after hospital discharge
Existence of a suicide
Reiteration of suicidal attempt after hospital discharge

Secondary Outcome Measures

Number of suicide attempts
To know total number of suicide
Number of deaths by suicide
To know number of deaths by suicide
Scores at the Hospital Anxiety and Depression Scale (HADS)
Pass the scale HADS
Assessment of suicidal risk by the Sad Persons Scale and the Columbia Suicide Severity Rating Scale (C-SSRS).
Pass the scale Columbia

Full Information

First Posted
January 30, 2017
Last Updated
January 26, 2021
Sponsor
University Hospital Center of Martinique
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
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1. Study Identification

Unique Protocol Identification Number
NCT03427190
Brief Title
Suicide Prevention Algorithm in the French Overseas Territories
Acronym
APSOM
Official Title
Assessment of Preventive Efficacy of an Algorithm Taking Place After Suicide Attempts Among Attempters Admitted to Hospital in the French Overseas Territories
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
October 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Attempt
Keywords
Suicide, Suicide attempted, Secondary Prevention, Relapse prevention, Case Management, Intervention Study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
259 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
APSOM
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
APSOM vs Control
Intervention Description
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 Measure Information:
Title
Existence of a suicide
Description
Reiteration of suicidal attempt after hospital discharge
Time Frame
6 months
Title
Existence of a suicide
Description
Reiteration of suicidal attempt after hospital discharge
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Number of suicide attempts
Description
To know total number of suicide
Time Frame
6 and 13 months after hospital discharge
Title
Number of deaths by suicide
Description
To know number of deaths by suicide
Time Frame
6 and 13 months after hospital discharge
Title
Scores at the Hospital Anxiety and Depression Scale (HADS)
Description
Pass the scale HADS
Time Frame
6 and 13 months after hospital discharge
Title
Assessment of suicidal risk by the Sad Persons Scale and the Columbia Suicide Severity Rating Scale (C-SSRS).
Description
Pass the scale Columbia
Time Frame
6 and 13 months after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JEHEL Louis, MD-PhD
Organizational Affiliation
CHU de Martinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH de Cayenne
City
Cayenne
ZIP/Postal Code
97306
Country
French Guiana
Facility Name
CH Ouest Guyanais
City
Saint-Laurent du Maroni
ZIP/Postal Code
97393
Country
French Guiana
Facility Name
CHU de Pointe à Pitre
City
Les Abymes
ZIP/Postal Code
97189
Country
Guadeloupe
Facility Name
CH de Monteran
City
Saint-claude
ZIP/Postal Code
97120
Country
Guadeloupe
Facility Name
CHU Martinique
City
Fort-de-France
ZIP/Postal Code
97261
Country
Martinique
Facility Name
Etablissement Psychiatrique de Santé Mentale
City
Saint-Benoit
ZIP/Postal Code
97470
Country
Réunion
Facility Name
Centre d'Accueil Psychiatrique Nord
City
Saint-denis
ZIP/Postal Code
97405
Country
Réunion
Facility Name
Centre d'Accueil Psychiatrique Ouest-Centre
City
Saint-Paul
ZIP/Postal Code
97863
Country
Réunion
Facility Name
Centre d'Accueil d'Urgences Médico-Psychologique
City
Saint-Pierre
ZIP/Postal Code
97448
Country
Réunion

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived

Learn more about this trial

Suicide Prevention Algorithm in the French Overseas Territories

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