NOTIFY 2: Picture of Incidental Calcium To Understand Risk Estimate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Number of new statin prescriptions
研究概览
简要总结
This is a prospective randomized controlled trial assessing the impact of notifying patients and their clinicians of an incidental finding of coronary artery calcification (CAC) indicating increased cardiovascular risk. Patients will be identified through completed radiology orders for non-gated, non-contrast chest CT in the appropriate clinical context and then will have an EHR screen for inclusion criteria. The presence of CAC will be confirmed by a radiologist. Eligible patients will be randomized to CAC notification or usual care using a 1:1 stratified block randomization method based on baseline ASCVD.
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
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above and <85
- •Non-gated chest CT with CAC
- •An encounter after July 1, 2021 with a Stanford-affiliated clinician from one of the following clinics:
- •Stanford Internal Medicine (includes University affiliated clinics)
- •Stanford Family Medicine (includes University affiliated clinics)
- •Non-EP cardiologist
排除标准
- •Advanced or poor-prognostic cancer
- •No active primary care or cardiology care at Stanford Health Care
- •Primary language other than English, Spanish, Vietnamese, Cantonese, or Mandarin
- •Baseline statin or non-statin lipid lowering therapy
- •Allergy to statin medication or identification of statin-associated muscle symptom
研究组 & 干预措施
Notification
The notification arm will have its CT scans interpreted and reported according to standard clinical practice. A standardized notification message using the EHR will be sent to the patient's Stanford affiliated non-EP cardiologist, if present, or the primary care clinician if there is no non-EP cardiologist. After a two week delay from notifying the patient's non-EP cardiologist or PCP, a standardized notification message will be sent to the patient. The message will include an image of the CAC from the chest CT. All communications will be signed by the Principal Investigator. Any treatment decisions will be made by the patient and their clinician.
干预措施: Notification (Other)
Usual Care
The usual care arm will have its CT scans interpreted and reported according to standard clinical practice. This may mention the presence of CAC in the official radiology imaging report, per usual practice. The usual care arm will not receive any notification beyond this standard of care.
We intend to notify patients in the usual care arm when study ends, if we determine that notification is effective at increasing statin rates.
结局指标
主要结局
Number of new statin prescriptions
时间窗: Baseline through Month 6
6-month new statin prescription rate
次要结局
- Number of participants using statin medication(Month 6)
- Change in Low-density lipoprotein (LDL) cholesterol(Baseline and Month 6)
- Change in 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Pooled Cohort Equation(Baseline and Month 6)
- Number of events requiring primary care intervention, cardiology referrals, or cardiac testing(Baseline through Month 6)
研究者
Fatima Rodriguez
Associate Professor of Medicine (Cardiovascular Medicine)
Stanford University