Impact of Patient-Centered Approach for Communicating Coronary Calcium on Cardiovascular Health

NCT06055972 | Active Not Recruiting

• 1 other identifier: ACR 4708
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Smoking

Keywords

Coronary Artery Calcification; Patient-Centered Approach; Lung Cancer Screening

Outcome Measures

Primary Outcomes (7)

• Guideline-Appropriate High Cholesterol Care

  Rate of statin use (how often patients are required to take statin medications) and adherence (how often patents comply with taking statin medications as prescribed) to prescription in patients with known hypercholesterolemia. This will be determined by patients' self-reported answers to questions during interviews and review of medical records. Both rate of statin use and patient compliance will be used to generate a single, overall assessment of how well patients are being treated for and managing their hypercholesteremia.

  6 Months

• Exercise Level

  Changes in exercise level, surveyed using International Physical Activity Questionnaire (IPAQ-short) questionnaire. The IPAQ-short questionnaire is comprised of 7, self-reported, open-ended questions surrounding individuals' last 7-day recall of physical activity. The questionnaire estimates the total physical activity in Metabolic Equivalent of Task (METs)- min/week and time spent sitting. Scores vary depending on the person's activity level throughout the preceding 7 days, and there is not defined range for scores, as the questions are open ended (e.g. How many hours did you spend doing vigorous activities during the last 7days?).

  6 Months

• Patient Self-Reported Smoking Habits and Cessation

  Patients' self-reported smoking habits will be assessed via phone call or questionnaire at baseline and 6-month follow-up.

  6 Months

• Weight loss

  Patient reported weight changes

  6 Months

• Blood Pressure Control

  Patient reported blood pressure changes and initiation of anti-hypertensive therapy. Both systolic/diastolic blood pressure will be measured.

  6 Months

• Patient Anxiety

  Patient anxiety, measured by changes in Generalize Anxiety Disorder-7 (GAD-7) anxiety questionnaire 6 months after intervention. The GAD-7 questionnaire is rated on a scale from 0-21, with higher scores indicating higher patient self-reported anxiety levels.

  6 Months

• Number of Invasive/Noninvasive Hospitalizations

  Clinical visits, cardiac imaging tests, and hospitalizations 6 months after the intervention, to be measured by medical record review (to be assessed by research coordinator at 6 month follow-up) and follow up phone survey (patient self-reporting). Number of visits, obtained from both the patient interview and patient medical records, for both invasive and noninvasive hospitalizations, will be combined to generate a single number, or complete total number of visits patients have experienced 6 months after intervention.

  6 Months

Study Arms (2)

Letter Recipients with Coronary Calcium Score/Educational Materials

EXPERIMENTAL

Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination.

Other: Educational Letter Post CT Examination

Non-Letter Recipients (Control)

NO INTERVENTION

Patients in the control group will not receive any letter in the mail with their coronary calcium score and educational materials.

Interventions

Educational Letter Post CT Examination OTHER

Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination which will include the following: 1. Their calcium score, brief educational content explaining what the calcium score means and how the presence of coronary calcifications is associated with an increased risk of a cardiac event. 2. Guidance on what actions could be taken to decrease the risk of a heart event, including blood cholesterol management, smoking cessation, weight loss, dieting, exercise, and blood pressure control. 3. For patients with CAC\>0, the letter will encourage the patient to pursue a shared decision- making discussion with his/her primary care physician or cardiologist regarding risk reduction strategies. 4. Links to American Heart Association (AHA) and phone number for study research coordinator.

Letter Recipients with Coronary Calcium Score/Educational Materials

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American College of Radiology: lead

Study Sites (2)

University of Michagan

Ann Arbor, Michigan, 48109, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Smoking

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 28, 2023
• Study Start: December 19, 2023
• Primary Completion: January 30, 2025
• Study Completion: February 2, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)