Assessment of Factors Involved in the Decision-making for ICU Patients' Care
- Conditions
- Decision Making
- Interventions
- Procedure: Decision making for ICU patients' care
- Registration Number
- NCT03013530
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- Exclusion criteria for physician :
- Decline to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with chronic disease Decision making for ICU patients' care -
- Primary Outcome Measures
Name Time Method Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France