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

NCT ID: NCT02515344

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48649 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-08-31

Brief 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.

Detailed 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Providing a list of patients not compliant with CRC sreening

Intervention Type: OTHER

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

Intervention Type: OTHER

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)

Group Type: ACTIVE_COMPARATOR

Providing general information about CRC sreening

Intervention Type: OTHER

C: usual practice

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Providing general information about CRC sreening

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Public Health Insurance

UNKNOWN

Sponsor Role: collaborator

Université de Nantes

OTHER

Sponsor Role: collaborator

Organisms in charge of local cancer screening programs - France

UNKNOWN

Sponsor Role: collaborator

Local Cancer Registry - France

UNKNOWN

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Rat C, Pogu C, Le Donne D, Latour C, Bianco G, Nanin F, Cowppli-Bony A, Gaultier A, Nguyen JM. Effect of Physician Notification Regarding Nonadherence to Colorectal Cancer Screening on Patient Participation in Fecal Immunochemical Test Cancer Screening: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):816-824. doi: 10.1001/jama.2017.11387.

Reference Type: DERIVED

PMID: 28873160 (View on PubMed)

Other Identifiers

RC12_0497

Identifier Type: -

Identifier Source: org_study_id