Fecal Immunochemical Test Outreach for Colorectal Cancer Screening in Community Health Centers

Importance Colorectal cancer (CRC) screening is suboptimal among people in traditionally underserved populations, many of whom receive primary care at federally qualified health centers (FQHCs). Mailed fecal immunochemical test (FIT) outreach improves screening, especially in underserved populations, but questions remain about impact over time. Objective To evaluate the effectiveness of centralized annual mailed FIT outreach delivered over 3 years to increase CRC screening in FQHCs. Design, Setting, and Participants This cluster randomized clinical trial was conducted between June 1, 2021, and May 31, 2024. Sixteen clinics from 2 FQHCs in Southern California were randomly assigned to mailed FIT outreach or usual care for patients aged 50 to 75 years and not up to date with screening. Intervention Intervention components followed best practices for mailed FIT outreach and included educational primers, FIT kits, and telephone reminders. Main Outcomes and Measures The primary outcome was the proportion of individuals up to date with any CRC screening after 3 years of intervention (point prevalence); screening at 2 years was a secondary outcome. Due to a resource constraint–related protocol modification, mailed FIT outreach began earlier in year 3, such that some individuals who completed screening in year 2 were not yet due for repeat FIT. Results Among 16 clinics serving 20 250 patients, 6 clinics serving 8334 individuals at baseline (4435 aged 55-64 years [53.2%]; 4896 female [58.7%]; 341 Asian [4.1%], 238 Black [2.9%], 2390 Hispanic [28.7%], and 4371 non-Hispanic White [52.4%]) were randomized to intervention and 10 clinics serving 11 916 individuals at baseline (6443 aged 55-64 years [54.1%]; 7250 female [60.8%]; 699 Asian [5.9%], 355 Black [3.0%], 4635 Hispanic [38.9%], and 4436 non-Hispanic White [37.2%]) were randomized to usual care. At year 3, screening was 39.4% (95% CI, 36.3% to 42.6%) in intervention clinics vs 36.5% (95% CI, 31.2% to 42.2%) in usual care clinics, which was not a statistically significant difference (2.9 percentage points; 95% CI, −3.2 to 9.0 percentage points). At year 2, screening was 37.8% (95% CI, 35.2% to 40.4%) in intervention clinics vs 27.0% (95% CI, 21.8% to 32.9%) in usual care clinics (difference, 10.8 percentage points; 95% CI, 4.9 to 16.7 percentage points). Conclusions and Relevance This study’s findings suggest that centralized mailed FIT outreach could increase CRC screening in FQHCs serving populations with persistent disparities, although maintaining intervention fidelity and providing ongoing implementation support over time are needed for consistent impact. Trial Registration ClinicalTrials.gov Identifier: NCT04941300