- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01396044
Daily Checklists and Outcome in the Intensive Care Unit
Medical errors account for tens of thousands of deaths and tens of billions of dollars in healthcare costs in the United States every year. One field that has seen the strongest push toward quality improvement has been critical care medicine, likely because its particularly high degree of medical complexity makes it a practice area prone to high error rates with serious consequences. One of the most commonly used interventions used to help reduce errors in the intensive care unit (ICU) has been the implementation of checklists.
The investigators propose a clinical trial in a University critical care setting to determine whether an electronic checklist versus verbal prompting to use a written checklist improves clinical practice and patient outcomes. The investigators also plan to compare these data with a time period prior to the study to determine if the electronic checklist or verbal prompting are better than usual care. The investigators hypothesize that both the electronic checklist and verbal prompting to use a written checklist will be better for clinical practice and patient outcomes than usual care, and that verbal prompting will lead to better outcomes compared to the electronic checklist.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Memorial Hospital
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Admission to a medical intensive care unit (MICU) team during the study timeframe
Exclusion Criteria:
- Transfer from MICU team to a separate ICU team within 12 hours of admission
- Transfer to MICU team from a separate ICU team after more than 72 hours on the separate ICU team
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Electronic checklist
|
Electronic checklist for process of care issues implemented in our institution.
Training on a regular basis of the electronic checklist arm to use the electronic checklist.
Process of care issues on the electronic checklist include several that are under investigation: antibiotics and mechanical ventilation.
|
|
Experimental: Verbal prompting
Verbal prompting with written checklist
|
Prompting by study investigators of physicians on the verbal prompting arm.
Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Empiric Antibiotic Duration
Periodo de tiempo: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
|
During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
|
|
|
Proportion of Empiric Antibiotics
Periodo de tiempo: ICU admission
|
The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
|
ICU admission
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hospital Mortality
Periodo de tiempo: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
|
|
Length of Stay
Periodo de tiempo: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
|
|
Ventilator-free Days
Periodo de tiempo: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.
|
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
|
Proportion of Successful Prompts
Periodo de tiempo: During ICU admission, an average of 5 days (although individual patients may vary)
|
Prompting group: number of patient-days that prompting led to empirical antibiotics being discontinued or narrowed/number of patient-days prompting occurred Electronic checklist group: number of patient-days that electronic checklist led to empirical antibiotics being discontinued or narrowed/number of patient-days electronic checklist was completed |
During ICU admission, an average of 5 days (although individual patients may vary)
|
|
Proportion of Patients-days on Which Empirical Antibiotics Were Used
Periodo de tiempo: ICU admission
|
Proportion of patients-days on which empirical antibiotics were used
|
ICU admission
|
|
Standardized Mortality Ratio
Periodo de tiempo: Hospital admission
|
Hospital admission
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Curtis H Weiss, MD, Northwestern University
Publicaciones y enlaces útiles
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NUIRBSTU00013313
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