- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03862794
CMO Letter to Reduce Unnecessary Antibiotic Prescribing and Broad Spectrum Prescribing Winter 2018-9 (CMO2018-9)
2 de marzo de 2020 actualizado por: Public Health England
A Randomized Controlled Trial of Behaviourally Informed Feedback Letters Sent by the Chief Medical Officer on the Amount of Antibiotics and the Percentage of Broad Spectrum Antibiotics Prescribed in Primary Care
This trial aims to reduce unnecessary prescription of antibiotics and broad spectrum antibiotics by general practitioners (GPs) in England.
Unnecessary prescriptions are defined as those that do not improve patient health outcomes.
The intervention is to send GPs a letter from the Chief Medical Officer (CMO) that gives feedback on their practice's prescribing levels.
Specifically the sample was GPs whose practices whose prescribed more than 1.161 items per STAR-PU or whose practices prescribed more that .965
items per STAR-PU and greater than 10% broad spectrum items.
The intervention groups received a letter telling them they are among the highest prescribers of either their total or broad spectrum antibiotics, with a graph showing their prescribing compared to average prescribing ("their peers").
The letter also contained a leaflet to help GPs discuss self-care advice with patients and some advice to use delayed prescriptions.
The investigators hypothesize that the antibiotic prescribing rate in will be lower for the treatment group compared to the control group, following the receipt of the letter.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
7000
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
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London, Reino Unido, SE1
- Public Health England
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- GP practices that prescribed more than 1.161 Antibacterial Items/STAR-PU for the twelve months (June 2017 - May 2018)
- GP practices that prescribed more than 0.965 Antibacterial Items/STAR-PU and also more than 10% broad spectrum items for the twelve months (June 2017 - May 2018).
Exclusion Criteria:
- none
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: high total and high broad spectrum prescribing letter
social norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average
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letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average
|
Comparador activo: high total and high broad spectrum prescribing control
standard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive the standard practice overall prescribing letter as a control
|
social norm feedback letter used as standard practice, without specific information about the prescribing percentile
|
Experimental: high total prescribing only intervention letter
social norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive a letter that has specific information about the percentile they are on for overall prescribing and a bar chart representing their overall prescribing compared to the average
|
letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average
|
Comparador activo: high total prescribing control letter
standard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive the standard practice overall prescribing letter as a control
|
social norm feedback letter used as standard practice, without specific information about the prescribing percentile
|
Experimental: moderate total prescribing and high broad spectrum letter
social norm feedback letter with bar chart GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum will receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average
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letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average
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Sin intervención: moderate total prescribing and high broad spectrum control
GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive no letter, which is standard practice, as a control.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
total antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) in November for each GP practice
Periodo de tiempo: 1 month
|
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
|
1 month
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice
Periodo de tiempo: 1 month
|
broad spectrum antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
|
1 month
|
percentage broad spectrum antibiotic prescribing in November for each GP practice
Periodo de tiempo: 1 month
|
percentage broad spectrum antibiotic prescribing
|
1 month
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice
Periodo de tiempo: 1 month
|
total overall antibiotic prescribing minus total broad spectrum antibiotic prescribing
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1 month
|
total antibiotic prescribing weighted by STAR-PU in December for each GP practice
Periodo de tiempo: 2 months
|
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
|
2 months
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice
Periodo de tiempo: 2 months
|
2 months
|
|
percentage broad spectrum antibiotic prescribing in December for each GP practice
Periodo de tiempo: 2 months
|
2 months
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice
Periodo de tiempo: 2 months
|
2 months
|
|
total antibiotic prescribing in January weighted by STAR-PU for each GP practice
Periodo de tiempo: 3 months
|
3 months
|
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total broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice
Periodo de tiempo: 3 months
|
3 months
|
|
percentage broad spectrum antibiotic prescribing in January for each GP practice
Periodo de tiempo: 3 months
|
3 months
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice
Periodo de tiempo: 3 months
|
3 months
|
|
total antibiotic prescribing weighted by STAR-PU in February for each GP practice
Periodo de tiempo: 4 months
|
4 months
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice
Periodo de tiempo: 4 months
|
4 months
|
|
percentage broad spectrum antibiotic prescribing in February for each GP practice
Periodo de tiempo: 4 months
|
4 months
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice
Periodo de tiempo: 4 months
|
4 months
|
|
total antibiotic prescribing weighted by STAR-PU in March for each GP practice
Periodo de tiempo: 5 months
|
5 months
|
|
total broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice
Periodo de tiempo: 5 months
|
5 months
|
|
percentage broad spectrum antibiotic prescribing in March for each GP practice
Periodo de tiempo: 5 months
|
5 months
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice
Periodo de tiempo: 5 months
|
5 months
|
|
total antibiotic prescribing weighted by STAR-PU in April for each GP practice
Periodo de tiempo: 6 months
|
6 months
|
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total broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice
Periodo de tiempo: 6 months
|
6 months
|
|
percentage broad spectrum antibiotic prescribing in April for each GP practice
Periodo de tiempo: 6 months
|
6 months
|
|
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice
Periodo de tiempo: 6 months
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6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de noviembre de 2018
Finalización primaria (Actual)
30 de abril de 2019
Finalización del estudio (Actual)
30 de mayo de 2019
Fechas de registro del estudio
Enviado por primera vez
27 de febrero de 2019
Primero enviado que cumplió con los criterios de control de calidad
1 de marzo de 2019
Publicado por primera vez (Actual)
5 de marzo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
2 de marzo de 2020
Última verificación
1 de diciembre de 2018
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- R&D 193
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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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