Mailed Reminders Plus Fecal Immunochemical Testing

Colorectal Cancer Clinical Trial

— MFIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176082
• Other study ID #: 16-0875
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 2018

Study information

• Verified date: December 2018
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2144
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 52 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Other:
• Mailed Reminders with Fecal Immunochemical Testing kits

• Reminder letter only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	21 months following baseline
Primary	Diagnoses of colorectal Cancer	Diagnoses of colorectal cancer will be assessed through Medicaid claim data.	21 months following baseline
Primary	Polypectomies	Number of polypectomies will be assessed through Medicaid claim data.	21 months following baseline