Mailed Reminders Plus Fecal Immunochemical Testing

NCT03176082 | Completed

• 1 other identifier: 16-0875
• Study Type: interventional
• Target: 2,144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer Screening; Colorectal Cancer

Keywords

colorectal cancer screening; colorectal cancer

Outcome Measures

Primary Outcomes (3)

• 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

• Diagnoses of colorectal Cancer

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

  21 months following baseline

• Polypectomies

  Number of polypectomies will be assessed through Medicaid claim data.

  21 months following baseline

Study Arms (2)

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

Other: Mailed Reminders with Fecal Immunochemical Testing kits

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

Other: Reminder letter only

Interventions

Mailed Reminders with Fecal Immunochemical Testing kits OTHER

Intervention Group

Reminder letter only OTHER

Comparison Group

Eligibility Criteria

• Age: 52 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Current Medicaid beneficiary,
• Enrolled in Community Care Partners of Greater Mecklenburg (CCPGM),
• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Alison Brenner, PhD, MPH

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: June 5, 2017
• Study Start: October 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share