Study to Increase Colorectal Screening

Study Overview
=================
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.

Official Title
-----------------
A RCT of Outreach and Inreach Strategies for Boosting CRC Screening in a Federally-Qualified Health Center

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Inreach strategy
* Behavioral: Outreach strategy
* Behavioral: Both Inreach and Outreach strategies
* Behavioral: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inreach strategy<br>This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders. | Behavioral: Inreach strategy<br>* Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit<br>|
| Experimental: Outreach strategy<br>This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders. | Behavioral: Outreach strategy<br>* Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders<br>|
| Experimental: Both Inreach and Outreach strategies<br>This is a combination of the above two strategies: Inreach and Outreach combined. | Behavioral: Both Inreach and Outreach strategies<br>* Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders<br>|
| Active Comparator: Usual care<br>Usual care in the clinic using the fecal immunochemical test (FIT) kit. | Behavioral: Usual care<br>* Usual care: FIT kit delivery as part of usual care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening completion rate | Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy) | up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early detection