NCT05609487 Evaluation of the Safety Plan to Prevent Suicidal Reiteration
| NCT ID | NCT05609487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hôpital le Vinatier |
| Condition | Suicide, Attempted |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,387 participants |
| Start Date | 2023-09-25 |
| Primary Completion | 2026-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,387 participants in total. It began in 2023-09-25 with a primary completion date of 2026-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
BENOIT CHALANCON, IDE
PRINCIPAL INVESTIGATOR
CH LE VINATIER
Frequently Asked Questions
Who can join the NCT05609487 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Suicide, Attempted. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05609487 currently recruiting?
Yes, NCT05609487 is actively recruiting participants. Contact the research team at benoit.chalancon@ch-le-vinatier.fr for enrollment information.
Where is the NCT05609487 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT05609487 clinical trial?
NCT05609487 is sponsored by Hôpital le Vinatier. The principal investigator is BENOIT CHALANCON, IDE at CH LE VINATIER. The trial plans to enroll 2,387 participants.