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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational | Other | Observation of disagreements and even real legal conflicts on life-sustaining therapies limitation decisions between relatives and physicians |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Life-sustaining therapies limitation decision is made (during the study)
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| Name | Affiliation | Role |
|---|---|---|
| Mikhael Giabicani, MD | Hôpital Beaujon - 100 boulevard du Général Leclerc - 92110 Clichy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH d'Aurillac (CH Henri Mondor) | Aurillac | 15000 | France | |||
| Hôpital Saint Camille |
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| 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 |
| Bry-sur-Marne |
| 94360 |
| France |
| CHU de Clermont Ferrand - Hôpital Gabriel Montpied | Clermont-Ferrand | 63000 | France |
| Hôpital Beaujon - Réanimation chirurgicale polyvalente | Clichy | 92110 | France |
| Hôpital Beaujon - Réanimation hépato-digestive | Clichy | 92110 | France |
| CH de Dieppe | Dieppe | 76202 | France |
| CHU de Dijon | Dijon | 21079 | France |
| Hôpital Simone Veil- Eaubonne | Eaubonne | 95602 | France |
| CH de Grasse | Grasse | 06130 | France |
| GHEF (Grand Hôpital de l'Est Francilien)-Site de Marne la Vallée | Jossigny | 77600 | France |
| CHU de Grenoble-Alpes | La Tronche | 38700 | France |
| CH de Lens | Lens | 62300 | France |
| CHU de Montpellier - Gui de Chauliac | Montpellier | 34295 | France |
| Hôpital Lariboisière_APHP - Réanimation Chirurgicale Polyvalente | Paris | 75010 | France |
| Institut Mutualiste Montsouris - | Paris | 75014 | France |
| Fondation Ophtalmologique Adolphe de Rothschild | Paris | 75019 | France |
| Hôpital privé Claude Galien | Quincy-sous-Sénart | 91480 | France |
| CHU de Reims - Réanimation chirurgicale | Reims | 51092 | France |
| CHU de Toulouse-Rangueil - Réanimation Polyvalente | Toulouse | 31400 | France |
| CHBA Vannes-Auray | Vannes | 56017 | France |
| CH Versailles | Versailles | 78150 | France |
| HIA Robert Picqué | Villenave-d'Ornon | 33140 | France |
| Médipôle Lyon Villeurbanne | Villeurbanne | 69100 | France |
| ID | Term |
|---|---|
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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