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

Not Applicable

Recruiting

• Conditions: Aortic Valve Stenosis; Mitral Regurgitation
• Interventions: Behavioral: Automated alert

• Registration Number: NCT06099665
• Lead Sponsor: Tempus AI

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Study Start: 2024-08-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2626

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated alert	Automated alert	Providers that will receive an automated alert sent via the EHR.

Primary Outcome Measures

Name	Time	Method
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).	90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation	Determining whether an automated alert improves recognition and management of severe AS and severe MR through its impact on the utilization of VI or follow-up visit with MHT, which is defined as the proportion of patients with a clinical indication for severe AS or severe MR that undergo VI 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 and severe MR for patients that do not have a scheduled follow-up with the MHT or an AVR procedure.

Trial Locations

Locations (6)

Saint Luke's Health System; 🇺🇸 Kansas City, Missouri, United States

OhioHealth; 🇺🇸 Columbus, Ohio, United States

Bon Secours Mercy Health - Lima Market; 🇺🇸 Lima, Ohio, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Vanderbilt; 🇺🇸 Nashville, Tennessee, United States

Bon Secours Mercy Health - Richmond Market; 🇺🇸 Richmond, Virginia, United States