NCT05453630

Colonoscopy Outreach for Rural Communities Aim 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 527 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 45 Years – 915 Months
• Healthy volunteers: Accepted

Summary

This study aims to test the effectiveness of a remotely-delivered patient navigation program for increasing colonoscopy completion for colorectal cancer screening, among rural populations. The study will partner with geographically disparate primary care organizations to recruit patients aged 45-75 to the study. The patient navigation program will be delivered through a community organization. This project is critical in advancing our knowledge of the effectiveness of patient navigation for increasing colonoscopy in this patient population as well as for understanding factors that can support long term implementation and sustainability of effective interventions.

Detailed description

Colorectal cancer (CRC) is a leading cause of cancer death in the United States and its burden is greater in rural and low-income communities. Failure to complete recommended colonoscopy contributes to later-stage CRC diagnosis and worse CRC outcomes, which means timely and successful colonoscopy is a key opportunity to reduce CRC mortality. Using a Type 1 Hybrid Implementation-Effectiveness design, we will randomize 480-600 subjects from 6-8 primary care clinical organizations in a randomized controlled trial (RCT) to accomplish the following: * Test the effectiveness of a patient navigation program, remotely-delivered by a community-based organization, for increasing colonoscopy completion rates for colorectal cancer screening among rural patients. * Assess implementation and sustainability of the patient navigation program from the perspectives of both community and clinical stakeholders.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Patient Navigation	Patients will receive navigation from a trained lay navigator at a community-based nonprofit organization that supports access to high quality healthcare. The patient navigator will work with patients to schedule their colonoscopy and identify, explore, and overcome barriers. They will educate patients about the colonoscopy procedure and preparation, provide resources, and coach and motivate patients.
BEHAVIORAL	Usual Care Control	Educational brochure about colonoscopy

Timeline

• Start date: 2022-06-16
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2022-07-12
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States