Picture of Incidental Calcium To Understand Risk Estimate (PICTURE) Trial

N/AActive Not RecruitingNCT05588895

Stanford University202 enrolled

Overview

This is a prospective randomized controlled trial assessing the impact of notifying patients and their clinicians of an incidental finding of coronary artery calcification (CAC) indicating increased cardiovascular risk. Patients will be identified through completed radiology orders for non-gated, non-contrast chest CT in the appropriate clinical context and then will have an EHR screen for inclusion criteria. The presence of CAC will be confirmed by a radiologist. Eligible patients will be randomized to CAC notification or usual care using a 1:1 stratified block randomization method based on baseline ASCVD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

202

Conditions

Coronary Artery Calcification

Interventions

For patients randomized to notification, the affiliated non-EP cardiologist, if present, or if patient does not have one, the PCP will be notified and will receive an electronic health record (EHR) message notifying them of the presence of CAC (with images) and the ACC/AHA guideline recommendation to consider starting statin therapy. Simultaneously, the patient will be notified via a MyHealth message describing the presence of CAC with personalized scan images, its significance, and the recommendation that statin therapy should be considered. For the notification arm, we will check for either statin prescription or a documented discussion in the EHR at 2 months. For those not prescribed a statin and without a documented discussion in Epic at 2 months follow-up, we will send a repeat notification to their home address and to their affiliated clinician.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 84 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 and above and \<85 * Non-gated chest CT with CAC * An encounter after July 1, 2021 with a Stanford-affiliated clinician from one of the following clinics: * Stanford Internal Medicine (includes University affiliated clinics) * Stanford Family Medicine (includes University affiliated clinics) * Non-EP cardiologist Exclusion Criteria: * Advanced or poor-prognostic cancer * No active primary care or cardiology care at Stanford Health Care * Primary language other than English, Spanish, Vietnamese, Cantonese, or Mandarin * Baseline statin or non-statin lipid lowering therapy * Allergy to statin medication or identification of statin-associated muscle symptom

Outcomes

Primary Outcomes

Number of new statin prescriptions

6-month new statin prescription rate

Time frame: Baseline through Month 6

Secondary Outcomes

Number of participants using statin medication

6-month assessment of statin prescription rates

Time frame: Month 6

Change in Low-density lipoprotein (LDL) cholesterol

Time frame: Baseline and Month 6

Change in 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Pooled Cohort Equation

This outcome measures the 10 year risk of ASCVD events.