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Trial registered on ANZCTR


Registration number
ACTRN12616000090415
Ethics application status
Approved
Date submitted
20/01/2016
Date registered
28/01/2016
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Type of registration
N/A

Titles & IDs
Public title
Improving translation of intensity and quality of upper limb rehabilitation provided by occupational therapists to children with cerebral palsy
Scientific title
Improving translation of intensity and quality of upper limb rehabilitation provided by occupational therapists to children with unilateral cerebral palsy: A cluster randomised trial.
Secondary ID [1] 288360 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 297357 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297547 297547 0 0
Occupational therapy
Musculoskeletal 297612 297612 0 0
Other muscular and skeletal disorders
Neurological 297613 297613 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multifaceted implementation program (MI): : (1) MI program is a multifaceted behavioural intervention and comprises (i) medical chart audit and feedback; (ii) barrier analysis and; (iii) tailored interactive training addressing barriers to implementation of contemporary rehabilitation, increasing dose and use of outcome measurement. Retrospective chart audits will be performed for all records of children with hemiplegia seen in the previous 1 year period by the chief investigator and participating occupational therapists. An audit form piloted in the TRIP project will be used to benchmark current practice against evidence criteria. Audit results for each team will be compiled by the chief investigator. Feedback of audit results will occur verbally (in a group meeting between the chief investigator and participating occupational therapists) and via written report separately to each cluster of occupational therapists. As part of the audit and feedback process, the chief investigator will lead a meeting with each cluster of occupational therapists (1-2 hours in duration) for facilitated goal setting and development of action plans to address gaps between current practice and evidence criteria identified in the file audit. Separate focus groups of approximately 1 hour duration involving each cluster of occupational therapists will be led by the chief investigator to determine unique contextual barriers to delivering the evidence-based UL intervention. Focus groups will be audiotaped, and transcribed verbatim and analysed using a framework approach (Pope et al. 2000). A validated questionnaire based on the Theoretical Domains Framework will quantitatively measure barriers to evidence based practice (Huijg et. 2014). Interactive education sessions (2 consecutive days, 4-5 hours duration each) will be conducted by the chief investigator with participating therapists in each cluster. Sessions will address knowledge and skills barriers identified during focus groups and involve small group case vignettes and problem solving. File audit and feedback will re-occur at 6 months accompanied with email project updates at 3 and 9 months to act as reminders and monitor adherence. Regular telephone and skype contact will be provided on an as needs basis determined by participating therapists. Final data collection via file audit will occur at 12 months.
Intervention code [1] 293665 0
Behaviour
Comparator / control treatment
Single faceted implementation program (SI): SI program is a single faceted behavioural program using audit and feedback alone. The same audit tool and process in the MI program will be used in the SI program including file audit, verbal and written feedback, facilitated goal setting and development of action plans. The file audit and feedback process will be performed again at 6 and 12 months, with email project updates at 3 and 9 months to act as reminders.
Control group
Active

Outcomes
Primary outcome [1] 297099 0
Process outcome: Percentage of eligible children with rehabilitation goals identified collaboratively with caregiver/child prior to rehabilitation (determined through medical chart audit)
Timepoint [1] 297099 0
12 months post start of implementation program
Primary outcome [2] 297100 0
Percentage of children who receive motor learning, evidence based rehabilitation approach (determined through medical chart audit)
Timepoint [2] 297100 0
12 months post start of implementation program
Primary outcome [3] 297101 0
Process outcome: Mean hours of direct and indirect (home program) therapy received by eligible children in each rehabilitation episode of care. (determined through medical chart audit and hospital/service patient statistics)

Timepoint [3] 297101 0
12 months post start of implementation program
Secondary outcome [1] 320021 0
Process outcome: Percentage of children with record of upper limb assessment before and after rehabilitation episode of care (determined through medical chart audit)
.
Timepoint [1] 320021 0
12 months post start of implementation program
Secondary outcome [2] 320022 0
Patient outcome: Percentage of individual child goals fully achieved (Canadian Occupational Performance Measure).
Timepoint [2] 320022 0
12 months post start of implementation program
Secondary outcome [3] 320054 0
Patient outcome: change in upper limb function pre-post episode of care (outcome dependent on availability at each site: e.g. Assisting Hand Assessment; Melbourne Assessment; Children's Hand Use Experience Questionnaire) (determined through medical chart audit)
Timepoint [3] 320054 0
12 months post start of implementation program
Secondary outcome [4] 320194 0
Process outcome: Percentage of eligible children with goals measured before and after and therapy episode of care (determined through medical chart audit)
Timepoint [4] 320194 0
12 months post start of implementation program
Secondary outcome [5] 320195 0
Process outcome: Percentage of eligible children who receive > 30 hours of therapy (direct from therapy & indirect through home program) in an episode of care (determined through medical chart audit, patient hospital statistics, and home program logs completed by parents)
Timepoint [5] 320195 0
12 months post the start of the implementation program
Secondary outcome [6] 320196 0
Patient outcome: Percentage of individualised goals achieving a clinically significant change following a therapy episode of care (Canadian Occupational Performance Measure).
Timepoint [6] 320196 0
12 months post start of implementation program

Eligibility
Key inclusion criteria
Occupational therapists across four geographical regions, working with children with cerebral palsy will be eligible to be included.

Patients: Children with unilateral cerebral palsy (aged 0-18) seen by each participating therapist will be eligible for inclusion
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Occupational therapists who have participated previously in a pilot implementation study conducted by the same research group will not be eligible for inclusion.

Patients: Children with bilateral presentation of cerebral palsy are not eligible for inclusion.

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)
Geographical location (cluster) will be matched according to population of children with cerebral palsy residing in the area, so to ensure that clusters are similar at baseline. Within the paired clusters, one will be randomised to the intervention group and the other to the comparison group using a computer generated random number sequence. A statistician independent of the study will conduct the randomisation. Allocation will be concealed from investigators until all baseline data is collected from participating therapists.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number sequence will be generated using STATA 12.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size was calculated to detect difference in number of rehabilitation hours for MI and SI groups at 12 months. Based on pilot data from the TRIP project, a mean difference of 6 hours of rehabilitation is proposed. Based on a SD of 3.5, significance level of 0.05 and 90% power, adjusted for the effect of clustering (Design Effect 1.7), and buffering 20% attrition, 36 therapists are required. Patient sample size of 40 children was determined based on a 2 point difference on the Canadian Occupational Performance Measure, SD of 1.5, 80% power and 0.05 significance level, and adjusted for clustering effect.
Data will be analysed using generalised estimating equations to adjust for clustering effects within geographical location. A cost-effectiveness ratio will be constructed to compare the additional costs of delivering the MI compared to SI intervention to the additional benefits gained.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Recruited sites: major changes in scope of work of recruited organisations (in preparation for the National Disability Insurance Scheme roll out in Queensland), significant staff turnover (80% in one site over a 1 year period) has impacted on data collection.
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)
QLD

Funding & Sponsors
Funding source category [1] 292729 0
Government body
Name [1] 292729 0
National Health and Medical Research Council
Address [1] 292729 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 292729 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
62 Graham St
South Brisbane, Queensland, 4101
Country
Australia
Secondary sponsor category [1] 291460 0
None
Name [1] 291460 0
None
Address [1] 291460 0
None
Country [1] 291460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294214 0
Children's Health Services Queensland
Ethics committee address [1] 294214 0
Centre for Children's Health Research
62 Graham St
South Brisbane Queensland 4101
Ethics committee country [1] 294214 0
Australia
Date submitted for ethics approval [1] 294214 0
01/05/2014
Approval date [1] 294214 0
20/05/2014
Ethics approval number [1] 294214 0
HREC/14/QRCH/77
Ethics committee name [2] 294215 0
The University of Queensland Instiutional Human Research Ethics
Ethics committee address [2] 294215 0
UQ Research and Innovation,
Cumbrae Stewart Building,
St Lucia Campus
Queensland 4072
Ethics committee country [2] 294215 0
Australia
Date submitted for ethics approval [2] 294215 0
27/05/2014
Approval date [2] 294215 0
29/05/2014
Ethics approval number [2] 294215 0
201400732

Summary
Brief summary
Congenital hemiplegia occurs in over 1 million children under 21 years of age in the industrialized world and is the most common type of cerebral palsy. Children with unilateral cerebral palsy (CP) usually present with greater upper limb (UL) than lower limb impairment, which impacts on daily independence, societal participation and vocational aspirations. Contemporary rehabilitation approaches for which there is strong evidence (e.g. constraint induced movement therapy (CIMT), intensive bimanual training, task-oriented training) have been developed based on motor learning theory and neuroscientific research which has increased our understanding of the mechanisms of use dependent neuroplasticity. Essential elements of contemporary approaches include therapy that uses; (1) intensive structured task repetition; (2) progressive incremental challenges of increasing difficulty; (3) goal-directed framework that is self-motivating. All these components are crucial, as intensity of intervention alone, without being goal directed and structured is not efficacious.
Recent surveys of paediatric therapists indicate that: (1) traditional neurodevelopmental treatment approaches remain commonly used as standard clinical practice, despite a lack of evidence of efficacy; (ii) collaborative goal setting does not often occur with patients; (iii) contemporary motor learning approaches are not often used; and (iv) objective measurement of treatment outcomes is infrequent. A tailored multi-faceted implementation strategy (using file audit and feedback, barrier identification and interactive training targeting barriers) was piloted with 9 occupational therapists from three paediatric teams and found promising changes in clinical practice behaviour including: (i) greater measurement of goals before (+17%) and after 15 (+22%) therapy; use of constraint therapy (+38%), bimanual therapy (+26%), home programs 16 (+14%); measurement of UL outcomes before (+29%) and after (+23%) therapy. Children receiving the target dose of therapy increased from 0 to 10%.
A cluster randomised trial will now be conducted to compare this tailored multi-faceted implementation strategy to a single faceted strategy alone (audit and feedback). Geographical regions (n=4 regions; 36 therapists) will be randomised to receive either the multi-faceted or single faceted implementation strategy. We aim to recruit 40 children with unilateral cerebral palsy seen by participating therapists. The outcomes of the study will be assessed at the level of the therapist against 5 key evidence criteria: (1) were goals set collaboratively with patients/families; (2) were goals measured objectively before and after an episode of care; (3) was a contemporary motor learning approach used; (4) was a target dose of therapy provided (min 30 hours); (5) were upper limb outcomes measured objectively before and after a therapy episode of care. Patient outcomes include goal attainment and change in upper limb function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62878 0
Dr Leanne Sakzewski
Address 62878 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
62 Graham St
South Brisbane, Queensland 4101
Country 62878 0
Australia
Phone 62878 0
+61 7 30697345
Fax 62878 0
Email 62878 0
l.sakzewski1@uq.edu.au
Contact person for public queries
Name 62879 0
Dr Leanne Sakzewski
Address 62879 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
62 Graham St
South Brisbane, Queensland 4101
Country 62879 0
Australia
Phone 62879 0
+61 7 30697345
Fax 62879 0
Email 62879 0
l.sakzewski1@uq.edu.au
Contact person for scientific queries
Name 62880 0
Dr Leanne Sakzewski
Address 62880 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Centre for Children's Health Research
62 Graham St
South Brisbane, Queensland 4101
Country 62880 0
Australia
Phone 62880 0
+61 7 30697345
Fax 62880 0
Email 62880 0
l.sakzewski1@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
No Results