Mailed Reminders Plus Fecal Immunochemical Testing

Not Applicable

Completed

• Conditions: Colorectal Cancer Screening; Colorectal Cancer
• Interventions: Other: Mailed Reminders with Fecal Immunochemical Testing kits; Other: Reminder letter only

• Registration Number: NCT03176082
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-05
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2144

Inclusion Criteria

1. Current Medicaid beneficiary,
2. Enrolled in Community Care Partners of Greater Mecklenburg (CCPGM),
3. 52-64 years old,
4. English or Spanish speaking,
5. 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,
6. No record of any CRC diagnosis or total colectomy

Exclusion Criteria

1. < 52 or >64 years of age;
2. History of colorectal cancer or total colectomy (see attached table for codes),
3. Persons dually enrolled in Medicare,
4. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Mailed Reminders with Fecal Immunochemical Testing kits	Intervention group will receive: 1. A reminder letter indicating need for screening 2. A FIT kit with completion instructions 3. 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) 4. A pre-paid return mailer for FIT Kit
Comparison Group	Reminder letter only	Comparison group will receive: 1. A reminder letter indicating need for screening 2. Instructions for obtaining a FIT kit 3. A health information card including the ability to update records for current screening and opt out from colon cancer screening communication from the MCPHD

Primary Outcome Measures

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