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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cessation of Treatment, End of Life

Intervention / Treatment
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* Other: observational


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Life-sustaining therapies limitation decision situations - observation only<br>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<br>* Observation of disagreements and even real legal conflicts on life-sustaining therapies limitation decisions between relatives and physicians<br>|

What is the study measuring?
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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 |