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Addressing Undertreatment and Health Equity in Aortic Stenosis Using an Integrated EHR Platform (ALERT)

Primary Purpose

Aortic Valve Stenosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Automated alert
Sponsored by
Tempus Labs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: an echocardiogram within the time frame that indicates for severe aortic stenosis, as defined by AHA guidelines, satisfying one of the follow: AVA ≤ 1.0 cm2 Dimensionless index ≤ 0.25 Mean Gradient ≥ 40 mmHg Peak Gradient ≥ 64 mmHg Peak Velocity ≥ 4.0 m/s Exclusion Criteria (satisfying one of the follow): Age < 18 years Patient has a non-native aortic valve (bioprosthetic or mechanical) The qualifying echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon Patient already has a scheduled clinic visit with the multidisciplinary heart team, or a recent (within 1 year) clinic visit with the multidisciplinary heart team Patient has a future stress test or cardiac CT scheduled in the next 90 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Automated alert

    Control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Establish impact of automated alerts on the hierarchical composite endpoint of aortic valve repair/replacement (AVR) or follow-up visit with a multi-disciplinary heart team (MHT).
    Determining whether an automated alert improves recognition and management of severe AS through its impact on the utilization of AVR or follow-up visit with MHT, which is defined as the proportion of patients with a clinical indication for severe AS that undergo AVR 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 for patients that do not have a scheduled follow-up with the MHT or an AVR procedure.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 19, 2023
    Last Updated
    October 19, 2023
    Sponsor
    Tempus Labs
    Collaborators
    Medtronic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06099665
    Brief Title
    Addressing Undertreatment and Health Equity in Aortic Stenosis Using an Integrated EHR Platform
    Acronym
    ALERT
    Official Title
    Addressing Undertreatment and Health Equity in Aortic Stenosis Using an Integrated EHR
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tempus Labs
    Collaborators
    Medtronic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This multi-center, prospective, cluster-randomized controlled trial will evaluate Mpirik automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Aortic Valve Replacement (AVR). This study will evaluate the impact of Mpirik automated notifications on: (1) AVR utilization (including time to AVR); and (2) multidisciplinary heart team clinic evaluation (including time to evaluation) for patients with definitive or possible severe AS 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? 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Valve Stenosis

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1058 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Automated alert
    Arm Type
    Experimental
    Arm Description
    Providers that will receive an automated alert sent via the EHR.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Care providers in the control arm will not receive an automated alert.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Automated alert
    Intervention Description
    Receiving an automated alert via the EHR to highlight that the patient in question presents for severe aortic stenosis according to the AHA guidelines and that they are a good candidate for aortic valve repair/replacement. The alert will not list any specific manufacturer's device.
    Primary Outcome Measure Information:
    Title
    Establish impact of automated alerts on the hierarchical composite endpoint of aortic valve repair/replacement (AVR) or follow-up visit with a multi-disciplinary heart team (MHT).
    Description
    Determining whether an automated alert improves recognition and management of severe AS through its impact on the utilization of AVR or follow-up visit with MHT, which is defined as the proportion of patients with a clinical indication for severe AS that undergo AVR 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 for patients that do not have a scheduled follow-up with the MHT or an AVR procedure.
    Time Frame
    90 days from a qualifying echocardiogram indicating severe aortic stenosis

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: an echocardiogram within the time frame that indicates for severe aortic stenosis, as defined by AHA guidelines, satisfying one of the follow: AVA ≤ 1.0 cm2 Dimensionless index ≤ 0.25 Mean Gradient ≥ 40 mmHg Peak Gradient ≥ 64 mmHg Peak Velocity ≥ 4.0 m/s Exclusion Criteria (satisfying one of the follow): Age < 18 years Patient has a non-native aortic valve (bioprosthetic or mechanical) The qualifying echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon Patient already has a scheduled clinic visit with the multidisciplinary heart team, or a recent (within 1 year) clinic visit with the multidisciplinary heart team Patient has a future stress test or cardiac CT scheduled in the next 90 days
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chris Rogers, BS
    Phone
    (414) 220-4384
    Email
    chris.rogers@tempus.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Loren Wagner, PhD
    Phone
    (414) 234-0384
    Email
    loren.wagner@tempus.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wayne Batchelor, MD
    Organizational Affiliation
    Director of Interventional Cardiology Inova Heart and Vascular Institute
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Brian Lindman, MD
    Organizational Affiliation
    Medical Director, Structural Heart and Valve Center Associate Professor of Medicine Vanderbilt University Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sreekanth Vemulapalli, MD
    Organizational Affiliation
    Assistant Professor of Medicine Duke University School of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Antoine Keller, MD
    Organizational Affiliation
    Cardiothoracic Surgeon Ochsner Lafayette General Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Megan Coylewright, MD
    Organizational Affiliation
    Director, Structural Heart Program Erlanger Cardiology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Addressing Undertreatment and Health Equity in Aortic Stenosis Using an Integrated EHR Platform

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