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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

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

      • London, Reino Unido, SE1
        • Public Health England

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

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
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
letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average
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.

¿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
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
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
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
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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