The goal of this pragmatic randomized clinical trial is to compare two colorectal (CRC)
screening outreach approaches (FIT and Cologuard) in community health centers (CHC) in
patients overdue for CRC screening. The main questions the project aims to answer are:
What screening test has a higher completion rate? What screening test is more feasible
and acceptable in a CHC setting? Patients will be sent a CRC screening test in the mail
and will be asked to complete it at home and mail it back. Researchers will compare the
completion rates for each screening test and will also look at the overall completion
rate of both tests.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05714644.
This is a 3-year pragmatic trial with four levels of intervention, including system-,
provider-, patient-, and community-level components at each of the CARES clinical sites.
Health system components will include the development and implementation of a CRC
screening registry and tracking database to systematically and actively track patients
overdue for screening, screening test completion, and abnormal screening results. Data
systems will be coupled with process re-design to improve clinical workflow for screening
outreach. Providers will receive educational support through a training session about the
importance of CRC screening, screening test options, population management, and an
instructional on how to complete a Cologuard kit (Cologuard arm only) or a FIT kit (FIT
arm only). Patient components of the intervention vary by study arm. In sites randomized
to Cologuard, patients will receive a mailed Cologuard kit and the Exact Sciences patient
support program. Patients in clinics randomized to FIT will receive a mailed FIT kit with
systematic reminders. Patients who test positive will be offered patient navigation to
assist with completing a diagnostic colonoscopy.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMassachusetts General Hospital
Principal InvestigatorJennifer S. Haas
