NCT04848051

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,127 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 50 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	CRC screening reminder	Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening
BEHAVIORAL	CRC Reminder & Short message	Participants randomized to the CRC Reminder \& short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening
BEHAVIORAL	CRC Reminder and Navigation Program	Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance
BEHAVIORAL	CRC Reminder & CRC education	Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online

Timeline

• Start date: 2021-10-12
• Primary completion: 2022-11-21
• Completion: 2022-11-21
• First posted: 2021-04-19
• Last updated: 2023-03-03

Locations

1 site across 1 country: United States