NCT03013530|Completed
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Sponsor study identifier
observational
20
1 country
1
Study Start
December 1, 2017
Actual (reported)Primary Completion
May 2, 2018
Actual (reported)Study Completion
May 2, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2016
Actual (reported)January 6, 2017
Actual (reported)December 1, 2017
Actual (reported)May 2, 2018
Actual (reported)May 2, 2018
Actual (reported)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
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
Study of factors involved in the decision-making for ICU patients' care. Effect of advance directives (AD).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
ICU patients' care
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
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.
Alexandre LAUTRETTE
University Hospital, Clermont-Ferrand
20 participants (actual enrollment reported by the registry).
First Submitted
December 19, 2016
First Posted
January 6, 2017
Study Start
December 1, 2017
Actual (reported)PROJECT 2 EXAMPLE: Feedback X Prevalence Using Dermatology Stimuli
Contact the study team to confirm eligibility.
Primary Completion
May 2, 2018
Actual (reported)Study Completion
May 2, 2018
Actual (reported)Last Updated
June 19, 2018
Record last verified: 2018-06
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Source: ClinicalTrials.gov.
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