Incidental Coronary Calcification Quality Improvement Project
试验速览
- 阶段
- 不适用
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Rate of Statin Prescription
研究概览
简要总结
This is a multi-center, randomized quality improvement project. At least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (CAC) on a prior non-gated chest CT will be enrolled across the Stanford Healthcare System and the Palo Alto Veteran's Affairs Healthcare System. Patients will be randomized in a 1:1 fashion to notification or usual care arms. The primary aim of this project is to estimate the increase in 6-month statin prescription among statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental CAC on a non-gated chest CT who are randomized to receive notification of their findings vs. usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Metastatic cancer or active cancer undergoing chemotherapy
- •History of medical nonadherence
研究组 & 干预措施
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.
干预措施: Notification (Other)
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.
结局指标
主要结局
Rate of Statin Prescription
时间窗: Within 6 months
Proportion of patients prescribed a statin
次要结局
- Number of primary Care Clinical Encounters(6 months)
- HDL Cholesterol Level(6 months)
- Triglyceride Level(6 months)
- Body Mass Index(6 months)
- Number of Cardiology Referrals(6 months)
- LDL Cholesterol Level(6 months)
- Systolic Blood Pressure(6 months)
- Hemoglobin A1c Level(6 months)
- Statin Intensity(6 months)
- Rate of Aspirin Prescription(6 months)
- Total Cholesterol Level(6 months)
- Number of Cardiovascular Diagnostic Tests(6 months)
- Number of Hypertension Medications(6 months)
- Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease(6 months)
研究者
Alexander Sandhu
Principal Investigator, Instructor of Medicine, Division of Cardiology
Stanford University