Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
NCT ID: NCT06099665
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2626 participants
INTERVENTIONAL
2024-08-27
2025-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Automated alert
Providers that will receive an automated alert sent via the EHR.
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.
Control
Care providers in the control arm will not receive an automated alert.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Exclusion Criteria
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 (since the start of the study at that site ) clinic visit with the MHT, or a scheduled transcatheter or surgical VI in the future.
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Tempus AI
INDUSTRY
Responsible Party
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Principal Investigators
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Wayne Batchelor, MD
Role: PRINCIPAL_INVESTIGATOR
Director of Interventional Cardiology Inova Heart and Vascular Institute
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Adnan Chhatriwalla, M.D.
Role: primary
Kevin Stiver, M.D.
Role: primary
Sunny Patel, M.D.
Role: primary
Firas Zahr, M.D.
Role: primary
Brian Lindman, M.D.
Role: primary
Brody Wehman, M.D.
Role: primary
Other Identifiers
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TMPS-Cardio-01
Identifier Type: -
Identifier Source: org_study_id
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