Clinical trial NCT06499337: Safety Plan in Emergency Department to Prevent Suicidal Attempt Recidive
Official title: Evaluation of the Feasabilty and Acceptability of a Safety Plan After Suicidal Attempt to Prevent Recurrence After an Emergency Department Admission.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Suicidal Ideations
Suicidal Attempt
Prevention
Safety Plan
Keywords: Safety plan
Suicidal attempt
feasability
acceptability
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals included in the study were patients hospitalized at the post-emergency short-term psychiatric unit following a visit to the emergency room for a suicide attempt. The recruitment took place between June 2022 and December 2023. Patients eligible for inclusion had to be adults, admitted to the hospital following a suicide attempt, and willing to participate in the study. The criteria for non-inclusion were: a) patients who were minors, b) patients who were unable to be informed or to understand the course of the study (if they did not understand French or if their condition did not allow it), c) patients who were opposed to the collection of data for research purposes, d) patients whose psychiatric and/or somatic condition was incompatible with the brief intervention and/or the study questionnaire

Brief summary: Suicide is one of the leading causes of death worldwide, with more than 700 000 deaths due to suicide every year, according to the World Health Organisation (WHO). In France, mortality rate by suicide is 17% higher than the European average; moreover, around 7% if the population (aged 18-75 years old) attempted suicide in their life.

Since years 2000, a series of preventative interventions have been developed to reduce suicide risk, with perhaps the most widely used is suicide safety planning. Several studies showed positive results after evaluating the efficacy of suicide safety planning for reducing patient risk. However, this intervention hasn't been yet evaluated in French emergency department settings.

Safety planning is a collaborative intervention between a therapist and the patient, by which a series of preventive actions are planned in the event patient experiences suicide ideation. Patients are provided with a paper form of the completed safety plan, including the following: personal warning signs, self-management strategies, reasons for living, social supports, and crisis supports.

In this study, we aim to assess the feasability and the acceptabilty of using the safety plan among patients hospitalised in a short-term unit, after an emergency department admission for suicidal attempt.

Detailed description: Suicide is one of the leading causes of death worldwide, with more than 700 000 deaths due to suicide every year, according to the World Health Organisation (WHO). In France, mortality rate by suicide is 17% higher than the European average; moreover, around 7% if the population (aged 18-75 years old) attempted suicide in their life.

Since years 2000, a series of preventative interventions have been developed to reduce suicide risk, with perhaps the most widely used is suicide safety planning, which is a brief intervention to help individuals who survived a suicide attempt to develop a set of tools and steps, to reduce the likelihood of engaging in suicidal behaviour. Several studies showed positive results after evaluating the efficacy of suicide safety planning for reducing patient risk. Recently, a systematic review concluded that Safety Planning is a valuable intervention for patients experiencing suicide-related distress, and was associated with improvements in suicidal ideation and behaviour and reductions in hospitalizations. Qualitative studies suggest a Safety Planning intervention is acceptable and feasible, as well as adaptable to the clinical area in its modality and delivery. Despite positive outcomes, this intervention has not been fully evaluated in French settings. A previous study concluded it was not adapted to emergency department due to a lack of time or available exam rooms for professionals to conduct the intervention. Therefore, in our study, participants will be recruited in a post-ED unit, where patients are monitored for maximum 72 hours, before being discharged home or transferred to hospital facilities.

Safety planning is a collaborative intervention between a healthcare worker and the patient, by which a series of preventive actions are planned in the event patient experiences suicide ideation. Safety planning included identifying: 1) warning signs or triggers that indicate suicide ideation is likely to occur, 2) internal coping strategies (e.g., distracting activities) for use when those triggers occur or when experiencing suicide ideation, 3) social contacts for further distraction or social locations that may provide distraction, 4) supportive contacts (who can provide assistance), 5) emergency resources (e.g., therapist phone numbers, hotlines, local hospital emergency room locations), and also included steps to ensure the safety of the home environment that minimize the patient's ability to act on suicidal thoughts or urges (i.e., reducing access to lethal means).

In this study, Safety plan was delivered face-to-face, during the post-ED stay; upon discharge, participants were provided with the paper-based plan they completed with their physician.

The main outcome of our study was to evaluate the feasibility - assessed by healthcare workers- and the acceptability - from patients' point of view- of conducting a Safety plan in a post-ED setting, after suicidal attempt. Secondary outcomes included to evaluate Safety plan utility, assessed by patients based on their use or not of the Safety plan at 1 and 6 months after inclusion, and its efficacy, on the recurrence of suicidal attempt over the 6 months after inclusion.

To evaluate the outcomes at 1 and 6 months, patients were recontacted by a psychologist to complete a brief questionnaire over the phone.

At baseline, we also collected sociodemographics information, including marital status and living situation; patients completed the Hospital anxiety and depression scale, and suicidal ideations evaluated with the Columbia-Suicide Severity Rating Scale (C-SSRS).

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Patients hospitalised in a post-emergency unit following a suicidal attempt

Exclusion Criteria:

* Patients whose clinical state or French level prevent to understand the information regarding the study and to consent to the study
* Pattients whose clinical state or French level prevent to participate to the Safety plan intervention
* patients who do not agree to participate

Primary outcomes:
measure: Feasibility
timeFrame: Day of intervention (D0)
measure: Acceptability
timeFrame: Day of intervention (D0)
Secondary outcomes:
measure: Utility
timeFrame: 1 month after discharge
measure: Efficacy
timeFrame: Any suicidal attempt occuring up to 6 months after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: GHU Paris Psychiatrie et Neurosciences
state: Ile-de-France
Study officials:
References:
citation: de Ganay M, Duroy D, Perozziello A, Lejoyeux M, Geoffroy PA. Study assessing the feasibility and acceptability of implementing the Safety Plan for suicide prevention in a French emergency department. Encephale. 2023 Dec;49(6):656-657. doi: 10.1016/j.encep.2023.03.002. Epub 2023 Apr 28. No abstract available.