Healing Right Way: study protocol for a stepped wedge cluster randomised controlled trial to enhance rehabilitation services and improve quality of life in Aboriginal Australians after brain injury

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dc.contributor.authorArmstrong, E.
dc.contributor.authorCoffin, J.
dc.contributor.authorHersh, D.
dc.contributor.authorKatzenellenbogen, J.M.
dc.contributor.authorThompson, S.
dc.contributor.authorFlicker, L.
dc.contributor.authorMcAllister, M.
dc.contributor.authorCadilhac, D.A.
dc.contributor.authorRai, T.
dc.contributor.authorGodecke, E.
dc.contributor.authorHayward, C.
dc.contributor.authorHankey, G.J.
dc.contributor.authorDrew, N.
dc.contributor.authorLin, I.
dc.contributor.authorWoods, D.
dc.contributor.authorCiccone, N.
dc.date.issued2021
dc.description.abstractIntroduction Despite higher incidence of brain injury among Aboriginal compared with non-Aboriginal Australians, suboptimal engagement exists between rehabilitation services and Aboriginal brain injury survivors. Aboriginal patients often feel culturally insecure in hospital and navigation of services post discharge is complex. Health professionals report feeling ill-equipped working with Aboriginal patients. This study will test the impact of a research-informed culturally secure intervention model for Aboriginal people with brain injury. Methods and analysis Design: Stepped wedge cluster randomised control trial design; intervention sequentially introduced at four pairs of healthcare sites across Western Australia at 26-week intervals. Recruitment: Aboriginal participants aged ≥18 years within 4 weeks of an acute stroke or traumatic brain injury. Intervention: (1) Cultural security training for hospital staff and (2) local, trial-specific, Aboriginal Brain Injury Coordinators supporting participants. Primary outcome: Quality-of-life using EuroQOL-5D-3L (European Quality of Life scale, five dimensions, three severity levels) Visual Analogue Scale score at 26 weeks post injury. Recruitment of 312 participants is estimated to detect a difference of 15 points with 80% power at the 5% significance level. A linear mixed model will be used to assess the between-condition difference. Secondary outcome measures: Modified Rankin Scale, Functional Independence Measure, Modified Caregiver Strain Index, Hospital Anxiety and Depression Scale at 12 and 26 weeks post injury, rehabilitation occasions of service received, hospital compliance with minimum care processes by 26 weeks post injury, acceptability of Intervention Package, feasibility of Aboriginal Brain Injury Coordinator role. Evaluations: An economic evaluation will determine the potential cost-effectiveness of the intervention. Process evaluation will document fidelity to study processes and capture changing contexts including barriers to intervention implementation and acceptability/feasibility of
dc.description.statementofresponsibilityElizabeth Armstrong, Juli Coffin, Deborah Hersh, Judith M Katzenellenbogen, Sandra Thompson, Leon Flicker … et al.
dc.identifier.citationBMJ Open, 2021; 11(9):e045898-1-e045898-9
dc.identifier.doi10.1136/bmjopen-2020-045898
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.orcidThompson, S. [0000-0003-0327-7155]
dc.identifier.urihttps://hdl.handle.net/2440/133065
dc.language.isoen
dc.publisherBMJ
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1132468
dc.rights© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
dc.source.urihttps://doi.org/10.1136/bmjopen-2020-045898
dc.subjectHumans
dc.subjectAftercare
dc.subjectPatient Discharge
dc.subjectQuality of Life
dc.subjectAdolescent
dc.subjectAdult
dc.subjectOceanic Ancestry Group
dc.subjectAustralia
dc.subjectRandomized Controlled Trials as Topic
dc.subjectBrain Injuries, Traumatic
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshAftercare
dc.subject.meshAustralia
dc.subject.meshBrain Injuries, Traumatic
dc.subject.meshHumans
dc.subject.meshOceanic Ancestry Group
dc.subject.meshPatient Discharge
dc.subject.meshQuality of Life
dc.subject.meshRandomized Controlled Trials as Topic
dc.titleHealing Right Way: study protocol for a stepped wedge cluster randomised controlled trial to enhance rehabilitation services and improve quality of life in Aboriginal Australians after brain injury
dc.typeJournal article
pubs.publication-statusPublished

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