Dominique A Cadilhac, Andrew G Ross, Kathleen L Bagot, Jannette M Blennerhassett, Monique F Kilkenny, Joosup Kim, Tara Purvis, Karen M Barclay, Fiona Ellery, Julie Morrison, Jennifer Cranefield, Timothy J Kleinig, Rohan Grimley, Katherine Jaques, Dana Wong, Lisa Murphy, Grant Russell, Mark R Nelson, Vincent Thijs, Colin Scott, Sandy Middleton
{"title":"以登记为基础的随机对照试验可行性方案，调查中风定制随访服务 (A-LISTS)。","authors":"Dominique A Cadilhac, Andrew G Ross, Kathleen L Bagot, Jannette M Blennerhassett, Monique F Kilkenny, Joosup Kim, Tara Purvis, Karen M Barclay, Fiona Ellery, Julie Morrison, Jennifer Cranefield, Timothy J Kleinig, Rohan Grimley, Katherine Jaques, Dana Wong, Lisa Murphy, Grant Russell, Mark R Nelson, Vincent Thijs, Colin Scott, Sandy Middleton","doi":"10.1186/s40814-024-01527-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>ACTRN12622001015730pr.</p><p><strong>Trial sponsor: </strong>Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, VIC, 3084, PH: +61 3 9035 7032.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"103"},"PeriodicalIF":1.5000,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11290067/pdf/","citationCount":"0","resultStr":"{\"title\":\"Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS).\",\"authors\":\"Dominique A Cadilhac, Andrew G Ross, Kathleen L Bagot, Jannette M Blennerhassett, Monique F Kilkenny, Joosup Kim, Tara Purvis, Karen M Barclay, Fiona Ellery, Julie Morrison, Jennifer Cranefield, Timothy J Kleinig, Rohan Grimley, Katherine Jaques, Dana Wong, Lisa Murphy, Grant Russell, Mark R Nelson, Vincent Thijs, Colin Scott, Sandy Middleton\",\"doi\":\"10.1186/s40814-024-01527-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Stroke affects long-term physical and cognitive function; many survivors report unmet health needs, such as pain or depression. 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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). 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Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS).
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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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