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

Aortic Stenosis Clinical Trial

— DETECT AS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230225
• Other study ID #: 2022P000016
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: February 15, 2026

Study information

• Verified date: April 2022
• Source: Massachusetts General Hospital
• Contact: Roukoz Abou Karam
• Phone: (617)-412-1147
• Email: raboukaram[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 940
• Est. completion date: February 15, 2026
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact on mortality rate	Establishing the mortality rate among patients with severe AS followed until one year after symptom onset. Using data analysis we will investigate the impact of physician notification letters on recognition and management of AS based on it's effect on mortality rate.	1 year
Secondary	Impact on rate of heart failure hospitalization	Determining the rate of heart failure hospitalizations among patients with severe AS followed until one year after symptom onset. Using data analysis we will investigate the impact of physician notification letters on recognition and management of AS based on it's effect on likelihood of heart failure hospitalization.	1 year
Secondary	Impact on rate of trans-thoracic echocardiogram utilization and frequency of surveillance	Identifying all trans-thoracic echocardiograms ordered by physicians for patients with severe AS until one year after symptom onset in order to Investigate the impact of physician notification letters on the number of follow up echocardiograms ordered and the frequency of surveillance.	1 year
Secondary	Impact on proportion of patients referred to Cardiology/Heart Valve Team	Determining when patients with severe AS get referred to a Cardiology/Heart valve team. Providers receive physician notification letters detailing ACC/AHA Clinical Practice Guideline Recommendations that suggest patients with severe valvular heart disease should be evaluated by a Multidisciplinary Heart Valve Team when intervention is considered. Using data analysis we will investigate the impact of physician notification letters on rate of referral and time to referral to a Cardiology/Heart Valve Team.	1 year