Work

Time to Follow-Up Colonoscopy After Positive Fecal Immunochemical Test with Centralized Patient Navigation: A Randomized Clinical Trial

Year: 2026

Type: article

Abstract: BACKGROUND: Patients in federally qualified health centers (FQHCs) are at risk of delay in or non-completion of follow-up colonoscopy (FC) after a positive fecal immunochemical test (FIT). Increased time to FC is associated with increased colorectal cancer (CRC) incidence, late-stage diagnosis, and mortality. OBJECTIVE: We evaluated the impact of centralized patient navigation on completion of FC and time to FC after a positive FIT. DESIGN: This survival analysis is a sub-analysis of a randomized clinical trial conducted in FQHC systems in North Carolina. Trial patients were randomly assigned to mailed FIT outreach and to centralized patient navigation for a positive FIT or to usual care alone. PARTICIPANTS: RCT participants with a positive FIT. INTERVENTION: Intervention patients with a positive FIT were offered centralized telephone-based navigation to FC, including support with procedure scheduling, bowel preparation, and social needs. Patients in the control arm received usual care. MAIN MEASURES: We compared the restricted mean time to FC in an intention-to-screen survival analysis over 1 year of follow-up. We censored by last observation date when FC was not completed. KEY RESULTS: Among 4002 trial patients, 842 completed a FIT, of whom 89 (10.6%) tested positive and were included in this analysis. Forty-eight (53.9%) were female, 29 (32.6%) identified as Black, 53 (59.6%) identified as White, and 53 (59.6%) had no prior CRC screening. Fifty-eight (65.2%) were intervention patients, and 31 (34.8%) received usual care (control). Intervention patients were more likely to complete FC at 1 year than control patients (69.0% vs 38.7%, p = 0.006). The difference in mean time to FC between the arms was 80.4 days (95% CI 13.6-147.2, p = 0.018). As-screened sensitivity analyses showed that the difference in time to FC increased further with increasing levels of engagement with navigation. CONCLUSIONS: Centralized patient navigation significantly increased FC completion and reduced the mean time to FC after a positive FIT among FQHC patients. Patient navigation is an important intervention to support the timely diagnostic resolution of positive CRC screening in under-resourced settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04406714.

Source: Journal of General Internal Medicine

DOI: 10.1007/s11606-025-10151-2