Evaluating the Effectiveness and Implementation of Point-of-Care NT-proBNP Testing in Acute Care for Patients With Newly Suspected Heart Failure: A Hybrid Effectiveness-Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Time to New Heart Failure Diagnosis
研究概览
简要总结
Heart failure is a serious condition that can be difficult to diagnose quickly when patients present to hospital with symptoms such as breathlessness. Delays in diagnosis may delay treatment and adversely affect patient outcomes. N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a blood biomarker recommended in national and international guidelines to support the diagnosis of heart failure. Conventional laboratory testing can take several hours before results are available.
This study will evaluate the use of point-of-care NT-proBNP testing, which provides results at the bedside within approximately 12 minutes, in patients presenting to hospital with suspected new heart failure. The study will compare time to heart failure diagnosis, time to treatment initiation, length of hospital stay, 30-day hospital readmission, and 30-day mortality between patients receiving point-of-care NT-proBNP testing and a retrospective comparison cohort managed before its introduction.
In addition, healthcare professionals involved in delivering the service will complete a questionnaire to evaluate the acceptability and feasibility of implementing point-of-care NT-proBNP testing within routine clinical practice. The findings will help determine the clinical and operational impact of point-of-care NT-proBNP testing and inform future service development and research in heart failure care.
详细描述
Heart failure (HF) is a serious condition in which the heart is unable to pump blood effectively around the body. It affects millions of people worldwide and is a common cause of hospital admission. Symptoms of HF, such as breathlessness, tiredness and swelling, can be difficult to distinguish from other medical conditions, which may lead to delays in diagnosis and treatment. Earlier diagnosis and treatment are associated with improved patient outcomes and may reduce the need for prolonged hospitalisation.
National and international clinical guidelines recommend measuring levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP), a hormone released by the heart when it is under strain, to help diagnose or exclude HF. Currently, NT-proBNP samples are typically sent to a laboratory for analysis. Although accurate, laboratory testing may take several hours before results are available, potentially delaying clinical decision-making.
Point-of-care testing (POCT) is an alternative method that enables NT-proBNP levels to be measured at the patient's bedside. Results are available within approximately 12 minutes, allowing clinicians to use the information much earlier during assessment and treatment planning. While POCT has the potential to improve the speed of care, there is limited evidence regarding its impact on clinical outcomes in patients presenting to hospital with suspected new HF.
This study will evaluate whether introducing POCT NT-proBNP testing improves the timeliness of HF diagnosis and treatment compared with usual care. The study will also explore the impact of POCT NT-proBNP testing on hospital outcomes and evaluate healthcare professionals' experiences of implementing the test in routine clinical practice.
The study will be conducted in three phases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Aged 18 years or older
- •Presenting with new suspected heart failure
- •Presenting with unexplained breathlessness suggestive of heart failure
- •Able to provide written informed consent
- •Has capacity to consent to study participation
排除标准
- •Previous or existing clinical diagnosis of heart failure
- •Aged less than 18 years
- •Lacks capacity to provide informed consent
- •Acute myocardial infarction at presentation
研究组 & 干预措施
Phase 1: POCT NT-proBNP
Patients who are assessed within unscheduled care who are suspected to have signs and symptoms of heart failure, will be tested at the point of care with LumiraDx device (CE Mark certification June 2022). Data will be collected on the outcome of the test, together with key demographic and clinical history data. In this study POC NT-proBNP level is the independent variable (the control variable) and the primary dependent variables (outcome variables) are time to new HF diagnosis and treatment initiation.
干预措施: NT-proBNP testing (Diagnostic Test)
结局指标
主要结局
Time to New Heart Failure Diagnosis
时间窗: From hospital presentation until confirmed heart failure diagnosis by echocardiography, assessed up to hospital discharge (maximum 90 days).
Time (hours) from hospital presentation to confirmed heart failure diagnosis.
Time to Heart Failure Treatment Initiation.
时间窗: From hospital presentation until initiation of heart failure treatment, assessed up to hospital discharge (maximum 90 days).
Time (hours) from hospital presentation to initiation of heart failure therapy.
次要结局
- Length of Hospital Stay(Through hospital discharge, up to 90 days.)
- 30-Day Hospital Readmission.(Within 30 days following hospital discharge.)
- 30-Day Mortality(Within 30 days following hospital presentation.)