Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001616460
Ethics application status
Approved
Date submitted
16/11/2016
Date registered
23/11/2016
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Date results provided
11/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cerebral palsy check up: Supporting allied health professionals to provide the best service at the best time
Scientific title
Effect of a tailored multi-faceted knowledge translation intervention on allied health professionals' treatment implementation behaviours for children with cerebral palsy: A before and after study.
Secondary ID [1] 290546 0
Nil
Universal Trial Number (UTN)
U1111-1189-8947
Trial acronym
Best Service Best Time (BSBT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 300987 0
Condition category
Condition code
Neurological 300781 300781 0 0
Other neurological disorders
Musculoskeletal 300782 300782 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300783 300783 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tailored multi-faceted knowledge translation intervention provided to allied health professionals (AHP: physiotherapists, occupational therapists, speech pathologists) who provide services to children with cerebral palsy in four Australian non-government organisations (collectively defined as the Commencing Knowledge Translation group) with the aim on increasing the implementation of routine clinical assessment and provision of evidence-based interventions provided to children aged 3-18 years.

The intervention is implemented at each organisation for 2 years and includes four strands:
(1) Identification of “Knowledge Brokers” (expert research translators) based at each organisation who will aim to re-dress workplace barriers unique to each site. Each organisation will nominate one or more knowledge brokers for their site. The knowledge brokers will work with the project team, the organisation’s management and the AHPs to act as agents in the process of translating and contextualising evidence for users within the organisation.
Materials and procedures used to support knowledge brokers include 1 day training sessions, about the knowledge broker role, delivered by researchers at the beginning and mid-way through the project; peer support through periodic (approximately twice yearly) telephone conferences involving knowledge brokers across organisations; provision of an on-line discussion forum monitored by researchers. Knowledge brokers are intended to provide support to AHP within their own organisation throughout the trial period. Experience and ongoing fidelity of the broker role will be evaluated through focus groups conducted at baseline, 6, 12, and 24 months.

(2) Provision of a customised e-evidence library - “CP Decision” - to enable AHPs rapid access to synthesised and critiqued cerebral palsy research evidence. This library employs a traffic light system corresponding to evidence levels and will be updated on an ongoing basis to accommodate new evidence as it emerges.
Materials are an on-line database of cerebral palsy specific evidence. Procedures include providing all participating organisations with a password that can be used by employees to log in and review the information as frequently as each individual AHP wishes. CP Decision will be available to all organisations throughout the study period. Intervention fidelity will be assessed for each organisation monthly, by evaluating the frequency of 'visits' to the site as well as by determining the most frequently viewed pages.

(3) Negotiated education and professional development days for AHP at partner organisations (implemented by the project investigators, organisation-based knowledge brokers and other experts) about ‘how to’ implement or administer the current and most effective treatment and measurement options for cerebral palsy.
This intervention strand will include two elements: a) a study specific element provided to all organisations and b) an organisation-specific element, tailored to meet the needs of individual organisations.
The study-specific element is provided at baseline, 6, 12 and 24 months by researchers in a face to face professional development workshop format for half a day. Attendance of participating AHP is recorded, and fidelity assessed via feedback on learning sought through an evaluation form.
Organisation-specific elements are negotiated annually with the researchers and can include purchase of educational events (e.g. experts to deliver training sessions on site at the organisation; or payment of registration fees for individual AHP to attend courses) or resources to support implementation of evidence based practices for children with cerebral palsy (e.g. purchase of evidence-based assessment tool). Procedures involve knowledge brokers collaborating with local AHP and managers to develop an annual professional development plan, presenting (in writing) the plan to researchers for consideration and approval against an agreed budget. Fidelity/processes will be assessed by recording of all education events and professional development purchases made for each organisation throughout the project and monthly reporting to the project steering committee.

(4) Provision of an electronic cerebral palsy clinical outcomes database (CP Check-UpTM, provided by Cerebral Palsy Alliance). This electronic tool will be used by AHPs to record routine valid and reliable clinical measurements of participating children and to summarise the therapeutic interventions provided to these children. Through generation of an electronic report, the tool will provide feedback about changes in outcomes of individual children over time, guiding evidence-based clinical decision making to support direct therapeutic intervention and timely referral to ancillary services.
Materials provided are a study manual and paper-based forms to enable AHP to learn what is included and how to access the database and enter details for children. In addition, personalised log-in details are provided for all participating AHP so that they can access the electronic database and enter data for included children. The Database is made available to each organisation for the period of the study. Support is provided by researchers and the manager of the database.
Fidelity is assessed as one key outcome of the study - by extracting data related to number of children for whom an assessment is recorded, frequency of assessment of each included child and proportion of the minimum data set recorded for each assessment.
Intervention code [1] 296407 0
Rehabilitation
Intervention code [2] 296408 0
Behaviour
Comparator / control treatment
A fifth organisation is identified as the 'Comparison organisation' as the four strands of the tailored intervention are mandated in that organisation and embedded in routine practice. This organisation is deemed to be further along the knowledge translation implementation time line than the Commencing KT organisations.
Control group
Active

Outcomes
Primary outcome [1] 300202 0
Longitudinal change in AHP evidence-based behaviours measured in two ways:
1) self report using the Evidence Based Practice Competency Questionnaire-Cerebral Palsy (Campbell et al., 2013) scored as two reliable sub-scales (Kerr et al.) and
2) actual AHP assessment behaviours evaluated using data extracted from the CP Check-Up TM database to assess changes in number of children receiving assessment (proportion of those eligible) and amount of evidence-based assessment provided (compliance score range 0-100).
Timepoint [1] 300202 0
Baseline, 6, 12 and 24 months
Primary outcome [2] 300203 0
Longitudinal changes in AHP evidence based practice knowledge assessed using a knowledge quiz adapted from Campbell et al. 2013,
Timepoint [2] 300203 0
Baseline, 6 months, 12 months, 24 months
Secondary outcome [1] 329346 0
Longitudinal change in supports and barriers to implementation of evidence-based assessment. evaluated using a multiple methods approach to derive an outcome from composite measures including:
1) Supports and Barriers questionnaire, adapted from Rivard et al. 2010, and
2) Focus groups held with AHP;
Timepoint [1] 329346 0
Baseline, 6 months, 12 months, and 24 months.
Secondary outcome [2] 329348 0
Longitudinal change in adverse outcomes for children with cerebral palsy, including severe scoliosis, hip dislocation, progressive limb contractures over the study period.
Assessed using data extracted from the CP Check Up electronic database in which AHP record measures taken using goniometry, reports from X-Rays.
Timepoint [2] 329348 0
Baseline, 6 months, 12 months, 24 months, 29 months
Secondary outcome [3] 329350 0
Longitudinal changes in AHP attitudes to evidence based practices assessed using 2 sub-scales from the Evidence Based Practice Attitudes Scale (Aarons et al. 2004, 2012):
1) Perceived Divergence sub-scale and
2) Openness to Innovation sub-scale.
Timepoint [3] 329350 0
Baseline, 6 months, 12 months, 24 months
Secondary outcome [4] 329435 0
Longitudinal changes in supports and barriers to implementation of evidence based assessment processes assessed through data gathered through composite outcomes including focus groups held with (i) Knowledge brokers; (ii) clinical service managers and (iii) individual interviews with Chief Executive Officer or senior managers.
Timepoint [4] 329435 0
Baseline, 6, 12 and 24 months for focus group data collection and baseline and 24 months for senior managers.

Eligibility
Key inclusion criteria
The study has 2 groups:
The primary outcomes are focused on the Allied Health Professionals:
All physiotherapists, occupational therapists and speech pathologists working, or having the potential to work with children with cerebral palsy in participating service providers, will be eligible to participate. There are no exclusion criteria.

The secondary outcomes are focused on children with cerebral palsy:
Children aged 3-18 years with a diagnosis of cerebral palsy will also be recruited to the study. There are no exclusion criteria.
Minimum age
3 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study will employ a before and after design in four Australian non-government organisations that provide allied health services to children with cerebral palsy, with a fifth organisation acting as a comparison site.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Estimated Sample Size and Power of the Study
Based on organisational commitment to the project, and expected workforce changes during the course of the study, it is anticipated that 80% of the eligible AHP will take part in the study (i.e. 192 participants from an estimated 240 eligible AHP participants across all partner organisations). Calculations indicate that this sample will be sufficient to detect a difference of 6 points on the Best Service Best Time Evaluation with >90% power.

Pre-study estimation of the number of participating children, suggests a sample size of 614 may be achieved (80% of the 768 eligible children identified across all partner organisations). A 10% arithmetic difference between baseline and subsequent child-based quality measures (e.g. range of movement) will be able to be detected with >90% power (where baseline percentage is around 50%; power will be greater where the baseline percentage is smaller or larger than 50%).

Statistical analyses
Cross-sectional data will be examined and reported, however primary analyses will focus on the longitudinal design of this study, assessing change over time in AHP evidence-based practice behaviours, and in clinical outcomes for participating children.

Quantitative analyses will be carried out with multivariate statistical models such as population-averaged generalized estimating equations and subject-specific generalized linear and latent mixed models. These models allow for correlated longitudinal data structures and intraclass correlation coefficients (required due to children being clustered within AHP and AHP within organisations). In addition, these models can include outcomes of mixed types including counts, ordered and un-ordered responses, and dichotomous and metric outcomes. Potential confounders will be examined and study sites will be treated as covariates to account for differing adoption of new practices rates. The significance of the covariates will be ascertained with 95% confidence intervals.

Qualitative focus group and interview data will be digitally recorded and transcribed, coded and analysed using a grounded theory approach to thematic analysis. Themes within and between participants, and groups of participants, will be used to understand the feasibility and acceptability of the knowledge broker role and aligned evidence based practices within the different organisations.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/05/2013
Date of last participant enrolment
Anticipated
Actual
1/12/2015
Date of last data collection
Anticipated
Actual
15/12/2015
Sample size
Target
192
Accrual to date
Final
447
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment postcode(s) [1] 14622 0
2086 - Frenchs Forest
Recruitment postcode(s) [2] 14623 0
7250 - Launceston
Recruitment postcode(s) [3] 14624 0
7000 - Hobart
Recruitment postcode(s) [4] 14625 0
5010 - Regency Park
Recruitment postcode(s) [5] 14626 0
3220 - Geelong
Recruitment postcode(s) [6] 14627 0
3127 - Surrey Hills
Recruitment postcode(s) [7] 14628 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 294981 0
Government body
Name [1] 294981 0
National Health and Medical Research Council
Country [1] 294981 0
Australia
Funding source category [2] 294982 0
Other Collaborative groups
Name [2] 294982 0
Yooralla
Country [2] 294982 0
Australia
Funding source category [3] 294983 0
Other Collaborative groups
Name [3] 294983 0
Novita Children's Services
Country [3] 294983 0
Australia
Funding source category [4] 294984 0
Other Collaborative groups
Name [4] 294984 0
St Giles
Country [4] 294984 0
Australia
Funding source category [5] 294985 0
Other Collaborative groups
Name [5] 294985 0
Cerebral Palsy Alliance
Country [5] 294985 0
Australia
Funding source category [6] 294986 0
Other Collaborative groups
Name [6] 294986 0
Kids Plus
Country [6] 294986 0
Australia
Primary sponsor type
Individual
Name
Christine Imms
Address
Australian Catholic University,
17 Young Street, Fitzroy, Melbourne 3065,
Country
Australia
Secondary sponsor category [1] 293802 0
Individual
Name [1] 293802 0
Iona Novak
Address [1] 293802 0
Cerebral Palsy Alliance,
PO Box 6427, Frenchs Forest NSW 2086, Sydney,
Country [1] 293802 0
Australia
Secondary sponsor category [2] 293803 0
Individual
Name [2] 293803 0
Nora Shields
Address [2] 293803 0
School of Allied Health, Corner of Plenty Road & Kingsbury Drive La Trobe University, Bundoora, Victoria 3086
Country [2] 293803 0
Australia
Secondary sponsor category [3] 293804 0
Individual
Name [3] 293804 0
H. Kerr Graham
Address [3] 293804 0
Royal Children's Hospital, 50 Flemington Road Parkville, VICTORIA 3052
Country [3] 293804 0
Australia
Secondary sponsor category [4] 293805 0
Individual
Name [4] 293805 0
Dinah Reddihough
Address [4] 293805 0
Royal Children's Hospital, 50 Flemington Road Parkville, VICTORIA 3052
Country [4] 293805 0
Australia
Secondary sponsor category [5] 293806 0
Individual
Name [5] 293806 0
Steve Bowe
Address [5] 293806 0
Deakin Biostatistics Unit, Faculty of Health, Deakin University,
221 Burwood Hwy, Burwood VIC 3125
Country [5] 293806 0
Australia
Other collaborator category [1] 279307 0
Individual
Name [1] 279307 0
Claire Kerr
Address [1] 279307 0
Australian Catholic University, 17 Young Street, Fitzroy, Melbourne 3065
Country [1] 279307 0
Australia
Other collaborator category [2] 279308 0
Individual
Name [2] 279308 0
Petra Karlsson
Address [2] 279308 0
Cerebral Palsy Alliance,
PO Box 6427, Frenchs Forest NSW 2086, Sydney,
Country [2] 279308 0
Australia
Other collaborator category [3] 279309 0
Individual
Name [3] 279309 0
Sarah Foley
Address [3] 279309 0
Kids Plus Foundation, 163 Myers St, Geelong, Victoria 3220
Country [3] 279309 0
Australia
Other collaborator category [4] 279310 0
Individual
Name [4] 279310 0
Lyndsay Quarmby
Address [4] 279310 0
St Giles, PO Box 416, Launceston, Tasmania 7250
Country [4] 279310 0
Australia
Other collaborator category [5] 279311 0
Individual
Name [5] 279311 0
Kerry Evans
Address [5] 279311 0
Novita Children’s Services, 171 Days Road Regency Park, Adelaide, South Australia 5010
Country [5] 279311 0
Australia
Other collaborator category [6] 279312 0
Individual
Name [6] 279312 0
Marisa McCague
Address [6] 279312 0
Yooralla, PO Box 223, Surrey Hills, Victoria 3127,
Country [6] 279312 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296338 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 296338 0
Ethics committee country [1] 296338 0
Australia
Date submitted for ethics approval [1] 296338 0
23/11/2012
Approval date [1] 296338 0
05/03/2013
Ethics approval number [1] 296338 0
2012 309V
Ethics committee name [2] 296339 0
Cerebral Palsy Alliance
Ethics committee address [2] 296339 0
Ethics committee country [2] 296339 0
Australia
Date submitted for ethics approval [2] 296339 0
15/03/2013
Approval date [2] 296339 0
03/04/2013
Ethics approval number [2] 296339 0
2013-04-02
Ethics committee name [3] 296340 0
Department of Education and Early Childhood Development
Ethics committee address [3] 296340 0
Ethics committee country [3] 296340 0
Australia
Date submitted for ethics approval [3] 296340 0
15/04/2013
Approval date [3] 296340 0
07/06/2013
Ethics approval number [3] 296340 0
2013-001962

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

Contacts
Principal investigator
Name 70490 0
Prof Christine Imms
Address 70490 0
University of Melbourne
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia
Country 70490 0
Australia
Phone 70490 0
+61393454953
Fax 70490 0
Email 70490 0
[email protected]
Contact person for public queries
Name 70491 0
Christine Imms
Address 70491 0
University of Melbourne
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia
Country 70491 0
Australia
Phone 70491 0
+61393454953
Fax 70491 0
Email 70491 0
[email protected]
Contact person for scientific queries
Name 70492 0
Christine Imms
Address 70492 0
University of Melbourne
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia
Country 70492 0
Australia
Phone 70492 0
+61393454953
Fax 70492 0
Email 70492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10571Study protocolImms,C.,Novak,I., Kerr,C., Shields, N., Randall, M., Harvey, A., Graham, H.K., Reddihough, D. (2015) Improving Allied Health Professionals research implementation behaviours for children with cerebral palsy: Protocol for a before and after study. Implementation Science, 10(1), 16. DOI 10.1186/s13012-014-0202-0https://DOI 10.1186/s13012-014-0202-0 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of a knowledge translation approach in changing allied health practitioner use of evidence-based practices with children with cerebral palsy: a before and after longitudinal study.2021https://dx.doi.org/10.1080/09638288.2020.1727576
N.B. These documents automatically identified may not have been verified by the study sponsor.