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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Clermont-Ferrand, Francia, 63003
- Chu Clermont-Ferrand
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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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).
Periodo de tiempo: at day 1
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at day 1
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Comparison for each question
Periodo de tiempo: 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
Periodo de tiempo: at day 1
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at day 1
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Drafting time for the realization of the AD
Periodo de tiempo: at day 1
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at day 1
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alexandre LAUTRETTE, University Hospital, Clermont-Ferrand
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CHU-0296
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