跳至主要内容
临床试验/NCT06733974
NCT06733974招募中不适用

A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department: a Cluster Randomized Trial

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 924 人开始时间: 2025年6月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
924
试验地点
2
主要终点
Prolonged Grief 13-item revised scale (PG-R-13)

研究概览

简要总结

In France, a study has reported that about 0.2% of patients visiting the ED died in the ED. A large survey of 145 EDs in 3 French speaking countries has reported that a median of 2 patients dies each week in each ED and its observation unit.

After the death of a loved one, prolonged grief disorder (PGD) is a bereavement-specific syndrome that is defined as intense, prolonged yearning and preoccupation with thoughts of the deceased. PGD prevalence after the loss of a relative was 10% (95%CI 7-14) in the general population.Post-traumatic stress disorder (PTSD) is a mental health condition that is triggered by experiencing a terrifying event. Symptoms may include flashbacks, nightmares, and severe anxiety. The reported lifetime PTSD prevalence is 7% among adults in the general population. Admission and death in the hospital can be a traumatic and stressful experience for relatives, and is associated with an up to 50% risk of PGD and PTSD at 6 months.

In the setting of ICU, several studies have reported that implementation of simple human interventions (information supports including written information on end-of-life care and pro-active communication strategy with systematic interviews with relatives), was associated with a lower risk of PTSD at 3 months (45% vs. 69%) and PGD at 6 months (21% vs 57%). Furthermore, it has been reported that offering the possibility of relatives to be present during nursing and medical care may be beneficial.

In the out of hospital setting, offering the possibility for relative to be present during resuscitation was also associated with a reduction of PTSD at 3 months (15% vs 26%), which was confirmed at 1 year.

The ED setting differs from the one of ICU mainly because exposition time to the dying process is shorter and healthcare workers are less used to manage end of life.

Whether these strategies are beneficial for patients dying in the ED, where dying patients are older with more end- stage chronic diseases and shorter length of stay, remains unknown. The hypothesize of the study is that a multifaceted intervention, including pro-active communication strategy, visual supports, and offering the possibility to be present during nursing and medical care would decrease the risk of PGD in relatives of patients dying in the ED.

研究设计

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

入排标准

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

入选标准

  • - Relative of a patient, that is dying in the ED, defined by an anticipated life expectancy of less than 72H with previous do not resuscitate order or treatment withholding.
  • If several relative are present, participation to the trial will be offered in priority to the patient's trustworthy person, the relative most involved in the patient's care, the partner, a parent or child, another family member.
  • Age >= 18 years
  • Agrees to be followed-up by phone interview at 3 and 6 months
  • Informed oral consent
  • Relative with health insurance (except AME).

排除标准

  • Relative of a patient under 18 years of age
  • Relative who do not understand, read, or speak French
  • Relatives of organ donor patients (these relatives benefit from specific support and communication by the transplant coordination teams)
  • Inability to follow up
  • Participation in another intervention trial
  • Relative under legal protection (tutorship or curatorship)
  • Relative deprived of their liberty by a judicial or administrative decision
  • Relative physically unable to give his/her oral consent

研究组 & 干预措施

Usual care

No Intervention

Multi-faceted Intervention

Experimental

干预措施: Multi-faceted Intervention (Other)

结局指标

主要结局

Prolonged Grief 13-item revised scale (PG-R-13)

时间窗: 6 months after inclusion.

The PG-R-13 measures the new DSM-V criteria for prolonged grief: yearning, preoccupation, identity disruption, disbelief, avoidance, intense emotional pain, difficulty with reintegration, emotional numbness, feeling that life is meaningless and intense loneliness. The score ranges from 10-50 and a score of 30 or more defined the prolonged grief disorder.

次要结局

  • Signs of PTSD assessed by the PCL-5 scale.(3 months)
  • signs of anxiety and depression HADS scale(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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