Evaluation of the Safety Plan to Prevent Suicidal Reiteration

NCT05609487 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2387

Last updated 2024-09-19

No results posted yet for this study

Summary

Each year, suicide is the cause of 8,580 deaths in France, it is the second leading cause of death among 15-24 year olds. People who have made a first suicide attempt are identified as being at greater risk of repeating a suicidal gesture, particularly in the first month following the gesture . At the same time, Brief Intervention Contact (BIC) is recognized as effective in reducing suicide deaths.

A new brief intervention to prevent suicidal attempts has been developed in the United States by Santley \& Brown (2012) the results of its effectiveness are very encouraging.

Investigators hypothesise that the implementation of a safety plan by the emergency department for suicidal patients included in the Vigilans system leads to a greater reduction in the reiteration of suicidality at 6 months compared to the usual management.

Our main objective is to evaluate the effectiveness of the implementation of a safety plan by the emergency department nurse before discharge from the emergency department in reducing suicidal reiteration at six months after the suicide attempt, for suicidal patients included in the Vigilans programe, compared with the Vigilans programe alone.

Our secondary objectives are

* Reduce the reiteration of the suicidal act at 1 month
* Encourage engagement in care at 1 month and 6 months
* Reduce the use of emergency departments at 1 month and 6 months due to a suicidal crisis
* Decrease suicide mortality at 6 months

To study the implementation of the intervention:

* To measure the quality of completion, and the duration of completion of the safety plan at 1 month, and 6 months.
* Assess the acceptability of the safety plan by emergency department nurses, and then by the vigilantes.
* Assess the acceptability of the safety plan by patient

Conditions

  • Suicide, Attempted

Interventions

OTHER

As usual

Patients included in the control phase, i.e. without intervention, will be asked not to oppose participation in the research, after having received the presentation of the study and the information notice. The data collection will be similar to the data collection during the intervention period.

DEVICE

Protection plan

The intervention consists of making the protection plan in a co-constructed process with the care user. This tool is built in 6 steps, is written and takes 20 to 40 minutes to complete. These 6 steps allow to identify the first signs of a suicidal crisis and to identify different strategies to face it. They are constructed in an ascending order, with the aim of being used by the care user in an autonomous situation.

Sponsors & Collaborators

  • Hôpital le Vinatier

    lead OTHER

Principal Investigators

  • BENOIT CHALANCON, IDE · CH LE VINATIER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2026-01-15
Completion
2026-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609487 on ClinicalTrials.gov