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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)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Providing a list of patients not compliant with CRC sreening
Providing general information about CRC sreening
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring Patients, early detection of cancer, patient compliance

Eligibility Criteria

25 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    A: nominative list

    B: general information

    C: usual practice

    Arm Description

    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

    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)

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

    Outcomes

    Primary Outcome Measures

    Patient participation rate to colorectal cancer screening

    Secondary Outcome Measures

    Number of cancers screened in (versus diagnosed outside) the screening procedure.

    Full Information

    First Posted
    July 21, 2015
    Last Updated
    September 15, 2016
    Sponsor
    Nantes University Hospital
    Collaborators
    Public Health Insurance, Université de Nantes, Organisms in charge of local cancer screening programs - France, Local Cancer Registry - France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02515344
    Brief Title
    Impact of the Distribution to Attending Physicians of a Nominative List of Their Patients Not Participating in the Organised Screening of Colorectal Cancer
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nantes University Hospital
    Collaborators
    Public Health Insurance, Université de Nantes, Organisms in charge of local cancer screening programs - France, Local Cancer Registry - France

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    Patients, early detection of cancer, patient compliance

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48649 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A: nominative list
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    B: general information
    Arm Type
    Active Comparator
    Arm Description
    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)
    Arm Title
    C: usual practice
    Arm Type
    No Intervention
    Arm Description
    General Practitioners allocated to group (C) will not receive any information (as in usual practice)
    Intervention Type
    Other
    Intervention Name(s)
    Providing a list of patients not compliant with CRC sreening
    Intervention Description
    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
    Intervention Name(s)
    Providing general information about CRC sreening
    Primary Outcome Measure Information:
    Title
    Patient participation rate to colorectal cancer screening
    Time Frame
    12 months after starting date of the study
    Secondary Outcome Measure Information:
    Title
    Number of cancers screened in (versus diagnosed outside) the screening procedure.
    Time Frame
    12 months after starting date of the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28873160
    Citation
    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.
    Results Reference
    derived

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