Mailed Outreach and Patient Navigation for Colorectal Cancer Screening Among Rural Medicaid Enrollees: A Cluster Randomized Clinical Trial.

Importance: Approximately 60 million adults live in rural regions of the US, which historically have low rates of colorectal cancer (CRC) screening and follow-up. Rural residents enrolled in Medicaid have particularly low CRC screening and follow-up rates. Objective: To determine the effectiveness and implementation of a collaborative Medicaid health plan-clinic program of mailed fecal immunochemical test (FIT) outreach and patient navigation to colonoscopy following an abnormal FIT result when implemented in rural clinics as part of standard care. Design, Setting, and Participants: This cluster randomized clinical trial was conducted at 28 rural clinic units in Oregon affiliated with 3 Medicaid health plans. The clinics were randomized to the intervention (n = 14) or to usual care (n = 14). Participants were Medicaid enrollees (aged 50-75 years) due for CRC screening. The intervention was delivered from May 11, 2021, through June 4, 2022, and analyses were performed from June 2023 through September 2024. Intervention: The stepwise intervention involved (1) mailed FIT outreach and (2) patient navigation to colonoscopy following an abnormal FIT result. Implementation support included practice facilitation, training, collaborative learning, and patient tracking tools. Main Outcomes and Measures: The primary effectiveness outcome was completion of any CRC screening within 6 months of eligibility determination. An additional effectiveness outcome was follow-up colonoscopy completion within 6 months of an abnormal FIT result. Implementation was measured as (1) the proportion of intervention-eligible enrollees who were mailed an FIT and who were sent an advance notification or reminder and (2) the proportion with an abnormal FIT result who were offered patient navigation. Results: This study included 5614 Medicaid enrollees (2613 in intervention clinics and 3001 in usual care clinics). Enrollees had a mean (SD) age of 58.2 (5.5) years; most (4940 [88.0%]) were aged 50 to 64 years. A total of 2948 enrollees (52.5%) were female, 325 (6.2%) were Hispanic and 3774 (67.2%) were White, and 4457 (79.4%) lived in rural regions. Compared with Medicaid enrollees in usual care clinics, enrollees in intervention clinics had a higher adjusted 6-month proportion of any CRC screening completion (11.8% vs 4.5%; difference, 7.3 [95% CI, 5.3-9.2] percentage points). Implementation was 100% (all 1489 intervention-eligible enrollees) for mailed FIT outreach, 88.5% for advance notification, 78.1% for reminders, and 57.9% for patient navigation. Conclusions and Relevance: In this cluster randomized clinical trial of rural clinics, mailed FIT outreach and patient navigation boosted participation in CRC screening among Medicaid enrollees. More efforts are needed to address low participation in both FIT testing and follow-up colonoscopy. Trial Registration: ClinicalTrials.gov Identifier: NCT04890054.