Study to Increase Colorectal Screening

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Outreach strategy; Behavioral: Both Inreach and Outreach strategies; Behavioral: Usual care; Behavioral: Inreach strategy

• Registration Number: NCT02870049
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of this study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone.

Detailed Description

Colorectal cancer (CRC) screening saves lives, but screening rates are low among underserved populations, particularly Latinos. The screening rate in the predominantly Latino population served by San Ysidro Health Center (SYHC, a Federally Qualified Health Center (FQHC)), is just 31%, similar to that reported for Latinos nationally, but lower than the overall national average of 65%. Previous research has demonstrated that inreach interventions at point of medical care such as patient navigation after screening referral, and outreach outside of usual medical care (such as with mailed invitations) can increase screening rates among underserved populations. However, since these have undergone limited evaluation among low income predominantly Spanish-speaking Latinos, it is unclear which approach is best, and whether implementing both approaches would be synergistic for optimizing screening rates. We hypothesize that two culturally and linguistically tailored interventions: a) an inreach strategy (IR, consisting of community health worker-delivered in clinic education regarding CRC screening and other components), and b) an outreach strategy (OS, consisting of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) and telephone reminders) can substantially increase screening, and further, that the two interventions together will be substantially better than either alone. To test these hypotheses, we propose a randomized trial comparing usual care, IR, OS, and IR+OS for CRC screening.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-17
• Primary Completion: 2018-07-09
• Status Verified: 2019-08
• Study Completion: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 673

Inclusion Criteria

• Individuals age 50 to 75 years,
• One or more SYHC visits in the last year,
• Not uptodate with CRC screening

Exclusion Criteria

• Individuals with personal history of CRC or colorectal polyps

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Outreach strategy	Outreach strategy	This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.
Both Inreach and Outreach strategies	Both Inreach and Outreach strategies	This is a combination of the above two strategies: Inreach and Outreach combined.
Usual care	Usual care	Usual care in the clinic using the fecal immunochemical test (FIT) kit.
Inreach strategy	Inreach strategy	This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders.

Primary Outcome Measures

Name	Time	Method
Screening completion rate	up to 24 months	Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)