An interventional study of Delivery of patient navigation in Colorectal Cancer Screening, sponsored by Medstar Health Research Institute. Enrolling by invitation at 15 sites in United States. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-22.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Screening
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.
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.
Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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Patient navigation will be rolled out at the clinic level (15 clinics). Referral orders will become available to participating clinics, with education and audit and feedback for providers. The study team will tailor patient navigation supports by clinic site for specifics on how the intervention is delivered.
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
Colorectal cancer screening completion
Completion of any USPSTF approved screening test
Time frame: 12 months
Reach
Percent of patients referred out of those eligible
Time frame: 6 months
Adoption
Percent of providers referring to patient navigation
Time frame: 6 months
Acceptability measured by the Acceptability of Intervention Measure (AIM)
Stakeholder assessments of acceptability of navigation and implementation strategies measured on a four-item scale
Time frame: 12 months
Appropriateness measured by the Intervention Appropriateness Measure (IAM)
Stakeholder assessments of appropriateness of navigation and implementation strategies measured on a four-item scale
Time frame: 12 months
Feasibility measured by the Feasibility of Implementation Measure (FIM)
Stakeholder assessments of feasibility of navigation and implementation strategies measured on 4 item scale
Time frame: 12 months
Sustainability measured by the clinical sustainability assessment tool
Understanding clinical sustainability of interventions
Time frame: 12 months
Plan to share: No
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Medstar Health Research Institute