TY - JOUR
T1 - Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS)
AU - Cadilhac, Dominique A.
AU - Ross, Andrew G.
AU - Bagot, Kathleen L.
AU - Blennerhassett, Jannette M.
AU - Kilkenny, Monique F.
AU - Kim, Joosup
AU - Purvis, Tara
AU - Barclay, Karen M.
AU - Ellery, Fiona
AU - Morrison, Julie
AU - Cranefield, Jennifer
AU - Kleinig, Timothy J.
AU - Grimley, Rohan
AU - Jaques, Katherine
AU - Wong, Dana
AU - Murphy, Lisa
AU - Russell, Grant
AU - Nelson, Mark R.
AU - Thijs, Vincent
AU - Scott, Colin
AU - Middleton, Sandy
AU - on behalf of the A-LISTS investigator group
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/7/30
Y1 - 2024/7/30
N2 - 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.
AB - 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.
KW - Clinical Quality Registry
KW - Clinical trial protocol
KW - Follow-up service
KW - Stroke
UR - https://www.scopus.com/pages/publications/85200319512
U2 - 10.1186/s40814-024-01527-y
DO - 10.1186/s40814-024-01527-y
M3 - Article
C2 - 39080727
AN - SCOPUS:85200319512
SN - 2055-5784
VL - 10
JO - Pilot and Feasibility Studies
JF - Pilot and Feasibility Studies
IS - 1
M1 - 103
ER -