Addressing Undertreatment and Health Equity in Aortic Stenosis Using an Integrated EHR Platform

Aortic Valve Stenosis Clinical Trial

— ALERT  

Official title:

Addressing Undertreatment and Health Equity in Aortic Stenosis Using an Integrated EHR

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06099665
• Other study ID #: TMPS-Cardio-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Tempus AI
• Contact: Chris Rogers, BS
• Phone: (414) 220-4384
• Email: chris.rogers[@]tempus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multi-center, prospective, cluster-randomized controlled trial will evaluate Mpirik automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Aortic Valve Replacement (AVR). This study will evaluate the impact of Mpirik automated notifications on: (1) AVR utilization (including time to AVR); and (2) multidisciplinary heart team clinic evaluation (including time to evaluation) for patients with definitive or possible severe AS 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?

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1058
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: an echocardiogram within the time frame that indicates for severe aortic stenosis, as defined by AHA guidelines, satisfying one of the follow:

• AVA = 1.0 cm2

• Dimensionless index = 0.25

• Mean Gradient = 40 mmHg

• Peak Gradient = 64 mmHg

• Peak Velocity = 4.0 m/s

Exclusion Criteria (satisfying one of the follow):

• Age < 18 years

• Patient has a non-native aortic valve (bioprosthetic or mechanical)

• The qualifying echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon

• Patient already has a scheduled clinic visit with the multidisciplinary heart team, or a recent (within 1 year) clinic visit with the multidisciplinary heart team

• Patient has a future stress test or cardiac CT scheduled in the next 90 days

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Behavioral:
• Automated alert
Receiving an automated alert via the EHR to highlight that the patient in question presents for severe aortic stenosis according to the AHA guidelines and that they are a good candidate for aortic valve repair/replacement. The alert will not list any specific manufacturer's device.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tempus AI	Medtronic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish impact of automated alerts on the hierarchical composite endpoint of aortic valve repair/replacement (AVR) or follow-up visit with a multi-disciplinary heart team (MHT).	Determining whether an automated alert improves recognition and management of severe AS through its impact on the utilization of AVR or follow-up visit with MHT, which is defined as the proportion of patients with a clinical indication for severe AS that undergo AVR or have a follow-up visit with MHT. We will utilize an automated alert to highlight TTE results that are consistent with or may be consistent with severe AS for patients that do not have a scheduled follow-up with the MHT or an AVR procedure.	90 days from a qualifying echocardiogram indicating severe aortic stenosis