An interventional study of Our Practice Advisory (OPA) in ASCVD, ASCVD Management and Coronary Artery Calcium, sponsored by Weill Medical College of Cornell University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Health services research
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.
Researchers will conduct an implementation pilot using a pre- and post-implementation design to evaluate the impact of an electronic health record (EHR)-based Practice Advisory (OPA) on clinical and implementation outcomes. The study will take place at Weill Cornell Internal Medicine Associates (WCIMA), a large academic, hospital-based primary care practice at Weill Cornell Medicine and NewYork-Presbyterian Hospital in New York, NY. The study will include EHR data from adults without known cardiovascular disease (CVD) who have borderline to intermediate PREVENT-estimated 10-year ASCVD risk and are between 30 and 79 years of age. These patients will be seen by primary care providers at WCIMA during an 8-month implementation period in 2027. The OPA will be implemented in the EHR for primary care physicians at WCIMA as part of routine clinical practice. The OPA will be triggered for eligible patients and will provide guidance on three potential actions: ordering a coronary artery calcium (CAC) test, initiating or changing the dose of lipid-lowering therapy, and referring the patient to cardiology. Researchers will evaluate the impact of the OPA by comparing outcomes before and after implementation. The primary outcome will be the proportion of eligible patient encounters resulting in a CAC test order. Secondary outcomes will include completed CAC testing, initiation or dose titration of lipid-lowering therapy, and referrals to cardiology. The implementation of the OPA will also be evaluated using a modified RE-AIM framework, including Reach, Effectiveness, Adoption, Implementation, and Maintenance. Following the 8-month implementation period, primary care clinicians at WCIMA will be invited to complete a brief survey and participate in a semi-structured interview. The survey will assess the acceptability and feasibility of the OPA using the validated Acceptability of Implementation Measure (AIM) and Feasibility of Implementation Measure (FIM). Interviews will explore clinicians' perspectives on whether the OPA affected clinical decision-making, CAC ordering, lipid-lowering therapy prescribing, cardiology referrals, and workflow. Interviews will be audio-recorded, transcribed, and analyzed using thematic analysis guided by the RE-AIM framework.
839 studies on the registry are indexed under Hyperlipidemias; 107 are open to participants now.
This study's planned enrollment of 20 is below the median of 88 across 707 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 164 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
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Exclusion Criteria:
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)
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Change in Number of Completed CAC Tests
Change in the number of CAC tests completed among eligible patients between the pre-OPA implementation and post-OPA implementation periods.
Time frame: 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
Change in the number of eligible patients for whom lipid-lowering therapy is initiated between the pre-OPA implementation and post-OPA implementation periods.
Time frame: 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
Change in the number of eligible patients for whom lipid-lowering therapy is titrated between the pre-OPA implementation and post-OPA implementation periods, including an increase in dosage, decrease in dosage, or change in LLT type.
Time frame: 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
Change in the number of referrals to cardiology or subspecialty care among eligible patients between the pre-OPA implementation and post-OPA implementation periods.
Time frame: Pre-implementation, up to 4 months and during the 4-month post-implementation period, up to 4 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Oct 2027, 8 months later.
Of 161 non-industry interventional studies with no phase under Hyperlipidemias, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 8 months is below that.
Counting every sponsor, half of 165 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University →