Clinical trial NCT06099665: Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
Official title: Addressing Under-treatment and Health Equity in Aortic Stenosis and Mitral Regurgitation Using an Integrated EHR Platform
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Mitral Regurgitation
Lead sponsor: Tempus AI
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2023-10-25
Enrollment: 2626
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve Intervention (VI). This study will evaluate the impact of Tempus Next's automated notifications on: (1) Transcatheter or surgical procedure for AS or MR; and (2) Clinic visit with at least one member of the Multidisciplinary Heart Team (including time to evaluation) for patients with definitive or possible severe AS or MR on echocardiogram. These endpoints will also be examined within and between assigned groups according to race, ethnicity, sex, and geography.

The primary question that will be answered:

Do automated alerts sent to clinical providers decrease under-treatment of severe aortic stenosis and severe mitral regurgitation?

The study will compare the rate of clinical follow-up and aortic valve surgery in a control group (no alerts sent) to a treatment group (alerts sent to an appropriate care provider).


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.

Primary outcomes:
measure: Establish impact of automated alerts on the hierarchical composite endpoint of valve intervention (VI) or follow-up visit with a multi-disciplinary heart team (MHT).
timeFrame: 90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Health System
state: Missouri
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
city: Lima
country: United States
facility: Bon Secours Mercy Health - Lima Market
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
city: Richmond
country: United States
facility: Bon Secours Mercy Health - Richmond Market
state: Virginia
Study officials:
affiliation: Director of Interventional Cardiology Inova Heart and Vascular Institute
name: Wayne Batchelor, MD
role: PRINCIPAL_INVESTIGATOR
References: