(DIS)AGREE: (DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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To assess the level of agreement/disagreement between family members and physicians regarding LST limitation decisions
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To assess the proportion of disagreements experienced as conflictual
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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...)
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To describe possible factors that contribute to disagreement and conflict
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To describe national LST limitation decision-making practices.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: observational
Observation of disagreements and even real legal conflicts on life-sustaining therapies limitation decisions between relatives and physicians
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Outcome Measures
Primary Outcome Measures
- Frequency of disagreements - Using linkert scale [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 Outcome Measures
- Level of agreement/disagreement - Using linkert scale [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.
- Proportion of disagreements experienced as conflictual - Using linkert scale [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.
- Impact of the disagreement on the life-sustaining therapies limitation decision. Evaluation by questionnary. [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.
- Factors identification [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
- Description of national practices - Aggregation of responses from all sites [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Consecutive inclusion of all situations in which a life-sustaining therapies limitation decision was made
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Patients hospitalized in a French intensive care unit
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Age of the patient ≥ 18 years
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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:
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Minor patient
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Patient under guardianship
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Conscious patient, able to express himself/herself and able to decide jointly with the medical team
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Patient for whom a life-sustaining therapies limitation decision was already made prior to inclusion
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Société Française d'Anesthésie et de Réanimation
Investigators
- Study Chair: Mikhael Giabicani, MD, Hôpital Beaujon - 100 boulevard du Général Leclerc - 92110 Clichy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-02