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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05768906
Acronym
(DIS)AGREE
Enrollment
429
Registered
2023-03-15
Start date
2023-07-01
Completion date
2025-09-01
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cessation of Treatment, End of Life

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.

Interventions

OTHERobservational

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

Sponsors

Société Française d'Anesthésie et de Réanimation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of disagreements - Using linkert scaleAt the latest by may 31, 2024Evaluate 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.

Secondary

MeasureTime frameDescription
Level of agreement/disagreement - Using linkert scaleAt the latest by may 31, 2024To 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.
Proportion of disagreements experienced as conflictual - Using linkert scaleAt the latest by may 31, 2024To 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.
Impact of the disagreement on the life-sustaining therapies limitation decision. Evaluation by questionnary.At the latest by may 31, 2024To 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.
Factors identificationAt the latest by may 31, 2024To 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
Description of national practices - Aggregation of responses from all sitesAt the latest by may 31, 2024To 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026