Clinical trial NCT03176082: Mailed Reminders Plus Fecal Immunochemical Testing
Official title: Mailed Reminders Plus Fecal Immunochemical Testing (FIT) to Increase Colorectal Cancer Screening Among Medicaid Beneficiaries in Mecklenburg County
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Colorectal Cancer
Keywords: colorectal cancer screening
colorectal cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 2144
Sex: ALL
Minimum age (years): 52
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, •
timeFrame: 21 months following baseline
measure: Diagnoses of colorectal Cancer
timeFrame: 21 months following baseline
measure: Polypectomies
timeFrame: 21 months following baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Alison Brenner, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: