Clinical trial NCT01123174: Effectiveness of a Case Management Algorithm: ALGOS After a Suicide Attempt
Official title: Effectiveness of a "Case Management Algorithm" After a Suicide Attempt in Terms of Repetition of the Suicidal Behaviors and Medico-economic Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Keywords: Suicide
case management algorithm
suicidal behaviors
prevention of suicide
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

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 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

Primary outcomes:
measure: Number of suicide re-attempters
timeFrame: six months
Secondary outcomes:
measure: Number of deaths per suicide
timeFrame: six months and 13 months
measure: Number of lost to follow up
timeFrame: six months and 13 months
measure: Number of suicide re-attempters
timeFrame: 13 months
measure: Number of suicide re-attempts
timeFrame: six months and 13 months
measure: Suicidal ideation intensity
timeFrame: six months and 13 months
measure: medical cost
timeFrame: six months and one year
measure: Evaluation of the psychopathological profile
timeFrame: six months and 13 months
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital, Angers
city: Boulogne sur Mer
country: France
facility: General Hospital, Boulogne sur Mer
city: Brest
country: France
facility: University Hospital, Brest
city: Caen
country: France
facility: University Hospital, Caen
city: Clermont-Ferrand
country: France
facility: University Hospital, Clermont Ferrand
city: Créteil
country: France
facility: Henri Mondor Hospital, Creteil
city: Douai
country: France
facility: General Hospital, Douai
city: Dunkerque
country: France
facility: General Hospital, Dunkerque
city: Henin Beaumont
country: France
facility: Health Centre Henin Beaumont
city: Lille
country: France
facility: University Hospital, Lille
city: Marseille
country: France
facility: University Hospital, Marseille
city: Montauban
country: France
facility: General Hospital, Montauban
city: Montpellier
country: France
facility: University Hospital, Montpellier
city: Nancy
country: France
facility: University Hospital, Nancy
city: Nantes
country: France
facility: University Hospital, Nantes
city: Nice
country: France
facility: University Hospital, Nice
city: Paris
country: France
facility: Georges Pompidou European Hospital, Paris
city: Quimper
country: France
facility: General Hospital, Quimper
city: Rennes
country: France
facility: University Hospital, Rennes
city: Roubaix
country: France
facility: General Hospital, Roubaix
city: Toulouse
country: France
facility: University Hospital, Toulouse
city: Tourcoing
country: France
facility: General Hospital, Tourcoing
city: Vannes
country: France
facility: General Hospital, Vannes
Study officials:
affiliation: University Hospital, Lille
name: Guillauma VAIVA
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Brest
name: Michel WALTER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.