Using automated alerts to improve treatment for heart valve conditions

Addressing Under-treatment and Health Equity in Aortic Stenosis and Mitral Regurgitation Using an Integrated EHR Platform

This study is testing if automated alerts can help doctors find and treat patients with severe heart valve problems better than those who don’t receive the alerts.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2626 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tempus AI (Industry-sponsored)
• Locations: 6 sites (Kansas City, Missouri and 5 other locations)
• Trial ID: NCT06099665 on ClinicalTrials.gov

What this trial studies

This multi-center, prospective, cluster-randomized controlled trial evaluates the effectiveness of Tempus Next's automated notifications in identifying patients who may need valve interventions for severe aortic stenosis and mitral regurgitation. The study compares clinical follow-up rates and surgical procedures between a treatment group receiving alerts and a control group without alerts. It also examines outcomes across different demographics, including race, ethnicity, sex, and geography, to address health equity in treatment. The primary goal is to determine if these automated alerts can reduce under-treatment of these serious heart conditions.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with severe aortic stenosis or mitral regurgitation based on specific echocardiogram findings.

Not a fit: Patients with mild or moderate aortic stenosis or mitral regurgitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved identification and treatment of patients with severe aortic stenosis and mitral regurgitation, enhancing patient outcomes.

How similar studies have performed: Other studies have shown promise in using automated alerts to improve clinical outcomes, suggesting this approach may be effective.

Eligibility criteria

At least one of the following three options for aortic stenosis and/or the single option for mitral regurgitation are determined from echocardiogram findings:

1. AVA or DI (Patients with either Aortic valve area (AVA) or Dimensionless Index (DI) measured in their echo as well as at least one hemodynamic measure above the minimum threshold)

   a. Either: i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ANY of i. Aortic Mean Gradient ≥ 15 mmHg ii. Aortic Peak Gradient ≥ 30 mmHg iii. Aortic Jet Velocity ≥ 2.75 m/s
2. AVA + OTHER (Patients with AVA and at least 1 other echo measurement in their echo above the threshold)

   1. 1.0 cm2 \< Aortic Valve Area ≤ 1.2 cm2
   2. AND ANY of:

   i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s
3. POSSIBLE (Possible Aortic Stenosis but requires human review) a. Aortic Valve Area is NULL OR \>1.2 cm2 b. AND ANY of: i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s OR a. EITHER i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ALL are: i. Aortic Mean Gradient \< 15 mmHg ii. Aortic Peak Gradient \< 30 mmHg iii. Aortic Peak Velocity \< 2.75 m/s

ALERT Study Clinical Investigation Plan Version 2.1 page 12 of 54

Any patient flagged for "POSSIBLE" does not result in automatically alerting the provider, instead a notification is sent to the Tempus research team for manual review in conjunction with the site Principal Investigator (PI) and if requested by Tempus or site PI, a Steering Committee member. If clinical confirmation is received for severe aortic stenosis from the site PI, an alert is sent to the provider. 1. Mitral Regurgitation

a. Mention of severe mitral regurgitation or moderate- severe mitral regurgitation

Any patient mentioned with only moderate MR or a lesser severity will be excluded.

Exclusion Criteria:

1. Age \< 18 years
2. Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve
3. The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon
4. Patient already has a scheduled clinic visit with a member of the MHT or a recent (since the start of the study at that site ) clinic visit with the MHT, or a scheduled transcatheter or surgical VI in the future.

Where this trial is running

Kansas City, Missouri and 5 other locations

• Saint Luke's Health System — Kansas City, Missouri, United States (Recruiting)
• OhioHealth — Columbus, Ohio, United States (Not_yet_recruiting)
• Bon Secours Mercy Health - Lima Market — Lima, Ohio, United States (Not_yet_recruiting)
• Oregon Health and Science University — Portland, Oregon, United States (Not_yet_recruiting)
• Vanderbilt — Nashville, Tennessee, United States (Recruiting)
• Bon Secours Mercy Health - Richmond Market — Richmond, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Wayne Batchelor, MD — Director of Interventional Cardiology Inova Heart and Vascular Institute
• Study coordinator: Chris Rogers, BS

Conditions Aortic Valve Stenosis; Mitral Regurgitation