跳至主要内容
临床试验/NCT04785807
NCT04785807Unknown不适用

STRESS From in Charge Relative Facing the Announcement of Decisions Limiting or Stopping Treatments in Emergency Room During the COVID-19 Epidemic

Hospices Civils de Lyon6 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年3月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
试验地点
6
主要终点
Post traumatic syndrome evaluated thanks to the Revised impact event scale (IES-R)

研究概览

简要总结

In the context of the COVID-19 pandemic, the emergency reception services had to be radically reorganized. In this tense environment, professionals must face ethical dilemmas, make referral decisions and prioritize patients. Due to the limited number of visits to many hospitals, interactions with relatives and families of patients are mainly conducted by phone. These limitations will continue as long as the context of uncertainty over the course of the pandemic persists. Limitation or discontinuation of treatment (LDT) announcements were therefore also impacted and the exceptional situation related to COVID-19 reinforces the difficulties encountered by professionals in usual time (place of announcement, inappropriate lack of time, etc.). Thus, LDTs are most often done over the phone without the families being able to go to the hospital. Because of this, these announcements can be more traumatic. Investigators have already highlighted in a recent study the lack of communication between caregivers and families in the context of LDT announcements and the context of COVID 19 exacerbated these aspects given the limitations of visits.

The investigators therefore propose to study the experiences of families who are notified of a decision to limit or stop treatment by phone in the emergency room during the COVID-19 crisis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Age over 18 years old.
  • Person of trust designated in writing or contact person if designated by the family or primary caregiver or failing that the family member or person of trust of an adult patient deemed unfit to receive the information (advanced dementia (lower MMS) to 10), disturbance of consciousness). Only one person per family will be included.
  • having been informed of a LAT decision in the emergency room by telephone during the pandemic
  • Having consented to participate in the study
  • Affiliated with social security

排除标准

  • Person of trust, family or close friend unable to understand or write in French.

结局指标

主要结局

Post traumatic syndrome evaluated thanks to the Revised impact event scale (IES-R)

时间窗: 30 days after limitation or discontinuation of treatment announcement

The primary endpoint is the evaluation of Post traumatic syndrome among the family member or person of trust of a patient who received a limitation or discontinuation of treatment, 30 days after this announcement. The post traumatic syndrome will be evaluated thanks to the Revised impact event scale (IES-R) giving a score going from 0 to 88. The greater the score, the worse the outcome is.

次要结局

  • Depression level at day 7, assessed using the Hospitalized Anxiety and Depression Scale(7 days after inclusion)
  • Anxiety level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)(30 days after inclusion)
  • Description of clinical factors(30 days after inclusion)
  • Anxiety level at day 7, assessed using the Hospitalized Anxiety and Depression Scale-(HADS)(7 days after inclusion)
  • Depression level at day 30, assessed using the Hospitalized Anxiety and Depression Scale (HADS)(30 days after inclusion)
  • Description of socio-demographic factors(30 days after inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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