Effectiveness of a Case Management Algorithm: ALGOS After a Suicide Attempt
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Purpose
The suicidal behaviors are phenomena eminently multifactorial. It is thus always difficult to define univocal strategies of prevention of suicide repetition, during the emergency stay, i.e. almost in general population. One find 23 clinical trials in this topic in the past 25 years, and 18 are negative. The majority of the positive trials have the concern of being dissociated from an assumption of responsibility of care strictly speaking, to adopt a position "méta", nearer to the concept of "case management": how to remain in contact with the suicide attempter, without forcing it in this every day life, replacing a possible proposing, but assumption of responsibility resources reliable and quickly accessible in the event of at risk situation? Each one of these studies tests devices which seem more appropriate to such or such characteristic of this population, by retaining only simple criteria like the sex, the number of former suicide attempts, the proposal or not for an assumption of responsibility of care, the observance or not with the plan of care. Thus, it would seem interesting to combine these approaches in an algorithm.
Main aim: To test the effectiveness of an algorithm of case management, named "ALGOS", in terms of reduction of suicide re-attempts in the 6 months following the attempt index, compared to controls committing suicide and treated as usual (i.e. primarily transmitted to the attending physician).
Secondary objectives: To evaluate, according to the method validated by Beecham in 1992, direct medico-economic impact in the year which follows the introduction of algorithm ALGOS. Reduction of the other suicidal behaviors in 6 months (reduction in the full number of suicidal repetitions in each group, evolution of the score of suicidal ideation, etc…). To evaluate the effect of the algorithm, at the 13th month. To study the possible differences within the time in terms of suicidal repetitions in the 2 groups. To propose different profiles of answers according to psychopathology, the number of suicide attempts, suicidal character, the sex,…
Methodology: Comparative simple blind prospective multicentric controlled study
| Condition | Intervention |
|---|---|
|
Suicide, Attempted |
Behavioral: ALGOS algorithm of case management Behavioral: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Effectiveness of a "Case Management Algorithm" After a Suicide Attempt in Terms of Repetition of the Suicidal Behaviors and Medico-economic Impact |
- number of suicide re-attempters [ Time Frame: six months ] [ Designated as safety issue: No ]the number of suicide re-attempters 6 months following the attempt index
- Number of suicide re-attempts [ Time Frame: six months ] [ Designated as safety issue: No ]Number of suicide re-attempts in the 6 months following the attempt index
- Suicidal ideation intensity [ Time Frame: six months and 13 months ] [ Designated as safety issue: No ]The suicidal ideation will be measured by Scale of Suicidal Ideation (A. Beck, M. Kovacs, and A. Weissman, 1979) in the 6 months following the attempt index and in the 13 months.
- Number of deaths per suicide [ Time Frame: six months and 13 months ] [ Designated as safety issue: No ]
- medical cost [ Time Frame: one year ] [ Designated as safety issue: No ]Numbers of hospitalisations, numbers of consultations, and drugs consummation during the year following the suicide attempt will be measured to estimate the medical cost
- Evaluation of the psychopathological profile [ Time Frame: six months and 13 months ] [ Designated as safety issue: No ]The psychopathological profile will be evaluated by the French version of Mini International Neuropsychiatric Interview (DSM IV)
| Estimated Enrollment: | 1200 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ALGOS group
Algorithm of case management over the 6 months following the suicidal gesture
|
Behavioral: ALGOS algorithm of case management
Group "ALGOS" : If the subject survives one 1st SA (first attempter): he leaves the center where he was included with a "chart resource" (crisis card) which contains addresses of the Web sites of associations of prevention of the suicide, as well as an accessible phone number 24/24h. If the subject is not a first attempter : he will be recontacted on the telephone between the 10th and the 21st day following the SA. If the subject is not contacted or little observing in the plan of care, it will receive a series of postcards then regularly, with 4 recoveries: to 2, 3, 4 and 5 months after the attempt. Other Name: ALGOS
|
|
No Intervention: Control group
Process as usual.
|
Behavioral: Control
Group "control" = The reference group will not profit from catch in specific charge and will follow the usual course of care (primarily a catch of load by the attending physician).
Other Name: As usual group
|
Detailed Description:
Evaluations: The subjects will be included in the participating centers following a suicide attempt (SA). After checking of the criteria, information and signature of the study consent, the subjects will be randomized in one of the 2 groups (ALGOS versus Control). A fax of inclusion will be sent to the centralized research team of the Clinical Investigation Center(CIC) of Lille. All the subjects included will be then evaluated at the 6th month and 13th month after the SA, during a phone call. The final evaluation will be carried out in the current of the 13th month, so as to avoid a recontact at the time of the period birthday, too charged affectively at the majority with the patients. This phone call, personal, will be carried out by an trained psychologist. A mail preventing the subject of the call will be addressed approximately 10 days before. During the evaluations at the 6th month and 13th month, the number of suicidal repetitions will be reported, consumption of care since inclusion will be noted, the scale of suicidal ideation of Beck assessed, and a psychopathological evaluation carried out (Mini International Neuropsychiatric Interview DSM IV).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Surviving to a suicide attempt (SA) directly leaving the Emergency unit or have been hospitalized less than 7 days
Exclusion Criteria:
- recidivists who made 4 SA and more in the 3 past years
Contacts and Locations| Contact: Guillaume VAIVA | 033 3 20 44 43 83 | guillaume.vaiva@chru-lille.fr |
| Contact: Anne-Laure DEMARTY | 033 3 20 44 68 91 | anne-laure.demarty@chru-lille.fr |
| France | |
| University Hospital, Angers | Recruiting |
| Angers, France | |
| Principal Investigator: Jean-Bernard GARRE | |
| General Hospital, Arras | Not yet recruiting |
| Arras, France | |
| Principal Investigator: Pierre VALETTE | |
| University Hospital, Brest | Recruiting |
| Brest, France | |
| Sub-Investigator: David GOETGHEBEUR | |
| Principal Investigator: Michel WALTER | |
| University Hospital, Caen | Not yet recruiting |
| Caen, France | |
| Sub-Investigator: Eric ROUPIE | |
| Principal Investigator: Francoise CHASTANG | |
| University Hospital, Clermont Ferrand | Recruiting |
| Clermont-Ferrand, France | |
| Principal Investigator: Georges BROUSSE | |
| Henri Mondor Hospital, Creteil | Recruiting |
| Créteil, France | |
| Sub-Investigator: Bertrand RENAUD | |
| Principal Investigator: Franck BELLIVIER | |
| General Hospital, Douai | Recruiting |
| Douai, France | |
| Sub-Investigator: Bruno LACRAMPE | |
| Principal Investigator: Olivier BROCHART | |
| General Hospital, Dunkerque | Recruiting |
| Dunkerque, France | |
| Sub-Investigator: Francis VILEYN | |
| Principal Investigator: Jean-Bernard CAMPAGNE | |
| Health Centre Henin Beaumont | Recruiting |
| Henin Beaumont, France | |
| Principal Investigator: Philippe LESTAVEL | |
| Sub-Investigator: Caroline MICHAUT | |
| University Hospital, Lille | Recruiting |
| Lille, France, 59037 | |
| Sub-Investigator: Virginie BOSS | |
| Sub-Investigator: Vincent JARDON | |
| Sub-Investigator: Francois DUCROCQ | |
| Sub-Investigator: Eric WIEL | |
| Sub-Investigator: Patrick GOLDSTEIN | |
| Sub-Investigator: Fréderique WAREMBOURG | |
| Sub-Investigator: Stéphane DUHEM | |
| Sub-Investigator: Anne-Sophie JEAN | |
| Principal Investigator: Guillaume VAIVA | |
| General Hospital, Montauban | Recruiting |
| Montauban, France | |
| Principal Investigator: Lionel CAILHOL | |
| University Hospital, Montpellier | Recruiting |
| Montpellier, France | |
| Principal Investigator: Philippe COURTET | |
| University Hospital, Nancy | Recruiting |
| Nancy, France | |
| Principal Investigator: Catherine PICHENE | |
| Sub-Investigator: Lionel NACE | |
| University Hospital, Nantes | Recruiting |
| Nantes, France | |
| Principal Investigator: Virginie LAGREE | |
| Georges Pompidou European Hospital, Paris | Recruiting |
| Paris, France | |
| Principal Investigator: Edmond GUILLIBERT | |
| Sub-Investigator: Rafik MASMOUDI | |
| General Hospital, Quimper | Recruiting |
| Quimper, France | |
| Principal Investigator: Christine CHANUDET | |
| Sub-Investigator: Gilles MEHU | |
| University Hospital, Rennes | Recruiting |
| Rennes, France | |
| Sub-Investigator: Jacques BOUGET | |
| Principal Investigator: David TRAVERS | |
| General Hospital, Roubaix | Recruiting |
| Roubaix, France | |
| Sub-Investigator: Frederic SECOUSSE | |
| Principal Investigator: Marie-Anne BABE | |
| University Hospital, Toulouse | Recruiting |
| Toulouse, France | |
| Sub-Investigator: Philippe BIRMES | |
| Sub-Investigator: Dominique LAUQUE | |
| Principal Investigator: Anjali MATHUR | |
| General Hospital, Tourcoing | Not yet recruiting |
| Tourcoing, France | |
| Principal Investigator: Catherine THEVENON-GIGNAC | |
| Sub-Investigator: Hacene MOUSSOUNI | |
| General Hospital, Vannes | Recruiting |
| Vannes, France | |
| Principal Investigator: Dominique HOUDET | |
| Principal Investigator: | Guillauma VAIVA | University Hospital, Lille |
| Principal Investigator: | Michel WALTER | University Hospital, Brest |
More Information
Publications:
| Responsible Party: | University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT01123174 History of Changes |
| Other Study ID Numbers: | 2009-A00893-54, B91171-60, PHRC 2009/1902 |
| Study First Received: | March 18, 2010 |
| Last Updated: | October 24, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Lille:
|
Suicide case management algorithm suicidal behaviors prevention of suicide |
Additional relevant MeSH terms:
|
Suicide Suicide, Attempted Self-Injurious Behavior Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013