Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Roukoz Abou Karam
raboukaram@mgh.harvard.edu
(617)-412-1147
Backup
Paris Jamiel
pjamiel@mgh.harvard.edu
(617)-726-0996
Time Frame
Start Date: 2022-02-09
Estimated Completion Date: 2026-02-15
Participants
Target number of participants: 940
Treatments
Experimental: Notification Letter Arm
Providers that will receive an electronic Physician Notification Letter.
No_intervention: Control Group
Providers that will not be contacted.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Edwards Lifesciences

This content was sourced from clinicaltrials.gov