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

Primary Purpose

Aortic Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician Notification Letter
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Aortic Valve Stenosis, Aortic Valve Disease, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Aortic Valve Replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Notification Letter Arm

Control Group

Arm Description

Providers that will receive an electronic Physician Notification Letter.

Providers that will not be contacted.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 13, 2022
Last Updated
April 4, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT05230225
Brief Title
Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial
Acronym
DETECT AS
Official Title
Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
February 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
Aortic Valve Stenosis, Aortic Valve Disease, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Aortic Valve Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
940 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Notification Letter Arm
Arm Type
Experimental
Arm Description
Providers that will receive an electronic Physician Notification Letter.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Providers that will not be contacted.
Intervention Type
Behavioral
Intervention Name(s)
Physician Notification Letter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Impact on mortality rate
Description
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.
Time Frame
1 year
Title
Impact on rate of heart failure hospitalization
Description
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.
Time Frame
1 year
Title
Impact on rate of trans-thoracic echocardiogram utilization and frequency of surveillance
Description
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.
Time Frame
1 year
Title
Impact on proportion of patients referred to Cardiology/Heart Valve Team
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roukoz Abou Karam
Phone
(617)-412-1147
Email
raboukaram@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Paris Jamiel
Phone
(617)-726-0996
Email
pjamiel@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
SELMARIAH@mgh.harvard.edu
Email
VTANGUTURI@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Sammy Elmariah, MD, MPH
First Name & Middle Initial & Last Name & Degree
Varsha Tanguturi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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