Clinical trial NCT05609487: Evaluation of the Safety Plan to Prevent Suicidal Reiteration
Official title: Evaluation of the Effectiveness of the Implementation of a Safety Plan by the Emergency Nurse to Prevent Suicidal Reiteration - National Multicenter Randomized Controlled Trial in Stepped-wedge
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 2387
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: PREVENTION

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

Detailed description: Each year, suicide is the cause of 8,580 deaths in France , and although the suicide rate in France has decreased by 10% over the last ten years, 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 recognised as effective in reducing suicide deaths.

In 2012, two American psychiatrists developed and evaluated the effectiveness of a tool for preventing the recurrence of suicide: the safety plan. It consists of a list of strategies co-constructed by a trained health professional with the person concerned, which make it possible to deal with thoughts of suicide. It is deployed in 6 steps.

Once completed, it is kept by the user and can be used in complete autonomy at the first signs of a potential suicidal crisis.

This prevention tool, whose initial results across the Atlantic are very encouraging, is not used in daily practice in France.

The main objective of the study is therefore to evaluate its effectiveness at 6 months when it is implemented by the emergency room nurse, before discharge, for people already included in the VigilanS programme.

The VigilanS programme is the national system for preventing suicidal recurrence and consists of three complementary strategies:

1. Firstly, a resource card indicates a toll-free number, open during the day, for people who have made a gesture. Respondents are health professionals (vigilance workers) who can assess and guide people in the event of a recurrence of suicidal thoughts.
2. Then investigators contact the person's existing care network, investigators inform the attending doctor, but also other care providers (psychologist, physiotherapist, liberal nurse...) of their patient's inclusion in the system.
3. Finally, telephone calls are made by the health professionals in the first month following discharge, and six months after the suicidal act. In parallel, a postcard is sent monthly during the first 4 months to continue the link.

This national study will work with 11 hospitals with a Vigilans service and will be implemented in 19 emergency departments. Doctors, nurses and health managers will be identified in each center.

The first step of the study is to translate the tool (the safety plan), with the help of a committee of experts and specialized translators.

Then investigators will evaluate its effectiveness with 2,387 study participants included in the 19 emergency departments over a two-year period.

Each participating center (the emergency department) will initially be in an observation (or control) phase, i.e. the safety plan will not be used by the care workers. Then in a second phase, the research team will implement the practice of the tool through training, and in a third phase the center will be in the intervention phase, i.e. it will use the tool in daily practice.

The order of training, where the practice is implemented in the units, is chosen by randomization.

The main objective of the study is to evaluate six months after the suicide attempt, by a telephone call that will ask the patient if he or she has made a suicidal attempt again.

Investigators will thus be able to compare a population that has not received the tool (the control group) with a population that has received the tool (the intervention group) and thus measure its effectiveness.

Finally, the last stage of the study consists of evaluating the use of the tool by emergency service professionals, the Vigilans device, and the participants in the study. To do this, investigators will use questionnaires (evaluation scales) and conduct semi-structured interviews with several participants

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Suicidal recurrence at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Suicidal recurrence
timeFrame: one month
measure: Commitment to healthcare
timeFrame: One month and 6 months
measure: Death by suicide attempt
timeFrame: 6 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier
state: Aura
Study officials:
affiliation: CH LE VINATIER
name: BENOIT CHALANCON, IDE
role: PRINCIPAL_INVESTIGATOR
References: