Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report

Study Overview
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Brief Summary
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The goal of this study is to examine if communication of image-based cardiovascular risk to patients undergoing coronary artery calcium scoring (CAC) improves patient understanding of their risk for cardiovascular disease when compared with usual care (physician-only report).

Official Title
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Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report: A Randomized-controlled Trial

Conditions
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Cardiac Computed Tomography for Calicum Scoring

Intervention / Treatment
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* Other: Image-Based Report


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range: from 40 to 89 Referred for CAC at UHHS Exclusion Criteria: Less than 40 years of age or over 89 years old. Underwent CAC at other locations besides UHHS.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Clinical Standard Report Only<br>Participants referred for Coronary Artery Calcium Score Test that receive clinical standard CAC risk report only. | |
| Experimental: Clinical Standard Report plus Image-Based Report<br>Participants referred for Coronary Artery Calcium Score Test that receive clinical standard CAC risk report plus additional image-based report. | Other: Image-Based Report<br>* Participants will receive the new coronary artery calcium score risk report plus the old report<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL Cholesterol | Change in LDL cholesterol levels obtained from EMR between baseline to 12 months | baseline-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Cholesterol | Change in Total Cholesterol | baseline-12 months | 
| Change in Triglycerides | Change in Triglycerides | baseline-12 months | 
| Change in HDL cholesterol | Change in HDL cholesterol | baseline-12 months | 
| Change in Weight | Change in Weight | baseline-12 months | 
| Change in Systolic blood pressure | Change in Systolic blood pressure | baseline-12 months | 
| Change in Diastolic blood pressure | Change in Diastolic blood pressure | baseline-12 months | 
| Change in HbA1c | Change in HbA1c | baseline-12 months | 
| Smoking Cessation Visits as measured by medical record review - yes/no | Smoking Cessation Encounters | 12 months | 
| Statin prescriptions written as measured by medical record review - yes/no | Statin prescriptions | 12 months | 
| Aspirin prescriptions written as measured by medical record review - yes/no | Aspirin prescriptions | 12 months | 
| Stress tests ordered as measured by medical record review - yes/no | Stress testing | 12 months |