Triple Cardiovascular Disease Detection With an Artificial Intelligence-enabled Stethoscope
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ratio of route to diagnosis of heart failure (co-primary) between emergency and community-based pathways
研究概览
简要总结
Heart failure (HF) is a condition in which the heart cannot pump blood adequately. It is increasingly common, consumes 4% of the UK National Health Service (NHS) budget and is deadlier than most cancers. Early diagnosis and treatment of HF improves quality of life and survival. Unacceptably, 80% of patients have their HF diagnosed only when very unwell, requiring an emergency hospital admission, with worse survival and higher treatment costs to the NHS. This is largely because General Practitioners (GPs) have no easy-to-use tools to check for suspected HF, with patients having to rely on a long and rarely completed diagnostic pathway involving blood tests and hospital assessment.
The investigators have previously demonstrated that an artificial intelligence-enabled stethoscope (AI-stethoscope) can detect HF in 15 seconds with 92% accuracy (regardless of age, gender or ethnicity) - even before patients develop symptoms. While the GP uses the stethoscope, it records the heart sounds and electrical activity, and uses inbuilt artificial intelligence to detect HF.
The goal of this clinical trial is to determine the clinical and cost-effectiveness of providing primary care teams with the AI-stethoscope for the detection of heart failure. The main questions it aims to answer are if provision of the AI-stethoscope:
- Increases overall detection of heart failure
- Reduces the proportion of patients being diagnosed with heart failure following an emergency hospital admission
- Reduces healthcare system costs
200 primary care practices across North West London and North Wales, UK, will be recruited to a cluster randomised controlled trial, meaning half of the primary care practices will be randomly assigned to have AI-stethoscopes for use in direct clinical care, and half will not. Researchers will compare clinical and cost outcomes between the groups.
详细描述
Triple Cardiovascular Disease Detection with Artificial Intelligence-enabled Stethoscope (TRICORDER) is an open label, cluster randomised controlled trial. The aim is to determine whether use of an artificial intelligence-enabled stethoscope (AI-stethoscope) in UK Primary Care improves community-based detection of heart failure (HF), compared with usual care. 200 primary care practices in North West London (UK) will be randomised to receive the AI-stethoscope (intervention arm) or continue with usual care (control arm). The intervention arm will use the AI-stethoscope in routine clinical practice. Outcomes will be measured using pooled primary and secondary care clinical and cost-data, as well as clinician questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary care practices that care for adult patients and have the ability to request natriuretic peptide blood testing
- •Primary care practices within the NIHR North West London Clinical Research Network or Betsi Cadwaladr University Health Board.
排除标准
- •Poor WiFi and/or mobile data connectivity within primary care consulting rooms
- •No face-to-face patient consultations
研究组 & 干预措施
Intervention
Receive 3-6 AI-stethoscopes (Eko DUO, Eko Health Inc, CA, USA) including artificial intelligence software for detection of:
- Reduced left ventricular ejection fraction <40%
- Atrial fibrillation
- Cardiac murmurs
干预措施: AI-stethoscope (Device)
Control
Usual care
结局指标
主要结局
Ratio of route to diagnosis of heart failure (co-primary) between emergency and community-based pathways
时间窗: 24 months
Difference in ratio of the incidence of coded diagnoses of HF via hospital admission-based versus community-based pathways.
Incidence of heart failure (co-primary)
时间窗: 24 months
Difference in incidence of coded new diagnoses of heart failure (HF)
次要结局
- Device therapy(24 months)
- Cost-consequence (AF)(24 months)
- Determinants of uptake and utilisation(24 months)
- Incidence of atrial fibrillation(24 months)
- Incidence of valvular heart disease(24 months)
- Cost-consequence (HFrEF)(24 months)
- Proportion of patients prescribed guideline-directed medical therapy(24 months)
- Cost-consequence (VHD)(24 months)
- Patient quality of life(24 months)
- Health service utilisation(24 months)
- Uptake and utilisation(24 months)