Aortic Stenosis
Conditions
Keywords
Aortic Valve Stenosis, Aortic Valve Disease, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Aortic Valve Replacement
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.
Interventions
BEHAVIORALPhysician 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.
Sponsors
Edwards Lifesciences
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS | 1 year | 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
| Measure | Time frame | Description |
|---|---|---|
| Impact on mortality rate | 1 year | 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 | 1 year | 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 | 1 year | 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 | 1 year | 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. |
Countries
United States
Contacts
Primary ContactRoukoz Abou Karam
Backup ContactParis Jamiel
Outcome results
None listed