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

NCT ID: NCT03013530

Last Updated: 2018-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-05-02

Brief Summary

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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

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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).

Conditions

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Decision Making

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with chronic disease

Decision making for ICU patients' care

Intervention Type PROCEDURE

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

Interventions

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Decision making for ICU patients' care

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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


* Working in Intensive Care Unit (ICU)
* From the 10 ICUs involved in the protocol

Exclusion Criteria

* Decline to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre LAUTRETTE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33267904 (View on PubMed)

Other Identifiers

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CHU-0296

Identifier Type: -

Identifier Source: org_study_id

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