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NCT Number: NCT03013530

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.

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Key information

Conditions

Decision Making

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision making for ICU patients' care

Procedure

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

Primary outcomes

  1. Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients

    Time frame: at day 1

    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

Secondary outcomes

  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).

    Time frame: at day 1

  2. Comparison for each question

    Time frame: at day 1

  3. 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

    Time frame: at day 1

  4. Drafting time for the realization of the AD

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2017
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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