The purpose of this research is to look at an approved intervention (Stethophone application) to obtain additional information about improving detection of moderate or severe aortic stenosis when compared with usual standard of care.
This study employs a stepped-wedge cluster randomized design involving four primary care practices affiliated with KMH Cardiology. Each family practice constitutes a single cluster. All participating practices will start as usual standard of care. At three-month intervals, one practice will be randomly selected to crossover from usual standard of care (control group) to the intervention group. There will be a 2-week wash in period when a family practice crosses over from control to intervention. This process will continue until all practices have implemented the intervention, resulting in full intervention by 15 months. Investigators hypothesize that the Sparrow screening pathway will result in a higher proportion of patients with a positive echo for moderate or severe aortic stenosis than usual care without protocol driven screening.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
1,000
The device is a FDA \& HC approved mobile application, the Stethophone (developed by Sparrow BioAcoustics), that transforms a smartphone into a digital stethoscope and analytic tool able to identify murmurs that may indicate aortic stenosis.
Number of new diagnosis of moderate or severe aortic stenosis on transthoracic echo/1000 patients screened of patients over 70 years
Determine whether Sparrow app based screening increases the number of patients with a new diagnosis of moderate or severe aortic stenosis confirmed by transthoracic echo within 3 months
Time frame: Within 3 months after enrolment.
Proportion of eligible participants screened during intervention periods
Proportion of eligible participants screened during intervention periods
Time frame: From enrollment until Day 1
Distribution of algorithm outputs
Distribution of algorithm outputs as normal, suggestive of aortic stenosis, other murmur detected, or inconclusive
Time frame: From enrollment until Day 1
Proportion completing transthoracic echocardiography after an abnormal or inconclusive result
Proportion of participants completing transthoracic echocardiography after an abnormal or inconclusive result
Time frame: Enrollment to 3 months
Average time from abnormal screen to echocardiography
Average time from abnormal screen to echocardiography
Time frame: Enrollment to transthoracic echocardiography, assessed up to 3 months
Average time from confirmed diagnosis to referral to valve clinic, where applicable
Average time from confirmed diagnosis to referral to valve clinic, where applicable
Time frame: ECHO confirmation to valve clinic referral, an average of 3 months
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Diagnostic yield of transthoracic echocardiography
1. proportion of completed TTE studies demonstrating moderate or severe aortic stenosis or other clinically significant structural heart disease among all abnormal screening result; 2. proportion of moderate/severe aortic stenosis with referral to the valve clinic
Time frame: enrollment to ECHO confirmation or valve clinic referral whichever comes last, an average of 3 months