Promoting Equity for Cancer Screening and Follow-up
Promoting Equity Through Multicomponent Strategies for Cancer Screening and Follow-up (PREMiS)
研究概览
详细说明
Colorectal cancer (CRC) is the third leading cause of cancer-related death in the United States, and screening has been shown to reduce mortality from CRC. Screening is underutilized in the United States, particularly in some communities such as Blacks/African Americans, American Indians/Alaskan Natives, and rural populations, contributing to disparities in mortality.
For CRC screening, mt-sDNA testing is one of several tests that are recommended by the United States Preventive Services Task Force (USPSTF). As part of a quality improvement program at our institution, those who are due for CRC screening are identified using a validated electronic algorithm and a kit is mailed directly to each patient. Our intervention is initiated on non-respondents to the mailed mt-sDNA outreach by testing the use of a technology-enabled reminder system.
Thirty days after being mailed a mt-sDNA kit, patients who have not completed the screening will be randomized to receive a reminder to complete the mt-sDNA screening by one of three mechanisms (time 0):
- Automated reminder using the EHR patient portal messaging system.
- Automated reminder using a customized interactive voice response (IVR) system
- Personalized reminder phone calls from the clinical team
This will allow for an empirical test of processes that can be employed to improve delivery of CRC screening and reduce preventable deaths in populations that are underserved with evidence-based interventions.
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults, between 50 to 75 years old.
- Due for colorectal cancer screening based on not having a record of a colonoscopy within 10 years, sigmoidoscopy, or CT colonography within 5 years, mt-sDNA within 3 years, or FIT within 1 year.
- Asymptomatic for colorectal cancer such as rectal bleeding or reported abdominal mass.
Exclusion Criteria:
- For the intervention study, patients will be restricted to those aged 50 to 75 years and are due for colorectal cancer screening.
- We will exclude any patient who has:
- Had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, mt-sDNA within 3 years, CT colonography within 5 years, and FOBT/FIT within twelve months of inclusion into the study;
- A diagnosis of CRC or other GI cancer;
- History of confirmed Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis) or other colitis;
- Had a colectomy, partial or total;
- A diagnosis of Lynch Syndrome;
- A diagnosis of Familial Adenomatous Polyposis (FAP);
- Iron deficiency anemia;
- Lower GI bleeding;
- A metastatic (Stage IV) blood or solid tumor cancer;
- End stage renal disease;
- A first degree relative with CRC prior to age 50 or 2+ first degree relatives diagnosed at any age.
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:IVR Reminder
Participants will receive an interactive voice reminder
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Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21.
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有源比较器:Personalized Phone Call Reminder
Participants will receive a personalized phone call
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Patients will receive a scripted phone call from the research team to remind them to complete the mt-sDNA screening at day 7 and 21.
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有源比较器:Portal Message Only
Participants will receive a online patient portal message reminder
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Patients will receive an EHR patient portal message with a scripted message to remind them to complete the mt-sDNA screening at day 7 and 21.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Primary Endpoint (intention-to-treat)
大体时间:Completion by 6 months post randomization
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The completion rate of mt-sDNA among eligible patients.
The primary comparison will be the return rate compared across intervention arms.
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Completion by 6 months post randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Secondary Outcome (per protocol analysis)
大体时间:Completion by 6 months post randomization
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The completion rate of mt-sDNA among eligible patients.
The comparison will be the return rate compared across intervention arms, excluding participants who received an alternative intervention due to not having appropriate portal access.
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Completion by 6 months post randomization
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合作者和调查者
赞助
调查人员
- 首席研究员:Chyke Doubeni, MBBS, MPH、Mayo Clinic
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.