Incidental Coronary Calcification Quality Improvement Project

Study Overview
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Brief Summary
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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.

Official Title
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Incidental Coronary Calcification Quality Improvement Project

Conditions
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Atherosclerotic Cardiovascular Disease, Coronary Artery Disease

Intervention / Treatment
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* Other: Notification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Notification<br>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. | Other: Notification<br>* Notification of coronary calcium to the patient and their clinician<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Statin Prescription | Proportion of patients prescribed a statin | Within 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin Intensity | Proportion of patients prescribed a high intensity, intermediate intensity, and low intensity statin | 6 months | 
| Total Cholesterol Level |  | 6 months | 
| LDL Cholesterol Level |  | 6 months | 
| HDL Cholesterol Level |  | 6 months | 
| Triglyceride Level |  | 6 months | 
| Systolic Blood Pressure |  | 6 months | 
| Number of Hypertension Medications |  | 6 months | 
| Hemoglobin A1c Level |  | 6 months | 
| Body Mass Index |  | 6 months | 
| Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease |  | 6 months | 
| Rate of Aspirin Prescription | Proportion of patients prescribed aspirin | 6 months | 
| Number of primary Care Clinical Encounters |  | 6 months | 
| Number of Cardiology Referrals |  | 6 months | 
| Number of Cardiovascular Diagnostic Tests |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Calcium, Statin, Non-gated Chest CT