Targeted heart failure screening pathway using artificial intelligence in UK primary care: design of a cluster randomised controlled implementation study
S Nakhare, C F Petri, R Velmurugan, H Young, J Zaman, K Chhatwal, A Schmidt, T Aslan, J Boorer, D B Kramer, C M Plymen, N S Peters, P Bachtiger, M A KelshikerAbstract
Background
Heart failure is a progressive condition with poor prognosis that is frequently diagnosed late in the UK, often following emergency hospital admission despite the availability of effective guideline-directed medical therapies, reflecting the challenges of early identification in primary care. Population-wide screening for HF has not been implemented in the UK, reflecting both the historical absence of inexpensive and specific screening tests and the stringent evidentiary framework applied by the UK National Screening Committee. Recent policy developments have expanded the remit to consider targeted screening in higher-risk populations; however, evidence of implementing targeted HF screening pathways within routine primary care, particularly when augmented by artificial intelligence (AI)–enabled tools, remains limited.
Purpose
To describe the design of TRICORDER-PLUS, a pragmatic cluster randomised controlled implementation trial evaluating an artificial intelligence–enabled targeted heart failure screening pathway in UK primary care.
Methods
TRICORDER-PLUS is a pragmatic, open-label, cluster randomised controlled implementation trial conducted across approximately 40 general practices (GP) in England and Wales. GP practices are the unit of randomisation. Primary care clinicians apply an electronic health record–based risk stratification algorithm to identify patients at risk of undiagnosed HF. In the intervention arm, patients identified as being at risk for undiagnosed HF are invited to attend a structured screening appointment within routine care, including examination with an AI-enabled stethoscope, NT-proBNP testing, and a symptom questionnaire. Downstream investigation and management follow existing clinical pathways. Control practices continue usual care without deployment of the targeted screening pathway.
Results
The primary outcome is all-cause mortality at 12 months following an index heart failure diagnosis, ascertained through linkage to routinely collected health records. Secondary outcomes include incidence of heart failure, major adverse cardiovascular events, all-cause mortality among patients at risk of heart failure, prescription of guideline-directed medical therapies, health-related quality of life, healthcare utilisation and costs, and uptake of screening invitations.
Conclusion
TRICORDER-PLUS is a cluster randomised controlled implementation trial evaluating delivery of an AI-enabled targeted heart failure screening pathway within routine UK primary care, designed to inform future policy decisions regarding targeted heart failure screening in the UK.TRICORDER-PLUS Study Flow DiagramTRICORDER-PLUS Screening Pathway