Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop. Detection currently depends on a clinician hearing a murmur and then ordering an echocardiogram, which is easily missed or delayed.
This study tests whether a brief, artificial intelligence (AI)-guided handheld heart ultrasound - point-of-care ultrasound, or POCUS - performed by trained clinic staff during a routine visit identifies these conditions earlier than usual care.
Primary care and geriatrics providers, rather than individual patients, are assigned by chance to one of two groups. Patients seen by providers in the AI-ultrasound group are offered a POCUS scan and a one-time blood test at their regular visit, and are referred for a confirmatory echocardiogram if the scan is abnormal. Patients seen by providers in the usual care group receive standard clinic care. Researchers will compare how often previously undiagnosed structural heart disease is newly identified in each group.
Physician or advanced practice provider (physician assistant or nurse practitioner) practicing in primary care or geriatrics at a participating institution who independently assesses patients
Patient panel comprising >50% adults aged 65 years or older
Sees patients in ambulatory clinic at least 1 day per week on average
Agrees to participate, to undergo randomization, and to permit inclusion of all eligible patients from the panel
Serving in a locum tenens or other temporary capacity
Unwilling or unable to nominate an AI-POCUS champion from the clinic
Echocardiogram performed within the past 5 years
At least moderate aortic or mitral valve disease, or left ventricular ejection fraction 50% or less, documented on any prior echocardiogram
Parallel
Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)
DeviceA single AI-guided handheld POCUS examination performed by trained clinic staff (medical or certified nursing assistants) during a routine primary care or geriatrics visit. Acquisition is standardized, including parasternal long- and short-axis and apical 3- and 4-chamber views, with 2D imaging, color Doppler, M-mode of the mitral valve, and continuous-wave Doppler of the aortic and mitral valves. Images are transmitted to a central echocardiographic core laboratory, which screens for adequacy; adequate studies are analyzed by pre-specified AI algorithms based on 2017 ASE guidelines, blinded to arm assignment. A positive screen is defined as moderate or greater valvular heart disease or left ventricular ejection fraction of 50% or less. Positive results are communicated to the participant's primary care provider with a recommendation to consider confirmatory TTE; ordering remains at provider discretion, and the study team facilitates completion within 90 days of index visit.
New diagnosis of structural heart disease (≥ moderate valvular heart disease or left ventricular systolic dysfunction)
New diagnosis of ≥ moderate aortic or mitral valvular heart disease or left ventricular systolic dysfunction (ejection fraction ≤50%), confirmed by standard transthoracic echocardiography performed within 90 days of the index clinic visit. Assessed using the disease detection rate (true positives/total number of patients in the study).
Recall Rate
Proportion of AI-POCUS screening studies requiring further workup, defined as total number of positive screens (true + false positives) divided by total number of patients in the study.
Referrals to cardiology or cardiac surgery
Proportion of participants with a new referral to cardiology or cardiac surgery, ascertained through electronic health record review.
Major adverse cardiac events (MACE)
Composite of all-cause mortality, stroke, and cardiovascular hospitalization. Deaths ascertained through EHR review and annual National Death Index query. Stroke and cardiovascular hospitalization ascertained through participant self-report at follow-up, EHR review, and primary discharge diagnoses (ICD-10-CM), with additional confirmation from regional hospital claims data.
Downstream Processes of Care
Composite of additional cardiac testing (transthoracic or transesophageal echocardiography, cardiac catheterization, cardiac CT, cardiac MRI), medication initiation, and valve procedures (surgical or transcatheter aortic or mitral valve repair or replacement), ascertained via EHR review using CPT codes.
AI-POCUS Adoption
Rate of AI-POCUS use among providers randomized to the intervention arm, assessed through structured clinic observations at baseline, 3 months, and 6 months post-implementation.
Acceptability and Feasibility of AI-POCUS
Assessed through semi-structured interviews with providers, clinic staff, and patients in the intervention arm, guided by the Consolidated Framework for Implementation Research (CFIR) and Proctor's taxonomy of implementation outcomes.
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