- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01745406
Benefits of the Involvement of Nurses in Meetings Between Physicians and the Families of Patients in the ICU. (NEWS)
When a patient is admitted to the ICU this often happens so suddenly that this can create a significant amount of stress and anxiety for family members for several reasons. Firstly, the family does not have a pre existing relationship with the ICU team. Secondly, the urgency of the situation and the technic it requires is often such that minimal information can be given to family members. And finally, as a result of the unpredictability of each patient's condition, it can be difficult to predict outcome for family members. Together, these factors compound the stress and anxiety of family members. This anxiety is natural and it is important for health caregivers to be able to offer the best support possible. A high quality communication provided by structured information given by physicians and nurses as well could improve support to the families and lead to greater satisfaction.
Giving information to families during meetings is crucial at 3 moments: at the first day when the patient is admitted, at day 3, weekly and each time important news is given (surgery, deterioration in condition, end-of-life).
The purpose of this project is to evaluate if the involvement of nurses during those meetings could improve quality in communication which is assessed by mixed methods. Families and healthcare workers satisfaction will be assessed by qualitative methodology. Family peritraumatic stress, symptoms of anxiety and depression and PTSD will be assessed using validated scales.
Training of healthcare workers will be done by role play. Information to the families is delivered using a framework for physicians and nurses. All the meetings of the study will be audited by a psychologist.
Descripción general del estudio
Estado
Descripción detallada
-Randomized trial with two arms: arm 1: information is delivered by a team (physician and nurse) arm 2: information is delivered by the physician alone
-During the different meetings of the study: at day 1, at day 3, weekly and in case of deterioration of the patient condition.
The other days, family information is delivered as usually in both arms.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Paris, Francia, 75014
- Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente
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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:
- patient : adult, 1 relative at minimum, mechanically ventilated at least 48 hours; and
- family : french-speaking, adult;
Exclusion Criteria:
- Conflict, organ donor, refusal to participate.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Doctor and nurse
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Doctor without nurse
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Family satisfaction assessed by qualitative approach
Periodo de tiempo: Patient's ICU discharge day (up to 3 months after Day 1)
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Patient's ICU discharge day (up to 3 months after Day 1)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Healthcaregivers' satifaction assessed by qualitative approach
Periodo de tiempo: End of the study (up to 2 years)
|
End of the study (up to 2 years)
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
---|---|
Family PTSD
Periodo de tiempo: 3 months after patient's ICU discharge (up to 6 months after Day 1)
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3 months after patient's ICU discharge (up to 6 months after Day 1)
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Family HADS
Periodo de tiempo: 3 months after patient's ICU discharge (up to 6 months after Day 1)
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3 months after patient's ICU discharge (up to 6 months after Day 1)
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Family peri-traumatic dissociation
Periodo de tiempo: Patient's ICU discharge (up to 3 months after Day 1)
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Patient's ICU discharge (up to 3 months after Day 1)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CPP/107-11
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