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临床试验/NCT02410538
NCT02410538已完成不适用

Frequently Asked Questions as an Help to Improve the Information of ICU Patients' Families.

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年4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
300
试验地点
1
主要终点
Evaluation of understanding at day 5 by a method of reformulation questionnaire

研究概览

简要总结

The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of the stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The information comprehension at Day 5 (± 1) will be compared between families that received the list of "FAQ" and families that received information as usual (without providing the list of FAQ

详细描述

Half of the families of ICU patients do not understand the information provided by doctors and nurses. Receiving clear, loyal and appropriate information is one of their main expectations. We have previously reported that relatives had difficulty asking questions that allow them to improve their understanding regarding ICU issues. In a preliminary study, we developed a list of questions considered as important by families, ICU doctors and nurses.

The aim of this prospective, randomized and controlled trial is to test the effectiveness of a list of frequently asked questions to relatives of ICU patients on their understanding of the provided information.

The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in intensive care, intubated and mechanically ventilated in the first 48 hours of ICU stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The information comprehension at Day 5 (± 1) will be compared between families that received the list of "FAQ" and families that received information as usual (without providing the list of FAQ).

研究设计

研究类型
Observational
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

  • The subjects that will be included are relatives of patients. The patients must be
  • Receiving invasive mechanical ventilation
  • Intubated in the first 48 hours of ICU admission
  • For an expected duration of mechanical ventilation > 48 hours
  • With a life expectancy of at least 5 days and a SAPS 2 at baseline < 75
  • Who received a visit within 24 hours after intubation. Only one relative will be included.

排除标准

  • person unable to read French

结局指标

主要结局

Evaluation of understanding at day 5 by a method of reformulation questionnaire

时间窗: 5th day after inclusion

The physician in charge of the patient provides the diagnosis, the treatment and the prognosis to the investigator prior to meet the relative. After the meeting, the relative gives to the investigator the diagnosis, main treatements and the prognosis as they have undestood them. In a final step, the investigator will indicate whether similar responses are consistent or not consistent.

Scale of satisfaction out of intensive care.

时间窗: 3 months and at one yearfter inclusion

HADS scores and IES-R at day 5 to day 10.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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