Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
At least one of the following three options for aortic stenosis and/or the single option for mitral regurgitation are determined from echocardiogram findings: 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 Any patient flagged for "POSSIBLE" does not result in automatically alerting the clinician, instead a notification is sent to the Tempus research team for manual review in conjunction with the site PI and if requested by Tempus or site PI, a Steering Committee member. If clinical confirmation is received for severe aortic stenosis from the site PI, an alert is sent to the clinician. 1. Mitral Regurgitation a. Mention of severe mitral regurgitation or moderate-severe mitral regurgitation Any patient mentioned with only moderate MR or a lesser severity will be excluded.
Exclusion Criteria
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Automated alert |
Providers that will receive an automated alert sent via the EHR. |
|
No Intervention Control |
Care providers in the control arm will not receive an automated alert. |
|
Recruiting Locations
Nashville, Tennessee 37235
Brian Lindman, M.D.
More Details
- Status
- Recruiting
- Sponsor
- Tempus AI