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

Yale University

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: CRC Reminder & Short message; Behavioral: CRC Reminder and Navigation Program; Behavioral: CRC Reminder & CRC education; Behavioral: CRC screening reminder

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04848051

2P30CA016359-39 (U.S. NIH Grant/Contract)

2000030006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,127 patients

Sex: All

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,127 participants in 4 patient groups

CRC screening reminder

Experimental group

Description:

Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening

Treatment:

Behavioral: CRC screening reminder

CRC Reminder & Short message

Experimental group

Description:

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

Treatment:

Behavioral: CRC Reminder & Short message

CRC Reminder and Navigation Program

Experimental group

Description:

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

Treatment:

Behavioral: CRC Reminder and Navigation Program

CRC Reminder & CRC education

Experimental group

Description:

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

Treatment:

Behavioral: CRC Reminder & CRC education