Clinical trial NCT01176929: Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt
Official title: Effectiveness of Telephone Contact and Professional Coordination for Preventing Recurrent Suicidal Acts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Keywords: Suicide, Attempted
prevention suicidal act
telephone contact
professional coordination
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The prevention of recurrent suicidal about people who have made a suicide attempt is a major strand in the prevention of suicide. It is estimated that 10-15 % of people who made a suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at one year. Most people who made a suicide attempt receive ambulatory monitoring. On this population, there is a low adherence to care.

The main objective of the study is to test the effectiveness of a prevention program of recurrent suicidal acts for people who made a suicide attempt.

The secondary objectives of this study are the assessment of adherence to care; the identification of sub - populations benefiting most from this program; the evaluation of the possible generalization level of the program (eligibles persons rate) and its feasibility level.

Detailed description: This is a randomized, controlled and prospective trial comparing an experimental group (usual treatment + interventions) to a control group (usual treatment only). All participants are evaluated after one year of monitoring. The search duration is 2 years (one inclusion year and one year of follow-up). It is planned to include 330 patients, 165 patients in each group.

The program (experimental group) includes three interventions:

* A series of three telephone calls ( the second week , one month and three months after discharge from hospital )
* A systematic telephone contact with the referring physician
* A telephone helpline for people who made a suicide attempt and referring physicians.

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years.
* Patients admitted to the emergency department for a suicide attempt.
* Patients referred to outpatient care.
* Patients who have given their written consent.

Exclusion Criteria:

* Patients not affiliated to social security.
* Patients do not have the faculties needed to be evaluated (cognitive or delusional disorder).
* Patients hospitalized for longer than 72 hours.
* Patients can not be recalled by phone (no phone, homeless, incarcerated)
* Patients who do not speak French.

Primary outcomes:
measure: suicidal act frequency
timeFrame: 12 months
Secondary outcomes:
measure: suicide attempts frequency
timeFrame: 12 months
measure: Adherence to health care
timeFrame: 12 months
measure: Number of eligibles persons
timeFrame: 12 months
measure: Number of participants responding to telephone calls
timeFrame: 12 months
measure: Number of people lost sight of
timeFrame: 12 months
Other outcomes:
Locations:
city: Le Kremlin Bicetre
country: France
facility: Assistance Publique - Hôpitaux de Paris : BICETRE Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Arnaud MARCHAND, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.