Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001116516
Ethics application status
Approved
Date submitted
13/08/2024
Date registered
17/09/2024
Date last updated
17/09/2024
Date data sharing statement initially provided
17/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing health equity by screening for neurodevelopmental concerns in primary healthcare
Scientific title
Evaluating the effect of the Tracking Cube on identification of neurodevelopmental concerns in primary healthcare
Secondary ID [1] 308925 0
GNT2024766
Secondary ID [2] 312692 0
MRRART000043
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Fetal Alcohol Spectrum Disorder 334653 0
Attention Deficit Hyperactivity Disorder 334654 0
Autism Spectrum Disorder 334655 0
Intellectual Disabilities 334656 0
Specific Learning Disorder 334661 0
Condition category
Condition code
Neurological 331230 331230 0 0
Other neurological disorders
Mental Health 331231 331231 0 0
Autistic spectrum disorders
Mental Health 331232 331232 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Tracking Cube is a 6 tiered process. It is considered to be the intervention for this project. The six tiers are: Informed consent (Tier 1), history (Tier 2), the Rapid Neurodevelopmental Assessment (RNDA; Tier 3); collaborative information from carers and teachers (Tier 4); feedback and support (Tier 5), and comprehensive assessment (Tier 6). Tiers are woven into usual care medical components. This project evaluates the implementation of the first 4 tiers. Tiers 5 and 6 are completed at the discretion of the health service. The occasions of service for Tiers 5 and 6 will be documented as ‘follow-up’, but outcomes from these occasions of service will not be evaluated, as this is not the research question.

Tier 1 takes around 10 minutes. Tier 2 takes around 30 minutes. Tier 3 takes around 30 minutes. Tier 4 takes around 30 minutes. However, the Health Care Providers (HCP), carer and child work together through each Tier of the Tracking Cube - there is no time limit. Children and carers can take breaks as needed. Therefore, eligible participants will progress with the Tracking Cube at their own pace. For example, in Tier 1 the HCP discusses participation with carers and patients. Participation can be discussed over multiple appointments as needed. The health service determines the most appropriate time to start the Tracking Cube. For example, at child well-health checks or at any appointment with the HCP.

HCPs enter information into a digital platform, allowing site-based data control. Each primary healthcare site has a license to use this platform. This previously developed digital infrastructure was co-designed for research purposes. Examples of factors/data that will be entered into the digital platform are: historical factors (e.g. family history, maternal birth complications if known, developmental milestones); neurodevelopmental assessment results (e.g., cognitive, speech, attention, vision and hearing) and caregiver concerns about the child (e.g. behavioural and sleep patterns).

The digital platform is hosted securely and meets all national compliance and security standards. Providing an intuitive user experience, aggregated data is presented in dashboards, which summarise risk and protective factors, screening results and carer concerns for HCPs to view at a glance. This helps practitioners augment real-time clinical decisions. This is a point of difference with usual care.

Built-in e-consent has the potential for data exchange with other organisations involved in the child's care. An editable summary, recommendations and referral can be generated as needed for HCP review.

Using a stepped-wedge randomised design, each site will commence 3 months after each other. Each site will progress through 4 phases: exploration (3 months), preparation (3 months), intervention (2 years), and sustainability (6 months). Exploration is about understanding the workflow at each site to ensure the Tracking Cube can fit into existing workflows, and co-designing the localisation of the Tracking Cube where needed. Each HCP is trained to a standard during the preparation phase. The training protocol involves online modules (6 hours) that include video examples, follow-up tele-mentoring (Microsoft Teams) by the research team, and an online competency assessment at the end of training. During this time, the research team also works with the health service to integrate the Tracking Cube into usual care workflows. Weekly online tele-mentoring occurs to adjust organisational flow, and address barriers to incorporating the Tracking Cube.

The intervention phase continues tele-mentoring from project staff with allied health backgrounds as needed to ensure fidelity with the protocol. Monthly audits of the digital platform will highlight drift from protocol and feedback will be provided to HCPs. Fidelity checklists will be collected every 6 months to support HCPs in identifying where they may have drifted from protocol. This will provide insights about adherence to the Tiers. In the sustainability phase, clinicians will continue to use the Tracking Cube, but without support from the research team.
Intervention code [1] 329198 0
Early detection / Screening
Intervention code [2] 329199 0
Prevention
Intervention code [3] 329200 0
Treatment: Other
Comparator / control treatment
Stepped wedge cluster randomised controlled trial. This design incorporates a random and sequential transition of clusters from a control to an intervention group until all clusters undergo exposure.

Comparator (usual care): Primary healthcare sites deliver health checks per Australian Department of Health guidelines. This includes collecting a patient history, conducting examinations ‘as required’, recommending interventions and providing advice. The information collected and the tools used are based on HCP judgement. The Tracking Cube is different from this. It provides a structure to collecting the diverse information needed, has built in screening tools, auto-pipes information into reports and uses decision trees to augment HCP judgement by providing evidence-based clinical decision support.
Control group
Active

Outcomes
Primary outcome [1] 339003 0
Change in identification of neurodevelopmental concerns at sites not currently systematically screening 0 to < 18 year olds, compared to usual care.
Timepoint [1] 339003 0
Chart audits will be collected pre- and post- Tracking Cube implementation. One chart audit will be collected from health records for a 1 year retrospective period, prior to Tracking Cube implementation. A second chart audit will be collected over a 2 year intervention period from health records. Chart audits are designed specifically for the purpose of the study to answer the research question.
Secondary outcome [1] 438246 0
Change in identification of children (0 to < 18 year olds) at-risk of Fetal Alcohol Spectrum Disorder (FASD) compared to usual care.
Timepoint [1] 438246 0
Chart audits will be collected pre- and post- Tracking Cube implementation. One chart audit will be collected from health records for a 1 year retrospective period, prior to Tracking Cube implementation. A second chart audit will be collected over a 2 year intervention period from health records. Chart audits are designed specifically for the purpose of the study to answer the research question.
Secondary outcome [2] 438247 0
Change in identification of children (0 to < 18 year olds) at-risk of Attention Deficit Hyperactivity Disorder (ADHD) compared to usual care.
Timepoint [2] 438247 0
Chart audits will be collected pre- and post- Tracking Cube implementation. One chart audit will be collected from health records for a 1 year retrospective period, prior to Tracking Cube implementation. A second chart audit will be collected over a 2 year intervention period from health records. Chart audits are designed specifically for the purpose of the study to answer the research question.
Secondary outcome [3] 438248 0
Change in identification of children (0 to < 18 year olds) at-risk of Autism Spectrum Disorder (ASD) compared to usual care.
Timepoint [3] 438248 0
Chart audits will be collected pre- and post- Tracking Cube implementation. One chart audit will be collected from health records for a 1 year retrospective period, prior to Tracking Cube implementation. A second chart audit will be collected over a 2 year intervention period from health records. Chart audits are designed specifically for the purpose of the study to answer the research question.
Secondary outcome [4] 438249 0
Change in identification of children (0 to < 18 year olds) at-risk of intellectual disability compared to usual care.
Timepoint [4] 438249 0
Chart audits will be collected pre- and post- Tracking Cube implementation. One chart audit will be collected from health records for a 1 year retrospective period, prior to Tracking Cube implementation. A second chart audit will be collected over a 2 year intervention period from health records. Chart audits are designed specifically for the purpose of the study to answer the research question.
Secondary outcome [5] 438261 0
Change in identification of children (0 to < 18 year olds) at-risk of Specific Learning Disorder compared to usual care.
Timepoint [5] 438261 0
Chart audits will be collected pre- and post- Tracking Cube implementation. One chart audit will be collected from health records for a 1 year retrospective period, prior to Tracking Cube implementation. A second chart audit will be collected over a 2 year intervention period from health records. Chart audits are designed specifically for the purpose of the study to answer the research question.
Secondary outcome [6] 438262 0
Change in follow-up of at-risk children (0 to < 18 year olds) in primary healthcare, compared to usual care.
Timepoint [6] 438262 0
Chart audits will be collected pre- and post- Tracking Cube implementation. One chart audit will be collected from health records for a 1 year retrospective period, prior to Tracking Cube implementation. A second chart audit will be collected over a 2 year intervention period from health records. Chart audits are designed specifically for the purpose of the study to answer the research question.
Secondary outcome [7] 438263 0
Change in appropriateness of referrals to specialists, compared to usual care.
Timepoint [7] 438263 0
Chart audits will be collected pre- and post- Tracking Cube implementation. One chart audit will be collected from health records for a 1 year retrospective period, prior to Tracking Cube implementation. A second chart audit will be collected over a 2 year intervention period from health records. Chart audits are designed specifically for the purpose of the study to answer the research question. Referrals will be reviewed by a chart audit. Appropriateness of referrals will be coded according to a coding manual by the research team. The research team will be blinded to whether the audit data is from before or after the intervention while reviewing.
Secondary outcome [8] 438264 0
Identification of enablers to implementing neurodevelopmental screening in primary healthcare across multiple sites and contexts.
Timepoint [8] 438264 0
Patients, practitioners and service providers will be interviewed and surveyed twice per year throughout the project. Interviews and surveys will be created for the purpose of the study. Enablers identified during telementoring will also be qualitatively documented and addressed.
Secondary outcome [9] 438265 0
Cost-effectiveness assessment to inform action plans for nationwide scaling of neurodevelopmental screening in primary healthcare for children and adolescents.
Timepoint [9] 438265 0
The direct healthcare costs of using the Tracking Cube (compared to usual care), and indirect cost savings associated with using the Tracking Cube (compared to usual care) in primary healthcare will be colleced by survey. Families and health care providers will complete the survey when they have completed the Tracking Cube. The survey was designed specifically for the study.
Secondary outcome [10] 439365 0
Identification of barriers to implementing neurodevelopmental screening in primary healthcare across multiple sites and contexts.
Timepoint [10] 439365 0
Patients, practitioners and service providers will be interviewed and surveyed formally twice a year throughout the project. Interviews and surveys will be created for the purpose of the study. Barriers identified during telementoring will also be qualitatively documented and addressed.

Eligibility
Key inclusion criteria
Inclusion criteria for primary healthcare sites:
(1) provide accredited primary healthcare service;
(2) a consenting HCP providing <18-year-old health checks;
(3) no systematic neurodevelopmental screening for <18-year-olds;
(4) no standardised triage to specialists for <18-year-olds at-risk of neurodevelopmental concerns;
(5) consent of health service management to participate.

Inclusion criteria for families: All consenting families receiving a health check at an eligible site will be included; no exclusion criteria.
Minimum age
0 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No specific additional exclusion criteria, must meet inclusion criteria.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sites were randomised by software; the order of randomisation was not affected by sites or researchers. Once randomisation was complete, allocation was revealed to assist in preparing sites for implementation of the Tracking Cube.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped Wedge
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
29/02/2028
Actual
Date of last data collection
Anticipated
30/11/2028
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 313134 0
Government body
Name [1] 313134 0
National Health and Medical Research Council
Country [1] 313134 0
Australia
Funding source category [2] 317108 0
Government body
Name [2] 317108 0
Commonwealth Department of Health and Aged Care Medical Research Future Fund, Rapid Applied Research Translation
Country [2] 317108 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 314836 0
None
Name [1] 314836 0
Address [1] 314836 0
Country [1] 314836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312379 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 312379 0
Ethics committee country [1] 312379 0
Australia
Date submitted for ethics approval [1] 312379 0
19/04/2024
Approval date [1] 312379 0
16/05/2024
Ethics approval number [1] 312379 0

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

Contacts
Principal investigator
Name 124450 0
Prof Dianne Shanley
Address 124450 0
1 Parklands Drive, Southport (Griffith University Gold Coast Campus), Queensland, 4222
Country 124450 0
Australia
Phone 124450 0
+61 7 5678 8132
Fax 124450 0
Email 124450 0
[email protected]
Contact person for public queries
Name 124451 0
Louise Barnsbee
Address 124451 0
170 Kessels Road, Nathan (Griffith University Nathan Campus), Queensland, 4111
Country 124451 0
Australia
Phone 124451 0
+61 7 3735 8055
Fax 124451 0
Email 124451 0
[email protected]
Contact person for scientific queries
Name 124452 0
Louise Barnsbee
Address 124452 0
170 Kessels Road, Nathan (Griffith University Nathan Campus), Queensland, 4111
Country 124452 0
Australia
Phone 124452 0
+61 7 3735 8055
Fax 124452 0
Email 124452 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?

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
No additional documents have been identified.