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

NCT ID: NCT05768906

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 429 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-09-01

Brief Summary

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.

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.

Conditions

Cessation of Treatment; End of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

observational

Intervention Type: OTHER

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

Interventions

observational

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

Intervention Type: OTHER

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société Française d'Anesthésie et de Réanimation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikhael Giabicani, MD

Role: STUDY_CHAIR

Hôpital Beaujon - 100 boulevard du Général Leclerc - 92110 Clichy

Locations

CH d'Aurillac (CH Henri Mondor)

Aurillac, , France

Hôpital Saint Camille

Bry-sur-Marne, , France

CHU de Clermont Ferrand - Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Hôpital Beaujon - Réanimation chirurgicale polyvalente

Clichy, , France

Hôpital Beaujon - Réanimation hépato-digestive

Clichy, , France

CH de Dieppe

Dieppe, , France

CHU de Dijon

Dijon, , France

Hôpital Simone Veil- Eaubonne

Eaubonne, , France

CH de Grasse

Grasse, , France

GHEF (Grand Hôpital de l'Est Francilien)-Site de Marne la Vallée

Jossigny, , France

CHU de Grenoble-Alpes

La Tronche, , France

CH de Lens

Lens, , France

CHU de Montpellier - Gui de Chauliac

Montpellier, , France

Hôpital Lariboisière_APHP - Réanimation Chirurgicale Polyvalente

Paris, , France

Institut Mutualiste Montsouris -

Paris, , France

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Hôpital privé Claude Galien

Quincy-sous-Sénart, , France

CHU de Reims - Réanimation chirurgicale

Reims, , France

CHU de Toulouse-Rangueil - Réanimation Polyvalente

Toulouse, , France

CHBA Vannes-Auray

Vannes, , France

CH Versailles

Versailles, , France

HIA Robert Picqué

Villenave-d'Ornon, , France

Médipôle Lyon Villeurbanne

Villeurbanne, , France

Countries

France

Other Identifiers

(DIS)AGREE - 2022-02

Identifier Type: -

Identifier Source: org_study_id