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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
17/04/2019
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?
Scientific title
Knowledge Translation Interventions: which are most effective and feasible for staff behaviour change and improved patient upper limb outcomes in neurorehabilitation.
Secondary ID [1] 297906 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinician adherence to clinical practice guidelines 312287 0
Upper limb hemiplegia 312288 0
Stroke 312346 0
brain injury 312347 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310836 310836 0 0
Occupational therapy
Physical Medicine / Rehabilitation 310837 310837 0 0
Physiotherapy
Stroke 310839 310839 0 0
Ischaemic
Stroke 310840 310840 0 0
Haemorrhagic
Injuries and Accidents 310841 310841 0 0
Other injuries and accidents
Neurological 310909 310909 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 314127 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 319676 0
Feasibility: Study recruitment of occupational therapists and physiotherapists (i.e. target users of the guidelines), assessed by determining the proportion of consented/those approached.
Timepoint [1] 319676 0
3 Months post-intervention commencement
Primary outcome [2] 319730 0
Feasibility: Time commitment for study participation, assessed by calculating the total time reportedly spent on implementation activities per Group.
Timepoint [2] 319730 0
3 Months post-intervention commencement
Primary outcome [3] 319731 0
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.
Timepoint [3] 319731 0
3 Months post-intervention commencement
Secondary outcome [1] 369132 0
Efficacy: as measured by guideline adherence by therapists, assessed using medical file audits pre- and post-intervention

Timepoint [1] 369132 0
3 months post intervention commencement
Secondary outcome [2] 369133 0
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.
Timepoint [2] 369133 0
3 Months post-intervention commencement
Secondary outcome [3] 369320 0
Efficacy: as measured by upper limb outcomes of participating patients, assessed using the Box and Block Test (BBT)
Timepoint [3] 369320 0
3 Months post-intervention commencement
Secondary outcome [4] 369321 0
Study recruitment of patient participants, assessed by calculating the total number of patients who consented.
Timepoint [4] 369321 0
3 Months post-intervention commencement
Secondary outcome [5] 369322 0
Protocol adjustments, assessed by logging the numbers and description of changes.
Timepoint [5] 369322 0
3 Months post-intervention commencement
Secondary outcome [6] 369480 0
Efficacy: as measured by upper limb outcomes of participating patients, assessed using Fugl-Meyer Upper Extremity Assessment
Timepoint [6] 369480 0
3 Months post-intervention commencement

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient participants with a degenerative brain injury will be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster level allocation
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302424 0
Hospital
Name [1] 302424 0
Alfred Health
Address [1] 302424 0
PO Box 315. Prahran VIC 3181.
Country [1] 302424 0
Australia
Funding source category [2] 302464 0
Hospital
Name [2] 302464 0
Peninsula Health
Address [2] 302464 0
PO Box 52, Frankston Vic 3199
Country [2] 302464 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road, Bundoora, Melbourne Victoria 3086
Country
Australia
Secondary sponsor category [1] 302325 0
None
Name [1] 302325 0
Address [1] 302325 0
Country [1] 302325 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303094 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 303094 0
The Alfred, 55 Commercial Road, Melbourne, Victoria 3004
Ethics committee country [1] 303094 0
Australia
Date submitted for ethics approval [1] 303094 0
Approval date [1] 303094 0
30/01/2017
Ethics approval number [1] 303094 0
565/16

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92446 0
A/Prof Natasha Lannin
Address 92446 0
Alfred Health Occupational Therapy Department
The Alfred
55 Commercial Road
Melbourne, Victoria 3004
Country 92446 0
Australia
Phone 92446 0
+61 41 7135153
Fax 92446 0
Email 92446 0
n.lannin@latrobe.edu.au
Contact person for public queries
Name 92447 0
A/Prof Natasha Lannin
Address 92447 0
Alfred Health Occupational Therapy Department
The Alfred
55 Commercial Road
Melbourne, Victoria 3004
Country 92447 0
Australia
Phone 92447 0
+61 41 7135153
Fax 92447 0
Email 92447 0
n.lannin@latrobe.edu.au
Contact person for scientific queries
Name 92448 0
A/Prof Natasha Lannin
Address 92448 0
Alfred Health Occupational Therapy Department
The Alfred
55 Commercial Road
Melbourne, Victoria 3004
Country 92448 0
Australia
Phone 92448 0
+61 41 7135153
Fax 92448 0
Email 92448 0
n.lannin@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Both the facilitator-mediated (Group A) and the self-directed (Group B) implementation packages were feasible to deliver in the rehabilitation setting. Therapists in Group A displayed behaviour change and were found to adhere significantly more to clinical practice guideline recommendations after three months of intervention exposure. We found no significant behaviour change for participants of Group B or Group C from the beginning to the end of intervention. We found no significant differences between any of the groups for upper limb outcomes