Coronary Artery Calcium (CAC) Testing in Primary Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Our Practice Advisory (OPA)
Other interventionThis 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: All primary care providers at Weill Cornell Internal Medicine Associates (WCIMA)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 period2
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 period3
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: