Clinical trial NCT03013530: Assessment of Factors Involved in the Decision-making for ICU Patients' Care
Official title: Assessment of Factors Involved in the Decision-making for ICU Patients' Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decision Making
Keywords: Intensive care unit
Triage and Therapy.
Advance Directives (AD).
Simulation model of real situations. (hypothetical scenario)
Intensivist physician.
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients' care

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).

Eligibility criteria: 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

Primary outcomes:
measure: Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients
timeFrame: at day 1
Secondary outcomes:
measure: 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).
timeFrame: at day 1
measure: Comparison for each question
timeFrame: at day 1
measure: 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
timeFrame: at day 1
measure: Drafting time for the realization of the AD
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Alexandre LAUTRETTE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smirdec M, Jourdain M, Guastella V, Lambert C, Richard JC, Argaud L, Jaber S, Klouche K, Medard A, Reignier J, Rigaud JP, Doise JM, Chabanne R, Souweine B, Bourenne J, Delmas J, Bertrand PM, Verdier P, Quenot JP, Aubron C, Eisenmann N, Asfar P, Fratani A, Dellamonica J, Terzi N, Constantin JM, Van Lander A, Guerin R, Pereira B, Lautrette A. Impact of advance directives on the variability between intensivists in the decisions to forgo life-sustaining treatment. Crit Care. 2020 Dec 2;24(1):672. doi: 10.1186/s13054-020-03402-7.