Mailed Reminders Plus Fecal Immunochemical Testing (MFIT)

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Colorectal Cancer; Colorectal Cancer Screening

Treatments: Other: Reminder letter only; Other: Mailed Reminders with Fecal Immunochemical Testing kits

Study type: Interventional

Funder types: Other

Identifiers

NCT03176082

16-0875

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,144 patients

Sex: All

Ages: 52 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,144 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Other: Mailed Reminders with Fecal Immunochemical Testing kits

Comparison Group

Active Comparator group

Description:

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

Treatment:

Other: Reminder letter only