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

12 août 2026 mis à jour par: Dharam Kumbhani, University of Texas Southwestern Medical Center

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

1088

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Dépistage
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
New diagnosis of structural heart disease (≥ moderate valvular heart disease or left ventricular systolic dysfunction)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Recall Rate
Délai: 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
Délai: 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)
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Downstream Processes of Care
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Texas Southwestern Medical Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 juin 2028

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

4 août 2026

Première soumission répondant aux critères de contrôle qualité

4 août 2026

Première publication (Réel)

10 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STU20260660
  • 95057 (Autre identifiant: University of Texas Southwestern Medical Center)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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