BACKGROUND: Patient navigation is a recommended practice of the Guide to Community Preventive Services
little is known about whether it improves colonoscopy completion for adults who have received an abnormal stool test result. OBJECTIVE: To determine whether patient navigation delivered to persons with an abnormal stool test result increased follow-up colonoscopy completion (primary) at 1 year. DESIGN: Randomized controlled trial. (ClinicalTrials.gov: NCT03925883). SETTING: A federally qualified health center ( PATIENTS: Persons aged 50 to 75 years with an abnormal fecal test result in the prior month. INTERVENTION: A 6-topic, telephone-based patient navigation program delivered by bilingual (English and Spanish) clinical staff. MEASUREMENTS: Receipt of follow-up colonoscopy at 1 year (primary)
time to colonoscopy receipt (secondary)
and program effectiveness by patient characteristics, including patients' probability of obtaining a colonoscopy without navigation, derived using health record data (secondary). RESULTS: Of 985 participants enrolled (mean age, 61 years [SD, 6.8]
170 [18%] had a Spanish-language preference listed in the medical record), 967 were included in the primary intention-to-treat analysis (479 in patient navigation, 488 in usual care). Receipt of follow-up colonoscopy was higher in the patient navigation group than in the usual care group (55.1% vs. 42.1%
risk difference, 13.0 percentage points [95% CI, 6.5 to 19.4 percentage points]). The intervention effect was not moderated by patients' probability of obtaining a colonoscopy without navigation. LIMITATION: The study was primarily done during the height of the COVID-19 pandemic, which created additional barriers to colonoscopy at the health system and patient levels. CONCLUSION: These findings support the effectiveness of patient navigation for follow-up colonoscopy completion. PRIMARY FUNDING SOURCE: National Cancer Institute.