Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

Study Overview
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Brief Summary
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The goal of this pragmatic randomized clinical trial is to compare two colorectal (CRC) screening outreach approaches (FIT and Cologuard) in community health centers (CHC) in patients overdue for CRC screening. The main questions the project aims to answer are: What screening test has a higher completion rate? What screening test is more feasible and acceptable in a CHC setting? Patients will be sent a CRC screening test in the mail and will be asked to complete it at home and mail it back. Researchers will compare the completion rates for each screening test and will also look at the overall completion rate of both tests.

Detailed Description
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This is a 3-year pragmatic trial with four levels of intervention, including system-, provider-, patient-, and community-level components at each of the CARES clinical sites. Health system components will include the development and implementation of a CRC screening registry and tracking database to systematically and actively track patients overdue for screening, screening test completion, and abnormal screening results. Data systems will be coupled with process re-design to improve clinical workflow for screening outreach. Providers will receive educational support through a training session about the importance of CRC screening, screening test options, population management, and an instructional on how to complete a Cologuard kit (Cologuard arm only) or a FIT kit (FIT arm only). Patient components of the intervention vary by study arm. In sites randomized to Cologuard, patients will receive a mailed Cologuard kit and the Exact Sciences patient support program. Patients in clinics randomized to FIT will receive a mailed FIT kit with systematic reminders. Patients who test positive will be offered patient navigation to assist with completing a diagnostic colonoscopy.

Official Title
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Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: FIT kit Screening Test
* Other: Cologuard Screening Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45-75 Has had a visit at a participating community clinic within the last two years. Alive Patient's preferred language is English or Spanish Exclusion Criteria: Exclusion Criteria: Has Ulcerative Colitis or Crohn's disease documented in the problem list. (Codes below). Has colorectal cancer documented in the problem list. (Codes below). Has had a FIT in the past 1 year Has had a colonoscopy in the past 10 years ICD-10 codes for exclusion criteria: Ulcerative colitis: K51.0 K51.2 K51.3 K51.4 K51.5 K51.8 K51.9 K52.8 K52.9 Crohn's disease: K50.0 K50.1 K50.8 K50.9 Colorectal cancer C18 (malignant neoplasm of colon) C18.0 (malignant neoplasm of cecum) C18.1 (malignant neoplasm of appendix) C18.2 (malignant neoplasm of ascending colon) C18.3 (malignant neoplasm of hepatic flexure) C18.4 (malignant neoplasm of transverse colon) C18.5 (malignant neoplasm of splenic flexure) C18.6 (malignant neoplasm of descending colon) C18.7 (malignant neoplasm of sigmoid colon) C18.8 (malignant neoplasm of overlapping sites of colon) C18.9 (malignant neoplasm of colon, unspecified) C19 (malignant neoplasm of rectosigmoid junction) C20 (malignant neoplasm of rectum) C21.8 (malignant neoplasm of overlapping sites of rectum, anus and anal canal) C26.0 (malignant neoplasm of intestinal tract, part unspecified) C78.5 (secondary malignant neoplasm of large intestine and rectum) C78.6 (secondary malignant neoplasm of retroperitoneum and peritoneum) D37.4 (neoplasm of uncertain behavior of colon) D37.5 (neoplasm of uncertain behavior of rectum)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Health Centers are randomized to FIT testing or Cologuard.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mailed FIT Kit<br>A FIT kit mailed to the patient's home | Other: FIT kit Screening Test<br>* FIT kit mailed to the patient's home<br>|
| Active Comparator: Cologuard<br>A Cologuard test mailed to the patient's home | Other: Cologuard Screening Test<br>* Cologuard test mailed to the patient's home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRC Screening Completion Rates | completion rate of the stool-based screening test (Cologuard or FIT) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRC Screening Completion Rates | completion rate of the stool-based screening test (Cologuard or FIT) | 6 months | 
| Diagnostic Colonoscopy Completion Rates | completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm) | 6 months |