NCT Number: NCT03176082
Mailed Reminders Plus Fecal Immunochemical Testing
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.
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Notify MeKey information
Conditions
Age range
52 year–64 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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, 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
Treatment and study plan
Reminder letter only
OtherPrimary 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.
-
Diagnoses of colorectal Cancer
Time frame: 21 months following baseline
Diagnoses of colorectal cancer will be assessed through Medicaid claim data.
-
Polypectomies
Time frame: 21 months following baseline
Number of polypectomies will be assessed through Medicaid claim data.
Sponsors and collaborators
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Other
Registry information
Official study title
Mailed Reminders Plus Fecal Immunochemical Testing (FIT) to Increase Colorectal Cancer Screening Among Medicaid Beneficiaries in Mecklenburg County
Acronym: MFIT
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jun 5, 2017
- Registry last updated
- Dec 20, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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