Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000066482
Ethics application status
Approved
Date submitted
7/01/2025
Date registered
22/01/2025
Date last updated
22/01/2025
Date data sharing statement initially provided
22/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Connection and Kinship: Co-design of a Culturally Safe and Responsive Care for Aboriginal and Torres Strait Islander Children and Families in a Public Paediatric Service
Scientific title
Connection and Kinship: Culturally Safe and Responsive Care for Aboriginal and Torres Strait Islander Children and Families
Secondary ID [1] 313643 0
PCHCollab2024-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
developmental disorders 336207 0
neurodevelopmental disorders 336211 0
paediatric health 336210 0
Condition category
Condition code
Neurological 332743 332743 0 0
Other neurological disorders
Public Health 332742 332742 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-implementation activities
Baseline Standard Care data will be collected from the patient record for consumers attending the Paediatric service for one year prior to the service change and until completion of the project. This will include patient and family demographic information such as age, sex, gender identity, postcode, family composition and patient presenting complaint/s will be obtained from the medical record. Standard patient reported experience measures (PREMS) and patient reported outcome measures (PROMS) are currently collected as standard will be collated. Service level data such as failure to provide care rates and long wait data will be collected from relevant Information Management Systems.

Consumer Questionnaire
A questionnaire and yarning circles with consumers (carers) will be undertaken to determine barriers to care and to design the model of care. The questionnaire will be sent to all consumers of the Paediatric outpatient service with Aboriginal and/or Torres Strait Islander origin identified in the clinical record who attended the service from January 2024 to the conclusion of the project. Consenting consumers will then be directed to an online questionnaire, or the paper version, exploring their barriers to care, along with background demographic information will be collected for each participant including age, sex, gender identity, postcode, family composition and reason for attending the service, and paediatric team members engaged with. At the end of the questionnaire, all participants will be given the opportunity to participate in the pre-implementation yarning circles. Consumers will have the option to complete the questionnaire only, the yarning circle only, both, or neither.

Consumer Yarning Circles
Participants who indicate an interest to participate in yarning circles will be contacted by a member of the research team to participate in this project activity. In addition, an Expression of Interest (EOI) will be developed with support from the Cultural Capability team and the hospital Safety and Quality Unit and will be disseminated via the Safety and Quality and Cultural Capability team consumer networks as well as Aboriginal and Torres Strait Islander Leadership Communications and Planning Team. At the beginning of the yarning circle, non-identifying background demographic information will be collected for each participant including patient and family demographic information such as age, sex, gender identity, postcode, family composition, reason for attending the service, and paediatric team members engaged with. The yarning circle will then commence. The yarning circles will be conducted either in-person (preferred method), or via MS Teams. The yarning circles will be facilitated by the hospital Cultural Capability Officer with support from other members of the project team as needed. They will be recorded and transcribed verbatim. Yarning circle participants will be asked open questions about the barriers to care and their needs in order to co-design the new model of care. Yarning circles will last for approximately 90 minutes. At the conclusion of the yarning circle, consumers will complete three brief four item questionnaires asking about their perception about the acceptability of this service change, and the appropriateness of the service change, and the feasibility of the service change.

Community Elders Yarning Circles
An Expression of Interest (EOI) will be developed and disseminated in the same way described for Consumer yarning. At the beginning of the yarning circle, non-identifying background demographic information will be collected for each participant including patient and family demographic information such as age, sex, gender identity, postcode, engagement with the service (if any), and Paediatric Services team members engaged with. The yarning circles will be facilitated in the same way as that describe for consumers.

Staff questionnaire
All interdisciplinary team members of the Paediatric Service along with hospital Executive team will be approached to complete the staff questionnaire. The staff questionnaire which will explore barriers to care and satisfaction with the service, perception of acceptability, appropriateness and feasibility of the service change, and basic non-identifiable demographic information including sex, profession, and time working in the TPCH paediatrics service. At the end of the questionnaire, participants will be asked if they would like to be contacted to participate in staff semi-structured interviews.

Staff semi-structured interviews
Semi-structured interviews will be undertaken with staff who have indicated that they would consent to a follow-up interview. Staff will be selected by the investigators to ensure a purposeful sample is achieved (e.g. across individual professions) to ensure a breadth of data that is representative of the broader population. Interviews will be conducted either 1:1 or as a focus group (maximum n=6 per group), based on the suitability/availability of eligible staff. It is expected that 1:1 interviews will take approximately 20 minutes, while focus groups may take upwards of 1 hour. Participants will be asked open questions about the barriers to care for Aboriginal and/or Torres Strait Islander children and families, and will seek ideas on strategies to overcome these barriers through a new model of care. Aboriginal and/or Torres Strait Islander staff will have the option also to complete the interview/focus group in a yarning format if they prefer. Basic non-identifiable demographic information will be collected from respondents including sex, profession, and time working in the hospital’s paediatrics service.

Refinement and endorsement of the new model of care will follow from the pre-implementation activities, led by the research team with ongoing consultation with community via the Cultural Capability team with a view to long term sustainability. The developed model of care will be endorsed by the Aboriginal and Torres Strait Islander Leadership oversight committee and presented to community for final consultation before implementation.

Implementation activities
Implementation of the model of care will occur following recruitment to the role with an approximately 12-month trial period. The impact of the service change will be measured via ongoing collection of patient reported experience and outcomes data and service level data, a post-implementation consumer questionnaire and yarning circles to elicit feedback on the model of care and further suggestions for refinements needed, and to strengthen the sustainability plan. As per the pre-implementation phase, the consent and contact measures will follow the same processes. Similarly, Elder groups yarning circles will be undertaken. A staff questionnaire and semi-structured interviews with staff to elicit feedback on the model of care. The aim of these implementation activities is to demonstrate the acceptability, sustainability, and appropriateness of the model.

Evaluation Activities
The impact of the service change will be assessed with reference to Ngaa-bi-nya Aboriginal and Torres Strait Islander program evaluation framework across domains of landscape, resources, ways of working and learnings as well as Implementation and Evaluation Outcomes which will allow evaluation across implementation, service and consumer outcomes. A full service evaluation will be undertaken including economic analysis using a cost utility approach to determine whether the model of care is cost-effective, taking into consideration costs and QALYs.
Intervention code [1] 330233 0
Other interventions
Comparator / control treatment
A pre-implementation phase (standard care) will act as the comparator for the implemented new model of care.

The pre-implementation phase represents a 'care as usual' period as the model of care is being developed, commencing with historical data to be obtained from the medical record from 1 January 2024 until the new model of care is implemented (approximately July 2025).
This will include patient and family demographic information such as age, sex, gender identity, postcode, family composition and patient presenting complaint/s will be obtained from the medical record. Standard patient reported experience measures (PREMS) and patient reported outcome measures (PROMS) are currently collected as standard will be collated.
Control group
Historical

Outcomes
Primary outcome [1] 340267 0
Effectiveness
Timepoint [1] 340267 0
This data will be collected at one time point for each participant at the conclusion of their engagement with the paediatric service (time from referral to first appointment). The data from pre-implementation phase participations will be compared between-subjects to the post-implementation phase participants (that is, comparing total failure to provide care metric between those in standard care versus those who were seen when the new model of care was implemented).
Primary outcome [2] 340266 0
mean wait time
Timepoint [2] 340266 0
This data will be collected at one time point for each participant at the commencement of their engagement with the paediatric service (time from referral to first appointment). The data from pre-implementation phase participations will be compared between-subjects to the post-implementation phase participants (that is, comparing wait time between those in standard care versus those who were seen when the new model of care was implemented).
Primary outcome [3] 340268 0
Cost effectiveness
Timepoint [3] 340268 0
This data will be collected at two time points for each participants - at the commencement of their engagement with the paediatric service, and at the conclusion of their engagement with the paediatric service. The data from pre-implementation phase participations will be compared between-subjects to the post-implementation phase participants.
Secondary outcome [1] 443550 0
Acceptability
Timepoint [1] 443550 0
This data will be collected at one time point for each participant at the conclusion of their engagement with the paediatric service. The data from pre-implementation phase participations will be compared between-subjects to the post-implementation phase participants
Secondary outcome [2] 443551 0
Patient reported outcome measures
Timepoint [2] 443551 0
This data will be collected at two time points for each participants - at the commencement of their engagement with the paediatric service, and at the conclusion of their engagement with the paediatric service. The data from pre-implementation phase participations will be compared between-subjects to the post-implementation phase participants.
Secondary outcome [3] 443552 0
Satisfaction
Timepoint [3] 443552 0
This data will be collected at one time point for each participant at the conclusion of their engagement with the paediatric service. The data from pre-implementation phase participations will be compared between-subjects to the post-implementation phase participants

Eligibility
Key inclusion criteria
Consumers (children and their carers) attending the Prince Charles Hospital Paediatric Outpatient service since January 2024 until the completion of the project; and consumers who identify as Aboriginal and/or Torres Strait Islander origin of who respond to an expression of interest.
Aboriginal and/or Torres Strait Islander Community Elders who have experience with services at TPCH, or family members with experience with the Paediatric service at TPCH who respond to an expression of interest to participate in this study.
All Paediatric Services team members and hospital Executive (Executive, Medical, Nursing, Administrative, Health Practitioners, Clinical Assistants, and Indigenous Hospital Liaison Officers) employed by the Prince Charles Hospital at the time of data collection
Minimum age
1 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no additional inclusion or exclusion criteria

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



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The project will employ a mixed methods approach. Measurement of Implementation and Evaluation Outcomes will allow evaluation across implementation, service and consumer outcomes, Baseline data of existing paediatric service Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) and patient flow metrics (eg. failure to provide service rates, numbers on waitlist outside of clinically recommended timeframes, occasions of service) will measure pre-implementation 'standard care'. In developing the new care pathway and health worker position model of care, outcomes from pre-implementation stakeholder engagement (questionnaires, yarning circles and staff interviews) will be analysed via descriptive analysis using Microsoft Excel and/or IBM SPSS, and reflexive thematic analysis using NVivo. Post-implementation stakeholder engagement activities will also be analysed via descriptive analysis and reflexive thematic analysis. Reflexive thematic analysis is a method used to analyse qualitative data by identifying, organising, and interpreting patterns (themes) within the data. This approach emphasizes the importance of reflexivity, meaning researchers actively reflect on their own perspectives, biases, and assumptions throughout the analysis. Researchers are encouraged to be transparent about how their backgrounds, experiences, and positions (e.g., cultural, social, or professional) might influence the themes they identify and interpret, thereby enhancing the reliability and depth of the findings. To ensure a robust and culturally informed analysis, at least two team members will conduct the thematic analysis, including at least one or more members of team with Aboriginal and/or Torres Strait Islander background. The process will begin with the researchers selecting and familiarising themselves with three transcripts, followed by initial discussions to explore emerging themes. These transcripts will then be independently coded using reflexive, inductive analysis. Subsequently, all remaining transcripts will be independently coded, with an equal distribution of transcripts between team members. Regular reflective team meetings will be held to review each other’s codes, maintain consensus, and make minor modifications as needed. Themes will be further categorized into sub-themes, supported by exemplar quotes, to provide a detailed and nuanced understanding of the data. Patient flow characteristics (including wait times, access within clinically recommended timeframes, occasions of service) and clinical outcomes (PREMS and PROMS), will be comparing between the ‘standard care’ pre-implementation period as a pre-measure, and the (NEW) model of care as post-measure and analysed using IBM SPSS. Quantitative data measuring pre- and post- service change outcomes on key indices of patient service satisfaction, service characteristics (e.g., occasions of service); as well as referrer and staff service satisfaction, and engagement with the new position and care pathway, will be evaluated via univariate statistical tests where indicated such as independent samples t-test, and median differences on key measures pre- and post- implementation will be tested using the non-parametric equivalent Mann-Whitney U-test as indicated. The Mann-Whitney U-test does not rely on the normal distribution of data, making it suitable for a wider range of data types, including ordinal data. Categorical comparisons will be evaluated using Pearson’s chi-square. The distribution of outcome measures will be assessed, and appropriate transformations will be applied for use in modelling. Differences between group means will be tested using generalised linear regression modelling. Throughout the implementation phase, consumer and stakeholder feedback will be collected to assess acceptability/experience, inform decision making regarding iterative refinement of the model of care and to enhance outcomes. A brief health-related quality of life measure (EuroQol-5) will allow preliminary health economics evaluation by performing quality-adjusted life year calculations as a measure of cost-effectiveness of the service change compared to pre-implementation, taking into consideration costs and QALYs. The objective is to capture all service events, clinical outcomes and quality of life changes for patients referred pre- and post- service change in order to perform a full evaluation including a cost effectiveness analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318110 0
Charities/Societies/Foundations
Name [1] 318110 0
The Prince Charles Hospital Foundation
Country [1] 318110 0
Australia
Primary sponsor type
Individual
Name
Dr Sara Winter, The Prince Charles Hospital
Address
Country
Australia
Secondary sponsor category [1] 320569 0
None
Name [1] 320569 0
Address [1] 320569 0
Country [1] 320569 0
Other collaborator category [1] 283370 0
Individual
Name [1] 283370 0
Marissa Galler, The Prince Charles Hospital
Address [1] 283370 0
Country [1] 283370 0
Australia
Other collaborator category [2] 283368 0
Individual
Name [2] 283368 0
Rebeckah Mooney, The Prince Charles Hospital
Address [2] 283368 0
Country [2] 283368 0
Australia
Other collaborator category [3] 283369 0
Individual
Name [3] 283369 0
Peter Stevenson, The Prince Charles Hospital
Address [3] 283369 0
Country [3] 283369 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316755 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 316755 0
Ethics committee country [1] 316755 0
Australia
Date submitted for ethics approval [1] 316755 0
15/09/2024
Approval date [1] 316755 0
17/12/2024
Ethics approval number [1] 316755 0
HREC/2024/QTDD/111028

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

Contacts
Principal investigator
Name 138910 0
Dr Sara Winter
Address 138910 0
Psychology Department, The Prince Charles Hospital, Rode Rd, Chermside, Queensland, Australia, 4032
Country 138910 0
Australia
Phone 138910 0
+61 7 3139 6387
Fax 138910 0
Email 138910 0
[email protected]
Contact person for public queries
Name 138911 0
Sara Winter
Address 138911 0
Psychology Department, The Prince Charles Hospital, Rode Rd, Chermside, Queensland, Australia, 4032
Country 138911 0
Australia
Phone 138911 0
+61 7 3139 6387
Fax 138911 0
Email 138911 0
[email protected]
Contact person for scientific queries
Name 138912 0
Sara Winter
Address 138912 0
Psychology Department, The Prince Charles Hospital, Rode Rd, Chermside, Queensland, Australia, 4032
Country 138912 0
Australia
Phone 138912 0
+61 7 3139 6387
Fax 138912 0
Email 138912 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Only aggregate data will be available for publication/dissemination to the public



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Study Protocol_v2_111028_clean.docx


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.