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Clinical Trials/NCT03176082
NCT03176082CompletedNot 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 enrollmentStarted: October 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,144
Primary Endpoint
Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, •

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
52 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention Group

Experimental

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

Intervention: Mailed Reminders with Fecal Immunochemical Testing kits (Other)

Comparison Group

Active Comparator

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

Intervention: Reminder letter only (Other)

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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