NOTIFY (New Observations Taking Information From Yesterday)

Stanford University

Status: Begins enrollment this month

Conditions: Atherosclerotic Cardiovascular Disease

Treatments: Other: Clinician Guideline Reminder; Other: CAC Notification

Study type: Interventional

Funder types: Other

Identifiers

NCT05977413

71202

Details and patient eligibility

About

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.

Enrollment: 40,000 estimated patients

Sex: All

Ages: 50 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40,000 participants in 2 patient groups

Patient-Clinician CAC Notification

Experimental group

Description:

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.

Treatment:

Other: CAC Notification

Clinician Guideline Reminder

Other group

Description:

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.

Treatment:

Other: Clinician Guideline Reminder