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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Notification | Experimental | 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. |
|
| Usual Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Notification | Other | Notification of coronary calcium to the patient and their clinician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Statin Prescription | Proportion of patients prescribed a statin | Within 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander T Sandhu, MD, MS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital & Clinics | Stanford | California | 94066 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36342823 | Derived | Sandhu AT, Rodriguez F, Ngo S, Patel BN, Mastrodicasa D, Eng D, Khandwala N, Balla S, Sousa D, Maron DJ. Incidental Coronary Artery Calcium: Opportunistic Screening of Previous Nongated Chest Computed Tomography Scans to Improve Statin Rates (NOTIFY-1 Project). Circulation. 2023 Feb 28;147(9):703-714. doi: 10.1161/CIRCULATIONAHA.122.062746. Epub 2022 Nov 7. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2021 | Jul 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| D003327 |
| Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |