(DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU. ((DIS)AGREE)

In the ICU, the vast majority of patients die following a life-sustaining therapies (LST) limitation decision. Most often, the patient is not able to express himself and has not made his wishes known beforehand, for example in the form of advance directives. The "relatives" are then the only recourse to state the patient's wishes, without any guarantee that they are aware of them. In France, the final decision is made by the physician (or the medical team) who is responsible for it. In this context, disagreements and even real legal conflicts on LST limitation decisions between relatives and physicians seem to be more and more frequent. To our knowledge, few data exist on the frequency of these disagreements over LST limitation decisions.

The main objective of this study is to evaluate the frequency of disagreements between relatives and physicians over LST limitation decisions in adult intensive care.

Study Overview

• Status: Completed
• Conditions: End of Life; Cessation of Treatment
• Intervention / Treatment: Other: observational

Detailed Description

Context In the ICU, the vast majority of patients die following a life-sustaining therapies (LST) limitation decision. Most often, the patient is not able to express himself and has not made his wishes known beforehand, for example in the form of advance directives. The "relatives" are then the only recourse to state the patient's wishes, without any guarantee that they are aware of them. In France, the final decision is made by the physician (or the medical team) who is responsible for it. In this context, disagreements and even real legal conflicts on LST limitation decisions between relatives and physicians seem to be more and more frequent. To our knowledge, few data exist on the frequency of these disagreements over LST limitation decisions.

Purpose The main objective of this study is to evaluate the frequency of disagreements between relatives and physicians over LST limitation decisions in adult intensive care.

The secondary objectives are:

• To assess the level of agreement/disagreement between family members and physicians regarding LST limitation decisions
• To assess the proportion of disagreements experienced as conflictual
• To assess the impact of the disagreement on the LST limitation decision (implementation of the decision, time between the decision and its implementation, length of hospitalization...)
• To describe possible factors that contribute to disagreement and conflict
• To describe national LST limitation decision-making practices.

• Study Type: Observational
• Enrollment (Actual): 429

Contacts and Locations

Study Locations

• France
  • Aurillac, France, 15000
    • CH d'Aurillac (CH Henri Mondor)
  • Bry-sur-Marne, France, 94360
    • Hôpital Saint Camille
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont Ferrand - Hôpital Gabriel Montpied
  • Clichy, France, 92110
    • Hôpital Beaujon - Réanimation chirurgicale polyvalente
  • Clichy, France, 92110
    • Hôpital Beaujon - Réanimation hépato-digestive
  • Dieppe, France, 76202
    • CH de Dieppe
  • Dijon, France, 21079
    • CHU de DIJON
  • Eaubonne, France, 95602
    • Hôpital Simone Veil- Eaubonne
  • Grasse, France, 06130
    • CH de Grasse
  • Jossigny, France, 77600
    • GHEF (Grand Hôpital de l'Est Francilien)-Site de Marne la Vallée
  • La Tronche, France, 38700
    • CHU de Grenoble-Alpes
  • Lens, France, 62300
    • CH de Lens
  • Montpellier, France, 34295
    • CHU de Montpellier - Gui de Chauliac
  • Paris, France, 75019
    • Fondation Ophtalmologique Adolphe de Rothschild
  • Paris, France, 75010
    • Hôpital Lariboisière_APHP - Réanimation Chirurgicale Polyvalente
  • Paris, France, 75014
    • Institut Mutualiste Montsouris -
  • Quincy-sous-Sénart, France, 91480
    • Hôpital Privé Claude Galien
  • Reims, France, 51092
    • CHU de Reims - Réanimation chirurgicale
  • Toulouse, France, 31400
    • CHU de Toulouse-Rangueil - Réanimation Polyvalente
  • Vannes, France, 56017
    • CHBA Vannes-Auray
  • Versailles, France, 78150
    • CH Versailles
  • Villenave-d'Ornon, France, 33140
    • HIA Robert Picqué
  • Villeurbanne, France, 69100
    • Médipole Lyon Villeurbanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Life-sustaining therapies limitation decision is made (during the study)

Description

Inclusion Criteria:

• Consecutive inclusion of all situations in which a life-sustaining therapies limitation decision was made
• Patients hospitalized in a French intensive care unit
• Age of the patient ≥ 18 years
• If relatives are present, age of at least one of the relatives ≥ 18 years NB: situations of "non-re-admission" decisions in intensive care are not taken into account in the inclusion criteria.

Exclusion Criteria:

• Minor patient
• Patient under guardianship
• Conscious patient, able to express himself/herself and able to decide jointly with the medical team
• Patient for whom a life-sustaining therapies limitation decision was already made prior to ICU admission.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Life-sustaining therapies limitation decision situations - observation only; For each participating center, consecutive inclusion of the first 10 life-sustaining therapies limitation decision situations from the study start date over a maximum of 12 months. Data collection for these patients especialy information concerning disagreements and even real legal conflicts on life-sustaining therapies limitation decisions between relatives and physicians.

Other: observational; Observation of disagreements and even real legal conflicts on life-sustaining therapies limitation decisions between relatives and physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of disagreements - Using linkert scale	Evaluate the frequency of disagreements between relatives and physicians over LST limitation decisions in adult intensive care. A linkert scale will be used to cote the disagreements and will be completed by the investigator.	At the latest by may 31, 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of agreement/disagreement - Using linkert scale	To assess the level of agreement/disagreement between family members and physicians regarding life-sustaining therapies limitation decisions. A linkert scale will be used to cote the level of agreement/disagreement and will be completed by the investigator. Data will be expressed as numbers and percentages or medians and interquartile ranges. The data will be compared by the appropriate non-parametric tests.	At the latest by may 31, 2024
Proportion of disagreements experienced as conflictual - Using linkert scale	To assess the proportion of disagreements experienced as conflictual. A linkert scale will be used to cote the level of Proportion of disagreements experienced as conflictual and will be completed by the investigator. Data will be expressed as numbers and percentages or medians and interquartile ranges. The data will be compared by the appropriate non-parametric tests.	At the latest by may 31, 2024
Impact of the disagreement on the life-sustaining therapies limitation decision. Evaluation by questionnary.	To assess the impact of the disagreement on the life-sustaining therapies limitation decision. Questionnary will be completed by the investigator.Data will be expressed as numbers and percentages or medians and interquartile ranges. The data will be compared by the appropriate non-parametric tests.	At the latest by may 31, 2024
Factors identification	To describe possible factors that contribute to disagreement and conflict. Data will be expressed as numbers and percentages or medians and interquartile ranges. The data will be compared by the appropriate non-parametric tests	At the latest by may 31, 2024
Description of national practices - Aggregation of responses from all sites	To describe national life-sustaining therapies limitation decision-making practices. Aggregation of responses to questions of the CRF from all sites Data will be expressed as numbers and percentages or medians and interquartile ranges. The data will be compared by the appropriate non-parametric tests.	At the latest by may 31, 2024

Collaborators and Investigators

• Sponsor: Société Française d'Anesthésie et de Réanimation
• Investigators: Study Chair: Mikhael Giabicani, MD, Hôpital Beaujon - 100 boulevard du Général Leclerc - 92110 Clichy

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: (DIS)AGREE - 2022-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No