YIA22-005: A Randomized Trial of Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting

Background: Effective prevention and screening exists for colorectal cancer (CRC) but is underutilized, particularly in community health settings. Colonoscopy and fecal immunochemical testing (FIT) are both considered top-tier tests according to guidelines, but it is not clear how to offer choice through mailed outreach. Insights from behavioral science suggest that opt-out framing may increase participation, while choice overload may reduce uptake. Methods: This is a 3-arm randomized trial aimed at increasing rates of CRC screening by outreach to patients’ homes using choice architecture informed by behavioral science principles. We will randomize approximately 738 patients in a 1:1:1 ratio to one of three study arms: 1) colonoscopy only, 2) choice between colonoscopy or FIT, and 3) FIT only. The setting is a community health center in southeastern Pennsylvania with a baseline screening rate of 22%. Patients aged 50-74 who are overdue for CRC screening by screening guidelines will be enrolled (with a waiver of informed consent) if they have been seen at least once in the past 3 years for an outpatient visit. We will exclude patients at high risk of CRC (who should receive colonoscopy) or history of metastatic cancer. All patients will receive a letter from the health center informing them that they are overdue for CRC screening and requesting their participation in screening per their group assignment. Those in the colonoscopy arms will receive information about scheduling at a local endoscopy center. Those in the FIT arms will receive a FIT kit with instructions for completion. If screening is not completed, participants will additionally receive a reminder mailing or text message 2 months after initial outreach, and a final reminder phone call 3 months after initial outreach. The primary study endpoint is the completion of CRC screening within 6 months, and the secondary outcome is the choice of screening test. At the conclusion of the intervention, 20 participants in each of the three study arms will be randomly selected for a follow-up phone interview. Results: We have recently started enrollment, and we will describe our study population and present lessons learned regarding study implementation. Conclusions: The results of this trial will inform community health centers on how best to offer the choice of CRC screening to patients through mailed outreach. Trial Registration: clinicaltrials.gov NCT04711473