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

Primary Purpose

Suicide, Attempted

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ALGOS algorithm of case management
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Suicide, Attempted focused on measuring Suicide, case management algorithm, suicidal behaviors, prevention of suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ALGOS group

Control group

Arm Description

Algorithm of case management over the 6 months following the suicidal gesture (systematic telephone contact, postcards and crisis card)

Treatment as usual (referral back to the general practitioner)

Outcomes

Primary Outcome Measures

Number of suicide re-attempters
the number of suicide re-attempters 6 months following the attempt index

Secondary Outcome Measures

Number of deaths per suicide
Number of suicide re-attempts in the 6 months following the attempt index
Number of lost to follow up
Number of suicide re-attempters
Number of suicide re-attempts
Number of suicide re-attempts in the 6 months following the attempt index
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.
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
Evaluation of the psychopathological profile
The psychopathological profile will be evaluated by the French version of Mini International Neuropsychiatric Interview (DSM IV)

Full Information

First Posted
March 18, 2010
Last Updated
June 17, 2015
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT01123174
Brief Title
Effectiveness of a Case Management Algorithm: ALGOS After a Suicide Attempt
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
Suicide, case management algorithm, suicidal behaviors, prevention of suicide

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1040 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALGOS group
Arm Type
Experimental
Arm Description
Algorithm of case management over the 6 months following the suicidal gesture (systematic telephone contact, postcards and crisis card)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Treatment as usual (referral back to the general practitioner)
Intervention Type
Behavioral
Intervention Name(s)
ALGOS algorithm of case management
Other Intervention Name(s)
ALGOS Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of suicide re-attempters
Description
the number of suicide re-attempters 6 months following the attempt index
Time Frame
six months
Secondary Outcome Measure Information:
Title
Number of deaths per suicide
Description
Number of suicide re-attempts in the 6 months following the attempt index
Time Frame
six months and 13 months
Title
Number of lost to follow up
Time Frame
six months and 13 months
Title
Number of suicide re-attempters
Time Frame
13 months
Title
Number of suicide re-attempts
Description
Number of suicide re-attempts in the 6 months following the attempt index
Time Frame
six months and 13 months
Title
Suicidal ideation intensity
Description
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.
Time Frame
six months and 13 months
Title
medical cost
Description
Numbers of hospitalisations, numbers of consultations, and drugs consummation during the year following the suicide attempt will be measured to estimate the medical cost
Time Frame
six months and one year
Title
Evaluation of the psychopathological profile
Description
The psychopathological profile will be evaluated by the French version of Mini International Neuropsychiatric Interview (DSM IV)
Time Frame
six months and 13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillauma VAIVA
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel WALTER
Organizational Affiliation
University Hospital, Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Angers
City
Angers
Country
France
Facility Name
General Hospital, Boulogne sur Mer
City
Boulogne sur Mer
Country
France
Facility Name
University Hospital, Brest
City
Brest
Country
France
Facility Name
University Hospital, Caen
City
Caen
Country
France
Facility Name
University Hospital, Clermont Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
Henri Mondor Hospital, Creteil
City
Créteil
Country
France
Facility Name
General Hospital, Douai
City
Douai
Country
France
Facility Name
General Hospital, Dunkerque
City
Dunkerque
Country
France
Facility Name
Health Centre Henin Beaumont
City
Henin Beaumont
Country
France
Facility Name
University Hospital, Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
University Hospital, Marseille
City
Marseille
Country
France
Facility Name
General Hospital, Montauban
City
Montauban
Country
France
Facility Name
University Hospital, Montpellier
City
Montpellier
Country
France
Facility Name
University Hospital, Nancy
City
Nancy
Country
France
Facility Name
University Hospital, Nantes
City
Nantes
Country
France
Facility Name
University Hospital, Nice
City
Nice
Country
France
Facility Name
Georges Pompidou European Hospital, Paris
City
Paris
Country
France
Facility Name
General Hospital, Quimper
City
Quimper
Country
France
Facility Name
University Hospital, Rennes
City
Rennes
Country
France
Facility Name
General Hospital, Roubaix
City
Roubaix
Country
France
Facility Name
University Hospital, Toulouse
City
Toulouse
Country
France
Facility Name
General Hospital, Tourcoing
City
Tourcoing
Country
France
Facility Name
General Hospital, Vannes
City
Vannes
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16735333
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.
Results Reference
background
PubMed Identifier
16183654
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.
Results Reference
background
PubMed Identifier
16055834
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.
Results Reference
background
PubMed Identifier
21194496
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.
Results Reference
background
PubMed Identifier
33999539
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.
Results Reference
derived
PubMed Identifier
33884617
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.
Results Reference
derived
PubMed Identifier
30256552
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.
Results Reference
derived

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

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