Head to Head Trial of Mailed Cologuard to Mailed FIT

Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach

The objective of this study is to measure the comparative effectiveness of mailed outreach of two stool based tests, multi-target stool DNA (Cologuard) and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.

Adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. Eligible participants will be randomized to either mailed Cologuard outreach, facilitated by Exact Sciences or mailed FIT outreach. Colorectal cancer screening completion within 12 months of randomization will be measured as the primary outcome, in addition to secondary outcomes of Cologuard or FIT positivity rate measured within 12 months of randomization, and follow-up colonoscopy uptake and CRC incidence, measured within 24 months of randomization.

Inclusion Criteria:

• Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health
• ≥1 UCSD Health System health visit within the last year
• Resides in San Diego or Imperial County
• Currently not up to date with CRC screening
• Insured by private, public or other health insurance.

Exclusion Criteria:

• Up-to-date with screening
• Prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer.
• Prior history of colectomy
• Lack of health insurance