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Patient Navigation for Colorectal Cancer Screening

Bridging the Gap: Delivering Equitable Colorectal Cancer Screening

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06401174
Acronym
SCREEN
Enrollment
1800
Registered
2024-05-06
Start date
2024-06-01
Completion date
2028-07-30
Last updated
2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening

Keywords

disparities, Patient navigation

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.

Interventions

BEHAVIORALDelivery 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

Sponsors

National Committee for Quality Assurance
CollaboratorOTHER
Medstar Health Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Step wedge trial with 5 six-month steps, three clinics at a time, for a total of 15 clinics.

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Colorectal cancer screening completion12 monthsCompletion of any USPSTF approved screening test

Secondary

MeasureTime frameDescription
Adoption6 monthsPercent of providers referring to patient navigation
Acceptability measured by the Acceptability of Intervention Measure (AIM)12 monthsStakeholder assessments of acceptability of navigation and implementation strategies measured on a four-item scale
Reach6 monthsPercent of patients referred out of those eligible
Feasibility measured by the Feasibility of Implementation Measure (FIM)12 monthsStakeholder assessments of feasibility of navigation and implementation strategies measured on 4 item scale
Sustainability measured by the clinical sustainability assessment tool12 monthsUnderstanding clinical sustainability of interventions
Appropriateness measured by the Intervention Appropriateness Measure (IAM)12 monthsStakeholder assessments of appropriateness of navigation and implementation strategies measured on a four-item scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026