Assessment of Factors Involved in the Decision-making for ICU Patients' Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients
研究概览
简要总结
A new law about the advance directives (AD) has been recently voted in France on February 2, 2016. This " Claeys-Leonetti " law has made the AD more binding, as in other countries. This should lead to a greater respect of the human autonomy principle. However, the interpretation of these guidelines is often difficult and may differ between doctors. Indeed, the subjectivity of these interpretations could lead to different medical decisions by physicians.
The investigators intend to assess the effect of advance directives (AD) on decision making in care by intensivists, using a simulated (hypothetical) situation.
详细描述
Observational simulation (hypothetical) study of intensivist decisions for selected real patients.
Each patient writes advance directives (AD) after receiving clear information (videos and interview with an independent intensivist).
Intensivists answer to 5 questions for two simulations (hypothetical) models (scenario) on pneumonia and occlusive syndrome, in 3 times: without the AD, with AD, and with AD by knowing the drafting conditions (information from intensivist).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for patients :
- •20 patients with chronic diseases or 80 years old patient or older,
- •4 patients with chronic cardiac failure challenged in heart transplant
- •4 patients with chronic renal failure challenged in kidney transplant
- •4 COPD patients in terminal stage
- •4 patients with lung cancer challenged in surgery
- •4 patients, 80 years old or older, without cognitive impairment
- •Inclusion criteria for physician :
- •Working in Intensive Care Unit (ICU)
- •From the 10 ICUs involved in the protocol
排除标准
- •Exclusion criteria for physician :
- •Decline to participate
结局指标
主要结局
Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients
时间窗: at day 1
Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients, in 3 times: without AD first, then with AD and AD with knowing they were made with an intensivist, in this order
次要结局
- Assessment of the concordance between the AD and the intensivists's answers. Direct comparison for objective criteria (organ replacement) between the patients's AD and intensivists's answers. And expert opinion for subjective criteria(at day 1)
- Drafting time for the realization of the AD(at day 1)
- Comparison of answers to 5 questions for the 2 scenarios for each of the 20 patients between the 3 scenarios submission time for each intensivist (intra-individual variability).(at day 1)
- Comparison for each question(at day 1)