Mailed Reminders Plus Fecal Immunochemical Testing

UNC Lineberger Comprehensive Cancer Center2,144 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

2,144

Conditions

Colorectal Cancer Screening Colorectal Cancer

Interventions

Mailed Reminders with Fecal Immunochemical Testing kitsOTHER

Reminder letter onlyOTHER

Eligibility

Sex: ALLMin age: 52 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 21 months following baseline

Diagnoses of colorectal Cancer

Diagnoses of colorectal cancer will be assessed through Medicaid claim data.

Time frame: 21 months following baseline

Polypectomies

Number of polypectomies will be assessed through Medicaid claim data.

Time frame: 21 months following baseline

Data from ClinicalTrials.gov

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