跳至主要内容
临床试验/NCT02870049
NCT02870049已完成不适用

A RCT of Outreach and Inreach Strategies for Boosting CRC Screening in a Federally-Qualified Health Center

University of California, San Diego0 个研究点目标入组 673 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
673
主要终点
Screening Completion Rate

研究概览

简要总结

The purpose of this study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone.

详细描述

Colorectal cancer (CRC) screening saves lives, but screening rates are low among underserved populations, particularly Latinos. The screening rate in the predominantly Latino population served by San Ysidro Health Center (SYHC, a Federally Qualified Health Center (FQHC)), is just 31%, similar to that reported for Latinos nationally, but lower than the overall national average of 65%. Previous research has demonstrated that inreach interventions at point of medical care such as patient navigation after screening referral, and outreach outside of usual medical care (such as with mailed invitations) can increase screening rates among underserved populations. However, since these have undergone limited evaluation among low income predominantly Spanish-speaking Latinos, it is unclear which approach is best, and whether implementing both approaches would be synergistic for optimizing screening rates. We hypothesize that two culturally and linguistically tailored interventions: a) an inreach strategy (IR, consisting of community health worker-delivered in clinic education regarding CRC screening and other components), and b) an outreach strategy (OS, consisting of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) and telephone reminders) can substantially increase screening, and further, that the two interventions together will be substantially better than either alone. To test these hypotheses, we propose a randomized trial comparing usual care, IR, OS, and IR+OS for CRC screening.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Screening
盲法
Single (Participant)

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

入选标准

  • Individuals age 50 to 75 years,
  • One or more SYHC visits in the last year,
  • Not uptodate with CRC screening

排除标准

  • Individuals with personal history of CRC or colorectal polyps

研究组 & 干预措施

Inreach strategy

Experimental

This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders.

干预措施: Inreach strategy (Behavioral)

Outreach strategy

Experimental

This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.

干预措施: Outreach strategy (Behavioral)

Both Inreach and Outreach strategies

Experimental

This is a combination of the above two strategies: Inreach and Outreach combined.

干预措施: Both Inreach and Outreach strategies (Behavioral)

Usual care

Active Comparator

Usual care in the clinic using the fecal immunochemical test (FIT) kit.

干预措施: Usual care (Behavioral)

结局指标

主要结局

Screening Completion Rate

时间窗: 23 months

Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samir Gupta

Associate Professor of Clinical Medicine

University of California, San Diego

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