Colonoscopy Outreach for Rural Communities (CORC): A study protocol of a pragmatic randomized controlled trial of a patient navigation program to improve colonoscopy completion for colorectal cancer screening

Background: Colonoscopy is one of the primary methods of screening for colorectal cancer (CRC), a leading cause of cancer mortality in the United States. However, up to half of patients referred to colonoscopy fail to complete the procedure, and rates of adherence are lower in rural areas. Objectives: Colonoscopy Outreach for Rural Communities (CORC) is a randomized controlled trial to test the effectiveness of a centralized patient navigation program provided remotely by a community-based organization to six geographically distant primary care organizations serving rural patients, to improve colonoscopy completion for CRC. Methods: CORC is a type 1 hybrid implementation-effectiveness trial. Participants aged 45-76 from six primary care organizations serving rural populations in the northwestern United States are randomized 1:1 to patient navigation or standard of care control. The patient navigation is delivered remotely by a trained lay-person from a community-based organization. The primary effectiveness outcome is completion of colonoscopy within one year of referral to colonoscopy. Secondary outcomes are colonoscopy completion within 6 and 9 months, time to completion, adequacy of patient bowel preparation, and achievement of cecal intubation. Analyses will be stratified by primary care organization. Discussion: Trial results will add to our understanding about the effectiveness of patient navigation programs to improve colonoscopy for CRC in rural communities. The protocol includes pragmatic adaptations to meet the needs of rural communities and findings may inform approaches for future studies and programs. Trial registration: National Clinical Trial Identifier: NCT05453630. Trial registration: ClinicalTrials.gov. Identifier: NCT05453630. Registered July 6, 2022.