Study to Increase Colorectal Screening

University of California San Diego

Status: Unknown

Conditions: Colorectal Cancer

Treatments: Behavioral: Outreach strategy; Behavioral: Usual care; Behavioral: Inreach strategy; Behavioral: Both Inreach and Outreach strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT02870049

U54132379 (Other Identifier)

20153270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 673 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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673 participants in 4 patient groups

Inreach strategy

Experimental group

Description:

This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders.

Treatment:

Behavioral: Inreach strategy

Outreach strategy

Experimental group

Description:

This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.

Treatment:

Behavioral: Outreach strategy

Both Inreach and Outreach strategies

Experimental group

Description:

This is a combination of the above two strategies: Inreach and Outreach combined.

Treatment:

Behavioral: Both Inreach and Outreach strategies

Usual care

Active Comparator group

Description:

Usual care in the clinic using the fecal immunochemical test (FIT) kit.

Treatment:

Behavioral: Usual care