Coronary Artery Calcium Testing for Cardiovascular Disease

MR
MS
Overseen ByMichelle Shum, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to improve how primary care providers identify and manage patients at risk for heart disease. One tool that can help with this is a coronary artery calcium (CAC) test, which looks for calcium buildup in the heart's arteries and can help estimate a person's risk of future heart problems.

The main questions this study aims to answer are:

Will a new electronic health record (EHR) alert that provides guidance on when to consider a CAC test be feasible and acceptable to primary care providers? Does the alert change how often providers order CAC tests, start or change the dose of cholesterol-lowering medications, and refer patients to cardiology?

In this study, a new EHR alert will be implemented as part of routine clinical practice for primary care providers at Weill Cornell Internal Medicine Associates (WCIMA). The alert will provide guidance on considering a CAC test, cholesterol-lowering medication, or referral to cardiology for eligible patients. Researchers will compare clinical care before and after the alert is implemented. They will look at how often CAC tests are ordered and completed, how often cholesterol-lowering medications are started or their doses are changed, and how often patients are referred to cardiology. After the implementation period, primary care providers will also be asked to complete a brief survey and participate in an interview about the alert.

Who Is on the Research Team?

MR

Madeline R Sterling, MD, MPH

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adult patients at risk for heart disease, such as those with high blood pressure or high cholesterol, who receive care at Weill Cornell Internal Medicine Associates. There are no detailed inclusion or exclusion criteria listed.

Inclusion Criteria

Primary care provider (physician or nurse practitioner) at Weill Cornell Internal Medicine Associates (WCIMA)

Exclusion Criteria

Not a primary care provider (physician or nurse practitioner) at WCIMA

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the electronic health record (EHR) alert for primary care providers to guide CAC testing, lipid-lowering therapy, and cardiology referrals

8 months
Routine clinical visits as part of primary care

Post-implementation Evaluation

Evaluation of the impact of the EHR alert on clinical outcomes and provider feedback through surveys and interviews

4 months

Follow-up

Participants are monitored for changes in clinical practices and outcomes after the implementation period

4 months

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests whether a new electronic health record alert helps primary care doctors decide when to order a coronary artery calcium (CAC) test, start or adjust cholesterol medicine, or refer patients to a heart specialist. Care before and after the alert will be compared.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: All primary care providers at Weill Cornell Internal Medicine Associates (WCIMA)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
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Merck Sharp & Dohme LLC

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Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University