NOTIFY (New Observations Taking Information From Yesterday)

NCT ID: NCT05977413

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2032-06-30

Brief Summary

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.

Conditions

Atherosclerotic Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

CAC Notification

Intervention Type: OTHER

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 Reminder

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.

Group Type: OTHER

Clinician Guideline Reminder

Intervention Type: OTHER

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.

Interventions

CAC Notification

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.

Intervention Type: OTHER

Clinician Guideline Reminder

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

David Maron

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David J Maron, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Central Contacts

David J Maron, MD

Role: CONTACT

david.maron@stanford.edu

650-724-6152

References

Sandhu AT, Rodriguez F, Ngo S, Patel BN, Mastrodicasa D, Eng D, Khandwala N, Balla S, Sousa D, Maron DJ. Incidental Coronary Artery Calcium: Opportunistic Screening of Previous Nongated Chest Computed Tomography Scans to Improve Statin Rates (NOTIFY-1 Project). Circulation. 2023 Feb 28;147(9):703-714. doi: 10.1161/CIRCULATIONAHA.122.062746. Epub 2022 Nov 7.

Reference Type: BACKGROUND

PMID: 36342823 (View on PubMed)

Eng D, Chute C, Khandwala N, Rajpurkar P, Long J, Shleifer S, Khalaf MH, Sandhu AT, Rodriguez F, Maron DJ, Seyyedi S, Marin D, Golub I, Budoff M, Kitamura F, Takahashi MS, Filice RW, Shah R, Mongan J, Kallianos K, Langlotz CP, Lungren MP, Ng AY, Patel BN. Automated coronary calcium scoring using deep learning with multicenter external validation. NPJ Digit Med. 2021 Jun 1;4(1):88. doi: 10.1038/s41746-021-00460-1.

Reference Type: BACKGROUND

PMID: 34075194 (View on PubMed)

Other Identifiers

71202

Identifier Type: -

Identifier Source: org_study_id