A multilevel, low literacy dual language intervention to promote colorectal cancer screening in community clinics in Florida: A randomized controlled trial.

One of the largest disparities in cancer mortality in the United States occurs with colorectal cancer (CRC). The objectives of this multilevel two-arm intervention trial were to compare the efficacy of two interventions to promote CRC screening (CRCS) with fecal immunochemical test (FIT) and examine sociodemographic and psychosocial predictors of FIT screening. Individuals ages 50-75 (n = 326) who were not up-to-date with CRCS, could understand English or Spanish, and were at average CRC risk were recruited from two federally qualified health centers (FQHCs) in Florida. Prior to intervention, CRCS rates in the FQHCs were 27.1% and 32.9%, respectively. Study enrollment occurred April 2018-November 2019. System-level intervention components included leveraging electronic medical record (EMR) systems and delivering patient reminders. Participants were randomized to C-CARES (education+FIT) or C-CARES Plus (C-CARES+personalized coaching [for those not completing FIT within 90 days]). Primary outcome was completed FIT returned <1 year. Primary outcome analyses were performed using logistic regression. 225 participants completed FIT (69.0% [95% CI: 64.0-74.0%]), with no significant difference in FIT uptake by intervention arm (67.3% C-CARES Plus vs. 70.8% C-CARES; p = .49). FIT uptake was significantly higher among patients who received intervention materials in Spanish (77.2%) compared to those who received materials in English (63.2%, p < .01). The personalized coaching in the C-CARES Plus arm did not appear to provide added benefit beyond the C-CARES intervention. Multilevel approaches that include EMR prompts, reminders, FIT access, and provision of low-literacy, language-concordant education can support efforts to improved community clinics' CRCS rates. Future efforts should focus on repeat FIT screening. Trial registration: The trial was registered at ClinicalTrials.gov (NCT03906110).