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

Description

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

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Aortic Valve Stenosis
Intervention / Treatment

-

Contacts and Locations

Kansas City

Saint Luke's Health System, Kansas City, Missouri, United States, 64111

Columbus

OhioHealth, Columbus, Ohio, United States, 43202

Lima

Bon Secours Mercy Health - Lima Market, Lima, Ohio, United States, 45801

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Nashville

Vanderbilt, Nashville, Tennessee, United States, 37235

Richmond

Bon Secours Mercy Health - Richmond Market, Richmond, Virginia, United States, 23223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. AVA or DVI (Patients with either AVA or DVI measured in their echo)
  • 1. AVA ≤ 1.0 cm2
  • 2. OR Dimensionless index ≤ 0.25
  • 2. AVA + OTHER (Patients with AVA and at least 1 other echo measurement in their echo)
  • 1. AVA ≤ 1.2 cm2 AND
  • 2. Mean Gradient ≥ 40 mmHg OR
  • 3. Peak Gradient ≥ 64 mmHg OR
  • 4. Peak Velocity ≥ 4.0 m/s
  • 3. POSSIBLE (Possible Aortic Stenosis but AVA is not measured)
  • 1. AVA is missing AND
  • 2. Mean Gradient ≥ 40 mmHg OR
  • 3. Peak Gradient ≥ 64 mmHg OR
  • 4. Peak Velocity ≥ 4.0 m/s
  • 1. Mitral Regurgitation
  • 1. Age \< 18 years
  • 2. Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve
  • 3. The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon
  • 4. Patient already has a scheduled clinic visit with a member of the MHT or a recent (within 1 year) clinic visit with the MHT, or a scheduled transcatheter or surgical procedure in the future.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tempus AI,

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

Study Record Dates

2025-12