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

Completed · Not applicable

Conditions studied: Aortic Valve Stenosis, Mitral Regurgitation

In brief

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).

Key facts

Study ID

NCT06099665

Run by

Tempus AI

People needed

2118

Starts

2024-08-27

Expected to finish

2025-12-01

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Age < 18 years
• Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve
• The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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