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

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.

Study Overview

• Status: Completed
• Conditions: Decision Making
• Intervention / Treatment: Procedure: Decision making for ICU patients' care

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).

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU patients' care

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with chronic disease	Procedure: Decision making for ICU patients' care; Study of factors involved in the decision-making for ICU patients' care. Effect of advance directives (AD).

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Alexandre Lautrette, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 2, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Intensive care unit; Triage and Therapy.; Advance Directives (AD).; Simulation model of real situations. (hypothetical scenario); Intensivist physician.
• Other Study ID Numbers: CHU-0296