Eligible population and recruitment

All children under 16 years presenting or referred for treatment for burns to participating tertiary burn units in the Australian states of New South Wales (NSW), Queensland, South Australia (SA) and the Northern Territory (NT) will be eligible for participation. All parents/carers will be asked whether the child is Indigenous using the Standard Indigenous Question17 at time of presentation at the burn unit as part of routine admission questions. Once survival of the child is assured, patient care teams will be consulted about the optimal time for recruitment into the study. Eligible families will be approached and given written and verbal information about the study during the first visit to the burn unit, prior to patient discharge. If the patient care team feels it appropriate, on this visit, eligible families will be asked to participate and complete a baseline interview. If recruitment is not possible on the first visit, families will be approached on the subsequent visit.

Consent will be obtained from parent or guardian for participation in the study. Children will also participate in the consent process if they are aged 12 years and above and the parent or guardian deems them able to participate in the consent process. Consent will also be requested to contact the usual medical provider at participants’ places of residence or health practitioners who are involved in burn treatment subsequently and access burn-related medical records. Participants will also be asked to consent to primary care practitioners being involved in data collection, for example, in the case of those living in remote settings whereby local healthcare providers may be asked to administer follow-up questionnaires. Separate consent to access Medicare Benefit Scheme (MBS) and Pharmaceutical Benefit Scheme (PBS) records (allowing details of Government subsidised healthcare and pharmaceutical services utilised) will also be obtained.

Data will be collected using both quantitative and qualitative approaches. Data collection will include (1) participant interviews, (2) capture of clinical data from medical records and (3) linkage to MBS/PBS records. Additionally, to identify barriers and enablers to healthcare for Aboriginal and Torres Strait Islander children who sustain serious burns, from the perspective of the patient, their families and their healthcare providers, qualitative research will be conducted in a range of settings. Documentation of patient journeys, systems mapping of services and evaluation of health professionals’ enactment of care will also be conducted. The information from all sources will be brought together with key stakeholders in policy roundtable sessions to inform discussion around development of appropriate models of care.

Baseline interview

Information collected at the baseline interview will include basic sociodemographic data (age, place of residence, measures of family structure, income and education), the burns first aid treatment (type, time from injury and duration), the timing of treatment, mode and timing of transportation to hospital, and preinjury quality of life. Tools used to measure sociodemographic characteristics, family disruption and family structure will be adapted from previous surveys including the NSW Population Health Survey18 and the Western Australian Aboriginal Child Health Survey, which developed and tested measures specifically for Aboriginal children and their families;19 clinical data will be extracted from patient medical records and preinjury quality of life measured using the Pediatric Quality of Life Inventory (PedsQL).20 To assess parental trauma (as the trauma experienced by the parent may influence care sought for the child), parents will also be asked to complete the Kessler 5 scale.21 Brief questions will also be asked about family disruption and travel related to treatment needs. Recruitment and baseline interviews will be conducted by trained Aboriginal or Torres Strait Islander research staff or by research staff with significant experience working with Aboriginal or Torres Strait Islander people.

Follow-up interviews

Follow-up interviews will be conducted at 3, 6, 12 and 24 months postinjury; the multiple measures are needed to determine recovery patterns and the more permanent consequences of injury.22 The interview will be conducted with the parents/carers. Data will be collected on care received (and out of pocket costs) since the last interview, health-related quality of life using the PedsQL,20 pain, itch and activity limitations of the child as per baseline interviews, and return to school. If children are aged 5 years and over, they will also be asked to complete health-related quality of life measures, and measures of pain and itch. At annual interviews (12 and 24 months), parents/carers will also be asked to complete measures of psychological distress for themselves (Kessler 5), health-related quality of life measures for the child and brief questions on disruptions to family or employment due to treatment or caring needs. Details of outcomes measured are presented in table 1.

Clinical data

The study research assistant at each site will extract information from clinical notes at regular intervals, including at baseline. This will include external cause and context of injury, operative procedures, outpatient visits, including number of visits to each service (eg, occupational therapist, psychologist, Aboriginal health worker, access to interpreter services), and scar management. In order to collect data on treatment, the research assistant, when appropriate, will have access to attend the weekly case conference meeting for each unit. Clinical information collected at baseline: date of burn, %TBSA, depth of burn, location of burn (eg, hand, feet, face, genitals), ventilator days, surgical care (how much, timing, type), admission/length of stay to intensive care units, overall length of stay, complications (renal impairment, weight loss), where the patient is discharged to, type of care (use of splints, compression garments), assessment of activity limitation (from clinical notes) and measures of scarring using the Patient and Observer Scar Assessment Scale (POSAS).23 Clinical information will be collected at each follow-up visit or hospitalisation at the burn unit; if the patient follow-up interviews reveal care is received at other sites (eg, other hospitals), medical records will be accessed at those sites. Once the participant has agreed to participate in the study, a letter will be sent to the general practitioner and any allied health practitioners expected to be involved in follow-up care requesting cooperation in collection of study data including potential administration of questionnaires if required. At 6, 12 and 24 months from injury, a standard form (followed up by phone calls) will be sent to the participant's medical practitioner locally to request data on local clinical care, including services delivered by physiotherapists, nurses, counsellors or other allied health practitioners, and measures of patient health status if known.

We will also document the existing models of local and regional burn services in each study site. This will include mapping service provision at each site, documenting the model of care, from presentation to rehabilitation and follow-up care in the community. We will identify both structure—the organisation, communication, referral processes, rehabilitation and community outpatient care in place; and processes—the existence and use of structured care plans, clinical pathways, assessment protocols, rehabilitation prescriptions, and postdischarge management pathways in each site.

Medicare linkage

To access data on use of healthcare utilisation, participants will be asked for separate consent to link to MBS and PBS records. Items collected will include item numbers/description, including hospital and community items, type of specialty of provider, postcode of participant, postcode of provider and fee paid, including payments on Medicare-extended care plans which allow access to physiotherapy treatment and other allied health services. As, particularly in remote areas, a proportion of patients will be mobile, their Medicare records will allow ascertainment of location and frequency of treatment if contact with carers or participants is lost. Linkage will occur at the end of 24-month follow-up. Medicare is used to pay for most patient visits to medical practitioners in Aboriginal Medical Service settings, so this is a feasible way to track healthcare use, although it will not collect data on wound management, attendances at private practitioners. The proportion of visits missed will be checked by cross-referencing against patient interview data.

Qualitative research

In order to ascertain the impact of burn care and outcomes on family life, and understand needs of patients, and barriers to healthcare, including from the perspective of providers and policymakers, qualitative research is required. Qualitative research will be performed using Aboriginal ontology as a holistic framework that is based on interconnectedness, person-centred care and Aboriginal ways of knowing.24 Where required, the Aboriginal interpreter service will be employed for any families without English as a first language. Interviews will be audio recorded, transcribed in full and verified with participants to ensure trustworthiness of data.25

Patient and family perspectives

We will conduct semistructured interviews with individuals or small family groups, and a sample of families will be interviewed in each state. This will elicit feelings and reflections of the complexity of care experienced26 including the barriers to care and treatment, including components of treatment prescribed for use in community settings, such as use of compression garments. Families and their primary care providers at each site will be recruited by the research nurse and interviewed in the community until saturation of themes. Both urban and rural participants will be interviewed to identify issues relevant to each setting. Where qualitative interviews can generate rich contextual data,27 there is also a risk that data become a research commodity28 dissociated from cultural meanings.29 Particular care will be taken during interviews to ensure that the data remain connected to the larger moral community28 and are explicitly co-constructed between researcher and participants.30 Data will be transcribed and analysed thematically using content analysis. Detailed information on the participant's personal experience and factors influencing injury outcomes will be explored; results will be triangulated with questionnaire data to inform better understanding of factors impacting on outcomes.

Clinical and stakeholder perspectives

To better understand the barriers and enables at an institutional level, data will be collected following a three-tiered process to map patient journey, map health services and evaluate attitudes to care. In order to map patient journey, this study will utilise the Managing Two Worlds Together, Patient Journey Mapping Tool.31 Case study methodology will be used to map the actual patient journey of three Aboriginal or Torres Strait Islander children as they access health services following burn injury. The participants will be drawn from the overarching study. A narrative analytical approach will be used, and semistructured interviews with patients and their carers will be conducted asking questions about their experiences and the barriers and enablers to good care. The story will be written using Emden's core story creation narrative analysis and will use the relevant mapping tools as described in the Journey Mapping Tool.31 In order to map and describe the provision of care in health services enacted by health professionals, lead burn clinicians at each of the leading burn units in Australia will be consulted. During on-site consultation and observations, the lead burn clinicians will be asked in semistructured interviews to provide a description of typical patient burn care and pathways followed on presentation of a client with a burn injury. Health professionals and administrators involved in care along the patient pathways and state policy makers will also be consulted. Interviews will have a particular focus on system level approaches to care. The mapping will include both structure—the organisation, communication, referral processes, rehabilitation and community outpatient care in place; and processes—the existence and use of structured care plans, clinical pathways, assessment protocols, rehabilitation prescriptions and postdischarge management pathways in each site. To identify attitudes to care at an institutional level, including health professionals and policymakers involved in the management of burn injury, we will conduct a broad stakeholder consultation involving qualitative evaluation of knowledge, attitudes, practices and perceived needs of patients. The consultation will use in-depth semistructured interviews and will focus on management of burns, and perceived barriers to treatment, with a particular focus on system level approaches to establish a clear representation of how clinical guidelines are enacted.

All qualitative data will be analysed thematically, contextualised and triangulated to enable a better understanding of burn care for Aboriginal and Torres Strait Islander children.

Sample size and analysis

Retrieval of data from each site suggests that there are approximately 120 children presenting to or being referred to the burn units participating in this study each year, with between 10 and 20 each year for NT and SA units, and 40 and 50 for NSW and Queensland. However, given possible undercounting this may be as large as 150 or greater. Participants will be recruited until 225 participants have been recruited (over approximately 18–20 months, expected conservative participation rate of at least 60%).32We anticipate collecting follow-up interview data for 2 years on approximately 70% of participants which will allow complete data on 130 children.32

We will document care received and describe patterns and characteristics of care by state, by place of residence, injury severity, and describe the proportions of children whose care meets standard clinical practice guidelines for medical management for paediatric burns.5 We will estimate the incidence of burn injuries in Aboriginal and Torres Strait Islander children presenting to burn units in each participating state, by extracting population counts for each state including age and gender distributions for Aboriginal and Torres Strait Islander people from the Australian Bureau of Statistics (ABS) Census data.

We will investigate the key predictors of health-related quality of life scores, and burn-related functional outcomes, including activity limitations, pain and return to school using random or mixed effects regression models. Measures to be assessed include age, gender, family function, type/amount of treatment received (including scar management/compression garments/splints), type of patient (inpatient vs outpatient), place of residence (urban/rural) and psychological distress of parent and child. Although there is no literature describing predictors of PedsQL in children with burns, the following variables have been found to have an impact on the SF-36 score in paediatric patients with burns: age at injury, gender, functional family, early reintegration and consistent clinic visits; PedsQL scores have also been described in Australian children sustaining trauma, including burns.33 With 130 patients, four postbaseline measures at 3, 6, 12 and 24 months for each patient, correlation between two scores from the same participant is assumed to be 50%, and assuming an exchangeable correlation matrix structure, we will have 80% power to determine a minimum absolute difference (increase or decrease) of +/− 0.3 in global scores for each of the factors examined. The calculations are based on optitxs.r macro using R software V.3.1.3.

Linkage to MBS and PBS data will also provide important data on healthcare utilisation, particularly important where we may have significant loss to follow-up. We will examine healthcare utilisation by severity of burn, remoteness of place of residence and sociodemographic factors such as family structure, and age of child.

The cost analysis will adopt a health sector perspective and include costs borne by government, other agencies and families/carers. Costs will be assessed using a micro costing approach with all costs identified and valued for individual patients. Information on the use of health services will be collected from multiple sources including follow-up interviews with families/carers, clinical data and Medicare and PBS records. The cost of treating children with burn injuries will be calculated based on their resource use and the corresponding costs. These data will then be analysed using two approaches. First, a prevalence-based approach will be used to identify (1) the overall cost of treating burn injuries for the cohort of Aboriginal children and (2) costs disaggregated by cost component, subgroup and source of funds. Second, an individual-based approach will be adopted in which we will investigate associations between the mean individual cost and various factors including patient characteristics, healthcare utilisation and health outcomes using multiple linear regression techniques.

Governance

The study is managed by a project management committee, comprising the investigators and associate investigators, and research staff. This group has oversight of the study protocol, implementation and production of key outputs. An advisory group ensures community input into the study, and provides high level oversight of methods and relevance. This committee will ensure the processes used are cognisant of Indigenous understandings of health and well-being, that data analysis is based in an appropriate context and that meaningful dissemination and knowledge transfer activities occur. This will be chaired by an Indigenous member of the investigative team, and will include healthcare providers from primary care, including from Aboriginal Community Controlled Health Organisations as well as tertiary care providers and Aboriginal liaison units from the participating hospitals as well as the investigators and other state burn representatives. Community members will also be invited from each state.