ALERT: Addressing Undertreatment and Health Equity in Aortic Stenosis Using an Integrated EHR Platform
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Automated alert Providers that will receive an automated alert sent via the EHR. |
Behavioral: Automated alert
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.
|
| No Intervention: Control Care providers in the control arm will not receive an automated alert. |
Outcome Measures
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). [90 days from a qualifying echocardiogram indicating severe aortic stenosis]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tempus Labs
- Medtronic
Investigators
- Principal Investigator: Wayne Batchelor, MD, Director of Interventional Cardiology Inova Heart and Vascular Institute
- Principal Investigator: Brian Lindman, MD, Medical Director, Structural Heart and Valve Center Associate Professor of Medicine Vanderbilt University Medical Center
- Principal Investigator: Sreekanth Vemulapalli, MD, Assistant Professor of Medicine Duke University School of Medicine
- Principal Investigator: Antoine Keller, MD, Cardiothoracic Surgeon Ochsner Lafayette General Hospital
- Principal Investigator: Megan Coylewright, MD, Director, Structural Heart Program Erlanger Cardiology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TMPS-Cardio-01