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

NCT06099665 | Completed DMC

• 1 other identifier: TMPS-Cardio-01
• Study Type: interventional
• Target: 2,118
• Locations: 1 country
• Sites: 6

Brief 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

Mitral Regurgitation; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation

Study Arms (2)

Automated alert

EXPERIMENTAL

Providers that will receive an automated alert sent via the EHR.

Behavioral: Automated alert

Control

NO INTERVENTION

Care providers in the control arm will not receive an automated alert.

Interventions

Automated alert BEHAVIORAL

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.

Automated alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Tempus AI: lead
• Medtronic: collaborator

Study Sites (6)

Saint Luke's Health System

Kansas City, Missouri, 64111, United States

Location

OhioHealth

Columbus, Ohio, 43202, United States

Location

Bon Secours Mercy Health - Lima Market

Lima, Ohio, 45801, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt

Nashville, Tennessee, 37235, United States

Location

Bon Secours Mercy Health - Richmond Market

Richmond, Virginia, 23223, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Wayne Batchelor, MD

  Director of Interventional Cardiology Inova Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: August 27, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)