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- Title
Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS).
- Authors
Cadilhac, Dominique A.; Ross, Andrew G.; Bagot, Kathleen L.; Blennerhassett, Jannette M.; Kilkenny, Monique F.; Kim, Joosup; Purvis, Tara; Barclay, Karen M.; Ellery, Fiona; Morrison, Julie; Cranefield, Jennifer; Kleinig, Timothy J.; Grimley, Rohan; Jaques, Katherine; Wong, Dana; Murphy, Lisa; Russell, Grant; Nelson, Mark R.; Thijs, Vincent; Scott, Colin
- 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, 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. Trial registration: ACTRN12622001015730pr. Trial sponsor: Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, VIC, 3084, PH: +61 3 9035 7032
- Subjects
STROKE; PHYSICAL mobility; RANDOMIZED controlled trials; QUALITY of life; SERVICE design; PATIENT readmissions
- Publication
Pilot & Feasibility Studies, 2024, Vol 10, Issue 1, p1
- ISSN
2055-5784
- Publication type
Article
- DOI
10.1186/s40814-024-01527-y