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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA
- Telefonnummer: 214-645-7508
- E-post: dharam.kumbhani@utsouthwestern.edu
Studera Kontakt Backup
- Namn: Ritika Dhruve, MBBS, MPH
- E-post: ritika.dhruve@utsouthwestern.edu
Studieorter
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75390
- University of Texas Southwestern Medical Center
-
Kontakt:
- Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA
- Telefonnummer: 214-645-7508
- E-post: dharam.kumbhani@utsouthwestern.edu
-
Kontakt:
- Ritika J Dhruve, MBBS, MPH
- E-post: ritika.dhruve@utsouthwestern.edu
-
Huvudutredare:
- Dharam J Kumbhani, MD
-
Dallas, Texas, Förenta staterna, 75390
- Parkland Health
-
Kontakt:
- Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA
- Telefonnummer: 214-645-7508
- E-post: dharam.kumbhani@utsouthwestern.edu
-
Kontakt:
- Ritika J Dhruve, MBBS, MPH
- E-post: ritika.dhruve@utsouthwestern.edu
-
Huvudutredare:
- Dharam J Kumbhani, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Inget ingripande: Usual Care
Eligible patients receive standard provider-driven care.
Echocardiography referral occurs per routine clinical indications such as auscultated murmur or patient-reported symptoms.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
New diagnosis of structural heart disease (≥ moderate valvular heart disease or left ventricular systolic dysfunction)
Tidsram: 90 days from index clinic visit
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recall Rate
Tidsram: 90 days from index clinic visit
|
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
Tidsram: 2 years from index clinic visit
|
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)
Tidsram: 2 years from index clinic visit
|
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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Downstream Processes of Care
Tidsram: 90 days from index clinic visit
|
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
Tidsram: 6 months post-implementation
|
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
Tidsram: Through study completion, estimated 2 years
|
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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STU20260660
- 95057 (Annan identifierare: University of Texas Southwestern Medical Center)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .