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Completed

NCT Number: NCT05768906

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH d'Aurillac (CH Henri Mondor), Aurillac, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

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

Primary outcomes

  1. Frequency of disagreements - Using linkert scale

    Time frame: At the latest by may 31, 2024

    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.

Secondary outcomes

  1. Level of agreement/disagreement - Using linkert scale

    Time frame: At the latest by may 31, 2024

    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.

  2. Proportion of disagreements experienced as conflictual - Using linkert scale

    Time frame: At the latest by may 31, 2024

    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.

  3. Impact of the disagreement on the life-sustaining therapies limitation decision. Evaluation by questionnary.

    Time frame: At the latest by may 31, 2024

    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.

  4. Factors identification

    Time frame: At the latest by may 31, 2024

    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

  5. Description of national practices - Aggregation of responses from all sites

    Time frame: At the latest by may 31, 2024

    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.

Sponsors and collaborators

Lead sponsor

Société Française d'Anesthésie et de Réanimation

Other

Registry information

Acronym: (DIS)AGREE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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