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

This study is currently recruiting participants.
Verified October 2011 by University Hospital, Lille
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

March 18, 2010
October 24, 2011
February 2010
February 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01123174 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Effectiveness of a Case Management Algorithm: ALGOS After a Suicide Attempt
Effectiveness of a "Case Management Algorithm" After a Suicide Attempt in Terms of Repetition of the Suicidal Behaviors and Medico-economic Impact

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

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Suicide, Attempted
  • 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
  • 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
  • Experimental: ALGOS group
    Algorithm of case management over the 6 months following the suicidal gesture
    Intervention: Behavioral: ALGOS algorithm of case management
  • No Intervention: Control group
    Process as usual.
    Intervention: Behavioral: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
 
NCT01123174
2009-A00893-54, B91171-60, PHRC 2009/1902
No
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Guillauma VAIVA University Hospital, Lille
Principal Investigator: Michel WALTER University Hospital, Brest
University Hospital, Lille
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP