NOTIFY (New Observations Taking Information From Yesterday)

Stanford University

Overview

This trial will investigate whether notifying patients and their clinicians of the presence of moderate or severe coronary artery calcium on a low-dose CT scan performed for lung cancer screening results in a lower incidence of death, nonfatal myocardial infarction, or nonfatal stroke as compared with practice guideline reminders.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Atherosclerotic Cardiovascular Disease

Interventions

CAC NotificationOTHER

Patient-Clinician CAC Notification. The CAC Notification intervention sent to both patients and clinicians has five features. 1) Results of a high CAC score (\>100 AU) detected on the patient's prior chest CT, 2) an image of the patient's CAC clearly marked, 3) a recommendation to have a patient-clinician risk discussion, 4) specific statin dosing recommended by guidelines, and 5) a link to the prevention gidelines.

Clinician Guideline ReminderOTHER

The Guideline Reminder intervention sent to primary care clinicians has five features. 1) A reminder that all patients should have their 10-year risk for ASCVD events calculated, 2) a figure of the recommended treatment algorithm according to ASCVD 10-year risk, 3) a nudge that patients who qualify for lung cancer screening are generally at high ASCVD risk, 4) a reminder that patients at elevated risk should be engaged in shared decision-making to discuss statin therapy and other preventive interventions, and 5) access to the complete ACC/AHA Primary Prevention Guidelines and the online 10-year ASCVD risk estimator.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 84 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>=18 years * No known ASCVD * Lung cancer screenee with low dose CT scan (LDCT) within the last 5 years * Coronary artery calcium (CAC) score on LDCT \>100 Agatston units (AU) * Not taking a statin or other lipid-lowering therapy (e.g., ezetimibe, bempedoic acid, or PCSK9-lowering therapy) Exclusion Criteria: * Dementia or other neuropsychiatric disorder that interferes with medication adherence * CAC scan, coronary CT angiogram, or invasive angiogram since LDCT * Statin medication intolerance or allergy * Life expectancy \<2 years, e.g., metastatic cancer or active cancer undergoing chemotherapy

Outcomes

Primary Outcomes

Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke

Time frame: 6 years

Secondary Outcomes

Rate of All-cause Death

Number (%) of participants in each treatment group with death from any cause.

Time frame: 6 years

Rate of Cardiovascular Death

Number (%) of participants in each treatment group with cardiovascular death

Time frame: 6 years

Rate of Nonfatal Myocardial Infarction

Number (%) of participants in each treatment group with nonfatal myocardial infarction

Time frame: 6 years

Rate of Nonfatal Stroke

Number (%) of participants in each treatment group with nonfatal stroke

Time frame: 6 years

Initial lipid-lowering therapy prescription rate

Number (%) of participants in each treatment group with active prescriptions of lipid-lowering therapy at 6 months following randomization

Time frame: within 6 months of 1st notification

Number of Participants with active lipid-lowering therapy prescriptions

Persistence of need for lipid-lowering therapy at 18 months following randomization.

Time frame: At 18 months

Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)

Data from ClinicalTrials.gov

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