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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: CRC Reminder and Navigation Program; Behavioral: CRC Reminder & Short message; Behavioral: CRC screening reminder; Behavioral: CRC Reminder & CRC education

• Registration Number: NCT04848051
• Lead Sponsor: Yale University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-19
• Study Start: 2021-10-12
• Primary Completion: 2022-11-21
• Study Completion: 2022-11-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3127

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

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Exclusion Criteria

• Documented history of colorectal cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRC Reminder and Navigation Program	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
CRC Reminder & Short message	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
CRC screening reminder	CRC screening reminder	Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening
CRC Reminder & CRC education	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

Primary Outcome Measures

Name	Time	Method
Total number of participants who completed their colorectal cancer screening	18 months	The total number of participants that completed their colorectal cancer screening will be measured between the different arms

Secondary Outcome Measures

Name	Time	Method
Screening outcomes: follow up	18 months	Screening outcomes will be defined as the following: descriptive summaries of need and completion of follow up among the 4 arms.
Time to engagement	18 months	The time to engagement will be measured as the days between reminder or reminder + intervention and days to screening among the 4 arms
Screening outcomes: results of screening	18 months	Screening outcomes will be defined as the following: descriptive summaries of the result of screening among the 4 arms.
Screening outcomes: biopsy results	18 months	Screening outcomes will be defined as the following: descriptive summaries of biopsy results (if needed) among the 4 arms.
Screening outcomes: diagnostic results	18 months	Screening outcomes will be defined as the following: descriptive summaries of the diagnostic result(s) among the 4 arms.

Trial Locations

Locations (1)

Cornell Scott Hill Health Center; 🇺🇸 New Haven, Connecticut, United States