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Impact of the Distribution to Attending Physicians of a Nominative List of Their Patients Not Participating in the Organised Screening of Colorectal Cancer (IDLN)

15 de septiembre de 2016 actualizado por: Nantes University Hospital

Impact of the Distribution to Attending Physicians of a Nominative List of Their Patients Not Participating in the Organised Screening of Colorectal Cancer: Randomised Study Measuring the Impact on Participation

Objective : to demonstrate that providing to GPs a list of their patients who are not compliant to colorectal cancer screening will 1) enhance patient participation to screening, and 2) decrease the proportion of cancer diagnosed outside the screening organisation. Design : Randomised controlled study, 3 parallel arms. Enrollment: GPs allocated in the 3 groups of the study will be all GPs 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average) and 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services). Patients will be eligible to the study depending on their eligibility to the Faecal Occult Blood Test for colorectal cancer screening : 1) they should be older than 50 and younger than 74; 2) they should not have a personal history of colorectal cancer (or history of adenoma bigger than 1 cm) nor a family history of colorectal cancer. Main outcomes measures : Patient participation to colorectal cancer screening, and number of cancers screened in (versus diagnosed outside) the screening procedure.

Descripción general del estudio

Descripción detallada

Background:

Participation rate for colorectal cancer screening in France is 39%. In a Cochrane review, patient participation rates to colorectal cancer screening varies from 30 to 60%. Policy makers usually consider that these participation rates should be higher, based on the premise that the impact of the screening mainly depends on patient participation. In France, patients at average risk of colorectal cancer are eligible to the Faecal Occult Blood Test for colorectal cancer screening if: 1) they are older than 50 and younger than 74; 2) they have no personal history of colorectal cancer (or history of adenoma bigger than 1 cm) and no family history of colorectal cancer.

Objective:

To demonstrate that providing to GPs a list of their patients who are not compliant to colorectal cancer screening will 1) enhance patient participation to screening, and 2) decrease the proportion of cancer diagnosed outside the screening organisation. Design : Randomised controlled study, 3 parallel arms.

Design:

Randomized controlled study. 3 parallel arms.

Setting:

Primary care setting in France.

Enrollment:

In this study, the intervention will focus on the GP. The statistical unit for the results analysis will be the GP. GPs allocated in the 3 groups of the study will be all GPs 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average) and 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services).

Intervention:

GPs allocated to the intervention group (A) will receive a list of the patients who are not compliant to colorectal cancer screening, while GPs allocated to the others groups will not receive the corresponding information.

Randomization:

3 groups : (A) GPs will receive a list of the patients who are not compliant to colorectal cancer screening, (B) GPs will receive a document providing general information on colorectal cancer screening, (C) GPs will not receive any specific document (they continue regular practice).

Primary outcome measure: Patient participation to colorectal cancer screening Secondary Outcome Measures: number of cancers screened in (versus diagnosed outside) the screening procedure.

Tipo de estudio

Intervencionista

Inscripción (Actual)

48649

Fase

  • No aplica

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

25 años a 74 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

In this study, the statistical unit is the GP.

Inclusion Criteria:

GPs allocated in the 3 groups of the study will be all GPs

  • 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average)
  • 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services).

Exclusion Criteria:

  • GPs who have less than 100 patients in their patient list

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: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: A: nominative list

Providing a list of patients not compliant with CRC sreening

General Practitioners allocated to the intervention group (A) will receive:

  • a nominative list of their patients who were not compliant to colorectal cancer screening.
  • a document providing general information about colorectal cancer screening
GPs allocated to the intervention group (A) will receive a list of the patients who are not compliant to colorectal cancer screening, while GPs allocated to the others groups will not receive this information.
Comparador activo: B: general information

Providing general information about CRC screening

General Practitioners allocated to group (B) will receive:

- a document providing general information about colorectal cancer screening (but will not receive the nominative list of patients non compliant to colorectal cancer screening)

Sin intervención: C: usual practice
General Practitioners allocated to group (C) will not receive any information (as in usual practice)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Patient participation rate to colorectal cancer screening
Periodo de tiempo: 12 months after starting date of the study
12 months after starting date of the study

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Number of cancers screened in (versus diagnosed outside) the screening procedure.
Periodo de tiempo: 12 months after starting date of the study
12 months after starting date of the study

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

1 de agosto de 2015

Finalización primaria (Actual)

1 de agosto de 2016

Finalización del estudio (Actual)

1 de agosto de 2016

Fechas de registro del estudio

Enviado por primera vez

21 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

3 de agosto de 2015

Publicado por primera vez (Estimar)

4 de agosto de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de septiembre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2016

Última verificación

1 de septiembre de 2016

Más información

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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