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Trial registered on ANZCTR


Registration number
ACTRN12618000170224
Ethics application status
Approved
Date submitted
23/01/2018
Date registered
2/02/2018
Date last updated
2/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving speech pathologists' implementation of recommended practices in acute aphasia management: What works?
Scientific title
The Acute Aphasia IMplementation Study (AAIMS): A pilot cluster randomised controlled trial to evaluate the efficacy of behaviour change interventions in Speech Pathologists
Secondary ID [1] 293867 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 306330 0
Aphasia 306331 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305415 305415 0 0
Speech therapy
Stroke 305416 305416 0 0
Ischaemic
Stroke 305417 305417 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multifaceted behaviour change interventions were delivered to speech pathologists working with people with acute post-stroke aphasia, in 4 hospitals. Sites were randomised to receive either intervention A (which focussed on improving the provision of aphasia friendly information to patients) or B (which focussed on improving collaborative goal setting with people with aphasia), with two sites randomised to each arm.
The interventions comprised of a single, face-to-face, two-and-a-half hour interactive education session and workshop. The session included intervention functions aimed at addressing the known barriers to the target behaviours (either Information Provision or Goal Setting), including education, persuasion, environmental restructuring, modelling and enablement.
These functions were used in the following ways:
1. Education - Education about the target behaviour to increase knowledge and understanding about the key evidence underlying the guideline recommendations, how to modify information to meet patient and family needs, and resources available. Feedback of
each cluster’s own baseline audits was also provided.
2. Persuasion - Persuasive communication was used to motivate increased performance. A video was presented of a person with aphasia and a family member discussing the importance of receiving information about aphasia from their therapist and how they would
have liked to receive this information (using persuasive language). The researchers also
presented case studies of people with aphasia who reported improved outcomes after receiving information.
3. Environmental restructuring - Teams were provided with resources to help change the physical environment and increase the target behaviour. For Intervention A, this included a newly-developed interactive PDF information package (called "What’s happening to me now?"), and instructions to support the package. Written protocols were provided in order to assist the participants embed the enhanced information package into their departments, as well as opportunities for discussion and action planning.
4. Modelling – Use of the information package was explained and modelled by the researchers using different case examples. Following this, experiential learning opportunities were created to impart skills and participants practiced and observed each
other using the various information resources in role-play scenarios.
5. Enablement – The workshop was interactive and promoted discussion, with teams asked to identify barriers and strategies to implement better information provision throughout. At the completion of each workshop, teams were asked to identify a goal for their implementation phase, and brainstorm strategies for success.
Records kept by research SP re intervention fidelity, and participant feedback and interaction during the intervention session, along with goals and strategies identified by participants.
Following the intervention, participating clusters implemented the recommended practices in an 'implementation phase' for a minimum of 12 weeks until 10 eligible patients with aphasia were seen, up to a maximum of 24 weeks.
Intervention code [1] 300128 0
Behaviour
Comparator / control treatment
Sites allocated to Intervention B received an attention control intervention.
This intervention was of comparable length and format, targeting the implementation of collaborative goal setting with people with aphasia. This session included intervention functions aimed at addressing the known barriers to this behaviour including education, persuasion, environmental restructuring, modelling and enablement.
Records kept by research SP re intervention fidelity, and participant feedback and interaction during the intervention session, along with goals and strategies identified by participants.
Control group
Active

Outcomes
Primary outcome [1] 304549 0
The primary outcome measure was the change in the targeted behaviour as determined by a medical record audit. Medical records were audited by an independent speech pathologist in each cluster and blinded to group allocation. Audits occurred both before and approximately four months after delivery of the implementation intervention using identical procedures. Auditors received training by the first author, and intra-rater reliability was completed for 20% of the medical charts.
Timepoint [1] 304549 0
Audits occurred both before (pre) and approximately four months after (post) delivery of the implementation intervention using identical procedures.
Secondary outcome [1] 342358 0
Case encounter checklist (composite secondary outcome): Participants completed a checklist for each encounter with a patient with aphasia. The listed behaviours included both the targeted and non-targeted behaviours for both interventions, and other unrelated behaviours relating to aphasia management, such as language assessment, so that it would not act as a prompt or reminder. The recorded behaviours provided more detailed information than that expected in the patient files and was used to determine whether targeted aphasia recommendations were completed by the speech pathologist independently of recording them in the patient’s file. The concordance between the post-implementation medical record audits and the checklist was also determined to assess how closely the audit data (in the primary outcome) matched the self-report measure.
Timepoint [1] 342358 0
Participants completed these checklists during the implementation phase (for 12-24 weeks following the intervention/workshop).
Secondary outcome [2] 342359 0
Behavioural constructs survey: Participants in both arms completed a behavioural constructs survey. The survey, based on the Theoretical Domains Framework. It aimed to determine differences in hypothesised predictors of behaviours post-implementation and whether targeted barriers were successfully addressed by the interventions. The survey included both targeted and non-targeted behaviours (information provision and goal setting). It was disseminated online via SurveyMonkey with each cluster given a unique access point to the survey to ensure that results were attributed correctly.
Timepoint [2] 342359 0
At baseline (prior to attending the workshop) and following completion of the implementation phase (4-6 months post-commencement).
Secondary outcome [3] 342360 0
Focus groups were conducted to obtain specific feedback about the acceptability of the implementation intervention and their perceptions on the potential effectiveness (i.e. what changes they made to their practice and why).
Timepoint [3] 342360 0
4-6 months post commencement of intervention sessions.

Eligibility
Key inclusion criteria
For medical record audit: patient admitted to hospital with new cerebral event or stroke, and the presence of aphasia as confirmed in the file by the treating speech pathologist.

To be included in interventions and focus groups: speech pathologists working on acute stroke unit or with people with acute post-stroke aphasia.
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, no diagnosis of aphasia made by the treating speech pathologist, receiving palliative care.

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)
random integer set generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
As the purpose of this study was to provide pilot data regarding the feasibility, acceptability and potential effectiveness of a tailored implementation strategy, the sample size was not powered to detect significant clinical change. Between-group pre-post analysis on the primary outcome measure (change score) was used to determine if the intervention was successful using Fisher’s exact test of independence. Analysis took clusters into account (i.e. performance of clinicians in same hospital). Alpha level was set at p<0.05. This level of significance was utilised due to the pilot nature of this research and to minimise the large possibility of Type II errors.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
3/04/2017
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
30
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 298486 0
University
Name [1] 298486 0
The University of Queensland
Country [1] 298486 0
Australia
Funding source category [2] 298511 0
University
Name [2] 298511 0
The University of Sydney
Country [2] 298511 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia
QLD
4072
Country
Australia
Secondary sponsor category [1] 297657 0
None
Name [1] 297657 0
Address [1] 297657 0
Country [1] 297657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299473 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 299473 0
Ethics committee country [1] 299473 0
Australia
Date submitted for ethics approval [1] 299473 0
14/01/2016
Approval date [1] 299473 0
28/04/2016
Ethics approval number [1] 299473 0
HREC/16/QPAH/52

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80526 0
Ms Kirstine Shrubsole
Address 80526 0
Level 7
Human and Health Sciences
Southern Cross University
Southern Cross Drive
Bilinga
QLD
4225
Country 80526 0
Australia
Phone 80526 0
+61 7 5589 3129
Fax 80526 0
Email 80526 0
kirstine.shrubsole@scu.edu.au
Contact person for public queries
Name 80527 0
Kirstine Shrubsole
Address 80527 0
Level 7
Human and Health Sciences
Southern Cross University
Southern Cross Drive
Bilinga
QLD
4225
Country 80527 0
Australia
Phone 80527 0
+61 7 5589 3129
Fax 80527 0
Email 80527 0
kirstine.shrubsole@scu.edu.au
Contact person for scientific queries
Name 80528 0
Kirstine Shrubsole
Address 80528 0
Level 7
Human and Health Sciences
Southern Cross University
Southern Cross Drive
Bilinga
QLD
4225
Country 80528 0
Australia
Phone 80528 0
+61 7 5589 3129
Fax 80528 0
Email 80528 0
kirstine.shrubsole@scu.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
EmbaseThe Acute Aphasia IMplementation Study (AAIMS): a pilot cluster randomized controlled trial.2018https://dx.doi.org/10.1111/1460-6984.12419
N.B. These documents automatically identified may not have been verified by the study sponsor.