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临床试验/NCT05768906
NCT05768906已完成不适用

(DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU.

Société Française d'Anesthésie et de Réanimation23 个研究点 分布在 1 个国家目标入组 429 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
429
试验地点
23
主要终点
Frequency of disagreements - Using linkert scale

研究概览

简要总结

In the ICU, the vast majority of patients die following a life-sustaining therapies (LST) limitation decision. Most often, the patient is not able to express himself and has not made his wishes known beforehand, for example in the form of advance directives. The "relatives" are then the only recourse to state the patient's wishes, without any guarantee that they are aware of them. In France, the final decision is made by the physician (or the medical team) who is responsible for it. In this context, disagreements and even real legal conflicts on LST limitation decisions between relatives and physicians seem to be more and more frequent. To our knowledge, few data exist on the frequency of these disagreements over LST limitation decisions.

The main objective of this study is to evaluate the frequency of disagreements between relatives and physicians over LST limitation decisions in adult intensive care.

详细描述

Context In the ICU, the vast majority of patients die following a life-sustaining therapies (LST) limitation decision. Most often, the patient is not able to express himself and has not made his wishes known beforehand, for example in the form of advance directives. The "relatives" are then the only recourse to state the patient's wishes, without any guarantee that they are aware of them. In France, the final decision is made by the physician (or the medical team) who is responsible for it. In this context, disagreements and even real legal conflicts on LST limitation decisions between relatives and physicians seem to be more and more frequent. To our knowledge, few data exist on the frequency of these disagreements over LST limitation decisions.

Purpose The main objective of this study is to evaluate the frequency of disagreements between relatives and physicians over LST limitation decisions in adult intensive care.

The secondary objectives are:

  • To assess the level of agreement/disagreement between family members and physicians regarding LST limitation decisions
  • To assess the proportion of disagreements experienced as conflictual
  • To assess the impact of the disagreement on the LST limitation decision (implementation of the decision, time between the decision and its implementation, length of hospitalization...)
  • To describe possible factors that contribute to disagreement and conflict
  • To describe national LST limitation decision-making practices.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Consecutive inclusion of all situations in which a life-sustaining therapies limitation decision was made
  • Patients hospitalized in a French intensive care unit
  • Age of the patient ≥ 18 years
  • If relatives are present, age of at least one of the relatives ≥ 18 years NB: situations of "non-re-admission" decisions in intensive care are not taken into account in the inclusion criteria.

排除标准

  • Minor patient
  • Patient under guardianship
  • Conscious patient, able to express himself/herself and able to decide jointly with the medical team
  • Patient for whom a life-sustaining therapies limitation decision was already made prior to ICU admission.

结局指标

主要结局

Frequency of disagreements - Using linkert scale

时间窗: At the latest by may 31, 2024

Evaluate the frequency of disagreements between relatives and physicians over LST limitation decisions in adult intensive care. A linkert scale will be used to cote the disagreements and will be completed by the investigator.

次要结局

  • Proportion of disagreements experienced as conflictual - Using linkert scale(At the latest by may 31, 2024)
  • Impact of the disagreement on the life-sustaining therapies limitation decision. Evaluation by questionnary.(At the latest by may 31, 2024)
  • Level of agreement/disagreement - Using linkert scale(At the latest by may 31, 2024)
  • Factors identification(At the latest by may 31, 2024)
  • Description of national practices - Aggregation of responses from all sites(At the latest by may 31, 2024)

研究者

发起方
Société Française d'Anesthésie et de Réanimation
申办方类型
Other
责任方
Sponsor

研究点 (23)

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