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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Behavioral: Automated alert

• Study Type: Interventional
• Enrollment (Estimated): 1058
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chris Rogers, BS; Phone Number: (414) 220-4384; Email: chris.rogers@tempus.com
• Study Contact Backup: Name: Loren Wagner, PhD; Phone Number: (414) 234-0384; Email: loren.wagner@tempus.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated alert; Providers that will receive an automated alert sent via the EHR.	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.
No Intervention: Control; Care providers in the control arm will not receive an automated alert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tempus AI
• Collaborators: Medtronic
• Investigators: Principal Investigator: Wayne Batchelor, MD, Director of Interventional Cardiology Inova Heart and Vascular Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: TMPS-Cardio-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No