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临床试验/NCT05275530
NCT05275530已完成不适用

The Impact of Choice on Colorectal Cancer (CRC) Screening Uptake Among Average-risk Individuals 45-49 Years of Age

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 20,509 人开始时间: 2022年2月21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
20,509
试验地点
2
主要终点
Overall completion of any Colorectal Cancer Screening test

研究概览

简要总结

In May of 2021, the United States Preventive Service Task Force (USPSTF) updated their colorectal cancer (CRC) screening guidelines by recommending screening at an earlier age for average-risk adults starting at the age of 45 years old (Grade B recommendation). This is in addition to their Grade A recommendations of continuing to screen average-risk adults ages 50-75 years old. UCLA Health previously implemented a fecal immunochemical test (FIT) outreach program wherein FIT kits are mailed to average-risk patients overdue for CRC screening twice annually to promote screening uptake. As the investigators health system aims to screen the newly eligible population of average-risk patients between the ages of 45-49, the investigators proposed randomized controlled trial is aimed to determine the most effective patient outreach approach to maximize screening uptake within this age-group.

详细描述

Colorectal cancer (CRC) is the second leading cause of cancer-related death for both men and women in the United States. One in 17 Americans will suffer from CRC during their lifetime and early detection of cancers and polyps by screening is shown to reduce CRC mortality. In 2021, the USPSTF updated its CRC screening guidelines to start screening average-risk individuals at the age of 45 years due in part to a rising incidence of CRC and premalignant polyps in younger patients.

Conventional screening options include both invasive (or direct-visualization) and non-invasive (or stool-based) options. Invasive screening tests include flexible sigmoidoscopy, CT colonography, and colonoscopy. Non-invasive screening tests include the fecal immunochemical test (FIT), the high sensitivity guaiac fecal occult blood test, and stool DNA testing. All of these screening tests are recommended by the USPSTF for CRC screening.

Nationally (and at UCLA Health), the two most common CRC screening modalities are the colonoscopy and the FIT. UCLA Health has previously implemented a FIT mailer outreach program wherein FIT kits are mailed to average-risk patients overdue for CRC screening twice annually to promote screening uptake. The program has been extremely effective in increasing CRC screening adherence rates, with an increase in the health system's screening rate over the past several years.

The investigators current study aims to determine the most effective patient outreach approach to maximize CRC screening utilization in average-risk individuals ages 45-49 years. In addition, the investigators aim to understand the impact of screening modality choice on uptake of CRC screening, patients' preference for screening modality, and sociodemographic differences in screening utilization among individuals ages 45-49 years.

There are approximately 18,000 patients eligible for inclusion. The investigators will randomly assign approximately 17,000 average-risk patients aged 45-49 to one of four arms. 1,000 of the patients will be reserved for an internal pilot project. In all arms, all patients will receive a text message encouraging them to access their patient communication portal via Epic electronic health record (EHR) (referred to as "MyChart"). In all arms, once a patient visits MyChart, a message on MyChart will state that they are due for CRC screening and the importance of CRC screening. In the control (standard care) arm, patients will treated as part of our "FIT-kit mailer program." These patients will receive a mailed FIT kit, and the message on MyChart will encourage them to complete the FIT kit. In the "FIT Kit Choice" arm, patients will be presented with the choice to complete screening with a FIT kit or opt out of screening. In the "Colonoscopy Choice" arm, patients will be presented with the choice to complete screening with a colonoscopy or opt out of screening. In the "Dual Choice" arm, patients will be presented with the choice to complete screening with a FIT kit, complete screening with a colonoscopy, or opt out of screening. After patients make the choice in MyChart, the patient will be asked why they made that choice.

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
45 Years 至 49 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •UCLA Health patient
  • •Age 45-49 (as of 1/1/2022)
  • •Active primary care provider at UCLA Health
  • •Visit within the last 3 years

排除标准

  • •Age <45 or >50 years old at time of randomization
  • •Documented family history of CRC in EMR
  • •History (personal or family) of prior adenomatous polyps in the EHR
  • •History of high-risk cancer syndromes (e.g., Lynch, FAP)
  • •Prior CRC screening with colonoscopy or FIT
  • •Inactive MyChart status at enrollment
  • •No documented SMS-capable phone number

研究组 & 干预措施

Standard of Care

No Intervention

No Intervention-"Standard Care"

UCLA Health has a mailed FIT outreach program. This group will receive standard FIT mailer protocol. They will receive a tailored MyChart message indicating the importance of CRC screening and not be presented with a choice for screening modalities.

FIT Choice

Experimental

This group will receive a tailored message via MyChart with information about CRC screening and using the FIT kit for noninvasive screening. They will then have to actively choose if they want CRC screening with a FIT kit vs no screening. If they opt for screening, the investigators will mail them a FIT kit.

干预措施: Active FIT Choice (Behavioral)

Colonoscopy Choice

Experimental

This group will receive a tailored message via MyChart with information about CRC screening and colonoscopy for CRC screening. They will then have to actively choose if they want CRC screening with a colonoscopy vs no screening. If they opt for screening, the investigators will direct them to our patient navigators to get scheduled for a colonoscopy.

干预措施: Active Colonoscopy Choice (Behavioral)

Dual Choice

Experimental

This group will receive a tailored message via MyChart with information about CRC screening and using either the FIT kit or colonoscopy for CRC screening. They will then have to actively choose if they want CRC screening with a FIT kit, a colonoscopy, or no screening. If they opt for screening, the investigators will either mail them a FIT kit or direct them to our patient navigators to schedule a colonoscopy, depending on their choice.

干预措施: Active Dual Choice (Behavioral)

结局指标

主要结局

Overall completion of any Colorectal Cancer Screening test

时间窗: 6 months after getting the text message

Rate of completion of any CRC screening (FIT Kit or Colonoscopy) throughout the observation window.

次要结局

  • Selection of modality in MyChart Survey(within 4 weeks from receiving the initial MyChart message)
  • CRC screening order placed by any modality(within 6 weeks from receiving the initial MyChart message)
  • Colorectal cancer screening uptake by modality(6 months after getting the initial MyChart message)

研究者

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

Daniel M. Croymans, MD, MBA, MS

Medical Director, DOM Quality

University of California, Los Angeles

研究点 (2)

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