Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)

Study Overview
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Brief Summary
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Estimate the impact of notifying both patients and their clinicians of the presence of incidental coronary artery calcium (CAC) on initiation of lipid-lowering therapy in patients with ASCVD who are not receiving lipid-lowering therapy.

Detailed Description
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This is a randomized quality improvement (QI) project evaluating the impact of notifying patients and their clinicians (primary care, cardiologists, neurologists, or vascular surgeon) of incidental CAC detected on a prior chest CT scan. Patients will be identified by screening previous non-gated chest CT scans and electronic health records. The presence of CAC will be confirmed by a radiologist. Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.

Official Title
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Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)

Conditions
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ASCVD, Coronary Artery Calcification

Intervention / Treatment
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* Other: Notification of patients and clinicians


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of CAC on non-gated chest CT scans performed from 2021 to 2023 Age <85 years Diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease Visit to Stanford affiliated clinician since 2021 at one of the following Stanford clinics including University affiliated clinics: Internal Medicine Family Medicine Cardiology Neurology Vascular surgery Exclusion Criteria: No diagnosis of ASCVD Patients receiving lipid-lowering therapy Dementia Metastatic cancer or active cancer undergoing chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Notification with a CAC image<br>Notification of presence of CAC with a CT scan image | Other: Notification of patients and clinicians<br>* Notification Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or US mail that will inform them of the CAC identified on their previous chest CT scan and a recommendation that they discuss this finding and initiation of lipid-lowering therapy with their clinician. The clinicians will be notified of these findings by an earlier EHR message that will be sent 2 weeks before the patient notification. Usual Care The usual care arm will not receive any additional notification beyond this standard of care.<br>|
| Active Comparator: Notification without a CAC image<br>Notification of presence of CAC without a CT scan image | Other: Notification of patients and clinicians<br>* Notification Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or US mail that will inform them of the CAC identified on their previous chest CT scan and a recommendation that they discuss this finding and initiation of lipid-lowering therapy with their clinician. The clinicians will be notified of these findings by an earlier EHR message that will be sent 2 weeks before the patient notification. Usual Care The usual care arm will not receive any additional notification beyond this standard of care.<br>|
| Placebo Comparator: Usual care<br>Usual care | Other: Notification of patients and clinicians<br>* Notification Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or US mail that will inform them of the CAC identified on their previous chest CT scan and a recommendation that they discuss this finding and initiation of lipid-lowering therapy with their clinician. The clinicians will be notified of these findings by an earlier EHR message that will be sent 2 weeks before the patient notification. Usual Care The usual care arm will not receive any additional notification beyond this standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of lipid-lowering therapy | Number of patients who had initiation of lipid-lowering therapy | Month 6 |