Frailty Response in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation (FRAIL-AS Response Trial): Study Protocol for a Cluster Randomised Controlled Trial

BACKGROUND & AIM: Aortic stenosis (AS) is a common valvular heart disease in older adults, affecting up to one in eight people over 65 years. Transcatheter aortic valve implantation (TAVI) offers a less invasive alternative surgical aortic valve replacement. However, approximately 30% of TAVI patients are frail, placing them at greater risk of complications and poorer outcomes post procedure. Despite this, evidence-based strategies to manage frailty in TAVI care remain limited. The FRAIL-AS Response Trial aims to implement and evaluate an evidence-based Frailty Response Program to improve care and outcomes for adults with AS and frailty undergoing TAVI. METHOD: We plan a multicentre, cluster-randomised controlled trial with embedded process evaluation being conducted in hospitals and their respective TAVI programs across Australia. Hospitals will be randomised 1:1 to the Frailty Response Program (intervention) or standard care (control). The intervention comprises: (1) a Frailty Response Clinical Protocol focusing on nutritional screening, patient frailty education, General Practitioner (GP) notification of patient's frailty classification, referrals for cardiac rehabilitation and geriatrician review; and (2) an Implementation Strategy informed by the Theoretical Domains Framework, incorporating meetings to determine local barriers and solutions, clinician education, local clinical champions, audit and feedback, action plans and remote facilitation. The primary outcome is the proportion of frail AS patients scheduled for TAVI receiving nutritional screening after frailty identification. Secondary outcomes are patient outcomes (as per the Valve Academic Research Consortium 3 endpoints), processes of care (frailty information provision, GP notifications, referrals for cardiac rehabilitation and geriatrician review) and implementation outcomes (intervention acceptability, feasibility and fidelity). CONCLUSIONS: The FRAIL-AS Response Trial will determine whether addressing frailty in older adults with AS undergoing TAVI enhances evidence-based care, reduces complications, and improves patient outcomes. If effective, the FRAIL-AS Response Program may provide a scalable, evidence-based model for managing patients with heart valve disease and frailty undergoing transcatheter procedures.