NCT06401174

Patient Navigation for Colorectal Cancer Screening

Bridging the Gap: Delivering Equitable Colorectal Cancer Screening

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patient navigation is an evidence-based strategy to increase screening rates among racial and ethnic minorities, but there is a gap in understanding the multi-level influences on implementation of such programs across primary care practices. The investigators will conduct a stepped-wedge, randomized trial to roll out patient navigation and patient and provider reminders across 15 clinics (3 clinics per step, 5 six-month steps). Implementation strategies will include assessing for readiness, audit and feedback, building a community coalition, engaging consumers, modifying referral tracking, and training and educating clinical stakeholders. The research team will use the electronic health record data with consideration for the Observational Medical Outcomes Partnership (OMOP) Common Data Model, additional patient-reported data, and study tracking logs to measure reach, effectiveness, adoption, implementation, and will use qualitative measures and site observations to document contextual factors, including examination of discrimination in patient experiences and provider referral patterns that may influence intervention delivery or colorectal cancer screening completion.

Detailed description

Colorectal cancer (CRC) screening is recommended by the United States Preventative Services Task Force for adults age 45-75. Patient navigation is an evidence-based strategy to increase screening rates among racial and ethnic minorities. While patient navigation is an evidence-based approach to improve screening, there is a gap in understanding the multi-level influences on implementation of such programs across primary care practices, particularly using a health-equity focused, stakeholder-centered approach. Guided by the Practical, Robust Implementation and Sustainability Model (PRISM) and core health and racial equity principles, the investigative team aims to increase reach of patient navigation and show effectiveness through improvement in the percentage of Black and Hispanic patients completing CRC screening. Investigators will also utilize longitudinal tracking of implementation strategies to better track implementation or intervention adaptations navigation delivery in order to inform future scale up. The research team will conduct a stepped-wedged, randomized trial to roll out patient navigation and patient and provider reminders across 15 clinics (3 clinics per step, 5 six-month steps). Implementation strategies will include assessing for readiness, audit and feedback, building a community coalition, engaging consumers, modifying referral tracking, and training and educating clinical stakeholders. Researchers will use the electronic health record data with consideration for the Observational Medical Outcomes Partnership (OMOP) Common Data Model, additional patient-reported data, and study tracking logs to measure reach, effectiveness, adoption, implementation, and will use qualitative measures and site observations to document contextual factors, including examination of discrimination in patient experiences and provider referral patterns that may influence intervention delivery or CRC screening completion.

Conditions

• Colorectal Cancer Screening

Interventions

Type	Name	Description
BEHAVIORAL	Delivery of patient navigation	Clinics will receive educational materials and access a referral order for patient navigation. Iterative strategies will be used to increase CRC screening

Timeline

• Start date: 2024-06-01
• Primary completion: 2028-01-30
• Completion: 2028-07-30
• First posted: 2024-05-06
• Last updated: 2025-10-22

Locations

15 sites across 1 country: United States