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

Colorectal Cancer Clinical Trial

— IDLN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515344
• Other study ID #: RC12_0497
• Status: Completed
• Phase: N/A
• First received: July 21, 2015
• Last updated: September 15, 2016
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: National Cancer Institute
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48649
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Providing a list of patients not compliant with CRC sreening
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.
• Providing general information about CRC sreening

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Nantes University Hospital	Local Cancer Registry - France, Organisms in charge of local cancer screening programs - France, Public Health Insurance, Université de Nantes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient participation rate to colorectal cancer screening		12 months after starting date of the study	No
Secondary	Number of cancers screened in (versus diagnosed outside) the screening procedure.		12 months after starting date of the study	No