Protocol for a feasibility registry-based randomised controlled trial investigating a tailored follow-up service for stroke (A-LISTS).
Clinical Quality Registry
Clinical trial protocol
Follow-up service
Stroke
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
30 Jul 2024
30 Jul 2024
Historique:
received:
05
12
2023
accepted:
01
07
2024
medline:
31
7
2024
pubmed:
31
7
2024
entrez:
31
7
2024
Statut:
epublish
Résumé
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. 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. 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. ACTRN12622001015730pr. Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, VIC, 3084, PH: +61 3 9035 7032.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ACTRN12622001015730pr.
TRIAL SPONSOR
UNASSIGNED
Florey Institute of Neuroscience and Mental Health, 245 Burgundy Street, Heidelberg, VIC, 3084, PH: +61 3 9035 7032.
Identifiants
pubmed: 39080727
doi: 10.1186/s40814-024-01527-y
pii: 10.1186/s40814-024-01527-y
doi:
Types de publication
Journal Article
Langues
eng
Pagination
103Subventions
Organisme : National Health and Medical Research Council
ID : APP2008668
Informations de copyright
© 2024. The Author(s).
Références
Feigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, et al. Update on the global burden of ischemic and hemorrhagic stroke in 1990–2013: the GBD 2013 study. Neuroepidemiology. 2015;45(3):161–76.
doi: 10.1159/000441085
pubmed: 26505981
Sturm JW, Donnan GA, Dewey HM, Macdonell RA, Gilligan AK, Srikanth V, et al. Quality of life after stroke: the North East Melbourne Stroke Incidence Study (NEMESIS). Stroke. 2004;35(10):2340–5.
doi: 10.1161/01.STR.0000141977.18520.3b
pubmed: 15331799
Andrew N, Kilkenny M, Naylor R, Purvis T, Lalor E, Moloczij N, et al. Understanding long-term unmet needs in Australian survivors of stroke. Int J Stroke. 2014. https://doi.org/10.1111/ijs.12325 .
doi: 10.1111/ijs.12325
pubmed: 25042019
Kilkenny MF, Dalli LL, Kim J, Sundararajan V, Andrew NE, Dewey HM, et al. Factors associated with 90-day readmission after stroke or transient ischemic attack: linked data from the Australian Stroke Clinical Registry. Stroke. 2020;51(2):571–8.
doi: 10.1161/STROKEAHA.119.026133
pubmed: 31822248
Kilkenny MF, Kim J, Andrew NE, Sundararajan V, Thrift AG, Katzenellenbogen JM, et al. Maximising data value and avoiding data waste: a validation study in stroke research. Med J Aust. 2019;210(1):27–31.
doi: 10.5694/mja2.12029
pubmed: 30636305
Andrew NE, Kim J, Cadilhac DA, Sundararajan V, Thrift AG, Churilov L, et al. Protocol for evaluation of enhanced models of primary care in the management of stroke and other chronic disease (PRECISE): a data linkage healthcare evaluation study. Int J Popul Data Sci. 2019;4(1):1–14.
Cadilhac DA, Dalli LL, Morrison JL, Lester M, Paice K, Moss K, et al. The Australian Stroke Clinical Registry Annual Report 2020. 2021.
Bridgwood B, Lager KE, Mistri AK, Khunti K, Wilson AD, Modi P. Interventions for improving modifiable risk factor control in the secondary prevention of stroke. Cochrane Database Syst Rev. 2018;5:CD009103.
pubmed: 29734470
Lawn S, Zabeen S, Smith D, Wilson E, Miller C, Battersby M, et al. Managing chronic conditions care across primary care and hospital systems: lessons from an Australian Hospital Avoidance Risk Program using the Flinders Chronic Condition Management Program. Aust Health Rev. 2018;42(5):542–9.
doi: 10.1071/AH17099
pubmed: 28835321
Jun-O’Connell AH, Grigoriciuc E, Gulati A, Silver B, Kobayashi KJ, Moonis M, et al. Stroke nurse navigator utilization reduces unplanned 30-day readmission in stroke patients treated with thrombolysis. Front Neurol. 2023;14:1205487.
doi: 10.3389/fneur.2023.1205487
pubmed: 37396755
pmcid: 10310532
Amatya B, Elmalik A, Lee SY, Song K, Galea M, Khan F. A process evaluation of patient care needs using the Post-Stroke Checklist: a prospective study. J Rehabil Med. 2022;54:jrm00259.
doi: 10.2340/jrm.v53.349
pubmed: 35001136
Pugh JD, McCoy K, Needham M, Jiang L, Giles M, McKinnon E, et al. Evaluation of an Australian neurological nurse-led model of postdischarge care. Health Soc Care Community. 2022;30(4):e962–73.
doi: 10.1111/hsc.13498
pubmed: 34245179
Wissel J, Olver J, Sunnerhagen KS. Navigating the poststroke continuum of care. J Stroke Cerebrovasc Dis. 2013;22(1):1–8.
doi: 10.1016/j.jstrokecerebrovasdis.2011.05.021
pubmed: 21733720
Ross A BJ, Barclay-Moss K, Purvis T, Frost T, Wong D, Hillier S, Kim J, Cranefield J, Jaques K, Nelson M R, Russell G, Grindon-Ekins K, Scott C, Murphy L, Bagot K, Kilkenny M F, Kleinig T J, Grimley R, Middleton S, Thijs V, Cadilhac D. Co-design of a tailored follow-up intervention package for people living with stroke who report extreme unmet needs: a two stage, four-round modified Delphi study. Int J Stroke. 2023;18(2S):Abstract 29 page 19. https://doi.org/10.1177/17474930231188838 .
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016;2:64.
doi: 10.1186/s40814-016-0105-8
pubmed: 27965879
pmcid: 5154046
Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, et al. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. BMJ. 2022;376:e067975.
doi: 10.1136/bmj-2021-067975
pubmed: 35017145
pmcid: 8749494
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research Electronic Data Capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.
doi: 10.1016/j.jbi.2008.08.010
pubmed: 18929686
Cadilhac DA, Lannin NA, Anderson CS, Levi CR, Faux S, Price C, et al. Protocol and pilot data for establishing the Australian Stroke Clinical Registry. Int J Stroke. 2010;5(3):217–26.
doi: 10.1111/j.1747-4949.2010.00430.x
pubmed: 20536618
The EurolQol group. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. https://doi.org/10.1016/0168-8510(90)90421-9 .
van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19(5):604–7.
doi: 10.1161/01.STR.19.5.604
pubmed: 3363593
Phan HT, Gall SL, Blizzard CL, Lannin NA, Thrift AG, Anderson CS, et al. Sex differences in quality of life after stroke were explained by patient factors, not clinical care: evidence from the Australian Stroke Clinical Registry. Eur J Neurol. 2021;28(2):469–78.
doi: 10.1111/ene.14531
pubmed: 32920917
LoTS care LUNS study team. Validation of the Longer-term Unmet Needs after Stroke (LUNS) monitoring tool: a multicentre study. Clin Rehabil. 2013;27(11):1020–8.
doi: 10.1177/0269215513487082
May CR, Cummings A, Girling M, Bracher M, Mair FS, May CM, et al. Using normalization process theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review. Implement Sci. 2018;13(1):80.
doi: 10.1186/s13012-018-0758-1
pubmed: 29879986
pmcid: 5992634
May CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, et al. Development of a theory of implementation and integration: normalization process theory. Implement Sci. 2009;4:29. https://doi.org/10.1186/1748-5908-4-29 .
Janssen MF, Pickard AS, Shaw JW. General population normative data for the EQ-5D-3L in the five largest European economies. Eur J Health Econ. 2021;22(9):1467–75.
doi: 10.1007/s10198-021-01326-9
pubmed: 34117986
pmcid: 8558182
Chen T, Zhang B, Deng Y, Fan J-C, Zhang L, Song F. Long-Term unmet needs after stroke: systematic review of evidence from survey studies. BMJ Open. 2019;9:e028137.
doi: 10.1136/bmjopen-2018-028137
pubmed: 31110106
pmcid: 6530326
Wilson A, Bath PM, Berge E, Cadilhac DA, Cuche M, Ford GA, et al. Understanding the relationship between costs and the modified Rankin Scale: a systematic review, multidisciplinary consensus and recommendations for future studies. Eur Stroke J. 2017;2(1):3–12.
doi: 10.1177/2396987316684705
pubmed: 29900405
pmcid: 5992734
Saver JL, Chaisinanunkul N, Campbell BCV, Grotta JC, Hill MD, Khatri P, et al. Standardized nomenclature for modified rankin scale global disability outcomes: consensus recommendations from stroke therapy academic industry roundtable XI. Stroke. 2021;52(9):3054–62.
doi: 10.1161/STROKEAHA.121.034480
pubmed: 34320814
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4:287–91.
doi: 10.1002/pst.185
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016;25(3):1057–73.
doi: 10.1177/0962280215588241
pubmed: 26092476
The Department of Health and Aged Care. Chronic Disease Management Patient Information. 2023. Available from: https://www1.health.gov.au/internet/main/publishing.nsf/Content/mbsprimarycare-chronicdisease-pdf-infosheet .
National Disability Insurance Scheme. 2023. Available from: https://www.ndis.gov.au/ .
My Aged Care 2023. Available from: https://www.myagedcare.gov.au/ .
Cook D, Lauzier F, Rocha MG, Sayles MJ, Finfer S. Serious adverse events in academic critical care research. CMAJ. 2008;178(9):1181–4.
doi: 10.1503/cmaj.071366
pubmed: 18427095
pmcid: 2292790
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: medical research council guidance. BMJ. 2015;350:h1258.
doi: 10.1136/bmj.h1258
pubmed: 25791983
pmcid: 4366184
Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, et al. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010;8:1–11.
doi: 10.1186/1741-7015-8-63
O’Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, Adamson J, et al. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasibility Stud. 2015;1:32.
doi: 10.1186/s40814-015-0026-y
pubmed: 27965810
pmcid: 5154038
Mauskopf JA, Paul JE, Grant DM, Stergachis A. The role of cost-consequence analysis in healthcare decision-making. Pharmacoeconomics. 1998;13(3):277–88.
doi: 10.2165/00019053-199813030-00002
pubmed: 10178653
Sim J. Should treatment effects be estimated in pilot and feasibility studies? Pilot Feasibility Stud. 2019;5:107.
doi: 10.1186/s40814-019-0493-7
pubmed: 31485336
pmcid: 6712606
Lee EC, Whitehead AL, Jacques RM, Julious SA. The statistical interpretation of pilot trials: should significance thresholds be reconsidered? BMC Med Res Methodol. 2014;14:41.
doi: 10.1186/1471-2288-14-41
pubmed: 24650044
pmcid: 3994566
Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117.
doi: 10.1186/1471-2288-13-117
pubmed: 24047204
pmcid: 3848812
Thurmond VA. The point of triangulation. J Nurs Scholarsh. 2001;33(3):253–8.
doi: 10.1111/j.1547-5069.2001.00253.x
pubmed: 11552552