Mailed Reminders Plus Fecal Immunochemical Testing (MFIT)

December 18, 2018 updated by: UNC Lineberger Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2144

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

52 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group

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
Other: Mailed Reminders with Fecal Immunochemical Testing kits
Active Comparator: Comparison Group

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
Other: Reminder letter only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
21 months following baseline
Diagnoses of colorectal Cancer
Time Frame: 21 months following baseline
Diagnoses of colorectal cancer will be assessed through Medicaid claim data.
21 months following baseline
Polypectomies
Time Frame: 21 months following baseline
Number of polypectomies will be assessed through Medicaid claim data.
21 months following baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Alison Brenner, PhD, MPH, UNC Lineberger Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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