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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01123174
First received: March 18, 2010
Last updated: June 17, 2015
Last verified: June 2015
  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 entitled "ALGOS".

Main aim: To test the effectiveness of this algorithm of case management, named "ALGOS", in reducing the number of death by suicide, in terms of reduction of suicide re-attempts and the number of loss of contact patients in the ALGOS group during 6 months period, compared to a control group of suicide attempters 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 deaths per suicide [ Time Frame: six months and 13 months ] [ Designated as safety issue: No ]
    Number of suicide re-attempts in the 6 months following the attempt index

  • Number of lost to follow up [ Time Frame: six months and 13 months ] [ Designated as safety issue: No ]
  • Number of suicide re-attempters [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Number of suicide re-attempts [ Time Frame: six months and 13 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.

  • medical cost [ Time Frame: six months and 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)


Enrollment: 1040
Study Start Date: February 2010
Study Completion Date: July 2014
Primary Completion Date: July 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 (systematic telephone contact, postcards and crisis card)
Behavioral: ALGOS algorithm of case management

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 Group
No Intervention: Control group
Treatment as usual (referral back to the general practitioner)

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   (Adult, Senior)
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

Locations
France
University Hospital, Angers
Angers, France
General Hospital, Boulogne sur Mer
Boulogne sur Mer, France
University Hospital, Brest
Brest, France
University Hospital, Caen
Caen, France
University Hospital, Clermont Ferrand
Clermont-Ferrand, France
Henri Mondor Hospital, Creteil
Créteil, France
General Hospital, Douai
Douai, France
General Hospital, Dunkerque
Dunkerque, France
Health Centre Henin Beaumont
Henin Beaumont, France
University Hospital, Lille
Lille, France, 59037
University Hospital, Marseille
Marseille, France
General Hospital, Montauban
Montauban, France
University Hospital, Montpellier
Montpellier, France
University Hospital, Nancy
Nancy, France
University Hospital, Nantes
Nantes, France
University Hospital, Nice
Nice, France
Georges Pompidou European Hospital, Paris
Paris, France
General Hospital, Quimper
Quimper, France
University Hospital, Rennes
Rennes, France
General Hospital, Roubaix
Roubaix, France
University Hospital, Toulouse
Toulouse, France
General Hospital, Tourcoing
Tourcoing, France
General Hospital, Vannes
Vannes, France
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_25  PHRC 2009/1902  2009-A00893-54 
Study First Received: March 18, 2010
Last Updated: June 17, 2015
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 September 23, 2016