(DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU.
(DIS)AGREE
1 other identifier
observational
429
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
23 active sites
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
February 14, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedSeptember 3, 2025
September 1, 2025
2.2 years
February 14, 2023
September 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Level of agreement/disagreement - Using linkert scale
At the latest by may 31, 2024
Proportion of disagreements experienced as conflictual - Using linkert scale
At the latest by may 31, 2024
Impact of the disagreement on the life-sustaining therapies limitation decision. Evaluation by questionnary.
At the latest by may 31, 2024
Factors identification
At the latest by may 31, 2024
Description of national practices - Aggregation of responses from all sites
At the latest by may 31, 2024
Study Arms (1)
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.
Interventions
Observation of disagreements and even real legal conflicts on life-sustaining therapies limitation decisions between relatives and physicians
Eligibility Criteria
Life-sustaining therapies limitation decision is made (during the study)
You may qualify if:
- Patients hospitalized in a French intensive care unit
- Age of the patient ≥ 18 years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
CH d'Aurillac (CH Henri Mondor)
Aurillac, 15000, France
Hôpital Saint Camille
Bry-sur-Marne, 94360, France
CHU de Clermont Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, 63000, France
Hôpital Beaujon - Réanimation chirurgicale polyvalente
Clichy, 92110, France
Hôpital Beaujon - Réanimation hépato-digestive
Clichy, 92110, France
CH de Dieppe
Dieppe, 76202, France
CHU de Dijon
Dijon, 21079, France
Hôpital Simone Veil- Eaubonne
Eaubonne, 95602, France
CH de Grasse
Grasse, 06130, France
GHEF (Grand Hôpital de l'Est Francilien)-Site de Marne la Vallée
Jossigny, 77600, France
CHU de Grenoble-Alpes
La Tronche, 38700, France
CH de Lens
Lens, 62300, France
CHU de Montpellier - Gui de Chauliac
Montpellier, 34295, France
Hôpital Lariboisière_APHP - Réanimation Chirurgicale Polyvalente
Paris, 75010, France
Institut Mutualiste Montsouris -
Paris, 75014, France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019, France
Hôpital privé Claude Galien
Quincy-sous-Sénart, 91480, France
CHU de Reims - Réanimation chirurgicale
Reims, 51092, France
CHU de Toulouse-Rangueil - Réanimation Polyvalente
Toulouse, 31400, France
CHBA Vannes-Auray
Vannes, 56017, France
CH Versailles
Versailles, 78150, France
HIA Robert Picqué
Villenave-d'Ornon, 33140, France
Médipôle Lyon Villeurbanne
Villeurbanne, 69100, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mikhael Giabicani, MD
Hôpital Beaujon - 100 boulevard du Général Leclerc - 92110 Clichy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2023
First Posted
March 15, 2023
Study Start
July 1, 2023
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
September 3, 2025
Record last verified: 2025-09