Implementation Research to Increase Colorectal Cancer Screening Rates Among Low Income and Ethnic Minority Groups

Study Overview
=================
Brief Summary
-----------------
This clinical trial implements research strategies to increase colorectal cancer (CRC) screening rates among low income and ethnic minority groups. CRC is the second most common cause of cancer mortality in the United States and disproportionately burdens low income and ethnic minority groups. Fecal immunochemical testing (FIT) is a test to check for blood in the stool. A brush is used to collect water drops from around the surface of a stool while it is still in the toilet bowl. The samples are then sent to a laboratory, where they are checked for a human blood protein. Blood in the stool may be a sign of colorectal cancer. Despite its potential for reducing CRC incidence and mortality, screening remains woefully underutilized. There is an unmet need for practical and effective programs to improve CRC screening rates. By implementing a culturally-tailored screening CRC program that supports providers and clinic staff to encourage eligible patients to complete FIT, researchers hope to reduce cancer disparities among low-income and ethnic groups and increase the CRC screening rate, which will help providers find CRC sooner, when it may be easier to treat.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To increase CRC screening rates within Northeast Valley Health Corporation (NEVHC). OUTLINE: Clinic sites are randomized to 1 of 2 groups. GROUP I CLINICS: Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial. GROUP II CLINICS: Physicians and clinic staff provide and patients recieve CRC screening usual care throughout the trial.

Official Title
-----------------
Implementation Research to Reduce Colorectal Cancer Disparities

Conditions
-----------------
Colorectal Carcinoma

Intervention / Treatment
-----------------
* Other: Best Practice
* Other: Consultation
* Other: Educational Intervention
* Other: Electronic Health Record Review
* Other: Fecal Immunochemical Test
* Behavioral: Feedback
* Behavioral: Health Education
* Other: Support Education Activity
* Other: Text Message-Based Navigation Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PATIENTS: 50-75 years of age PATIENTS: >= 1 clinic visit/past 2 years

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm II (usual care)<br>Physicians and clinic staff provide and patients recieve CRC screening usual care throughout the trial. | Other: Best Practice<br>* Recieve CRC screening usual care<br>* Other names: standard therapy;Other: Electronic Health Record Review<br>* Ancillary studies<br>|
| Experimental: Group I (education, feedback, consult, FIT kit, text message)<br>Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial. | Other: Consultation<br>* Recieve consultation with clinic staff<br>* Other names: Consult;Other: Educational Intervention<br>* Recieve education and training on CRC screening<br>* Other names: Intervention, Educational;Other: Electronic Health Record Review<br>* Ancillary studies<br>Other: Fecal Immunochemical Test<br>* Recieve FIT kit with culturally tailored instructions<br>* Other names: immunologic fecal occult blood test;Behavioral: Feedback<br>* Recieve feedback on CRC screening<br>Behavioral: Health Education<br>* Recieve CRC screening recommendations<br>Other: Support Education Activity<br>* Utilize clinical decision support tool<br>Other: Text Message-Based Navigation Intervention<br>* Recieve text message reminders<br>* Other names: Text Message-Based Navigation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal cancer (CRC) screening rate | Patient-level study data on the primary outcome of CRC screening receipt will be assessed through electronic health record data systems. Fecal immunochemical test (FIT) is the screening method most commonly utilized in NEVHC. Patients who have completed a FIT within the past 12 months will be considered screened. Consistent with current CRC screening guidelines, patients screened via a flexible sigmoidoscopy in the past five years (very rare) or colonoscopy (very small numbers) in the past ten years will also be considered screened. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients. | Up to 3 years | 
| Rate of failure to provide a FIT kit to an eligible patient making a clinic visit | Missed opportunity rates will be calculated at baseline, end of study, and intermediate time points by determining the number of eligible patients who made a clinic visit but did not receive a FIT kit. The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients. | Up to 3 years | 
| Return rate of completed FIT kits | The data will be analyzed using generalized linear mixed models that account for clustering within clinic and provider and multiple observations within patients. | Up to 3 years |