The FRAIL-AS Response Trial is a planned cluster-randomized controlled trial evaluating a Frailty Response Program to improve nutritional screening and outcomes in frail patients undergoing TAVI.
RCT
1:1
Yes
Does a Frailty Response Program improve nutritional screening rates and clinical outcomes in frail older adults with aortic stenosis undergoing TAVI?
The FRAIL-AS Response Trial protocol outlines a cluster-randomized trial to evaluate whether a structured Frailty Response Program improves care processes and outcomes for frail patients undergoing TAVI.
BACKGROUND 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.
Straiton et al. (Fri,) conducted a rct in Aortic stenosis. Frailty Response Program vs. Standard care was evaluated on Proportion of frail AS patients scheduled for TAVI receiving nutritional screening after frailty identification. The FRAIL-AS Response Trial is a planned cluster-randomized controlled trial evaluating a Frailty Response Program to improve nutritional screening and outcomes in frail patients undergoing TAVI.