Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,088
- 试验地点
- 2
- 主要终点
- New diagnosis of structural heart disease (≥ moderate valvular heart disease or left ventricular systolic dysfunction)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants, treating providers, and investigators are aware of cluster assignment. All AI-POCUS images and all transthoracic echocardiograms performed within 90 days of the index visit in either arm are interpreted by an independent echocardiographic core laboratory blinded to arm assignment and to participant clinical information.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.) (Device)
Usual Care
Eligible patients receive standard provider-driven care. Echocardiography referral occurs per routine clinical indications such as auscultated murmur or patient-reported symptoms.
结局指标
主要结局
New diagnosis of structural heart disease (≥ moderate valvular heart disease or left ventricular systolic dysfunction)
时间窗: 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).
次要结局
- Recall Rate(90 days from index clinic visit)
- Referrals to cardiology or cardiac surgery(2 years from index clinic visit)
- Major adverse cardiac events (MACE)(2 years from index clinic visit)
研究者
Dharam Kumbhani
Professor of Medicine
University of Texas Southwestern Medical Center