跳至主要内容
临床试验/NCT02955992
NCT02955992已完成不适用

Guiding ICU Physicians' Communication and Behavior Towards Bereaved Relatives: a Randomized Controlled Trial (COSMIC - EOL)

Assistance Publique - Hôpitaux de Paris19 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
900
试验地点
19
主要终点
PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief

研究概览

简要总结

As ICU mortality is high, end-of-life is a subject of major concern for intensivists. With a mortality rate of 20%, end-of-life care has become a daily responsibility. Among those deaths, 60 to 80% follow a decision to withhold or withdraw treatment, situations where physicians, nurses and relatives must work together towards the most consensual decision. In this context, patients' relatives feel vulnerable and, in the months that follow the death, they are most likely to present symptoms that negatively affect their quality of life (anxiety, depression, PTSD, prolonged grief). Many studies have shown that communication with caregivers is one of the most highly valued aspects of care that impacts on family members' experience during the patient's stay and after the patient's death. Improving communication during the end-of-life process in the ICU context is a necessity that has been put forward in palliative care and family-centered care guidelines.

This study aims to improve both communication skills and behaviour by giving precise recommendations to physicians (3 step strategy) in their direct contact with patients' relatives. A 3-step physician-driven support strategy is used, that consists in 3 meetings with the relative - one before, one during and one after the patient's death. The underlying hypothesis is that this strategy will improve communication in the end-of-life setting and thus should reduce post-ICU burden for family members, specifically the development of prolonged grief 6 months after the death.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Relatives of patients who died in the intensive care unit after a decision to withhold or withdraw treatment (adult ICUs only, ICU length of stay > 2 days).
  • Consent to participate in the study
  • Relative who was seen at least once by the physician before the patient's death

排除标准

  • Relative that does not understand, read or speak French
  • Relative who refuses to participate

结局指标

主要结局

PG-13 : Prolonged Grief Disorder-13 that measures symptoms of prolonged grief

时间窗: 6 months post patient's death

次要结局

  • Quality of dying and death (QODD-1)(1 month post patient's ddeath)
  • Miss-21 - Rapport subscale that describes communication with physician(1 month post patient's death)
  • Impact of Event Scale-Revised (IES-R) that measures post-traumatic stress symptoms(3 and 6 months post patient's death)
  • Hospital Anxiety and Depression Scale (HADS)(1, 3 and 6 months post patient's death)
  • CAESAR scale that measured quality of dying and death(1 month post patient's death)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (19)

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