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Trial registered on ANZCTR


Registration number
ACTRN12622000184774
Ethics application status
Approved
Date submitted
15/01/2022
Date registered
2/02/2022
Date last updated
6/02/2023
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
E-learning for early diagnosis of cerebral palsy: a randomised controlled trial evaluating the effectiveness of physician e-learning interventions on cerebral palsy diagnostic skills, behaviours and practice
Scientific title
A 3-arm parallel superiority randomised controlled trial comparing adaptive and non-adaptive e-learning instructional designs with a control group to evaluate effectiveness on physician behaviour, cerebral palsy diagnostic skills, and patient outcomes
Secondary ID [1] 306035 0
None
Universal Trial Number (UTN)
U1111-1272-5015
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 324671 0
Condition category
Condition code
Neurological 322118 322118 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention development:

The e-learning intervention was developed in two phases: 1) design of the behaviour change intervention following The Behaviour Change Wheel user guidelines, 2) design of the web-based evidence-centred education and training intervention using virtual video patients. Intervention design and development principles considered the evidence base and theoretical frameworks of behaviour change, learning processes and e-learning instructional design. Two e-learning interventions were developed for the RCT (adaptive and non-adaptive) to further the e-learning evidence base for comparing different instructional design.

E-learning structure:

Both intervention e-learning modules are self-paced with an estimated completion time of 30 - 60 minutes (depending on electronic knowledge resources accessed). The first 8-minute section is comprised of an opinion leader video introduction and a statement of objectives. In addition, interactive video features of knowledge questions, immediate feedback, and optional links to an e-book and fact sheet resources are available. The second section is comprised of a narrative virtual patient clinical case using an interactive video format. Interactive problem-solving and key-feature questions, with immediate feedback, are used throughout the virtual patients. Questions are multiple-choice. Immediate feedback via text onscreen is provided. A virtual patient bank of mixed practice key-feature cases is comprised of multi-media images, interactive videos and text onscreen.

An accessible menu is available at all times throughout the e-learning module and virtual patient bank, comprised of downloadable resource fact sheets, an e-book and link to a web-based library of electronic knowledge resources: opinion leader videos, parent experience videos, podcasts, and lecture series.

Adaptive e-learning intervention:

In our adaptive instructional design of interactive videos and key-features virtual patients, we utilised designed adaptation throughout the training according to participants’ responses to reflective questions, knowledge questions, key-feature cases and problem-solving tasks. We used adaptivity of content through adapted text onscreen information and links to curriculum content. Adaptive navigation is used within the interactive video content with an enforced path determined by answers. Adaptive tools with interactive multi-media are used, for example, with hotspot interactive videos and with the scoring of video assessments (General Movements Assessment and components of Hammersmith Infant Neurological Examination) for more expert participants who respond they have pre-training in these assessments. Direct instruction and modelling videos are shown for participants not trained in these assessments, with text onscreen explanations of scores and scoring systems.

Feedback to participant responses includes text onscreen knowledge information and adaptive video content displaying authentic, emotive patient reactions to their responses.

Non-adaptive e-learning intervention:

The non-adaptive intervention is linear in sequence, with no adaptivity of content, navigation, multi-media or tools. The only instructional design feature modified in the non-adaptive intervention is adaptivity.

Both intervention groups have equal access to the e-learning module, a menu of electronic knowledge resources and a virtual patient bank of key-feature cases. Participants can repeat the e-learning module and virtual patients as many times as they choose to.

Access:

Access control to e-learning modules is via REDCap and secure password and key management. Availability is restricted to study participants. Participants can access via their choice of desktop or tablet, from home or work. The e-learning is based on the open-source learning platform Moodle hosted by Amazon Web Servers for the duration of the study. The intervention is entirely web-based and asynchronous. Participants will be asked to complete the e-learning module within one month. Both intervention groups have equal access to the e-learning module, a menu of electronic knowledge resources and a virtual patient bank of key-feature cases. Participants can repeat the e-learning module and virtual patients as many times as they choose to. The total number of key-feature virtual patients is 15.

Moodle collects information about each user with a timestamp for each action and what resources are accessed in the e-learning package (for example, e-book and resource downloads). The duration of each e-learning session (module and virtual patient bank) and the number of links accessed in a session will be recorded. The number of reminders sent to participants to complete the eLearning module or virtual patients is recorded in REDcap.

Participants in all groups will be asked to complete a survey to provide information on any early diagnosis of CP training or continuing professional development they accessed during the study period.

The intervention e-learning and educational resources were custom designed for this study based on a published clinical guideline, consumer co-design, and Delphi survey of prospective learners perceived needs. A suite of early diagnosis of cerebral palsy electronic fact sheet resources, based on a published clinical guideline, have been published on Figshare: https://mcri.figshare.com/authors/Lynda_McNamara/5207980.
These fact sheet resources are accessible and downloadable through the study e-learning interventions in addition to new educational resources designed specifically for this study.
Intervention code [1] 322434 0
Behaviour
Comparator / control treatment
The waitlist control arm will not receive any e-learning intervention during the study period. However, participants who receive the control arm will be emailed a link to the adaptive
e-learning and virtual patient bank at the end of the study and after they have completed assessments at six months post baseline measures.
Control group
Active

Outcomes
Primary outcome [1] 329886 0
Physician key-feature examination of clinical decision making skills:
A web-based key features examination in the early diagnosis of cerebral palsy (CP) has been developed by experts in CP and the key-features methodology and piloted with practising physicians for psychometric reliability and acceptance. The examination target domains were mapped to priority behaviours and cognitive task analysis and comprised topic areas of CP risk factors; early detection using Prechtl’s General Movements Assessment, the Hammersmith Infant Neurological Examination and Neuroimaging; differential diagnosis; early intervention; and communication skills when communicating a diagnosis. The examination is comprised of 11 cases and 27 key feature questions with demonstrated reliability with Cronbach’s alpha 0.81 and mean item discrimination 0.31.
Timepoint [1] 329886 0
Assessed six months post-baseline (T3).
Primary outcome [2] 329887 0
Early Diagnosis Continuing Professional Development (CPD) Reaction Questionnaire:
The CPD-Reaction Questionnaire is a 12 item self-report instrument based on an integrated model combining the Theory of Planned Behaviour and Triandis Theory. It can assess the impact of CPD activities on individual professional behaviour change. Constructs are evaluated using a 12 item Likert scale for 1) intention, 2) social influence, 3) beliefs about capabilities, 4) moral norms, and 5) beliefs about consequences. Each early diagnosis CP priority target behaviour is scored individually against the 12 items. The questionnaire shows adequate validity and reliability with Cronbach's coefficient for constructs ranging from 0.77 to 0.85 and moderate test-retest reliability, with weighted kappa values between 0.4 and 0.6.
Timepoint [2] 329887 0
Assessed at baseline pre-intervention for all groups (T1), immediately post-intervention completion (e-learning module) for intervention groups (T2), and six months post intervention completion (e-learning module) for intervention groups, or six months post completion of baseline surveys in control group (T3).
Primary outcome [3] 329892 0
De-identified clinical behaviour physician self-report:
A self-assessment audit of clinical practice behaviours will provide evidence of physician clinical performance. A questionnaire has been developed (and piloted with three physicians) as a checklist against key priority physician clinical diagnostic behaviours retrospectively over the six months prior to study commencement. Responses are banded percentages (0, 0-20%, 21-40%, 41-60%, 61-80%, 81-100%), count numbers, yes-no, multi-choice questions and open text box.
Timepoint [3] 329892 0
Assessed at baseline pre-intervention for all groups (T1), and six months post intervention completion (e-learning module) for intervention groups, or six months post completion of baseline surveys in control group (T3).
Secondary outcome [1] 404179 0
Patient access requests to National Disability Insurance Scheme:
The Australian National Disability Insurance Scheme (NDIS) is a social and economic reform agenda supporting people with disabilities. The NDIS recognises children with a diagnosis of CP or high-risk of CP. Data is collected on all access requests made to the NDIS and data on participant demographics and outcomes for those eligible for the NDIS. For consenting parents, access requests made by physician study participants, NDIS eligibility and amount of funding provided per package will be evaluated, controlling for the physician intervention group, age at the time of access request and severity of CP.
Timepoint [1] 404179 0
Assessed throughout the 6-month study period (T1-T3)
Secondary outcome [2] 404180 0
Patient referrals to cerebral palsy (CP) registers:
Each Australian state and territory has a CP Register. The Australian CP Register contains de-identified data uploaded from each of state and territory register. For consenting parents, data transfer of electronic notification of referrals to each state and territory CP Register will be evaluated, controlling for the physician intervention group, age at the time of CP diagnosis and severity of CP.
Timepoint [2] 404180 0
Assessed throughout the 6-month study period (T1-T3).
Secondary outcome [3] 404181 0
Evaluation of technology-enhanced learning materials: learner perceptions short form (ETELM):
The ETELM is an evaluation instrument to assess learner perceptions of key quality web-based learning domains identified by educational frameworks and instructional design. Participants report their learning experience on a 7-point Likert scale (strongly agree to strongly disagree) in addition to free-text responses.
Timepoint [3] 404181 0
Assessed immediately post-intervention completion (T2).
Secondary outcome [4] 404182 0
Cost-consequences analysis:
A within-trial cost analysis will be conducted from a funder and decision-maker’s perspective in the Australian context. The cost ingredients method will be utilised to determine intervention costs. Cost measures include: direct costs of intervention components; intervention development; personnel costs; information and communication technologies; and website costs.
Timepoint [4] 404182 0
A within-trial cost analysis will utilise a 12 month time horizon to coincide with study recruitment and data collection.

Eligibility
Key inclusion criteria
The study population is paediatric physicians. To participate, paediatric physician participants must identify as working in a clinical setting in Australia. In addition, paediatric physicians can identify as General Paediatrician or in a sub-specialist role.

During the study period, if a physician participant provides a clinical diagnosis of CP to an infant in their regular clinical practice, they are asked to invite the parents of the infant to participate in the study to measure patient outcomes.

Patient participants eligible for this trial must comply with the following eligibility criteria: (1) infant with a clinical diagnosis of ‘cerebral palsy’ or ‘high-risk of cerebral palsy’ and (2) written consent from parent or person responsible for sharing of infant information with CP Registers and National Disability Insurance Scheme.

Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General practitioners and allied health professionals are not eligible.

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)
After completing baseline assessments, physician participants will be randomised using central concealed random allocation by computer with 1:1:1 allocation to intervention groups or control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study statistician will generate the allocation table. Randomisation will be computer generated using REDCap Electronic Data Capture Tools hosted at The University of Sydney.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total sample size of N = 275 physicians (approximately 10% of Australian registered General Paediatricians) enables detection of small magnitude effects (0.2) on primary outcome measure key-feature examination scores between intervention comparators both containing active learning strategies and large effects (0.8) compared with control with 90% power (a=0.05), allowing for 30% attrition. Sample size calculation was performed with software R and packages pwr and pwr2ppl..

Effect size assumptions on key-feature test primary outcome measure considered: (1) pilot study average test item score across 11 test items of 0.54 with a standard deviation of 0.16, (2) sensitivity of key-features examination to detect change post educational interventions and (3) systematic reviews of pooled effect sizes on health professionals skills for adaptive e-learning and virtual patients. We intend to use sample size re-estimation at the interim analysis after 50% recruitment.

Assumptions for primary outcomes of physician behavioural intentions and self-report audit of practice behaviours considered: (1) CPD-Reaction questionnaire effect sizes post online educational interventions in other fields; and (2) current Australian practice from a group of advisory experts.

Estimations from CP register data are indicative of approximately 126 new Australian babies receiving a diagnosis under 6 months of age within a 12 month period, predominantly severe forms of CP. However, with 600 new babies born with CP in Australia each year and with established high-risk infant follow up (and pathways for referral for the General Movements Assessment and the Hammersmith Infant Neurological Examination), we anticipate capturing milder forms of CP earlier and >50% of infants eligible for a high-risk of CP diagnosis by 6 months corrected age. Patients are recruited to this study through their physician. Variability in potential physician participant clinical location and role limits modelling of expected number of patients recruited to this study.

Statistical package for social sciences SPSS will be used. The cohort will be described and analysed according to demographic and baseline questionnaires. Descriptive statistics will summarise characteristics and factors measured. A comparison of outcomes between intervention and control groups will be made. An Analysis of Covariance will be used to test the primary hypotheses. Subgroup analysis will examine the effects modified by the intervention arms. The predictors of behaviour and intervention effects will also be reviewed through exploratory analysis. The primary analysis of all outcomes will include an adjustment for stratification variables and pre-specified potential confounders. Pre-specified confounders will be included in the models.

Generalized estimating equations will estimate the effectiveness of the intervention on primary and secondary outcomes and emerging patterns. In cases where interval data cannot be transformed appropriately for regression analysis, non-parametric methods (Mann –Whitney U) will be used for between-group comparisons. Multiple imputation approaches will be used to handle missing outcomes data.



Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
275
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310372 0
Charities/Societies/Foundations
Name [1] 310372 0
The Cerebral Palsy Alliance
Country [1] 310372 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Children's Hospital Westmead Clinical School, The University of Sydney, Corner Hawkesbury Road and Hainsworth Street, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 311509 0
None
Name [1] 311509 0
Address [1] 311509 0
Country [1] 311509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310025 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 310025 0
Research Integrity and Ethics Administration
The University of Sydney
Level 3, Administration Building (F23)
Corner of Eastern Avenue and City Road
Camperdown NSW 2006
Ethics committee country [1] 310025 0
Australia
Date submitted for ethics approval [1] 310025 0
30/03/2021
Approval date [1] 310025 0
12/07/2021
Ethics approval number [1] 310025 0
Project number 2021/386
Ethics committee name [2] 310171 0
Cerebral Palsy League of Queensland Ethics Committee
Ethics committee address [2] 310171 0
PO Box 386
Fortitude Valley
Queensland 4006
Ethics committee country [2] 310171 0
Australia
Date submitted for ethics approval [2] 310171 0
26/07/2021
Approval date [2] 310171 0
12/08/2021
Ethics approval number [2] 310171 0
CPL-2021-001

Summary
Brief summary
This study aims to close an identified research-practice gap and increase accurate cerebral palsy diagnosis (CP) under six months of age in Australia through tailored e-learning for physicians. This trial will determine whether adaptive e-learning using virtual patients, targeting CP diagnostic behaviours and skills, effectively changes physician behaviour and practice compared to non-adaptive e-learning instructional design or control. Our hypothesis is that physicians who complete adaptive e-learning will perform better on an examination of CP diagnostic skills, and self-report of real-world behaviours and practice compared to physicians that receive the non-adaptive e-learning or a control group who don’t receive an intervention. We also hypothesise that physicians who complete either type of e-learning will be more effective at clinically diagnosing and applying for National Disability Insurance Scheme funding for infants with a diagnosis of CP under six months of age compared to a control who don’t receive an intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116226 0
Prof Iona Novak
Address 116226 0
Faculty of Medicine and Health,
Level 7, Western Avenue
D18 Susan Wakil Health Building
The University of Sydney
NSW 2006 Australia
Country 116226 0
Australia
Phone 116226 0
+61 2 9975 8061
Fax 116226 0
Email 116226 0
[email protected]
Contact person for public queries
Name 116227 0
Lynda McNamara
Address 116227 0
The Children’s Hospital Westmead Clinical School, The University of Sydney, PO Box 6427, Frenchs Forest NSW 2086, AUSTRALIA.
Country 116227 0
Australia
Phone 116227 0
+61 2 9975 8061
Fax 116227 0
Email 116227 0
[email protected]
Contact person for scientific queries
Name 116228 0
Lynda McNamara
Address 116228 0
The Children’s Hospital Westmead Clinical School, The University of Sydney, PO Box 6427, Frenchs Forest NSW 2086, AUSTRALIA.
Country 116228 0
Australia
Phone 116228 0
+61 2 9975 8061
Fax 116228 0
Email 116228 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
No current ethics approval or participant consent for sharing of individual participant data other than outlined in Research Agreements between collaborating agencies.


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
EmbaseCan web-based implementation interventions improve physician early diagnosis of cerebral palsy? Protocol for a 3-arm parallel superiority randomised controlled trial and cost-consequence analysis comparing adaptive and non-adaptive virtual patient instructional designs with control to evaluate effectiveness on physician behaviour, diagnostic skills and patient outcomes.2022https://dx.doi.org/10.1136/bmjopen-2022-063558
N.B. These documents automatically identified may not have been verified by the study sponsor.