NCT05609487: PROTECT

Evaluation of the Safety Plan to Prevent Suicidal Reiteration

Recruiting now NA Last updated 19 September 2024

What this trial tests

NA trial testing As usual in Suicide, Attempted in 2,387 participants. Currently enrolling.

Timeline

25 September 2023

Primary endpoint
15 January 2026

31 December 2026

Quick facts

Lead sponsor	Hôpital le Vinatier
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	2,387
Start date	25 September 2023
Primary completion	15 January 2026
Estimated completion	31 December 2026
Sites	1 location across France

Drugs / interventions tested

• As usual
• Protection plan

Conditions studied

• Suicide, Attempted — all drugs for Suicide, Attempted →

Sponsor

Hôpital le Vinatier — full company profile →

Who can join

Adults 18 to 65, any sex, with Suicide, Attempted. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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).
   Chalancon B, Haesebaert J, Vacher A, Vieux M, et al · · 2025 · PMID 40389942 · DOI 10.1186/s12912-025-03121-w