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临床试验/NCT03176082
NCT03176082已完成不适用

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

UNC Lineberger Comprehensive Cancer Center0 个研究点目标入组 2,144 人开始时间: 2016年10月最近更新:
适应症

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

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

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

研究者

申办方类型
Other
责任方
Sponsor

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