Assessment of Factors Involved in the Decision-making for ICU Patients' Care
A new law about the advance directives (AD) has been recently voted in France on February 2, 2016. This " Claeys-Leonetti " law has made the AD more binding, as in other countries. This should lead to a greater respect of the human autonomy principle. However, the interpretation of these guidelines is often difficult and may differ between doctors. Indeed, the subjectivity of these interpretations could lead to different medical decisions by physicians.
The investigators intend to assess the effect of advance directives (AD) on decision making in care by intensivists, using a simulated (hypothetical) situation.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Observational simulation (hypothetical) study of intensivist decisions for selected real patients.
Each patient writes advance directives (AD) after receiving clear information (videos and interview with an independent intensivist).
Intensivists answer to 5 questions for two simulations (hypothetical) models (scenario) on pneumonia and occlusive syndrome, in 3 times: without the AD, with AD, and with AD by knowing the drafting conditions (information from intensivist).
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Inclusion criteria for patients :
- 20 patients with chronic diseases or 80 years old patient or older,
- 4 patients with chronic cardiac failure challenged in heart transplant
- 4 patients with chronic renal failure challenged in kidney transplant
- 4 COPD patients in terminal stage
- 4 patients with lung cancer challenged in surgery
- 4 patients, 80 years old or older, without cognitive impairment
Inclusion criteria for physician :
- Working in Intensive Care Unit (ICU)
- From the 10 ICUs involved in the protocol
Exclusion Criteria:
- Exclusion criteria for physician :
- Decline to participate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Patients with chronic disease
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Study of factors involved in the decision-making for ICU patients' care.
Effect of advance directives (AD).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients
Délai: at day 1
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Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients, in 3 times: without AD first, then with AD and AD with knowing they were made with an intensivist, in this order
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at day 1
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Comparison of answers to 5 questions for the 2 scenarios for each of the 20 patients between the 3 scenarios submission time for each intensivist (intra-individual variability).
Délai: at day 1
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at day 1
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Comparison for each question
Délai: at day 1
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at day 1
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Assessment of the concordance between the AD and the intensivists's answers. Direct comparison for objective criteria (organ replacement) between the patients's AD and intensivists's answers. And expert opinion for subjective criteria
Délai: at day 1
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at day 1
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Drafting time for the realization of the AD
Délai: at day 1
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at day 1
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Alexandre Lautrette, University Hospital, Clermont-Ferrand
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CHU-0296
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