Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effectiveness of a Case Management Algorithm: ALGOS After a Suicide Attempt

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University Hospital, Lille.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01123174
First received: March 18, 2010
Last updated: October 24, 2011
Last verified: October 2011
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123174

Contacts
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

Locations
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         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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
Behavioral Symptoms
Self-Injurious Behavior

ClinicalTrials.gov processed this record on November 23, 2014