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

NCT05230225 | Recruiting

• 1 other identifier: 2022P000016
• Study Type: interventional
• Target: 940
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS

  Determining whether an electronic physician notification letter improves recognition and management of severe AS through its impact on the utilization of aortic valve replacement, which is defined as the proportion of patients with a clinical indication for severe AS that undergo AVR. We will utilize electronic notification letter to highlight TTE results that are consistent with or may be consistent with severe AS and providers will also be reminded of ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS.

  1 year

Secondary Outcomes (4)

• Impact on mortality rate

  1 year

• Impact on rate of heart failure hospitalization

  1 year

• Impact on rate of trans-thoracic echocardiogram utilization and frequency of surveillance

  1 year

• Impact on proportion of patients referred to Cardiology/Heart Valve Team

  1 year

Study Arms (2)

Notification Letter Arm

EXPERIMENTAL

Providers that will receive an electronic Physician Notification Letter.

Behavioral: Physician Notification Letter

Control Group

NO INTERVENTION

Providers that will not be contacted.

Interventions

Physician Notification Letter 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.

Notification Letter Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects with bioprosthetic or mechanical valves in the aortic position

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Edwards Lifesciences: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 40159132 DERIVED

• 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.

  PMID: 38950668 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Ventricular Outflow Obstruction

Central Study Contacts

Roukoz Abou Karam

CONTACT

(617)-412-1147; raboukaram@mgh.harvard.edu

Paris Jamiel

CONTACT

(617)-726-0996; pjamiel@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 8, 2022
• Study Start: February 9, 2022
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2026
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)