Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS)

Abstract Background Stroke affects long-term physical and cognitive function; many survivors report unmet health needs, such as pain or depression. A hospital-led follow-up service designed to address ongoing health problems may avoid unplanned readmissions and improve quality of life. Methods This paper outlines the protocol for a registry-based, single-blind, randomised controlled trial. Based on an intention-to-treat analysis, we will evaluate the feasibility, acceptability, potential effectiveness, and cost implications of a new tailored, co-designed, hospital-led follow-up service for people within 6–12 months of stroke. Participants (n = 100) from the Australian Stroke Clinical Registry who report extreme health problems on the EQ5D-3L between 90–180 days after stroke will be randomly assigned (1:1) to intervention (follow-up service) or control (usual care) groups. All participants will be independently assessed at baseline and 12–14 weeks post-randomisation. Primary outcomes are the proportion of participants: receiving follow-up services; complete ng the trial; and reporting satisfaction (clinicians and participants). Secondary outcomes include: extreme health problems (EuroQoL 5 Dimensions 3 Level Version), unmet needs (Longer-term Unmet Needs questionnaire), unplanned presentations and hospital readmission, functional independence (modified Rankin scale), and health service utilisation. To inform future research or implementation, the design contains a process evaluation including clinical protocol fidelity and an economic evaluation. Discussion The results of this study will provide improved knowledge of service design and implementation barriers and facilitators, and associated costs and resource implications and inform a future fully powered effectiveness trial of the intervention. Trial registration ACTRN12622001015730pr