Clinical trial NCT05768906: (DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU.
Official title: (DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cessation of Treatment
End of Life
Lead sponsor: Société Française d'Anesthésie et de Réanimation
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Life-sustaining therapies limitation decision is made (during the study)

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.

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
* 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.

Primary outcomes:
measure: Frequency of disagreements - Using linkert scale
timeFrame: At the latest by may 31, 2024
Secondary outcomes:
measure: Level of agreement/disagreement - Using linkert scale
timeFrame: At the latest by may 31, 2024
measure: Proportion of disagreements experienced as conflictual - Using linkert scale
timeFrame: At the latest by may 31, 2024
measure: Impact of the disagreement on the life-sustaining therapies limitation decision. Evaluation by questionnary.
timeFrame: At the latest by may 31, 2024
measure: Factors identification
timeFrame: At the latest by may 31, 2024
measure: Description of national practices - Aggregation of responses from all sites
timeFrame: At the latest by may 31, 2024
Other outcomes:
Locations:
city: Aurillac
country: France
facility: CH d'Aurillac (CH Henri Mondor)
city: Bry-sur-Marne
country: France
facility: Hôpital Saint Camille
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied
city: Clichy
country: France
facility: Hôpital Beaujon - Réanimation chirurgicale polyvalente
city: Clichy
country: France
facility: Hôpital Beaujon - Réanimation hépato-digestive
city: Dieppe
country: France
facility: CH de Dieppe
city: Dijon
country: France
facility: CHU de Dijon
city: Eaubonne
country: France
facility: Hôpital Simone Veil- Eaubonne
city: Grasse
country: France
facility: CH de Grasse
city: Jossigny
country: France
facility: GHEF (Grand Hôpital de l'Est Francilien)-Site de Marne la Vallée
city: La Tronche
country: France
facility: CHU de Grenoble-Alpes
city: Lens
country: France
facility: CH de Lens
city: Montpellier
country: France
facility: CHU de Montpellier - Gui de Chauliac
city: Paris
country: France
facility: Hôpital Lariboisière_APHP - Réanimation Chirurgicale Polyvalente
city: Paris
country: France
facility: Institut Mutualiste Montsouris -
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Quincy-sous-Sénart
country: France
facility: Hôpital privé Claude Galien
city: Reims
country: France
facility: CHU de Reims - Réanimation chirurgicale
city: Toulouse
country: France
facility: CHU de Toulouse-Rangueil - Réanimation Polyvalente
city: Vannes
country: France
facility: CHBA Vannes-Auray
city: Versailles
country: France
facility: CH Versailles
city: Villenave-d'Ornon
country: France
facility: HIA Robert Picqué
city: Villeurbanne
country: France
facility: Médipôle Lyon Villeurbanne
Study officials:
affiliation: Hôpital Beaujon - 100 boulevard du Général Leclerc - 92110 Clichy
name: Mikhael Giabicani, MD
role: STUDY_CHAIR
References: