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Enrolling by Invitation

NCT Number: NCT06401174

Patient Navigation for Colorectal Cancer 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.

Enrolling by Invitation

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Key information

Conditions

Colorectal Cancer Screening

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Medicine Fort Lincoln, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Primary outcomes

  1. Colorectal cancer screening completion

    Time frame: 12 months

    Completion of any USPSTF approved screening test

Secondary outcomes

  1. Reach

    Time frame: 6 months

    Percent of patients referred out of those eligible

  2. Adoption

    Time frame: 6 months

    Percent of providers referring to patient navigation

  3. Acceptability measured by the Acceptability of Intervention Measure (AIM)

    Time frame: 12 months

    Stakeholder assessments of acceptability of navigation and implementation strategies measured on a four-item scale

  4. Appropriateness measured by the Intervention Appropriateness Measure (IAM)

    Time frame: 12 months

    Stakeholder assessments of appropriateness of navigation and implementation strategies measured on a four-item scale

  5. Feasibility measured by the Feasibility of Implementation Measure (FIM)

    Time frame: 12 months

    Stakeholder assessments of feasibility of navigation and implementation strategies measured on 4 item scale

  6. Sustainability measured by the clinical sustainability assessment tool

    Time frame: 12 months

    Understanding clinical sustainability of interventions

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • National Committee for Quality Assurance

Registry information

Official study title

Bridging the Gap: Delivering Equitable Colorectal Cancer Screening

Acronym: SCREEN

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 6, 2024
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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