跳至主要内容
临床试验/NCT05609487
NCT05609487招募中不适用

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

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 2,387 人开始时间: 2023年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,387
试验地点
2
主要终点
Suicidal recurrence at 6 months

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Suicidal recurrence at 6 months

时间窗: 6 months

Suicidal reiteration is characterized by non-fatal suicidal behavior, self-inflicted injury with a desire to end one's life that does not result in death (WHO).

次要结局

  • Death by suicide attempt(6 months)
  • Commitment to healthcare(One month and 6 months)
  • Suicidal recurrence(one month)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (2)

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