- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03173768
Appropriateness of Intravenous Antibiotics Prescriptions at Hospital Discharge
Quasi-experimental Study Comparing Intravenous Antibiotics Prescriptions at Hospital Discharge With and Without ID Consultation
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The pre-intervention period was started from November 1, 2015 to April 30, 2016 (6-month period), in which the intravenous antibiotics at hospital discharge were prescribed by the primary care team. The post-intervention period was started from May 1, 2016 to February 28, 2017 (10-month period), in which the intravenous antibiotics at hospital discharge were reviewed and intervened by ID team.
The appropriateness of intravenous antibiotics was assessed separately by the ID fellow and ID specialist. If disagreement occurred, the feedback to the ID fellow was performed and the decision by ID specialist was used in the final analysis of appropriateness.
In post-intervention period, ID fellow modified the intravenous antibiotics ordered by the primary team if those intravenous antibiotics were judged as inappropriate by ID fellow as follows: 1) discontinue intravenous antibiotics (treatment was complete), 2) switch to oral antibiotics, 3) change intravenous antibiotics to cover isolated pathogens, 4) adjust the dose of intravenous antibiotics, and 5) change the duration of intravenous antibiotics
Finally, ID specialist retrospectively assessed the appropriateness of intravenous antibiotics at hospital discharge managed by ID fellow in post-intervention period.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Chiang Mai, Tailandia, 50200
- Department of Medicine
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
All adult patients who met the following criteria were consecutively enrolled;
- age≥ 15 years old and
- had infections at any sites and received intravenous antibiotics.
Exclusion Criteria:
- They were evaluated by infectious diseases specialist for appropriate antibiotics during admission
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: pre-intervention period
The charts of patients who were prescribed intravenous antibiotics at hospital discharge were reviewed.
Appropriateness of intravenous antibiotics was assessed by ID specialists.
|
|
|
Experimental: post-intervention period
The intervention is the charts of patients who were prescribed intravenous antibiotics at hospital discharge by the primary team were prospectively reviewed and intervened by ID team (ID specialist approval)
|
Appropriateness of intravenous antibiotics ordered by the primary team was assessed by ID specialist.
ID fellow modified the intravenous antibiotics ordered by the primary team if those intravenous antibiotics were judged as inappropriate by ID fellow as follows: 1) discontinue intravenous antibiotics (treatment was complete), 2) switch to oral antibiotics, 3) change intravenous antibiotics to cover isolated pathogens, 4) adjust the dose of intravenous antibiotics, and 5) change the duration of intravenous antibiotics.
Finally, ID specialist retrospectively assessed the appropriateness of intravenous antibiotics at hospital discharge managed by ID fellow in post-intervention period.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The proportion of appropriateness of intravenous antibiotics prescriptions at hospital discharge between groups
Periodo de tiempo: 16 months
|
To calculate the number of antibiotic prescriptions at hospital discharge over the total number of prescriptions, comparing between pre-and post-intervention period.
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16 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The costs of antibiotics for the course of treatment
Periodo de tiempo: 16 months
|
To compare the cost of antibiotics for the course of treatment between the 2 periods
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16 months
|
|
Clinical improvement at 1 week
Periodo de tiempo: 1 week
|
To calculate the number of patients who had clinical improvement at 1 week over the total number of patients in each period, comparing between the 2 periods
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1 week
|
|
Readmission within 30 days, length of hospital stay
Periodo de tiempo: 30 days
|
To calculate the number of patients who were readmitted within 30 days over the total number of patients in each period, comparing between the 2 periods
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30 days
|
|
Length of hospital stay
Periodo de tiempo: 60 days
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To calculate the length of hospital stays in days between 2 periods
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60 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Romanee Chaiwarith, MD, Maharaj Nakorn Chiang Mai Hospital
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 (Actual)
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
- 3631
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .
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