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Background <p>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.</p> Objective <p>We evaluated the impact of centralized patient navigation on completion of FC and time to FC after a positive FIT.</p> Design <p>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.</p> Participants <p>RCT participants with a positive FIT.</p> Intervention <p>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.</p> Main Measures <p>We compared the restricted mean time to FC in an intention-to-screen survival analysis over 1&#xa0;year of follow-up. We censored by last observation date when FC was not completed.</p> Key Results <p>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&#xa0;year than control patients (69.0% vs 38.7%, <i>p</i> = 0.006). The difference in mean time to FC between the arms was 80.4&#xa0;days (95% CI 13.6–147.2, <i>p</i> = 0.018).&#xa0;As-screened sensitivity analyses showed that the difference in time to FC increased further with increasing levels of engagement with navigation.</p> Conclusions <p>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.</p> Trial Registration <p>ClinicalTrials.gov Identifier: NCT04406714.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月4日

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  • Anisha P. Ganguly,
  • Meghan C. O’Leary,
  • Seth D. Crockett,
  • Renée M. Ferrari,
  • Connor M. Randolph,
  • Lindsay R. Stradtman,
  • Alexis A. Moore,
  • Kevin Su,
  • Xianming Tan,
  • Alison T. Brenner,
  • Daniel S. Reuland

摘要

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.