Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE) (IMPROVE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Stenosis; Mitral Regurgitation; Valvular Heart Disease Patients; Left Ventricular Diastolic Dysfunction
• Intervention / Treatment: Device: Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)

Detailed Description

Structural heart disease (SHD) - principally degenerative valvular heart disease (VHD) and left ventricular systolic dysfunction (LVSD) - affects an estimated 21.7% of adults aged 65 and older and carries substantial morbidity and mortality, yet detection relies on passive case finding through auscultation and subsequent echocardiography referral. AI-guided point-of-care ultrasound (AI-POCUS) offers a means of systematic screening at the point of routine ambulatory care by operators without formal sonography training.

IMPROVE is a hybrid type 1 effectiveness-implementation, stratified, cluster-randomized trial. The unit of randomization is the provider cluster: each participating primary care or geriatrics physician or advanced practice provider, with their patient panel, constitutes one cluster. Thirty-two clusters are randomized 1:1 to AI-POCUS screening or usual care, stratified by hospital system (UT Southwestern Medical Center and Parkland Health & Hospital System), with approximately 1,088 patients aged 65-85 enrolled over 24 months.

In intervention clusters, trained clinic staff perform protocolized AI-guided POCUS using the Kosmos Torso-One device, together with a 2 mL NT-proBNP blood draw. Images are reviewed by a blinded echocardiographic core laboratory; participants with at least moderate VHD or LVEF 50% or less are referred for confirmatory transthoracic echocardiography, with all subsequent management at the treating provider's discretion. Usual care clusters receive standard care and are monitored for echocardiography referral within 90 days of the index visit. All echocardiograms performed within 90 days in either arm are interpreted in the core lab in a blinded fashion.

The primary outcome (Aim 1) is a new diagnosis of at least moderate VHD or LVSD confirmed by complete echocardiography within 90 days of screening. Secondary outcomes include downstream care processes and major adverse cardiovascular events over 2 years. Aim 2 evaluates implementation determinants and outcomes - adoption, acceptability, appropriateness, and feasibility - using CFIR and Proctor's taxonomy, through structured workflow observations and semi-structured interviews. The primary analysis is intention-to-treat using a generalized linear mixed model with provider-level random effects.

• Study Type: Interventional
• Enrollment (Estimated): 1088
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA; Phone Number: 214-645-7508; Email: dharam.kumbhani@utsouthwestern.edu
• Study Contact Backup: Name: Ritika Dhruve, MBBS, MPH; Email: ritika.dhruve@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
      • Contact: Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA; Phone Number: 214-645-7508; Email: dharam.kumbhani@utsouthwestern.edu
      • Contact: Ritika J Dhruve, MBBS, MPH; Email: ritika.dhruve@utsouthwestern.edu
      • Principal Investigator: Dharam J Kumbhani, MD
    • Dallas, Texas, United States, 75390
      • Parkland Health
      • Contact: Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA; Phone Number: 214-645-7508; Email: dharam.kumbhani@utsouthwestern.edu
      • Contact: Ritika J Dhruve, MBBS, MPH; Email: ritika.dhruve@utsouthwestern.edu
      • Principal Investigator: Dharam J Kumbhani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Provider (cluster) participants:

• 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
• Provides written informed consent

Patient participants:

• Adults aged 65 to 85 years, inclusive
• Attending a scheduled outpatient visit at a participating geriatrics or primary care clinic
• Willing and able to provide written informed consent and, if the AI-POCUS screen is positive, to return for a confirmatory echocardiogram

Exclusion Criteria:

Provider (cluster) participants:

• Serving in a locum tenens or other temporary capacity
• Unwilling or unable to nominate an AI-POCUS champion from the clinic

Patient participants:

• 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
• History of surgical or transcatheter intervention for aortic or mitral valve disease
• Self-reported structural heart disease

• Significant frailty burden or comorbidities limiting life expectancy to

  1 year or less

• Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-POCUS Screening; Trained clinic staff perform AI-guided point-of-care ultrasound using the Kosmos Torso-One device on eligible patients during routine primary care or geriatrics visits. Patients with ≥ moderate valvular heart disease or EF ≤50% are referred for confirmatory echocardiography within 90 days.	Device: Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.); A 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.
No Intervention: Usual Care; Eligible patients receive standard provider-driven care. Echocardiography referral occurs per routine clinical indications such as auscultated murmur or patient-reported symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	90 days from index clinic visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days from index clinic visit
Referrals to cardiology or cardiac surgery	Proportion of participants with a new referral to cardiology or cardiac surgery, ascertained through electronic health record review.	2 years from index clinic visit
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.	2 years from index clinic visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days from index clinic visit
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.	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.	Through study completion, estimated 2 years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 4, 2026
• First Submitted That Met QC Criteria: August 4, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Primary Care; Screening; Older Adults; Artificial Intelligence; Point-of-care ultrasound; Echocardiography; Geriatrics; Implementation Science; Early detection; POCUS; Cluster randomized Trial; AI-guided imaging
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Ventricular Dysfunction; Heart Failure; Aortic Valve Stenosis; Ventricular Dysfunction, Left; Mitral Valve Insufficiency
• Other Study ID Numbers: STU20260660; 95057 (Other Identifier: University of Texas Southwestern Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared at this time. The study involves vulnerable older adult populations across two clinical sites, and data sharing requires additional privacy and governance review. Data sharing may be considered upon study completion pending IRB approval and execution of appropriate data use agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes