NCT06099665

Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,118 (actual)
• Sponsor: Tempus AI · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Aortic Valve Stenosis
• Mitral Regurgitation

Interventions

Type	Name	Description
BEHAVIORAL	Automated alert	Receiving an automated alert via the EHR to highlight that the patient in question presents for severe aortic stenosis or severe mitral regurgitation according to the AHA guidelines and that they are a good candidate for valve intervention. The alert will not list any specific manufacturer's device.

Timeline

• Start date: 2024-08-27
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-10-25
• Last updated: 2026-03-06

Locations

6 sites across 1 country: United States