NCT03013530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2018

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

December 19, 2016

Last Update Submit

June 18, 2018

Conditions

Decision Making

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (1)

Patients with chronic disease

Procedure: Decision making for ICU patients' care

Interventions

Decision making for ICU patients' carePROCEDURE

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

Patients with chronic disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients' care

You may qualify if:

  • patients with chronic diseases or 80 years old patient or older,
  • patients with chronic cardiac failure challenged in heart transplant
  • patients with chronic renal failure challenged in kidney transplant
  • COPD patients in terminal stage
  • patients with lung cancer challenged in surgery
  • patients, 80 years old or older, without cognitive impairment
  • Working in Intensive Care Unit (ICU)
  • From the 10 ICUs involved in the protocol

You may not qualify if:

  • Decline to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 33267904DERIVED

Study Officials

  • Alexandre LAUTRETTE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

January 6, 2017

Study Start

December 1, 2017

Primary Completion

May 2, 2018

Study Completion

May 2, 2018

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations

FR(1)