Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS)
Journal article
Cadilhac, Dominique A., Ross, Andrew G., Bagot, Kathleen L., Blennerhassett, Jannette M., Kilkenny, Monique, Kim, Joosup, Purvis, Tara, Barclay, Karen M., Ellery, Fiona, Morrison, Julie, Cranefield, Jennifer, Kleinig, Timothy, Grimley, Rohan, Jaques, Katherine, Wong, Dana, Murphy, Lisa, Russell, Grant, Nelson, Mark, Thijs, Vincent, ... Middleton, Sandra Jane. (2024). Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS). Pilot and Feasibility Studies. 10(1), pp. 1-12. https://doi.org/10.1186/s40814-024-01527-y
Authors | Cadilhac, Dominique A., Ross, Andrew G., Bagot, Kathleen L., Blennerhassett, Jannette M., Kilkenny, Monique, Kim, Joosup, Purvis, Tara, Barclay, Karen M., Ellery, Fiona, Morrison, Julie, Cranefield, Jennifer, Kleinig, Timothy, Grimley, Rohan, Jaques, Katherine, Wong, Dana, Murphy, Lisa, Russell, Grant, Nelson, Mark, Thijs, Vincent, Scott, Colin and Middleton, Sandra Jane |
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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. |
Keywords | Stroke; Clinical trial protocol; Follow-up service; Clinical Quality Registry |
Year | 01 Jan 2024 |
Journal | Pilot and Feasibility Studies |
Journal citation | 10 (1), pp. 1-12 |
Publisher | BMC (BioMed Central) Springer |
ISSN | 2055-5784 |
Digital Object Identifier (DOI) | https://doi.org/10.1186/s40814-024-01527-y |
Web address (URL) | https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-024-01527-y |
Open access | Open access |
Research or scholarly | Research |
Page range | 1-12 |
Publisher's version | License File Access Level Open |
Output status | Published |
Publication dates | |
Online | 30 Jul 2024 |
Publication process dates | |
Accepted | 01 Jul 2024 |
Deposited | 11 Oct 2024 |
Supplemental file | License File Access Level Open |
Additional information | © The Author(s) 2024. |
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The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | |
Place of publication | United Kingdom |
https://acuresearchbank.acu.edu.au/item/91009/protocol-for-a-feasibility-registry-based-randomised-controlled-trial-investigating-a-tailored-follow-up-service-for-stroke-a-lists
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Supplemental file
SM_Bagot_2024_Protocol_for_a_feasibility_registry_based.pdf | |
License: CC BY 4.0 | |
File access level: Open |
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