Evaluation of the Safety Plan to Prevent Suicidal Reiteration

NCT05609487 | Recruiting DMC

• 1 other identifier: 2022-A00163-40
• Study Type: interventional
• Target: 2,387
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Suicidal recurrence at 6 months

  Suicidal reiteration is characterized by non-fatal suicidal behavior, self-inflicted injury with a desire to end one's life that does not result in death (WHO).

  6 months

Secondary Outcomes (3)

• Suicidal recurrence

  one month

• Commitment to healthcare

  One month and 6 months

• Death by suicide attempt

  6 months

Study Arms (2)

Control group

OTHER

Step in "control group" This stepped wedge study does not use two parallel treatment arms. The stepped wedge design allows each center to be its own "control group" and then, after implementation of the practice by the research team, to become a "intervention group". The characteristics of these two phases are detailed below. 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.

Other: As usual

Protection plan group

OTHER

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.

Device: Protection plan

Interventions

As usual OTHER

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.

Control group

Protection plan DEVICE

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.

Protection plan group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Seen in an emergency department
• Admitted in emergency department following a suicide attempt \<48h
• whose duration of care does not exceed 24 hours
• For whom the care project results in a return home,
• Who agree to be included in the Vigilans system
• Who have social security coverage
• Fluent in French

You may not qualify if:

• Refusal to participate in the study
• Refusal to be accompanied by the Vigilans system
• Hospitalisation for more than 24 hours in the immediate aftermath of the suicide attempt
• Under protective measures.

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, AURA, 69678 CEDEX, France

RECRUITING

Related Publications (1)

• Chalancon B, Haesebaert J, Vacher A, Vieux M, Simon L, Subtil F, Colin C, Poulet E, Leaune E; Investigator Associates; Expanded Scientific Nursing Committee. Implementing a nurse-led safety planning intervention in emergency departments to prevent suicide reattempts: a stepped-wedge randomized controlled trial protocol (French multicentre randomized controlled trial with a stepped-wedge design). BMC Nurs. 2025 May 19;24(1):558. doi: 10.1186/s12912-025-03121-w.

  PMID: 40389942 DERIVED

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• BENOIT CHALANCON, IDE

  CH LE VINATIER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BENOIT CHALANCON, IDE

CONTACT

0033437915210; benoit.chalancon@ch-le-vinatier.fr

VERONIQUE VIAL

CONTACT

0033437915522; veronique.vial@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is structured in three phases: 1) translation and adaptation of the safety plan into French; 2) effectiveness study; and 3) evaluation of the implementation of the safety plan in practice

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: September 25, 2023
• Primary Completion: January 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)