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Clinical Trials/NCT06401174
NCT06401174
Enrolling By Invitation
Not Applicable

Bridging the Gap: Delivering Equitable Colorectal Cancer Screening

Medstar Health Research Institute14 sites in 1 country1,800 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer Screening
Sponsor
Medstar Health Research Institute
Enrollment
1800
Locations
14
Primary Endpoint
Colorectal cancer screening completion
Status
Enrolling By Invitation
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
July 30, 2028
Last Updated
6 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Medstar Health Research Institute
Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Colorectal cancer screening completion

Time Frame: 12 months

Completion of any USPSTF approved screening test

Secondary Outcomes

  • Acceptability measured by the Acceptability of Intervention Measure (AIM)(12 months)
  • Sustainability measured by the clinical sustainability assessment tool(12 months)
  • Adoption(6 months)
  • Reach(6 months)
  • Appropriateness measured by the Intervention Appropriateness Measure (IAM)(12 months)
  • Feasibility measured by the Feasibility of Implementation Measure (FIM)(12 months)

Study Sites (14)

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