Coronary Artery Calcium (CAC) Testing in Primary Care

NCT07868809 | Not Yet Recruiting

• 1 other identifier: 26-01029730
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ASCVD; ASCVD Management; Coronary Artery Calcium; Hyperlipidemia

Keywords

Coronary Artery Calcium Testing; Primary Care; Lipid Lowering Therapy; ASCVD; Intermediate Risk ASCVD

Outcome Measures

Primary Outcomes (3)

• Feasibility of Intervention Measure

  Feasibility will be assessed with a validated, 4-item, Feasibility of Intervention Measure. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived feasibility of the intervention.

  Post-implementation, within 4 months following completion of the 8-month OPA implementation period

• Acceptability of Intervention

  Acceptability will be assessed through the 4-item, validated, Acceptability of Intervention Measure. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived acceptability of the intervention.

  Post-implementation, within 4 months following completion of the 8-month OPA implementation period

• Change in Number of Coronary Artery Calcium (CAC) Tests Ordered

  Change in the number of CAC tests ordered among eligible patients between the pre-OPA implementation and post-OPA implementation periods.

  Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months

Secondary Outcomes (4)

• Change in Number of Completed CAC Tests

  Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months

• Change in Number of Lipid-Lowering Therapy (LLT) Initiations

  Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months

• Change in Lipid-Lowering Therapy (LLT) titration

  Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months

• Change in Number of Referrals to Cardiology or Subspecialty

  Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months

Study Arms (1)

All primary care providers at Weill Cornell Internal Medicine Associates (WCIMA)

EXPERIMENTAL

For 8 months, an Our Practice Advisory (OPA) will be visible to primary care providers within Epic. The OPA will be activated for eligible adults without established CVD who have borderline or intermediate PREVENT-estimated 10-year ASCVD risk and for whom lipid-lowering treatment decisions remain uncertain. The proposed actions will be to order a CAC test, consider referral to cardiology, and initiate or intensify lipid-lowering therapy, including dose titration when appropriate.

Other: Our Practice Advisory (OPA)

Interventions

Our Practice Advisory (OPA) OTHER

This OPA, which will be within the EHR, will be visible when a patient has borderline or intermediate PREVENT-estimated 10-year ASCVD risk and lipid-lowering treatment decisions remain uncertain. The proposed actions will be: Discuss the patient's cholesterol and elevated cardiovascular risk. Guide the clinician on ordering a CAC test. Consider referral to a cardiologist or subspecialist. Consider initiation or dose titration of lipid-lowering therapy. The goal is to understand the impact of the OPA on primary care clinicians' clinical decision-making surrounding patients with borderline or intermediate ASCVD risk.

All primary care providers at Weill Cornell Internal Medicine Associates (WCIMA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Not a primary care provider (physician or nurse practitioner) at WCIMA.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Madeline R Sterling, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline R Sterling, MD, MPH

CONTACT

646-962-5029; mrs9012@med.cornell.edu

Michelle Shum, MS

CONTACT

646-962-7514; mis4047@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Practice-wide implementation of an EHR-based Practice Advisory (OPA), with outcomes evaluated using a pre- and post-implementation design.

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)