Clinical trial NCT06055972: Impact of Patient-Centered Approach for Communicating Coronary Calcium on Cardiovascular Health
Official title: Impact of Patient-Centered Approach for Communicating Coronary Calcium on Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Cardiovascular Diseases
Smoking
Keywords: Coronary Artery Calcification
Patient-Centered Approach
Lung Cancer Screening
Lead sponsor: American College of Radiology
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 800
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This multicenter clustered randomized prospective study will be managed by the American College of Radiology Center for Research and Innovation (ACR CRI). The research team aims to test the efficacy of a patient-centered educational intervention based on coronary artery calcification (CAC) information in cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.

Detailed description: Objectives:

The overall goal of the proposed study is to improve cardiovascular health of smokers and previous smokers, as CAD is the most common cause of death in this population. Patients enrolled in lung cancer screening programs compose a highly suitable cohort of heavy smokers and previous smokers with 55-80 years of age for testing interventions that could improve the cardiovascular health of the population

The objective is to use coronary artery calcification burden, derived from computed tomography studies obtained for lung cancer screening purposes, to motivate patients into improving their health habits. The specific goal of this study is to test the efficacy of a patient-centered educational intervention based on CAC information in appropriate statin use and cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.

Recruitment:

Patients will be sent a mail or email research packet containing the invitation to join the study, the consent form and the baseline survey. Alternatively, patients could receive a phone call regarding information about the study

Consenting:

Following screening for eligibility, IRB-approved, HIPAA-compliant informed consent will be obtained by the Research Coordinators medical at the two participating institutions Patient registration can occur only after evaluation for eligibility is complete, eligibility criteria have been met, and the study site is approved by the ACR. Participants must have signed and dated all applicable informed consents and authorization forms.

Randomization:

Investigators will randomly select (coin flipping) first month as intervention yes/no and then alternate monthly until the end of the enrollment period. Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination.

Baseline Questionnaire:

After consent form is signed, patients will have the option to either complete research questionnaire independently or with the help of the research coordinator over a virtual visit Patient will then mail or email the survey back to the research coordinator.

Patient's demographics and socioeconomic status will be inquired including age, gender, gender-identity and race/ethnicity, level of education, range of income, and health insurance status. The baseline cardiovascular health questionnaire will include data on lifestyle and eating habits, smoking status, known cardiovascular diseases, previous cardiovascular interventions, known cardiovascular risk factors such as obesity, hypercholesterolemia, hypertension, family history of heart disease, current use of statins or aspirin, current recommendation to use Statins or aspirin, willingness to pursue lifestyle modifications to reduce cardiovascular risk, and co-morbidities.

An exercise activity level questionnaire (IPAQ-7), a standardized anxiety questionnaire (GAD-7) and a patient activation questionnaire (PAM short) will also be applied.

In addition to data obtained in the baseline questionnaire, medical records, when available, will be reviewed for confirmation of height, weight, and blood pressure at the time of lung cancer screening appointment.

6-Month Follow Up Questionnaire: Approximately 6 months after consent, patients will receive the follow up mail or email research packet containing the follow up questionnaire. Alternatively, patients can receive a follow-up phone call to review the questionnaire. Questionnaire will address the main study outcomes including changes in lifestyle like exercise habit (IPAQ-7), smoking cessation, weight loss, initiation or dose change of Statin or aspirin, adherence to statin or aspirin prescription, level of anxiety (GAD-7), activation level for health self-care (PAM-short), number of cardiovascular imaging tests (echocardiography, catheterization, cardiac stress test, cardiac CT or cardiac MR) performed, and number of clinical visits motivated by the intervention or not.

Image Analysis for Coronary Artery Calcium Quantification:

All patients will have received a Low Dose CT of the chest for Lung cancer screening, as part of their clinical care. The LCS CT images will be analyzed by the site chest radiologist as per clinical care, and the report will include a qualitative statement on burden of coronary artery calcifications (none, mild, moderate, or severe), based on current guideline recommendations. In patients randomized to the intervention arm, quantification of calcium score using the Agatston score method will be performed by a member of the research team and reviewed by study site PI.

Eligibility criteria: Inclusion Criteria:

* Age 50 to 80 years old
* More than 20 pack years of smoking
* Actively smoking or previous smokers who quit with the last 15 years
* Completed a Low-dose CT Scan for Lung Cancer Screening within 30 day of registration

Exclusion Criteria:

* Patients unable to understand the informed consent process
* Patients without a contact phone number or permanent address to receive the study intervention.
* Patients who do not understand the English language
* Patients with known CAD or prior heart surgery /intervention

Primary outcomes:
measure: Guideline-Appropriate High Cholesterol Care
timeFrame: 6 Months
measure: Exercise Level
timeFrame: 6 Months
measure: Patient Self-Reported Smoking Habits and Cessation
timeFrame: 6 Months
measure: Weight loss
timeFrame: 6 Months
measure: Blood Pressure Control
timeFrame: 6 Months
measure: Patient Anxiety
timeFrame: 6 Months
measure: Number of Invasive/Noninvasive Hospitalizations
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michagan
state: Michigan
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: