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

Suicide, Attempted Clinical Trial

— ALGOS  

Official title:

Effectiveness of a "Case Management Algorithm" After a Suicide Attempt in Terms of Repetition of the Suicidal Behaviors and Medico-economic Impact

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123174
• Other study ID #: 2009_25
• Secondary ID: PHRC 2009/190220
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: June 17, 2015
• Start date: February 2010
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

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.

Locations

Country	Name	City	State
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	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (4)

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. Epub 2005 Sep 23. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of suicide re-attempters	the number of suicide re-attempters 6 months following the attempt index	six months	No
Secondary	Number of deaths per suicide	Number of suicide re-attempts in the 6 months following the attempt index	six months and 13 months	No
Secondary	Number of lost to follow up		six months and 13 months	No
Secondary	Number of suicide re-attempters		13 months	No
Secondary	Number of suicide re-attempts	Number of suicide re-attempts in the 6 months following the attempt index	six months and 13 months	No
Secondary	Suicidal ideation intensity	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	No
Secondary	medical cost	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	No
Secondary	Evaluation of the psychopathological profile	The psychopathological profile will be evaluated by the French version of Mini International Neuropsychiatric Interview (DSM IV)	six months and 13 months	No