- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02880826
Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews (REA-C-SUR)
Study on the Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews
The tools to measure safety culture (CS) have recently become available. No study has focused on the measure in France, apart from pilot studies. intensive services are particularly at risk of serious adverse events occurred (SAEs). Patients who are hospitalized are in fact fragile and precarious clinical condition requires rapid decision taken often. Diagnostic or therapeutic strategies have report "risk-benefit" narrow. They may well be complicated by EIG.Safety of care is a priority in the field of health in general, and especially in intensive care. CS measure in this context seems particularly relevant.
The main objective is to describe the CS intensive care units in France. The study will explore the development of the CS level for the units investigated.
This study will also describe the main features of RMM practiced in intensive care units in France.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Nantes, Francia, 44093
- CHU de Nantes
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
60 intensive care units in France. Each unit is estimated that an average of 80 professionals will be subject to the evaluation of the CS (doctors, IDE, assistant nurses, physiotherapists...) and thus nearly 4800 people will be included for the CS measurement.
Includes: all professionals providing care to patients and working full-time or part-time work in the respondent unit.
Descripción
Inclusion Criteria:
- practicing resuscitation activity (this practice is medical or surgical, pediatric or adult, in public or private sector)
- volunteer to participate in the study (agreement of the head of the unit)
for which at least 2 matching / references for the study were identified:
- a medical officer,
- caregiver responsible (Health Framework).
Exclusion Criteria:
- measurement safety culture done in a period of significant change during a period where the staff and activities of the respondent unit of work is relatively stable.
- the responses of professionals to the questionnaire can be influenced by internal factors in their work unit (recent accident occurred, change of close supervision, personnel changes ...) and by factors external to their unit work (establishment certification period, arrival of a new director, recent media coverage of medical accidents ...).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The measure of the CS of intensive care units in France using a validated questionnaire
Periodo de tiempo: The planned project duration is 12 months
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The planned project duration is 12 months
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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 (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RC13_0028
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .