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

NCT ID: NCT05230225

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 940 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-09
• Study Completion Date: 2026-02-15

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Notification Letter Arm

Providers that will receive an electronic Physician Notification Letter.

Group Type: EXPERIMENTAL

Physician Notification Letter

Intervention Type: BEHAVIORAL

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.

Control Group

Providers that will not be contacted.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sammy Elmariah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roukoz Abou Karam

Role: CONTACT

raboukaram@mgh.harvard.edu

(617)-412-1147

Paris Jamiel

Role: CONTACT

pjamiel@mgh.harvard.edu

(617)-726-0996

Facility Contacts

Role: primary

SELMARIAH@mgh.harvard.edu

Role: backup

VTANGUTURI@PARTNERS.ORG

References

Tanguturi VK, Abou-Karam R, Cheng F, Duan R, Inglessis-Azuaje I, Langer NB, Yucel EN, Passeri JJ, Hung JW, Elmariah S. Electronic Provider Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: A Randomized Clinical Trial. Circulation. 2025 May 27;151(21):1498-1507. doi: 10.1161/CIRCULATIONAHA.125.074470. Epub 2025 Mar 30.

Reference Type: DERIVED

PMID: 40159132 (View on PubMed)

Abou-Karam R, Tanguturi V, Cheng F, Elmariah S. Electronic physician notification to facilitate the recognition and management of severe aortic stenosis: Rationale, design, and methods of the randomized controlled DETECT AS trial. Am Heart J. 2024 Oct;276:39-48. doi: 10.1016/j.ahj.2024.06.009. Epub 2024 Jun 29.

Reference Type: DERIVED

PMID: 38950668 (View on PubMed)

Other Identifiers

2022P000016

Identifier Type: -

Identifier Source: org_study_id