Patient Navigation for Colorectal Cancer Screening

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Medstar Health Research Institute
Study ID
NCT06401174
Status
Enrolling By Invitation

Conditions

  • Colorectal Cancer Screening

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Oct 2025
Primary completion
Jan 30, 2028
Completion
Jul 30, 2028

Study Design

Enrollment
1,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING

Arms

  • Experimental: Patient navigation
    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.
  • No Intervention: Usual care

Primary Outcome Measure

Colorectal cancer screening completion [ Time Frame: 12 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
Family Medicine Fort LincolnWashington D.C.District of Columbia20722-
Family Medicine Spring ValleyWashington D.C.District of Columbia20016-
Internal Medicine Wisconsin AvenueWashington D.C.District of Columbia20007-
Primary Care LafayetteWashington D.C.District of Columbia20036-
Franklin SquareBaltimoreMaryland21237-
Harbor Hospital Primary Care Federal HillBaltimoreMaryland21230-
HoneygoBaltimoreMaryland21128-
MedStar Adult Medicine at Union MemorialBaltimoreMaryland21218-
Primary Care at Franklin SquareBaltimoreMaryland21237-
Charlotte HallCharlotte HallMaryland20622-
Internal Medicine ClintonClintonMaryland20735-
Family MedicineGaithersburgMaryland20878-
Internal Medicine HyattsvilleHyattsvilleMaryland20782-
Family MedicineOlneyMaryland20832-
Olney Prof ParkOlneyMaryland20832-

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