RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-08-27
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06099665

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. AVA or DVI (Patients with either AVA or DVI measured in their echo)
  2. 1. AVA ≤ 1.0 cm2
  3. 2. OR Dimensionless index ≤ 0.25
  4. 2. AVA + OTHER (Patients with AVA and at least 1 other echo measurement in their echo)
  5. 1. AVA ≤ 1.2 cm2 AND
  6. 2. Mean Gradient ≥ 40 mmHg OR
  7. 3. Peak Gradient ≥ 64 mmHg OR
  8. 4. Peak Velocity ≥ 4.0 m/s
  9. 3. POSSIBLE (Possible Aortic Stenosis but AVA is not measured)
  10. 1. AVA is missing AND
  11. 2. Mean Gradient ≥ 40 mmHg OR
  12. 3. Peak Gradient ≥ 64 mmHg OR
  13. 4. Peak Velocity ≥ 4.0 m/s
  14. 1. Mitral Regurgitation
  1. 1. Age \< 18 years
  2. 2. Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve
  3. 3. The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon
  4. 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.

Contacts and Locations

Study Contact

Chris Rogers, BS
CONTACT
(414) 220-4384
chris.rogers@tempus.com
Loren Wagner, PhD
CONTACT
(414) 234-0384
loren.wagner@tempus.com

Principal Investigator

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

Study Locations (Sites)

Saint Luke's Health System
Kansas City, Missouri, 64111
United States
OhioHealth
Columbus, Ohio, 43202
United States
Bon Secours Mercy Health - Lima Market
Lima, Ohio, 45801
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Vanderbilt
Nashville, Tennessee, 37235
United States
Bon Secours Mercy Health - Richmond Market
Richmond, Virginia, 23223
United States

Collaborators and Investigators

Sponsor: Tempus AI

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-27
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-08-27
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Aortic Valve Stenosis
  • Mitral Regurgitation