Recruiting

Detection System

Sponsor:

Massachusetts General Hospital

Code:

NCT05230225

Conditions

Aortic Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physician Notification Letter

Study Details

Brief summary:

The DETECT AS Trial is a randomized clinical trial and quality improvement initiative that seeks to investigate the impact of electronic provider notification of severe aortic stenosis (AS) on its management, on the utilization of aortic valve replacement (AVR), and on ethnic and racial disparities in AVR utilization.

After the investigators identify patients in whom echocardiography shows severe aortic stenosis, defined by an aortic valve area (AVA) <1.0cm2, the ordering provider of the echocardiogram will then be randomly assigned to either the intervention group or to the control group. Providers randomly assigned to the intervention group will be sent an electronic (email or message via the electronic health record) physician notification for every one of their patients with severe aortic stenosis on TTE. Electronic notification will also highlight relevant ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS. No intervention will be performed for patients belonging to physicians assigned to the control group.

The primary endpoint will be AVR utilization, defined as the proportion of patients with a clinical indication for severe AS that undergo AVR. Clinical indications will be based upon the 2020 AHA/ACC Clinical Practice Guidelines for Valvular Heart Disease.

Secondary end-points will be mortality, heart failure hospitalization, TTE utilization/surveillance, AS billing code diagnosis, and cardiology/Heart Valve Team referral. Pre-defined subgroup analyses will be performed to assess AVR utilization among women, racial/ethnic minority groups, low-gradient AS, cardiologist and non-cardiologist ordering provider, and inpatient and outpatient practice settings.

Conditions

Aortic Stenosis

Study ID

NCT05230225

Start date

Feb 9, 2022

Status verified date

Apr, 2022

Completion date

Feb 15, 2026

Anticipated

Primary completion date

Feb 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects with severe aortic stenosis having an aortic valve area of less than or equal to 1.0cm2.

Exclusion Criteria:

  • Subjects with bioprosthetic or mechanical valves in the aortic position

Study Design

Enrollment

940 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Notification Letter Arm

Providers that will receive an electronic Physician Notification Letter.

no intervention: Control Group

Providers that will not be contacted.

Interventions

Physician Notification Letter

Receiving the electronic Physician Notification Letter to highlight echocardiography results that are consistent with or may be consistent with severe AS and to be reminded of ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS.

Primary outcome measure

  • Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Sammy Elmariah, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 11, 2022

Last verified

Apr, 2022

Keywords

  • Aortic Valve Stenosis
  • Aortic Valve Disease
  • Heart Valve Diseases
  • Heart Diseases
  • Cardiovascular Diseases
  • Aortic Valve Replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2022-04-11.