Patient Navigation for Colorectal Cancer Screening (SCREEN)

Bridging the Gap: Delivering Equitable 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Behavioral: Delivery of patient navigation

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.

• Study Type: Interventional
• Enrollment (Estimated): 1800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Internal Medicine Wisconsin Avenue
    • Washington D.C., District of Columbia, United States, 20016
      • Family Medicine Spring Valley
    • Washington D.C., District of Columbia, United States, 20036
      • Primary Care Lafayette
    • Washington D.C., District of Columbia, United States, 20722
      • Family Medicine Fort Lincoln
  • Maryland
    • Baltimore, Maryland, United States, 21128
      • Honeygo
    • Baltimore, Maryland, United States, 21218
      • MedStar Adult Medicine at Union Memorial
    • Baltimore, Maryland, United States, 21230
      • Harbor Hospital Primary Care Federal Hill
    • Baltimore, Maryland, United States, 21237
      • Franklin Square
    • Baltimore, Maryland, United States, 21237
      • Primary Care at Franklin Square
    • Charlotte Hall, Maryland, United States, 20622
      • Charlotte Hall
    • Clinton, Maryland, United States, 20735
      • Internal Medicine Clinton
    • Gaithersburg, Maryland, United States, 20878
      • Family Medicine
    • Hyattsville, Maryland, United States, 20782
      • Internal Medicine Hyattsville
    • Olney, Maryland, United States, 20832
      • Family Medicine
    • Olney, Maryland, United States, 20832
      • Olney Prof Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal cancer screening completion	Completion of any USPSTF approved screening test	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	Percent of patients referred out of those eligible	6 months
Adoption	Percent of providers referring to patient navigation	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	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	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	12 months
Sustainability measured by the clinical sustainability assessment tool	Understanding clinical sustainability of interventions	12 months

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: National Committee for Quality Assurance

Publications and helpful links

General Publications

• Rivera Rivera JN, AuBuchon KE, Schubel LC, Starling C, Tran J, Locke M, Grady M, Mete M, Blumenthal HJ, Galarraga JE, Arem H. Supporting ColoREctal Equitable Navigation (SCREEN): a protocol for a stepped-wedge cluster randomized trial for patient navigation in primary care. Implement Sci Commun. 2024 Jun 3;5(1):60. doi: 10.1186/s43058-024-00598-5.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Patient navigation; disparities
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 6963 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No