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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Providing a list of patients not compliant with CRC sreening; Other: Providing general information about CRC sreening

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.

• Study Type: Interventional
• Enrollment (Actual): 48649
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.; Other: Providing general information about CRC sreening
Active Comparator: 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)	Other: Providing general information about CRC sreening
No Intervention: C: usual practice; General Practitioners allocated to group (C) will not receive any information (as in usual practice)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient participation rate to colorectal cancer screening	12 months after starting date of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of cancers screened in (versus diagnosed outside) the screening procedure.	12 months after starting date of the study

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Université de Nantes; Public Health Insurance; Organisms in charge of local cancer screening programs - France; Local Cancer Registry - France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (Estimate): August 4, 2015

Study Record Updates

• Last Update Posted (Estimate): September 16, 2016
• Last Update Submitted That Met QC Criteria: September 15, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Patients; patient compliance; early detection of cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: RC12_0497