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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

stroke

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Stroke

Haemorrhagic

Stroke

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]

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]

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]

6 months post-commencement of intervention

Secondary outcome [1]

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]

6 months post-commencement of intervention

Secondary outcome [2]

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]

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]

Government body

Name [1]

Department of Education and Training

Address [1]

Department of Education and Training
GPO Box 9880
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of South Australia

Address

PO Box 2471
Adelaide
SA 5001

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

NSW Agency for Clinical Innovation

Address [1]

Level 4,
67 Albert Avenue,
Chatswood NSW 2067

Country [1]

Australia

Secondary sponsor category [2]

Charities/Societies/Foundations

Name [2]

National Stroke Foundation

Address [2]

Level 7,
461 Bourke Street
Melbourne VIC 3000

Country [2]

Australia

Secondary sponsor category [3]

Government body

Name [3]

SA Health

Address [3]

PO Box 287
Rundle Mall
Adelaide SA 5000

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SA healthHREC

Ethics committee address [1]

Level 10 Citi-centre Building
11 Hindmarsh Square
Adelaide 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/08/2012

Approval date [1]

28/08/2012

Ethics approval number [1]

HREC/12/SAH/31

Ethics committee name [2]

Sydney Local Health District RPAH zone HREC

Ethics committee address [2]

Research Development Office
Royal Prince Alfred Hospital
Camperdown NSW 2050

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

14/11/2012

Approval date [2]

26/11/2012

Ethics approval number [2]

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

Dr Elizabeth Lynch

Address

International Centre of Allied Health Evidence
University of South Australia
GPO Box 2471
Adelaide
5001

Country

Australia

Phone

+61 8 8302 2099

Fax

elizabeth.lynch@unisa.edu.au

Contact person for public queries

Name

Elizabeth Lynch

Address

International Centre of Allied Health Evidence
University of South Australia
GPO Box 2471
Adelaide
5001

Country

Australia

Phone

+61 8 8302 2099

Fax

elizabeth.lynch@unisa.edu.au

Contact person for scientific queries

Name

Elizabeth Lynch

Address

International Centre of Allied Health Evidence
University of South Australia
GPO Box 2471
Adelaide
5001

Country

Australia

Phone

+61 8 8302 2099

Fax

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

Source	Title	Year of Publication	DOI
Embase	Education-only versus a multifaceted intervention for improving assessment of rehabilitation needs after stroke; a cluster randomised trial.	2016	https://dx.doi.org/10.1186/s13012-016-0487-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically