Viewing Study NCT06499337



Ignite Creation Date: 2024-07-17 @ 11:22 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06499337
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-07-12
First Post: 2024-07-04

Brief Title: Safety Plan in Emergency Department to Prevent Suicidal Attempt Recidive
Sponsor: Centre Hospitalier St Anne
Organization: Centre Hospitalier St Anne

Study Overview

Official Title: Evaluation of the Feasabilty and Acceptability of a Safety Plan After Suicidal Attempt to Prevent Recurrence After an Emergency Department Admission
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PLUS
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 hasnt 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 eg 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 eg therapist phone numbers hotlines local hospital emergency room locations and also included steps to ensure the safety of the home environment that minimize the patients ability to act on suicidal thoughts or urges ie 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None