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Trial registered on ANZCTR
Registration number
ACTRN12619000596101
Ethics application status
Approved
Date submitted
7/04/2019
Date registered
17/04/2019
Date last updated
23/12/2021
Date data sharing statement initially provided
17/04/2019
Date results information initially provided
17/04/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Knowledge Translation Interventions; which are most effective in upper limb rehabilitation?
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Scientific title
Knowledge Translation Interventions: which are most effective and feasible for staff behaviour change and improved patient upper limb outcomes in neurorehabilitation.
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Secondary ID [1]
297906
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clinician adherence to clinical practice guidelines
312287
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Upper limb hemiplegia
312288
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Stroke
312346
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brain injury
312347
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Condition category
Condition code
Physical Medicine / Rehabilitation
310836
310836
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0
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Occupational therapy
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Physical Medicine / Rehabilitation
310837
310837
0
0
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Physiotherapy
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Stroke
310839
310839
0
0
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Ischaemic
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Stroke
310840
310840
0
0
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Haemorrhagic
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Injuries and Accidents
310841
310841
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0
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Other injuries and accidents
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Neurological
310909
310909
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Group A received the facilitator mediated implementation package. Group B received the self-directed implementation package group. The Control Group received usual care (no intervention for implementation of the guidelines beyond access to the guidelines or usual continuing professional development).
Group A, the facilitator mediated implementation package group received: point of care videos, face to face education sessions (45mins duration, fortnightly), access to online education modules, written manuals, coaching and mentoring, audit and feedback each fortnight of recommendation adherence, access to physical resources and environmental alterations to encourage patient independent practice. Group B, the self-directed implementation package group received: point of care videos, online education modules, posters of clinical practice guideline recommendations, written manuals, access to physical resources (e.g. electrical stimulation machines), care pathways to simplify clinical reasoning and consumer information (i.e. handouts for patients).
Face to face education sessions (of 45mins in duration) were held every fortnight, each covering one of the six specified topic areas [Group A only]. Six online modules were made available every fortnight, each covering these same specified topic areas (written version of the content covered in face to face sessions). The duration of the online module content ranged from 15-20mins each, depending on topic area for that fortnight [Groups A and B].
All of the face-to-face education sessions and online modules were created specifically for this study by the research team, as were the written manuals (i.e. modified constraint induced movement therapy and electrical stimulation manuals). The videos were a combination of created videos, as well as videos available from YouTube (https://www.youtube.com/watch?v=Ze9j-IeTy8Q; https://www.youtube.com/watch?v=i_HbuynsRV8)
Throughout the study period, clinicians in Group A received specific coaching during the face to face sessions (approximately 10-15 minutes of the 45min session) by a researcher (and expert in upper limb rehabilitation) which included demonstration and problem solving some of the challenges therapists raised during the session. Outside of this, Group A had access to researchers (upper limb experts) for one on one mentoring sessions and/or joint therapy sessions with patients, scheduled at the request of the clinician [Group A only].
Physical resources were provided to clinicians in Groups A and B, although they requested different resources. Group A: Physical resources provided included 1) electrical stimulation machines 2) constrain induced movement therapy mitts 3) a trolley of dedicated upper limb therapy equipment (i.e. items for gross and fine motor retraining such as balls, coins, cups, jars and utensils) 4) patient handouts detailing exercises 5) posters outlining safe positioning for the upper limb to be displayed in patient’s room 6) Graded Repetitive Arm Supplementary Program (GRASP) kits 7) Upper limb assessments including the Fugl-Meyer. The environmental alterations included: 1) dedicated ward space for patients to completing upper limb rehabilitation and independent practice 2) community therapists received a ‘mobile upper limb kit’ to take to patient’s home’s 3) a trolley full of items for upper limb therapy was provided in the dedicated ward space 4) storage space in the ‘equipment store rooms’ was allocated and re-stocked with upper limb equipment and assessments.
Group B received: 1) electrical stimulation machines 2) patient handouts detailing exercises 3) Graded Repetitive Arm Supplementary Program (GRASP) kits 4) Upper limb assessments including the Fugl-Meyer
At the conclusion of the study, participants were asked to self-report the use of implementation strategies provided.
Method of allocation: Non-randomised; the six participating sites were pragmatically allocated into one of the three clusters (Group A, B and C).
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Intervention code [1]
314127
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Behaviour
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Comparator / control treatment
The definition of ‘usual care’ has not been standardised, for the purposes of this study it is defined as ‘the routine care received by patients at each participating site for the rehabilitation of their neurological condition’. Whilst there are likely to be differences between each site in regards to what ‘routine care’ looks like, we audited each site prior to the commencement of the intervention so that adherence to best practice recommendations could be compared within each site.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility: Study recruitment of occupational therapists and physiotherapists (i.e. target users of the guidelines), assessed by determining the proportion of consented/those approached.
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Assessment method [1]
319676
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Timepoint [1]
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3 Months post-intervention commencement
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Primary outcome [2]
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Feasibility: Time commitment for study participation, assessed by calculating the total time reportedly spent on implementation activities per Group.
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Assessment method [2]
319730
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Timepoint [2]
319730
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3 Months post-intervention commencement
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Primary outcome [3]
319731
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Feasibility: Therapists perspectives on intervention feasibility, assessed via a survey of participating therapists at completion of study. The survey was designed specifically for this study.
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Assessment method [3]
319731
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Timepoint [3]
319731
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3 Months post-intervention commencement
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Secondary outcome [1]
369132
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Efficacy: as measured by guideline adherence by therapists, assessed using medical file audits pre- and post-intervention
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Assessment method [1]
369132
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Timepoint [1]
369132
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3 months post intervention commencement
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Secondary outcome [2]
369133
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Acceptance: Therapist participants’ acceptance of the intervention, will be assessed by survey and focus groups.
Given that there were no appropriately validated surveys to meet the needs of this study, the survey we used was designed, piloted and used specifically for this study. One post-intervention focus group was held with participating therapists allocated to Group A. In total, 6 occupational therapists consented to participate (75% response rate from Group A participants) in the 60 minute focus group. The focus group was audio recorded and later transcribed verbatim for thematic coding.
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Assessment method [2]
369133
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Timepoint [2]
369133
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3 Months post-intervention commencement
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Secondary outcome [3]
369320
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Efficacy: as measured by upper limb outcomes of participating patients, assessed using the Box and Block Test (BBT)
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Assessment method [3]
369320
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Timepoint [3]
369320
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3 Months post-intervention commencement
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Secondary outcome [4]
369321
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Study recruitment of patient participants, assessed by calculating the total number of patients who consented.
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Assessment method [4]
369321
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Timepoint [4]
369321
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3 Months post-intervention commencement
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Secondary outcome [5]
369322
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Protocol adjustments, assessed by logging the numbers and description of changes.
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Assessment method [5]
369322
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Timepoint [5]
369322
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3 Months post-intervention commencement
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Secondary outcome [6]
369480
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Efficacy: as measured by upper limb outcomes of participating patients, assessed using Fugl-Meyer Upper Extremity Assessment
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Assessment method [6]
369480
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Timepoint [6]
369480
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3 Months post-intervention commencement
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Eligibility
Key inclusion criteria
Therapist participants inclusion criteria:
• Registered occupational therapist (OT) or physiotherapist (PT) working at one or two of the participating sites
• Working with an acquired brain injury patient (i.e. stroke and/or trauma) caseload.
Patient participants inclusion criteria:
• The treating therapist had consented to participating in the study;
• The patient was currently receiving therapy to address upper limb goal/s
• The patient has documented upper limb goals; and
• The patient (or their proxy) was able to provide consent to participate in the study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patient participants with a degenerative brain injury will be excluded.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Cluster level allocation
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
- Descriptive statistics to describe participant characteristics, recruitment rates and responses to multiple choice survey items.
- Focus group data (tape-recorded and transcribed verbatim) and free-text survey responses will be thematically coded
- Summary statistics for patient outcome measures and medical file audits will be analysed for medians (IQR), within group proportion differences (medians with 95% confidence intervals) and between group proportion differences (median and 95% confidence intervals) using Wilcoxon’s signed rank tests. Estimates of variability of proposed outcomes and confidence intervals around treatment effects will also be reported.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
28/05/2017
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Date of last participant enrolment
Anticipated
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Actual
4/09/2017
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Date of last data collection
Anticipated
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Actual
27/11/2017
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Sample size
Target
30
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Accrual to date
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Final
29
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
302424
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Hospital
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Name [1]
302424
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Alfred Health
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Address [1]
302424
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PO Box 315. Prahran VIC 3181.
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Country [1]
302424
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Australia
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Funding source category [2]
302464
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Hospital
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Name [2]
302464
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Peninsula Health
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Address [2]
302464
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PO Box 52, Frankston Vic 3199
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Country [2]
302464
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
Plenty Road, Bundoora, Melbourne Victoria 3086
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Country
Australia
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Secondary sponsor category [1]
302325
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None
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Name [1]
302325
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Address [1]
302325
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Country [1]
302325
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303094
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
303094
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The Alfred, 55 Commercial Road, Melbourne, Victoria 3004
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Ethics committee country [1]
303094
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Australia
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Date submitted for ethics approval [1]
303094
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Approval date [1]
303094
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30/01/2017
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Ethics approval number [1]
303094
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565/16
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Summary
Brief summary
Occupational therapists and physiotherapists face challenges to providing evidence-based rehabilitation and require support to implement clinical practice guidelines. The aim of this study is to test the feasibility of two different implementation packages which aim to improve guideline adherence, and to explore effect on patient upper limb outcomes.
Using a non-randomised clustered design, the study recruited occupational and physiotherapy rehabilitation services (n=3 inpatient and n=3 outpatient services) which were allocated to one of three groups: (Group A) Facilitator-mediated implementation package, (Group B) Self-directed implementation package, or (Group C) Usual care (control); we recruited n=1 inpatient and n=1 outpatient service per Group. Outcomes of feasibility, adherence to guidelines (medical file audits), and patient upper limb impairment (Fugl-Meyer Upper Extremity Assessment), activity (Box and Block Test), and practice (minutes/week) were collected at baseline and after 3-months of intervention.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Natasha Lannin
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Address
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Alfred Health Occupational Therapy Department
The Alfred
55 Commercial Road
Melbourne, Victoria 3004
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Country
92446
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Australia
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Phone
92446
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+61 41 7135153
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Fax
92446
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Email
92446
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[email protected]
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Contact person for public queries
Name
92447
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A/Prof Natasha Lannin
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Address
92447
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Alfred Health Occupational Therapy Department
The Alfred
55 Commercial Road
Melbourne, Victoria 3004
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Country
92447
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Australia
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Phone
92447
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+61 41 7135153
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Fax
92447
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Email
92447
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[email protected]
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Contact person for scientific queries
Name
92448
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A/Prof Natasha Lannin
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Address
92448
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Alfred Health Occupational Therapy Department
The Alfred
55 Commercial Road
Melbourne, Victoria 3004
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Country
92448
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Australia
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Phone
92448
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+61 41 7135153
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Fax
92448
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Email
92448
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Ethical approval was not provided for sharing individual participant data as participants are clinicians. Consent included a statement that data would not be individually identifiable, nor would it be shared with management. Given the numbers were small at each site, it is not possible to ensure confidentiality if IPD is shared.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Jolliffe, L., Hoffmann, T., Churilov, L. & Lannin,...
[
More Details
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Plain language summary
No
Both the facilitator-mediated (Group A) and the se...
[
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Documents added automatically
Source
Title
Year of Publication
DOI
Embase
What is the feasibility and observed effect of two implementation packages for stroke rehabilitation therapists implementing upper limb guidelines? A cluster controlled feasibility study.
2020
https://dx.doi.org/10.1136/bmjoq-2020-000954
N.B. These documents automatically identified may not have been verified by the study sponsor.
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