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

Decision Making Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013530
• Other study ID #: CHU-0296
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: June 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decision Making

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Comparison for each question		at day 1
Secondary	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
Secondary	Drafting time for the realization of the AD		at day 1