Statistical analysis plan for the stepped wedge clinical trial Healing Right Way-enhancing rehabilitation services for Aboriginal Australians after brain injury.
Armstrong, E
Rai, T
Hersh, D
Thompson, S
Coffin, J
Ciccone, N
Flicker, L
Cadilhac, D
Godecke, E
Woods, D
Hayward, C
Hankey, GJ
McAllister, M
Katzenellenbogen, J
- Publisher:
- Springer Nature
- Publication Type:
- Journal Article
- Citation:
- Trials, 2022, 23, (1), pp. 886
- Issue Date:
- 2022-10-22
Open Access
Copyright Clearance Process
- Recently Added
- In Progress
- Open Access
This item is open access.
Full metadata record
Field | Value | Language |
---|---|---|
dc.contributor.author | Armstrong, E | |
dc.contributor.author |
Rai, T https://orcid.org/0000-0003-1610-8983 |
|
dc.contributor.author | Hersh, D | |
dc.contributor.author | Thompson, S | |
dc.contributor.author | Coffin, J | |
dc.contributor.author | Ciccone, N | |
dc.contributor.author | Flicker, L | |
dc.contributor.author | Cadilhac, D | |
dc.contributor.author | Godecke, E | |
dc.contributor.author | Woods, D | |
dc.contributor.author | Hayward, C | |
dc.contributor.author | Hankey, GJ | |
dc.contributor.author | McAllister, M | |
dc.contributor.author | Katzenellenbogen, J | |
dc.date.accessioned | 2023-07-10T01:04:31Z | |
dc.date.available | 2022-09-28 | |
dc.date.available | 2023-07-10T01:04:31Z | |
dc.date.issued | 2022-10-22 | |
dc.identifier.citation | Trials, 2022, 23, (1), pp. 886 | |
dc.identifier.issn | 1745-6215 | |
dc.identifier.issn | 1745-6215 | |
dc.identifier.uri | http://hdl.handle.net/10453/171390 | |
dc.description.abstract | BACKGROUND: Aboriginal Australians are known to suffer high levels of acquired brain injury (stroke and traumatic brain injury) yet experience significant barriers in accessing rehabilitation services. The aim of the Healing Right Way trial is to evaluate a culturally secure intervention for Aboriginal people with newly acquired brain injury to improve their rehabilitation experience and quality of life. Following publication of the trial protocol, this paper outlines the statistical analysis plan prior to locking the database. METHODS: The trial involves a stepped wedge design with four steps over 3 years. Participants were 108 adult Aboriginal Australians admitted to one of eight hospitals (four rural, four urban) in Western Australia within 6 weeks of onset of a new stroke or traumatic brain injury who consented to follow-up for 26 weeks. All hospital sites started in a control phase, with the intervention assigned to pairs of sites (one metropolitan, one rural) every 26 weeks until all sites received the intervention. The two-component intervention involves training in culturally safe care for hospital sites and enhanced support provided to participants by Aboriginal Brain Injury Coordinators during their hospital stay and after discharge. The primary outcome is quality of life as measured by the Euro QOL-5D-3L VAS. A mixed effects linear regression model will be used to assess the between-group difference at 26 weeks post-injury. The model will control for injury type and severity, age at recruitment and time since commencement of the trial, as fixed effects. Recruitment site and participant will be included as random effects. Secondary outcomes include measurements of function, independence, anxiety and depression, carer strain, allied health occasions of service received and hospital compliance with minimum processes of care based on clinical guidelines and best practice models of care. DISCUSSION: The trial will provide the first data surrounding the effectiveness of an intervention package for Aboriginal people with brain injury and inform future planning of rehabilitation services for this population. The statistical analysis plan outlines the analyses to be undertaken. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12618000139279. Registered 30 January, 2018. | |
dc.format | Electronic | |
dc.language | eng | |
dc.publisher | Springer Nature | |
dc.relation | http://purl.org/au-research/grants/nhmrc/1132468 | |
dc.relation.ispartof | Trials | |
dc.relation.isbasedon | 10.1186/s13063-022-06800-0 | |
dc.rights | info:eu-repo/semantics/openAccess | |
dc.subject | 1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences | |
dc.subject.classification | Cardiovascular System & Hematology | |
dc.subject.classification | General & Internal Medicine | |
dc.subject.classification | 3202 Clinical sciences | |
dc.subject.classification | 4202 Epidemiology | |
dc.subject.classification | 4203 Health services and systems | |
dc.subject.mesh | Adult | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Australia | |
dc.subject.mesh | Brain Injuries, Traumatic | |
dc.subject.mesh | Native Hawaiian or Other Pacific Islander | |
dc.subject.mesh | Quality of Life | |
dc.subject.mesh | Stroke | |
dc.subject.mesh | Clinical Trials as Topic | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Quality of Life | |
dc.subject.mesh | Adult | |
dc.subject.mesh | Australia | |
dc.subject.mesh | Clinical Trials as Topic | |
dc.subject.mesh | Stroke | |
dc.subject.mesh | Brain Injuries, Traumatic | |
dc.subject.mesh | Native Hawaiian or Other Pacific Islander | |
dc.subject.mesh | Adult | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Australia | |
dc.subject.mesh | Brain Injuries, Traumatic | |
dc.subject.mesh | Native Hawaiian or Other Pacific Islander | |
dc.subject.mesh | Quality of Life | |
dc.subject.mesh | Stroke | |
dc.subject.mesh | Clinical Trials as Topic | |
dc.title | Statistical analysis plan for the stepped wedge clinical trial Healing Right Way-enhancing rehabilitation services for Aboriginal Australians after brain injury. | |
dc.type | Journal Article | |
utslib.citation.volume | 23 | |
utslib.location.activity | England | |
utslib.for | 1102 Cardiorespiratory Medicine and Haematology | |
utslib.for | 1103 Clinical Sciences | |
pubs.organisational-group | /University of Technology Sydney | |
pubs.organisational-group | /University of Technology Sydney/Faculty of Science | |
pubs.organisational-group | /University of Technology Sydney/Faculty of Science/School of Mathematical and Physical Sciences | |
utslib.copyright.status | open_access | * |
dc.date.updated | 2023-07-10T01:04:27Z | |
pubs.issue | 1 | |
pubs.publication-status | Published online | |
pubs.volume | 23 | |
utslib.citation.issue | 1 |
Abstract:
BACKGROUND: Aboriginal Australians are known to suffer high levels of acquired brain injury (stroke and traumatic brain injury) yet experience significant barriers in accessing rehabilitation services. The aim of the Healing Right Way trial is to evaluate a culturally secure intervention for Aboriginal people with newly acquired brain injury to improve their rehabilitation experience and quality of life. Following publication of the trial protocol, this paper outlines the statistical analysis plan prior to locking the database. METHODS: The trial involves a stepped wedge design with four steps over 3 years. Participants were 108 adult Aboriginal Australians admitted to one of eight hospitals (four rural, four urban) in Western Australia within 6 weeks of onset of a new stroke or traumatic brain injury who consented to follow-up for 26 weeks. All hospital sites started in a control phase, with the intervention assigned to pairs of sites (one metropolitan, one rural) every 26 weeks until all sites received the intervention. The two-component intervention involves training in culturally safe care for hospital sites and enhanced support provided to participants by Aboriginal Brain Injury Coordinators during their hospital stay and after discharge. The primary outcome is quality of life as measured by the Euro QOL-5D-3L VAS. A mixed effects linear regression model will be used to assess the between-group difference at 26 weeks post-injury. The model will control for injury type and severity, age at recruitment and time since commencement of the trial, as fixed effects. Recruitment site and participant will be included as random effects. Secondary outcomes include measurements of function, independence, anxiety and depression, carer strain, allied health occasions of service received and hospital compliance with minimum processes of care based on clinical guidelines and best practice models of care. DISCUSSION: The trial will provide the first data surrounding the effectiveness of an intervention package for Aboriginal people with brain injury and inform future planning of rehabilitation services for this population. The statistical analysis plan outlines the analyses to be undertaken. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12618000139279. Registered 30 January, 2018.
Please use this identifier to cite or link to this item:
Download statistics for the last 12 months
Not enough data to produce graph