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

NCT06099665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2118

Last updated 2026-03-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Wayne Batchelor, MD · Director of Interventional Cardiology Inova Heart and Vascular Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-27
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06099665 on ClinicalTrials.gov