Cadilhac, Dominique A.Ross, Andrew G.Bagot, Kathleen L.Blennerhassett, Jannette M.Kilkenny, MoniqueKim, JoosupPurvis, TaraBarclay, Karen M.Ellery, FionaMorrison, JulieCranefield, JenniferKleinig, TimothyGrimley, RohanJaques, KatherineWong, DanaMurphy, LisaRussell, GrantNelson, MarkThijs, VincentScott, ColinMiddleton, Sandra Jane2025-10-172025-10-1720242024-10-112055-578410.1186/s40814-024-01527-yhttps://hdl.handle.net/20.500.14802/17860Background: 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, randomised controlled trial with allocation concealment of participants and outcome assessors. Based on an intention-to-treat analysis, we will evaluate the feasibility, acceptability, potential effectiveness and cost implications of a new tailored, codesigned, 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 EuroQol EQ-5D-3L survey between 90 and 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-week post-randomisation. Primary outcomes for feasibility are the proportion of participants completing the trial and for intervention participants the proportion that received follow-up services. Acceptability is satisfaction of clinicians and participants involved in the intervention. Secondary outcomes include effectiveness: change in extreme health problems (EQ-5D-3L), unmet needs (Longer-term Unmet Needs questionnaire), unplanned presentations and hospital readmission, functional independence (modified Rankin Scale) and cost implications estimated from self-reported health service utilisation and productivity (e.g. workforce participation). 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 to inform a future fully powered effectiveness trial of the intervention.StrokeClinical trial protocolFollow-up serviceClinical Quality RegistryJournal articlePublished as ‘gold’ (paid) open accessOpenOpenPUB0201100865