Mailed Reminders Plus Fecal Immunochemical Testing (FIT) to Increase Colorectal Cancer Screening Among Medicaid Beneficiaries in Mecklenburg County
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,144
- 主要终点
- Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, •
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 52 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •< 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
研究组 & 干预措施
Intervention Group
Intervention group will receive:
- A reminder letter indicating need for screening
- A FIT kit with completion instructions
- 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)
- A pre-paid return mailer for FIT Kit
干预措施: Mailed Reminders with Fecal Immunochemical Testing kits (Other)
Comparison Group
Comparison group will receive:
- A reminder letter indicating need for screening
- Instructions for obtaining a FIT kit
- A health information card including the ability to update records for current screening and opt out from colon cancer screening communication from the MCPHD
干预措施: Reminder letter only (Other)
结局指标
主要结局
Number of participants who completed fecal testing, screening colonoscopy, and colonoscopies following positive fecal testing, •
时间窗: 21 months following baseline
Screening status will be assessed through participant response and Medicaid claim data.
Polypectomies
时间窗: 21 months following baseline
Number of polypectomies will be assessed through Medicaid claim data.
Diagnoses of colorectal Cancer
时间窗: 21 months following baseline
Diagnoses of colorectal cancer will be assessed through Medicaid claim data.
次要结局
未报告次要终点