Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000340437
Ethics application status
Approved
Date submitted
11/03/2016
Date registered
16/03/2016
Date last updated
16/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of the Assessment for Rehabilitation tool in improving proportions of patients with stroke assessed for rehabilitation
Scientific title
Efficacy of the Assessment for Rehabilitation tool in improving proportions of patients with stroke assessed for rehabilitation: A mixed methods cluster randomised trial.
Secondary ID [1] 288742 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 297984 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298138 298138 0 0
Other physical medicine / rehabilitation
Stroke 298157 298157 0 0
Haemorrhagic
Stroke 298158 298158 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multifaceted behaviour change intervention for health professionals working in acute stroke units. All sessions conducted onsite at acute hospitals. Comprised of
1. education sessions: Two education sessions delivered onsite to acute stroke unit team by research physiotherapist (>10 years clinical experience). Both education sessions (duration 30-60 minutes) held within a 1 month period, participants were invited to attend both sessions. Education regarding Assessment for Rehabilitation Tool (rationale for use, how to use) provided. Up to 3 additional education sessions provided if this was nominated as a strategy by participants in the strategy development workshop
2. Printed educational materials: paper copies of the Assessment for Rehabilitation Tool, and 3 copies of Assessment for Rehabilitation Tool user manual provided to acute stroke unit teams. Information provided regarding freely available associated electronic resources
3. Audit and feedback: medical record audit conducted by research physiotherapist, site-specific feedback provided verbally and written (paper-version) summary of audit distributed to participants working on acute stroke unit by research PT re proportions of patients assessed for rehabilitation, profiles of patients not assessed in audit, profiles of professionals who conducted the assessments in the audit, summary of assessment processes and access to rehabilitation
4. barrier identification and strategy development: workshops held with acute stroke unit team at each site (facilitated by research physiotherapist) to identify barriers to use of Assessment for Rehabilitation Tool, followed immediately by strategy development session (combined session 60 minute duration)
5. Site champions: each site nominated 1-3 site champions to lead implementation of strategies developed in workshop
6. reminders: 1-2 emails sent to all workshop participants by research PT regarding strategies developed to use Assessment for rehabilitation Tool. Monthly phone or email contact between research PT and site champion for 4 months following initial education session (more contact if initiated by site champion) to discuss implementation of strategies.
Records kept by research PT re which health professionals attended education sessions and strategy development workshop
Intervention code [1] 294177 0
Other interventions
Comparator / control treatment
Education intervention for health professionals working in acute stroke units
1. education session (1 only, 30 minute duration) delivered onsite to acute stroke unit team by research physiotherapist (>10 years clinical experience). Education regarding Assessment for Rehabilitation Tool (rationale for use, how to use) provided.
2. Printed educational materials: paper copies of the Assessment for Rehabilitation Tool, and 3 copies of Assessment for Rehabilitation Tool user manual provided to acute stroke unit teams. Information provided regarding freely available associated electronic resources
Records kept by research PT re which health professionals attended the education session
Control group
Active

Outcomes
Primary outcome [1] 297648 0
Proportions of patients with stroke who received a documented assessment for rehabilitation. Data collected by assessor blinded to hospital allocation via medical record audit. Also collecting data regarding details of assessment (conducted by which health discipline, recommendation from assessment),
Timepoint [1] 297648 0
6 months post-commencement of intervention
Secondary outcome [1] 321685 0
Proportions of patients who accessed stroke rehabilitation following discharge from acute hospital, collected via medical record audit by assessor blinded to hospital allocation. Details collected regarding rehabilitation setting (home, community, inpatient setting)
Timepoint [1] 321685 0
6 months post-commencement of intervention
Secondary outcome [2] 321768 0
Self-reported rehabilitation assessment and referral practices at each stroke unit. Factors identified by health professionals working on acute stroke units that influenced rehabilitation assessment and referral practices. Data collected by focus groups at each site, facilitated by research PT
Timepoint [2] 321768 0
4-6 months post-commencement of intervention sessions

Eligibility
Key inclusion criteria
For medical record audit: Admitted to hospital with stroke

To be included in interventions and focus groups: health professional working on acute stroke unit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For medical record audit: No signs of stroke on admission to hospital, receiving palliative care, transferred to another hospital for acute management/investigation

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation schedule generated by computer program by a third party blind to the specific hospital list
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
1/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
620
Accrual to date
Final
586
Recruitment in Australia
Recruitment state(s)
NSW,SA

Funding & Sponsors
Funding source category [1] 293092 0
Government body
Name [1] 293092 0
Department of Education and Training
Country [1] 293092 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
PO Box 2471
Adelaide
SA 5001
Country
Australia
Secondary sponsor category [1] 291879 0
Government body
Name [1] 291879 0
NSW Agency for Clinical Innovation
Address [1] 291879 0
Level 4,
67 Albert Avenue,
Chatswood NSW 2067
Country [1] 291879 0
Australia
Secondary sponsor category [2] 291880 0
Charities/Societies/Foundations
Name [2] 291880 0
National Stroke Foundation
Address [2] 291880 0
Level 7,
461 Bourke Street
Melbourne VIC 3000
Country [2] 291880 0
Australia
Secondary sponsor category [3] 291881 0
Government body
Name [3] 291881 0
SA Health
Address [3] 291881 0
PO Box 287
Rundle Mall
Adelaide SA 5000
Country [3] 291881 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294599 0
SA healthHREC
Ethics committee address [1] 294599 0
Level 10 Citi-centre Building
11 Hindmarsh Square
Adelaide 5000
Ethics committee country [1] 294599 0
Australia
Date submitted for ethics approval [1] 294599 0
01/08/2012
Approval date [1] 294599 0
28/08/2012
Ethics approval number [1] 294599 0
HREC/12/SAH/31
Ethics committee name [2] 294600 0
Sydney Local Health District RPAH zone HREC
Ethics committee address [2] 294600 0
Research Development Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [2] 294600 0
Australia
Date submitted for ethics approval [2] 294600 0
14/11/2012
Approval date [2] 294600 0
26/11/2012
Ethics approval number [2] 294600 0
HREC/12/RPAH/523

Summary
Brief summary
This project will use a cluster randomised trial design to assess the effectiveness of an implementation program designed to increase proportions of patients with stroke receiving a documented assessment for rehabilitation. Hospitals (clusters) will be randomly assigned to receive a multifaceted intervention or an education-only intervention. The multifaceted intervention consists of a decision-making tool, education, audit and feedback, reminders and a tailored implementation package consisting of identification of barriers and facilitators and development of site-specific strategies for implementation (identified in a workshop with health professionals as participants) to help improve rehabilitation assessment practices. The education-only intervention consists of a single education session and provision of a decision-making tool.
Observations will be conducted at sites assigned to the multifaceted intervention to observe how assessment are occurring prior to the intervention prior to the intervention.
Focus groups will be held at all sites after the implementation period to explore how staff assess and refer patients with stroke for rehabilitation
Medical records will be audited pre- and post-intervention at all hospitals to assess proportions of patients assessed for rehabilitation, and proportions of patients who access rehabilitation.
Trial website
NA
Trial related presentations / publications
E Lynch, J Luker, D Cadilhac, S Hillier (2015): Inequities in access to rehabilitation: Exploring how acute stroke unit clinicians decide who to refer to rehabilitation. Disability and Rehabilitation. Nov 25:1-10. [Epub ahead of print]
E Lynch, J Luker, D Cadilhac, S Hillier (2015): Rehabilitation assessments for patients with stroke in Australian hospitals do not always reflect rehabilitation requirements. Archives of Physical Medicine and Rehabilitation 96: 782-9.
Public notes

Contacts
Principal investigator
Name 64314 0
Dr Elizabeth Lynch
Address 64314 0
International Centre of Allied Health Evidence
University of South Australia
GPO Box 2471
Adelaide
5001
Country 64314 0
Australia
Phone 64314 0
+61 8 8302 2099
Fax 64314 0
Email 64314 0
elizabeth.lynch@unisa.edu.au
Contact person for public queries
Name 64315 0
Dr Elizabeth Lynch
Address 64315 0
International Centre of Allied Health Evidence
University of South Australia
GPO Box 2471
Adelaide
5001
Country 64315 0
Australia
Phone 64315 0
+61 8 8302 2099
Fax 64315 0
Email 64315 0
elizabeth.lynch@unisa.edu.au
Contact person for scientific queries
Name 64316 0
Dr Elizabeth Lynch
Address 64316 0
International Centre of Allied Health Evidence
University of South Australia
GPO Box 2471
Adelaide
5001
Country 64316 0
Australia
Phone 64316 0
+61 8 8302 2099
Fax 64316 0
Email 64316 0
elizabeth.lynch@unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEducation-only versus a multifaceted intervention for improving assessment of rehabilitation needs after stroke; a cluster randomised trial.2016https://dx.doi.org/10.1186/s13012-016-0487-2
N.B. These documents automatically identified may not have been verified by the study sponsor.