Back to resultsIncidental Coronary Calcification Quality Improvement Project (ICC QI)
Primary Purpose
Atherosclerotic Cardiovascular Disease, Coronary Artery Disease
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Notification
Sponsored by
About this trial
This is an interventional other trial for Atherosclerotic Cardiovascular Disease focused on measuring Coronary Calcium, Statin, Non-gated Chest CT
Eligibility Criteria
Inclusion Criteria:
- Non-gated chest CT between 2014-2019
- The presence of CAC confirmed by manual review by an experienced radiologist
- Stanford affiliated primary care provider or endocrinologist for Stanford healthcare system patients and VA primary care provider for VA patients with at least 1 encounter since 2018
Exclusion Criteria:
- Current or prior statin or PCSK9 inhibitor therapy
- Prior diagnosis of ASCVD (coronary artery disease, peripheral arterial disease, cerebrovascular disease, coronary/peripheral revascularization)
- Prior coronary imaging (cardiac CT, invasive coronary angiography)
- Dementia
- Metastatic cancer or active cancer undergoing chemotherapy
- History of medical nonadherence
Sites / Locations
- Stanford Hospital & Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Notification
Usual Care
Arm Description
Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or postal mail that will inform them of the CAC identified on their previous chest CT. It will provide an overview of CAC, an image of their chest CT, and a recommendation that they discuss this finding with their clinician. These clinicians will be notified of these findings via an earlier EHR message. Any treatment decisions will be made by the patient and their clinician. Patients randomized to notification who are not prescribed a statin medication and do not have a documented discussion regarding statin therapy within three months will be sent a second message at that time. Their primary care providers will receive a second EHR message concurrently.
Both arms have previously had their CT scans reported according to standard clinical practice. This may include notification of the CAC in the imaging report. The usual care arm will not receive any additional notification beyond this standard of care during the project.
Outcomes
Primary Outcome Measures
Rate of Statin Prescription
Proportion of patients prescribed a statin
Secondary Outcome Measures
Statin Intensity
Proportion of patients prescribed a high intensity, intermediate intensity, and low intensity statin
Total Cholesterol Level
LDL Cholesterol Level
HDL Cholesterol Level
Triglyceride Level
Systolic Blood Pressure
Number of Hypertension Medications
Hemoglobin A1c Level
Body Mass Index
Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease
Rate of Aspirin Prescription
Proportion of patients prescribed aspirin
Number of primary Care Clinical Encounters
Number of Cardiology Referrals
Number of Cardiovascular Diagnostic Tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04789278
Brief Title
Incidental Coronary Calcification Quality Improvement Project
Acronym
ICC QI
Official Title
Incidental Coronary Calcification Quality Improvement Project
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a multi-center, randomized quality improvement project. At least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (CAC) on a prior non-gated chest CT will be enrolled across the Stanford Healthcare System and the Palo Alto Veteran's Affairs Healthcare System. Patients will be randomized in a 1:1 fashion to notification or usual care arms. The primary aim of this project is to estimate the increase in 6-month statin prescription among statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental CAC on a non-gated chest CT who are randomized to receive notification of their findings vs. usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease, Coronary Artery Disease
Keywords
Coronary Calcium, Statin, Non-gated Chest CT
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Notification
Arm Type
Experimental
Arm Description
Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or postal mail that will inform them of the CAC identified on their previous chest CT. It will provide an overview of CAC, an image of their chest CT, and a recommendation that they discuss this finding with their clinician. These clinicians will be notified of these findings via an earlier EHR message. Any treatment decisions will be made by the patient and their clinician.
Patients randomized to notification who are not prescribed a statin medication and do not have a documented discussion regarding statin therapy within three months will be sent a second message at that time. Their primary care providers will receive a second EHR message concurrently.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Both arms have previously had their CT scans reported according to standard clinical practice. This may include notification of the CAC in the imaging report. The usual care arm will not receive any additional notification beyond this standard of care during the project.
Intervention Type
Other
Intervention Name(s)
Notification
Intervention Description
Notification of coronary calcium to the patient and their clinician
Primary Outcome Measure Information:
Title
Rate of Statin Prescription
Description
Proportion of patients prescribed a statin
Time Frame
Within 6 months
Secondary Outcome Measure Information:
Title
Statin Intensity
Description
Proportion of patients prescribed a high intensity, intermediate intensity, and low intensity statin
Time Frame
6 months
Title
Total Cholesterol Level
Time Frame
6 months
Title
LDL Cholesterol Level
Time Frame
6 months
Title
HDL Cholesterol Level
Time Frame
6 months
Title
Triglyceride Level
Time Frame
6 months
Title
Systolic Blood Pressure
Time Frame
6 months
Title
Number of Hypertension Medications
Time Frame
6 months
Title
Hemoglobin A1c Level
Time Frame
6 months
Title
Body Mass Index
Time Frame
6 months
Title
Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease
Time Frame
6 months
Title
Rate of Aspirin Prescription
Description
Proportion of patients prescribed aspirin
Time Frame
6 months
Title
Number of primary Care Clinical Encounters
Time Frame
6 months
Title
Number of Cardiology Referrals
Time Frame
6 months
Title
Number of Cardiovascular Diagnostic Tests
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-gated chest CT between 2014-2019
The presence of CAC confirmed by manual review by an experienced radiologist
Stanford affiliated primary care provider or endocrinologist for Stanford healthcare system patients and VA primary care provider for VA patients with at least 1 encounter since 2018
Exclusion Criteria:
Current or prior statin or PCSK9 inhibitor therapy
Prior diagnosis of ASCVD (coronary artery disease, peripheral arterial disease, cerebrovascular disease, coronary/peripheral revascularization)
Prior coronary imaging (cardiac CT, invasive coronary angiography)
Dementia
Metastatic cancer or active cancer undergoing chemotherapy
History of medical nonadherence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander T Sandhu, MD, MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital & Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94066
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Incidental Coronary Calcification Quality Improvement Project
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