Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,470
- 试验地点
- 2
- 主要终点
- Completion of FIT- one year
研究概览
简要总结
Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network and access to care may be limited so novel models of health care delivery are warranted. The objective of this study is to examine whether a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses.
详细描述
Rationale: Since uptake of colorectal cancer (CRC) screening is suboptimal in the SF safety-net system and access to care may be limited, novel models of health care delivery are warranted. The overall hypothesis is that a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses. Barriers to immunization of adults include missed opportunities during visits, limited access to providers, and provider and patient beliefs of efficacy.
Design: To rigorously examine the benefit of the centralized panel management to improve uptake of CRC screening with mailed FIT, the electronic health system will be used to identify eligible patients who are not up-to-date with CRC screening. Broadly, patients will be randomized 1:1 to usual care or intervention arm, stratified by clinic, gender, prior screening, and race to receive mailed FIT kits + usual care versus usual care alone. The cost-effectiveness of no screening, usual care, and centralized management with mailed FIT outreach will be compared using mathematical simulation models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic men and women
- •50 to 75 years of age
排除标准
- •Personal history of polyps requiring colonoscopic surveillance
- •Severe co-morbidities limiting life expectancy e.g., advanced stage cancer
研究组 & 干预措施
Usual Care
Patients in this study arm will receive usual care from their primary care clinic.
FIT Outreach + Usual Care
Patients in this study arm will receive usual care at their primary care clinic and the intervention.
干预措施: FIT Outreach (Behavioral)
结局指标
主要结局
Completion of FIT- one year
时间窗: One year
The primary outcome is the completion rate for CRC screening one-year after randomization between mailed FIT outreach and usual care.
次要结局
- Cost(Two years)
- Completed Colonoscopy(One year)
- Colonoscopy Findings(One year)
- Incomplete FIT- 28 days(28 days)
- FIT Positive(1 year)
研究者
Ma Somsouk, MD, MAS
Associate Professor
University of California, San Francisco