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

End of Life Clinical Trial

— (DIS)AGREE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768906
• Other study ID #: (DIS)AGREE - 2022-02
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: July 2023
• Source: Société Française d'Anesthésie et de Réanimation
• Contact: Mikhael Giabicani, MD
• Phone: +33 609135978
• Email: mikhael.giabicani[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death
• End of Life

Intervention

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

Locations

Country	Name	City	State
France	CH d'Aurillac (CH Henri Mondor)	Aurillac
France	Hôpital Saint Camille	Bry-sur-Marne
France	CHU de Clermont Ferrand - Hôpital Gabriel Montpied	Clermont-Ferrand
France	Hôpital Beaujon - Réanimation chirurgicale polyvalente	Clichy
France	Hôpital Beaujon - Réanimation hépato-digestive	Clichy
France	CH de Dieppe	Dieppe
France	CHU de Dijon	Dijon
France	Hôpital Simone Veil- Eaubonne	Eaubonne
France	CH de Grasse	Grasse
France	GHEF (Grand Hôpital de l'Est Francilien)-Site de Marne la Vallée	Jossigny
France	CHU de Grenoble-Alpes	La Tronche
France	CH de Lens	Lens
France	CHU de Montpellier - Gui de Chauliac	Montpellier
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Hôpital Lariboisière_APHP - Réanimation Chirurgicale Polyvalente	Paris
France	Institut Mutualiste Montsouris -	Paris
France	Hôpital privé Claude Galien	Quincy-sous-Sénart
France	CHU de Reims - Réanimation chirurgicale	Reims
France	CHU de Toulouse-Rangueil - Réanimation Polyvalente	Toulouse
France	CHBA Vannes-Auray	Vannes
France	CH Versailles	Versailles
France	HIA Robert Picqué	Villenave-d'Ornon
France	Médipôle Lyon Villeurbanne	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Anesthésie et de Réanimation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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