Incidental Coronary Calcification Quality Improvement Project (ICC QI)
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Stanford、California、美国、94066
- Stanford Hospital & Clinics
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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:
- Non-gated chest CT between 2014-2019
- The presence of CAC confirmed by manual review by an experienced radiologist
- Stanford affiliated primary care provider or endocrinologist for Stanford healthcare system patients and VA primary care provider for VA patients with at least 1 encounter since 2018
Exclusion Criteria:
- Current or prior statin or PCSK9 inhibitor therapy
- Prior diagnosis of ASCVD (coronary artery disease, peripheral arterial disease, cerebrovascular disease, coronary/peripheral revascularization)
- Prior coronary imaging (cardiac CT, invasive coronary angiography)
- Dementia
- Metastatic cancer or active cancer undergoing chemotherapy
- History of medical nonadherence
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Notification
Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or postal mail that will inform them of the CAC identified on their previous chest CT. It will provide an overview of CAC, an image of their chest CT, and a recommendation that they discuss this finding with their clinician. These clinicians will be notified of these findings via an earlier EHR message. Any treatment decisions will be made by the patient and their clinician. Patients randomized to notification who are not prescribed a statin medication and do not have a documented discussion regarding statin therapy within three months will be sent a second message at that time. Their primary care providers will receive a second EHR message concurrently. |
Notification of coronary calcium to the patient and their clinician
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无干预：Usual Care
Both arms have previously had their CT scans reported according to standard clinical practice.
This may include notification of the CAC in the imaging report.
The usual care arm will not receive any additional notification beyond this standard of care during the project.
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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 |
|---|---|---|
|
Rate of Statin Prescription
大体时间：Within 6 months
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Proportion of patients prescribed a statin
|
Within 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Mass Index
大体时间：6 months
|
6 months
|
|
|
Systolic Blood Pressure
大体时间：6 months
|
6 months
|
|
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Statin Intensity
大体时间：6 months
|
Proportion of patients prescribed a high intensity, intermediate intensity, and low intensity statin
|
6 months
|
|
Total Cholesterol Level
大体时间：6 months
|
6 months
|
|
|
LDL Cholesterol Level
大体时间：6 months
|
6 months
|
|
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HDL Cholesterol Level
大体时间：6 months
|
6 months
|
|
|
Triglyceride Level
大体时间：6 months
|
6 months
|
|
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Number of Hypertension Medications
大体时间：6 months
|
6 months
|
|
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Hemoglobin A1c Level
大体时间：6 months
|
6 months
|
|
|
Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease
大体时间：6 months
|
6 months
|
|
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Rate of Aspirin Prescription
大体时间：6 months
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Proportion of patients prescribed aspirin
|
6 months
|
|
Number of primary Care Clinical Encounters
大体时间：6 months
|
6 months
|
|
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Number of Cardiology Referrals
大体时间：6 months
|
6 months
|
|
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Number of Cardiovascular Diagnostic Tests
大体时间：6 months
|
6 months
|
合作者和调查者
调查人员
- 首席研究员：Alexander T Sandhu, MD, MS、Stanford University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
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.