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Clinical Trials/NCT04848051
NCT04848051
Completed
Not Applicable

Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations

Yale University1 site in 1 country3,127 target enrollmentOctober 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Yale University
Enrollment
3127
Locations
1
Primary Endpoint
Total number of participants who completed their colorectal cancer screening
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to understand best strategies for engaging high risk populations in a primary care setting to improved adherence to colorectal cancer screening guidelines. The results will be used to identify best practices that are scalable to other high-risk populations who are due or overdue for colorectal cancer (CRC) screening.

Detailed Description

This is a prospective implementation science study that will test 4 different approaches to increase colorectal cancer screening in a local primary care setting that provides services to individuals who are under-resourced. The interventions will include reminders from primary care providers with and without additional information and/or services to help complete colorectal cancer screening. A review of electronic medical records will be used to identify baseline information assessing risk factors and personal and family CRC history. For arm 3 of the study, participants may elect to enroll in our existing health navigation program. If so, additional baseline information will be collected, including information on Social Determinants of Health (SDOH). For arm 4 of the study, a questionnaire will be used to assess knowledge about colorectal cancer screening. The questionnaire will be repeated after the intervention (informational video). For all arms of the study, the primary outcome (engagement on CRC screening, receipt of CRC screening, results of CRC screening) will be collected through EPIC.

Registry
clinicaltrials.gov
Start Date
October 12, 2021
End Date
November 21, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • be 50-74 years of old at the time of enrollment
  • have one valid medical encounter with CSHHC Columbus Ave. location or Dixwell location between the dates of 11/01/2019 and 11/30/2020

Exclusion Criteria

  • Documented history of colorectal cancer

Outcomes

Primary Outcomes

Total number of participants who completed their colorectal cancer screening

Time Frame: 18 months

The total number of participants that completed their colorectal cancer screening will be measured between the different arms

Secondary Outcomes

  • Screening outcomes: follow up(18 months)
  • Time to engagement(18 months)
  • Screening outcomes: results of screening(18 months)
  • Screening outcomes: biopsy results(18 months)
  • Screening outcomes: diagnostic results(18 months)

Study Sites (1)

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