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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03013530
Enrollment
20
Registered
2017-01-06
Start date
2017-12-01
Completion date
2018-05-02
Last updated
2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Making

Keywords

Intensive care unit, Triage and Therapy., Advance Directives (AD)., Simulation model of real situations. (hypothetical scenario), Intensivist physician.

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).

Interventions

PROCEDUREDecision making for ICU patients' care

Study of factors involved in the decision-making for ICU patients' care. Effect of advance directives (AD).

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patientsat day 1Intensivists'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

MeasureTime 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 questionat 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 criteriaat day 1
Drafting time for the realization of the ADat day 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026