CRC Screening: FIT-DNA vs FIT Outreach in Community Care
Key Takeaways
- Higher screening participation was observed with FIT-DNA outreach than FIT outreach at both 90 and 180 days.
- Overall participation was higher in Boston than Los Angeles, and subgroup differences by age, race and ethnicity, language, and insurance status were reported.
- Among 100 participants with abnormal stool test results, 36 colonoscopies were completed within 180 days, with similar completion across outreach groups and higher completion in Boston.
The study included 8 community health centers serving English- or Spanish-speaking primary care patients aged 45 to 75 years who were due for screening. Investigators compared mailed FIT and automated text reminders with mailed FIT-DNA outreach supported by the manufacturer’s patient assistance program.
The randomized comparison spanned 8 community health centers in Boston and Los Angeles, alongside a parallel nonrandomized Rapid City, South Dakota, site that used a FIT-DNA-only protocol. Enrollment ran from June 7 to October 24, 2023. The primary endpoint was screening participation by any modality within 90 days after mailing, and secondary outcomes were 180-day participation and time to screening. In the randomized regions, 2435 participants were assigned to FIT and 2692 to FIT-DNA, and the cohort was largely Hispanic and Spanish-speaking. Most screening was completed within the first 90 days.
At 180 days, screening participation was 31.7% with FIT-DNA and 26.7% with FIT, for an adjusted difference of 4.5 percentage points with a 95% CI of 0.5 to 8.5. The 90-day adjusted difference was 4.7 percentage points, with a 95% CI of 0.8 to 8.6, and time to screening was shorter in the FIT-DNA group. In the CARES trial report, FIT mailings were paired with automated text reminders from study personnel, while FIT-DNA outreach used letters, phone calls, text messages, and occasional emails through the manufacturer protocol. Median outreach attempts in the FIT-DNA program were 10 overall. The participation difference reflected the combined test-and-outreach strategy evaluated in routine community health center practice.
Overall 90-day participation was higher in Boston than Los Angeles, at 28.4% versus 23.1%. Boston showed little separation between FIT and FIT-DNA, with 29.1% versus 28.0%, while Los Angeles showed higher participation with FIT-DNA, at 27.8% versus 18.5%. Higher 90-day participation with FIT-DNA was reported among participants aged 50 years or older, Hispanic participants, Spanish-speaking participants, Medicaid-insured participants, and uninsured participants. Among 100 screened participants with an abnormal stool test result, 36 completed colonoscopy within 180 days, including 39.7% in FIT-DNA and 31.0% in FIT, with similar completion across groups and higher completion in Boston than Los Angeles. Navigation was attempted for all 100 patients, 37 were never reached, 4 refused, and 59 received navigation.
The trial did not include a usual care control group and did not assess FIT or FIT-DNA costs. Randomization occurred at the clinic level, demographic imbalance between groups prompted a propensity score-matched secondary analysis, and the South Dakota site was not randomized. Investigators also noted that the contributions of follow-up intensity and test type could not be separated.