Mailed Reminders Plus Fecal Immunochemical Testing

Study Overview
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Brief Summary
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Purpose: The investigators propose to test the effectiveness, feasibility, and cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid enrollees in Mecklenburg County.

Detailed Description
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Purpose: The investigators propose to test the effectiveness, feasibility, and cost-effectiveness of a mailed reminder with and without FIT kits in a population of Medicaid enrollees in Mecklenburg County. Participants: Medicaid beneficiaries who are enrolled in Community Care of North Carolina, ages 52-64, currently living in Mecklenburg County, at average risk for colorectal cancer (CRC), with no record of recent CRC screening (FOBT within 12 months, colonoscopy within 10 years). Procedures (methods): Participants will be identified through the state Medicaid database and randomized to receive either: 1) a mailed reminder to complete CRC screening including a FIT kit, instructions for completion, and a return mailer, OR 2) a mailed reminder to complete CRC screening only. Any recipients testing positive will be guided by care managers from Community Care of North Carolina to ensure a follow-up colonoscopy is completed.

Official Title
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Mailed Reminders Plus Fecal Immunochemical Testing (FIT) to Increase Colorectal Cancer Screening Among Medicaid Beneficiaries in Mecklenburg County

Conditions
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Colorectal Cancer Screening, Colorectal Cancer

Intervention / Treatment
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* Other: Mailed Reminders with Fecal Immunochemical Testing kits
* Other: Reminder letter only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current Medicaid beneficiary, Enrolled in Community Care Partners of Greater Mecklenburg (CCPGM), 52-64 years old, English or Spanish speaking, No record of FOBT/FIT within 12 months or colonoscopy with 10 years, sigmoidoscopy within 5 years; barium enema within 5 years, CT colonography within 10 years, No record of any CRC diagnosis or total colectomy Exclusion Criteria: < 52 or >64 years of age; History of colorectal cancer or total colectomy (see attached table for codes), Persons dually enrolled in Medicare, Not enrolled in CCPGM, 5. Received FOBT or FIT within 12 months; colonoscopy within 10 years; sigmoidoscopy within 5 years; barium enema within 5 years, CT colonography within 10 years

Ages Eligible for Study
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Minimum Age: 52 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Intervention group will receive: A reminder letter indicating need for screening A FIT kit with completion instructions A health information card including the ability to update records for current screening and opt out from colon cancer screening communication from the Mecklenburg County Public Health Department (MCPHD) A pre-paid return mailer for FIT Kit | Other: Mailed Reminders with Fecal Immunochemical Testing kits<br> <br> |
| Active Comparator: Comparison Group<br>Comparison group will receive: A reminder letter indicating need for screening Instructions for obtaining a FIT kit A health information card including the ability to update records for current screening and opt out from colon cancer screening communication from the MCPHD | Other: Reminder letter only<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, • | Screening status will be assessed through participant response and Medicaid claim data. | 21 months following baseline | 
| Diagnoses of colorectal Cancer | Diagnoses of colorectal cancer will be assessed through Medicaid claim data. | 21 months following baseline | 
| Polypectomies | Number of polypectomies will be assessed through Medicaid claim data. | 21 months following baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer screening, colorectal cancer