Patient Navigation for Colorectal Cancer Screening
SCREEN
Bridging the Gap: Delivering Equitable Colorectal Cancer Screening
1 other identifier
interventional
1,800
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2024
CompletedFirst Posted
Study publicly available on registry
May 6, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2028
October 22, 2025
October 1, 2025
3.7 years
April 22, 2024
October 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colorectal cancer screening completion
Completion of any USPSTF approved screening test
12 months
Secondary Outcomes (6)
Reach
6 months
Adoption
6 months
Acceptability measured by the Acceptability of Intervention Measure (AIM)
12 months
Appropriateness measured by the Intervention Appropriateness Measure (IAM)
12 months
Feasibility measured by the Feasibility of Implementation Measure (FIM)
12 months
- +1 more secondary outcomes
Study Arms (2)
Patient navigation
EXPERIMENTALPatient 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.
Usual care
NO INTERVENTIONInterventions
Clinics will receive educational materials and access a referral order for patient navigation. Iterative strategies will be used to increase CRC screening
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Internal Medicine Wisconsin Avenue
Washington D.C., District of Columbia, 20007, United States
Family Medicine Spring Valley
Washington D.C., District of Columbia, 20016, United States
Primary Care Lafayette
Washington D.C., District of Columbia, 20036, United States
Family Medicine Fort Lincoln
Washington D.C., District of Columbia, 20722, United States
Honeygo
Baltimore, Maryland, 21128, United States
MedStar Adult Medicine at Union Memorial
Baltimore, Maryland, 21218, United States
Harbor Hospital Primary Care Federal Hill
Baltimore, Maryland, 21230, United States
Franklin Square
Baltimore, Maryland, 21237, United States
Primary Care at Franklin Square
Baltimore, Maryland, 21237, United States
Charlotte Hall
Charlotte Hall, Maryland, 20622, United States
Internal Medicine Clinton
Clinton, Maryland, 20735, United States
Family Medicine
Gaithersburg, Maryland, 20878, United States
Internal Medicine Hyattsville
Hyattsville, Maryland, 20782, United States
Family Medicine
Olney, Maryland, 20832, United States
Olney Prof Park
Olney, Maryland, 20832, United States
Related Publications (1)
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.
PMID: 38831365DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2024
First Posted
May 6, 2024
Study Start
June 1, 2024
Primary Completion (Estimated)
January 30, 2028
Study Completion (Estimated)
July 30, 2028
Last Updated
October 22, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share