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

A legfontosabb adatok

Ki végzi
Tempus AI
Hol
Columbus, Kansas City, Lima, Nashville, Portland és Richmond (Egyesült Államok)Mind a 6 helyszín megnézése
Azonosító
Állapot
Befejeződött
Résztvevők
2118 fő vett részt
Kezdés
2024. aug. 27.
Befejezés
2025. dec. 1.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
A vizsgált kezelések
  • Automated alert
A regiszteradat frissítve
2026. március 6.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 9 feltétel megnézéseKevesebb

Ki nem vehet részt

  • Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve
  • 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
  • The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon
  • Age < 18 years

Egyéb feltételek

  • At least one of the following three options for aortic stenosis and/or the single option for mitral regurgitation are determined from echocardiogram findings:
  • AVA or DI (Patients with either Aortic valve area (AVA) or Dimensionless Index (DI) measured in their echo as well as at least one hemodynamic measure above the minimum threshold); Either: i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ANY of i. Aortic Mean Gradient ≥ 15 mmHg ii. Aortic Peak Gradient ≥ 30 mmHg iii. Aortic Jet Velocity ≥ 2.75 m/s
  • AVA + OTHER (Patients with AVA and at least 1 other echo measurement in their echo above the threshold); 1.0 cm2 < Aortic Valve Area ≤ 1.2 cm2; AND ANY of:; Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s
  • POSSIBLE (Possible Aortic Stenosis but requires human review) a. Aortic Valve Area is NULL OR >1.2 cm2 b. AND ANY of: i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s OR a. EITHER i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ALL are: i. Aortic Mean Gradient < 15 mmHg ii. Aortic Peak Gradient < 30 mmHg iii. Aortic Peak Velocity < 2.75 m/s; ALERT Study Clinical Investigation Plan Version 2.1 page 12 of 54; Any patient flagged for "POSSIBLE" does not result in automatically alerting the provider, instead a notification is sent to the Tempus research team for manual review in conjunction with the site Principal Investigator (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 provider. 1. Mitral Regurgitation
  • Mention of severe mitral regurgitation or moderate- severe mitral regurgitation; Any patient mentioned with only moderate MR or a lesser severity will be excluded

Helyszínek itt: Egyesült Államok

  • OhioHealthColumbus, Egyesült ÁllamokNo longer taking part
  • Saint Luke's Health SystemKansas City, Egyesült ÁllamokNo longer taking part
  • Bon Secours Mercy Health - Lima MarketLima, Egyesült ÁllamokNo longer taking part
  • VanderbiltNashville, Egyesült ÁllamokNo longer taking part
  • Oregon Health and Science UniversityPortland, Egyesült ÁllamokNo longer taking part
  • Bon Secours Mercy Health - Richmond MarketRichmond, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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).

A vizsgálat 2 csoportja

  • Automated alertA vizsgált kezelés

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

  • ControlNincs vizsgálati kezelés, összehasonlításként

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

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Addressing Under-treatment and Health Equity in Aortic Stenosis and Mitral Regurgitation Using an Integrated EHR Platform
Publikációk
A regiszteradat frissítve
2026. március 6.