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

June 17, 2015 updated by: University Hospital, Lille

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 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

Study Overview

Status

Completed

Conditions

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).

Study Type

Interventional

Enrollment (Actual)

1040

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Angers, France
        • University Hospital, Angers
      • Boulogne sur Mer, France
        • General Hospital, Boulogne sur Mer
      • Brest, France
        • University Hospital, Brest
      • Caen, France
        • University Hospital, Caen
      • Clermont-Ferrand, France
        • University Hospital, Clermont Ferrand
      • Créteil, France
        • Henri Mondor Hospital, Creteil
      • Douai, France
        • General Hospital, Douai
      • Dunkerque, France
        • General Hospital, Dunkerque
      • Henin Beaumont, France
        • Health Centre Henin Beaumont
      • Lille, France, 59037
        • University Hospital, Lille
      • Marseille, France
        • University Hospital, Marseille
      • Montauban, France
        • General Hospital, Montauban
      • Montpellier, France
        • University Hospital, Montpellier
      • Nancy, France
        • University Hospital, Nancy
      • Nantes, France
        • University Hospital, Nantes
      • Nice, France
        • University Hospital, Nice
      • Paris, France
        • Georges Pompidou European Hospital, Paris
      • Quimper, France
        • General Hospital, Quimper
      • Rennes, France
        • University Hospital, Rennes
      • Roubaix, France
        • General Hospital, Roubaix
      • Toulouse, France
        • University Hospital, Toulouse
      • Tourcoing, France
        • General Hospital, Tourcoing
      • Vannes, France
        • General Hospital, Vannes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ALGOS group
Algorithm of case management over the 6 months following the suicidal gesture (systematic telephone contact, postcards and crisis card)

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 Names:
  • ALGOS Group
NO_INTERVENTION: Control group
Treatment as usual (referral back to the general practitioner)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of suicide re-attempters
Time Frame: six months
the number of suicide re-attempters 6 months following the attempt index
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of deaths per suicide
Time Frame: six months and 13 months
Number of suicide re-attempts in the 6 months following the attempt index
six months and 13 months
Number of lost to follow up
Time Frame: six months and 13 months
six months and 13 months
Number of suicide re-attempters
Time Frame: 13 months
13 months
Number of suicide re-attempts
Time Frame: six months and 13 months
Number of suicide re-attempts in the 6 months following the attempt index
six months and 13 months
Suicidal ideation intensity
Time Frame: six months and 13 months
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.
six months and 13 months
medical cost
Time Frame: six months and one year
Numbers of hospitalisations, numbers of consultations, and drugs consummation during the year following the suicide attempt will be measured to estimate the medical cost
six months and one year
Evaluation of the psychopathological profile
Time Frame: six months and 13 months
The psychopathological profile will be evaluated by the French version of Mini International Neuropsychiatric Interview (DSM IV)
six months and 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guillauma VAIVA, University Hospital, Lille
  • Principal Investigator: Michel WALTER, University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

May 11, 2010

First Posted (ESTIMATE)

May 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2009_25
  • PHRC 2009/1902 (OTHER: DHOS)
  • 2009-A00893-54 (OTHER: ID-RCB number, ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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