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RANDOMIZED CONTROLLED TRIAL OF FECAL IMMUNOCHEMICAL TEST (FIT)-BASED MAILED OUTREACH OFFERING ACTIVE CHOICE (FIT OR COLONOSCOPY UP-FRONT) VS. SEQUENTIAL CHOICE (INITIAL FIT, LATER INVITATION FOR COLONOSCOPY) FOR COLORECTAL CANCER (CRC) SCREENING
Date
May 19, 2024
Background: Screening decreases CRC incidence and mortality, but many persons remain unscreened. Offering FIT to those who decline colonoscopy improves screening participation. Offering colonoscopy in a FIT-based program has not been studied systematically.
Aims: To compare FIT-based mailed outreach with Active Choice (FIT or colonoscopy up-front) vs. Sequential Choice (initial FIT; colonoscopy only to FIT non-participants).
Methods: We performed a randomized controlled trial of CRC screen-eligible persons in eight primary care clinics. All mailed outreach included a FIT kit and a first letter with basic information on CRC and screening. The Active Choice letter also included a graphic comparing FIT and colonoscopy attributes, and an invitation to return the FIT kit or schedule a colonoscopy using a dedicated phone number. The Sequential Choice letter also included a graphic showing only FIT attributes and an invitation to return the FIT kit. Text reminders were sent at 6 weeks.
Second letters were sent at 3 months. The Active Choice letter reminded patients to return the FIT kit or schedule a colonoscopy. The Sequential Choice letter introduced colonoscopy for the first time, included the graphic comparing FIT and colonoscopy attributes, and an invitation to return the FIT kit or schedule a colonoscopy using the dedicated phone number.
The primary outcome was screening completion.
Results: The Sequential Choice arm included 2,035 persons and the Active Choice arm included 2,047 persons, with comparable demographics (55% women; median age 58.4 [IQR 53-66] years; 44% White, 27% Asian, 10% Hispanic, 3.4% Black, 15% Other/Unknown; prior CRC screening 36%).
Screening completion rates were comparable in the Sequential vs. Active Choice arms: at 3 months, 566/2,035 (28%) vs. 531/2,047 (26%), Odds ratio (OR) 1.10 (95% CI 0.96-1.26), p=0.2; at 9 months, 850/2,035 (42%) vs. 839/2,047 (41%), Odds ratio (OR) 1.03 (95% CI 0.91-1.17), p=0.6.
Screening modalities were comparable between Sequential vs. Active Choice arms at 9 months: 67% FIT, 29% colonoscopy, 1.5% FOBT, 2.4% MT-sDNA vs. 73% FIT, 25% colonoscopy, 0.5% FOBT, 1.7% MT-sDNA, p=NS.
Of the 1,180 patients screened by FIT, results were available for 1,165, and 54 (4.6%) were positive, with no difference by arm. Of the 54 FIT+ patients, 28 (52%) had a colonoscopy (14 per arm), with median time between FIT+ and colonoscopy of 40.5 [IQR 21-61] days.
Conclusion: FIT-based mailed outreach achieved similar overall screening participation rates with Active or Sequential Choice, with comparable patient preference rates for FIT vs. colonoscopy. Our results may not apply to our entire clinic populations, because those with past colonoscopy within 10 years were not eligible. High follow-up colonoscopy rates in FIT+ patients were not achieved. Colonoscopy for FIT+ patients must be ensured in any outreach program.
Aims: To compare FIT-based mailed outreach with Active Choice (FIT or colonoscopy up-front) vs. Sequential Choice (initial FIT; colonoscopy only to FIT non-participants).
Methods: We performed a randomized controlled trial of CRC screen-eligible persons in eight primary care clinics. All mailed outreach included a FIT kit and a first letter with basic information on CRC and screening. The Active Choice letter also included a graphic comparing FIT and colonoscopy attributes, and an invitation to return the FIT kit or schedule a colonoscopy using a dedicated phone number. The Sequential Choice letter also included a graphic showing only FIT attributes and an invitation to return the FIT kit. Text reminders were sent at 6 weeks.
Second letters were sent at 3 months. The Active Choice letter reminded patients to return the FIT kit or schedule a colonoscopy. The Sequential Choice letter introduced colonoscopy for the first time, included the graphic comparing FIT and colonoscopy attributes, and an invitation to return the FIT kit or schedule a colonoscopy using the dedicated phone number.
The primary outcome was screening completion.
Results: The Sequential Choice arm included 2,035 persons and the Active Choice arm included 2,047 persons, with comparable demographics (55% women; median age 58.4 [IQR 53-66] years; 44% White, 27% Asian, 10% Hispanic, 3.4% Black, 15% Other/Unknown; prior CRC screening 36%).
Screening completion rates were comparable in the Sequential vs. Active Choice arms: at 3 months, 566/2,035 (28%) vs. 531/2,047 (26%), Odds ratio (OR) 1.10 (95% CI 0.96-1.26), p=0.2; at 9 months, 850/2,035 (42%) vs. 839/2,047 (41%), Odds ratio (OR) 1.03 (95% CI 0.91-1.17), p=0.6.
Screening modalities were comparable between Sequential vs. Active Choice arms at 9 months: 67% FIT, 29% colonoscopy, 1.5% FOBT, 2.4% MT-sDNA vs. 73% FIT, 25% colonoscopy, 0.5% FOBT, 1.7% MT-sDNA, p=NS.
Of the 1,180 patients screened by FIT, results were available for 1,165, and 54 (4.6%) were positive, with no difference by arm. Of the 54 FIT+ patients, 28 (52%) had a colonoscopy (14 per arm), with median time between FIT+ and colonoscopy of 40.5 [IQR 21-61] days.
Conclusion: FIT-based mailed outreach achieved similar overall screening participation rates with Active or Sequential Choice, with comparable patient preference rates for FIT vs. colonoscopy. Our results may not apply to our entire clinic populations, because those with past colonoscopy within 10 years were not eligible. High follow-up colonoscopy rates in FIT+ patients were not achieved. Colonoscopy for FIT+ patients must be ensured in any outreach program.
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