Brief Title
Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial
Official Title
Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial
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.
Study Type
Interventional
Primary Outcome
Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS
Secondary Outcome
Impact on mortality rate
Condition
Aortic Stenosis
Intervention
Physician Notification Letter
Study Arms / Comparison Groups
Notification Letter Arm
Description: Providers that will receive an electronic Physician Notification Letter.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
940
Start Date
February 9, 2022
Completion Date
February 15, 2026
Primary Completion Date
February 15, 2025
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, (617)-412-1147, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05230225
Organization ID
2022P000016
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Collaborators
Edwards Lifesciences
Study Sponsor
, ,
Verification Date
April 2022