Assessment of Factors Involved in the Decision-making for ICU Patients' Care

Study Overview
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Brief Summary
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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
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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).

Official Title
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Assessment of Factors Involved in the Decision-making for ICU Patients' Care

Conditions
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Decision Making

Intervention / Treatment
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* Procedure: Decision making for ICU patients' care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: Exclusion criteria for physician : Decline to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic disease<br> | Procedure: Decision making for ICU patients' care<br>* Study of factors involved in the decision-making for ICU patients' care. Effect of advance directives (AD).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients | 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 | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive care unit, Triage and Therapy., Advance Directives (AD)., Simulation model of real situations. (hypothetical scenario), Intensivist physician.