Patient Navigation for Colorectal Cancer Screening
- Conditions
- Colorectal Cancer Screening
- Registration Number
- NCT06401174
- Lead Sponsor
- Medstar Health Research Institute
- Brief 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1800
- Age 45-75
- Due for colorectal cancer screening
- Identify as Black or Hispanic/Latino
- Attend primary care visit at one of the 15 selected clinics within the step time -period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Colorectal cancer screening completion 12 months Completion of any USPSTF approved screening test
- Secondary Outcome Measures
Name Time Method Acceptability measured by the Acceptability of Intervention Measure (AIM) 12 months Stakeholder assessments of acceptability of navigation and implementation strategies measured on a four-item scale
Sustainability measured by the clinical sustainability assessment tool 12 months Understanding clinical sustainability of interventions
Adoption 6 months Percent of providers referring to patient navigation
Reach 6 months Percent of patients referred out of those eligible
Appropriateness measured by the Intervention Appropriateness Measure (IAM) 12 months Stakeholder assessments of appropriateness of navigation and implementation strategies measured on a four-item scale
Feasibility measured by the Feasibility of Implementation Measure (FIM) 12 months Stakeholder assessments of feasibility of navigation and implementation strategies measured on 4 item scale
Trial Locations
- Locations (14)
Internal Medicine Wisconsin Avenue
🇺🇸Washington, District of Columbia, United States
Family Medicine Spring Valley
🇺🇸Washington, District of Columbia, United States
Primary Care Lafayette
🇺🇸Washington, District of Columbia, United States
Family Medicine Fort Lincoln
🇺🇸Washington, District of Columbia, United States
Honeygo
🇺🇸Baltimore, Maryland, United States
MedStar Adult Medicine at Union Memorial
🇺🇸Baltimore, Maryland, United States
Harbor Hospital Primary Care Federal Hill
🇺🇸Baltimore, Maryland, United States
Franklin Square
🇺🇸Baltimore, Maryland, United States
Primary Care at Franklin Square
🇺🇸Baltimore, Maryland, United States
Charlotte Hall
🇺🇸Charlotte Hall, Maryland, United States
Scroll for more (4 remaining)Internal Medicine Wisconsin Avenue🇺🇸Washington, District of Columbia, United States