Sequential choice vs colonoscopy outreach for colorectal cancer screening: Design and rationale of a pragmatic...

Colorectal cancer (CRC) screening rates remain limited, and effective methods for offering the choice of colonoscopy or stool testing through outreach have not been identified. We evaluate the effect of sequential choice compared to colonoscopy outreach on screening completion, and further evaluate behavioral nudges in the electronic health record (EHR).

In this pragmatic randomized clinical trial, patients were randomly allocated in a 1:2:2 ratio to 1) usual care (no outreach), 2) colonoscopy only, or 3) sequential choice of colonoscopy, then fecal immunochemical testing (FIT). Patients in arms 2 and 3 were additionally randomized to receive either (a) usual care, or (b) a visit-based, clinician-directed nudge facilitated by the EHR with follow-up texting to the patient. The primary outcome is CRC screening completion within 3 years by either colonoscopy, 2 negative fecal immunochemical tests (FIT), or 1 positive FIT followed by colonoscopy within one year.

For the patient-directed analysis, the primary outcome will be evaluated by comparing CRC screening completion among patients randomized to either outreach arm (2 or 3) to the no outreach arm (1). We will also compare completion between the colonoscopy only arm (1) and the sequential choice arm (2). For the visit-based analysis, we will compare CRC screening completion among patients between the usual care arms (2a and 3a) and the nudge arms (2b and 3b).

This trial is unique in evaluating the long-term effectiveness of offering sequential choice to colonoscopy alone through a multi-level, centralized outreach and visit-based design.

NCT05693649.