- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01123174
Effectiveness of a Case Management Algorithm: ALGOS After a Suicide Attempt (ALGOS)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Angers, France
- University Hospital, Angers
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Boulogne sur Mer, France
- General Hospital, Boulogne sur Mer
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Brest, France
- University Hospital, Brest
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Caen, France
- University Hospital, Caen
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Clermont-Ferrand, France
- University Hospital, Clermont Ferrand
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Créteil, France
- Henri Mondor Hospital, Creteil
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Douai, France
- General Hospital, Douai
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Dunkerque, France
- General Hospital, Dunkerque
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Henin Beaumont, France
- Health Centre Henin Beaumont
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Lille, France, 59037
- University Hospital, Lille
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Marseille, France
- University Hospital, Marseille
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Montauban, France
- General Hospital, Montauban
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Montpellier, France
- University Hospital, Montpellier
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Nancy, France
- University Hospital, Nancy
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Nantes, France
- University Hospital, Nantes
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Nice, France
- University Hospital, Nice
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Paris, France
- Georges Pompidou European Hospital, Paris
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Quimper, France
- General Hospital, Quimper
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Rennes, France
- University Hospital, Rennes
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Roubaix, France
- General Hospital, Roubaix
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Toulouse, France
- University Hospital, Toulouse
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Tourcoing, France
- General Hospital, Tourcoing
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Vannes, France
- General Hospital, Vannes
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Investigators
- Principal Investigator: Guillauma VAIVA, University Hospital, Lille
- Principal Investigator: Michel WALTER, University Hospital, Brest
Publications and helpful links
General Publications
- Vaiva G, Vaiva G, Ducrocq F, Meyer P, Mathieu D, Philippe A, Libersa C, Goudemand M. Effect of telephone contact on further suicide attempts in patients discharged from an emergency department: randomised controlled study. BMJ. 2006 May 27;332(7552):1241-5. doi: 10.1136/bmj.332.7552.1241.
- Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge project: randomised controlled trial of an intervention using postcards to reduce repetition of hospital treated deliberate self poisoning. BMJ. 2005 Oct 8;331(7520):805. doi: 10.1136/bmj.38579.455266.E0. Epub 2005 Sep 23.
- Evans J, Evans M, Morgan HG, Hayward A, Gunnell D. Crisis card following self-harm: 12-month follow-up of a randomised controlled trial. Br J Psychiatry. 2005 Aug;187:186-7. doi: 10.1192/bjp.187.2.186.
- Vaiva G, Walter M, Al Arab AS, Courtet P, Bellivier F, Demarty AL, Duhem S, Ducrocq F, Goldstein P, Libersa C. ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters. BMC Psychiatry. 2011 Jan 2;11:1. doi: 10.1186/1471-244X-11-1.
- Demesmaeker A, Chazard E, Vaiva G, Amad A. Risk Factors for Reattempt and Suicide Within 6 Months After an Attempt in the French ALGOS Cohort: A Survival Tree Analysis. J Clin Psychiatry. 2021 Feb 18;82(1):20m13589. doi: 10.4088/JCP.20m13589.
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Vaiva G, Berrouiguet S, Walter M, Courtet P, Ducrocq F, Jardon V, Larsen ME, Cailhol L, Godesense C, Couturier C, Mathur A, Lagree V, Pichene C, Travers D, Lemogne C, Henry JM, Jover F, Chastang F, Prudhomme O, Lestavel P, Gignac CT, Duhem S, Demarty AL, Mesmeur C, Bellivier F, Labreuche J, Duhamel A, Goldstein P. Combining Postcards, Crisis Cards, and Telephone Contact Into a Decision-Making Algorithm to Reduce Suicide Reattempt: A Randomized Clinical Trial of a Personalized Brief Contact Intervention. J Clin Psychiatry. 2018 Sep 25;79(6):17m11631. doi: 10.4088/JCP.17m11631.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009_25
- PHRC 2009/1902 (OTHER: DHOS)
- 2009-A00893-54 (OTHER: ID-RCB number, ANSM)
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