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Clinical Trials/NCT03176082
NCT03176082
Completed
Not Applicable

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

UNC Lineberger Comprehensive Cancer Center0 sites2,144 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer Screening
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
2144
Primary Endpoint
Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, •
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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,
  • 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, •

Time Frame: 21 months following baseline

Screening status will be assessed through participant response and Medicaid claim data.

Polypectomies

Time Frame: 21 months following baseline

Number of polypectomies will be assessed through Medicaid claim data.

Diagnoses of colorectal Cancer

Time Frame: 21 months following baseline

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

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