Incidental Coronary Calcification Quality Improvement Project

Not Applicable

• Conditions: Coronary Artery Disease; Atherosclerotic Cardiovascular Disease
• Interventions: Other: Notification

• Registration Number: NCT04789278
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-09
• Study Start: 2021-03-30
• Primary Completion: 2022-01-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-29
• Study Completion: 2022-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 173

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Notification	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.

Primary Outcome Measures

Name	Time	Method
Rate of Statin Prescription	Within 6 months	Proportion of patients prescribed a statin

Secondary Outcome Measures

Name	Time	Method
Number of primary Care Clinical Encounters	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	Proportion of patients prescribed a high intensity, intermediate intensity, and low intensity statin
HDL Cholesterol Level	6 months
Rate of Aspirin Prescription	6 months	Proportion of patients prescribed aspirin
Total Cholesterol Level	6 months
Number of Cardiovascular Diagnostic Tests	6 months
Triglyceride Level	6 months
Number of Hypertension Medications	6 months
Body Mass Index	6 months
Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease	6 months

Trial Locations

Locations (1)

Stanford Hospital & Clinics; 🇺🇸 Stanford, California, United States