Implementation of Negative Pressure for Acute Paediatric Burns

Intervention: Negative Pressure Wound Therapy Negative pressure wound therapy (NPWT) is a wound dressing system that provides sub-atmospheric pressure within a closed dressing. We propose to facilitate the early implementation of NPWT into Emergency Department (ED) burn care practice at four major paediatric hospitals in Australia (The Children’s Hospital at Westmead, Perth Children’s Hospital, Queensland Children’s Hospital, and Royal Children’s Hospital Melbourne) to provide Australian children access to evidence-based treatment that may improve clinical outcomes and reduce healthcare costs. We aim to co-design implementation strategies tailored to the complex acute burn care setting and evaluate the effectiveness of implementation. The co-design process will occur prior to implementation of the intervention. The co-design pathway aims to establish who will deliver the intervention. The intervention (NPWT) will be applied following initial presentation to hospital for acute burn treatment, and will be left on the child's burn wound until 95% re-epithelialisation occurs, or the child requires a skin graft. Our INPREP pathway co-design will allow clinicians to integrate NPWT into their model of care by considering important contextual factors. These factors will include: i. Who applies the dressing – ED and/or burns clinicians? ii. When and where is the dressing applied – ED, burns department, or operating theatre? iii. How to apply the dressing? We aim for a standard pathway, however contextualisation may be needed. For example, existing state burns models of care may require burns patients to have all dressings applied by burns staff, therefore bypassing ED clinicians. Experienced burns and ED clinicians (medical and nursing) will be involved in the co-design process. Furthermore, parents and guardians of children who have engaged in the burns service will also be involved in the co-design process. Key clinical stakeholders will be identified by local investigators and approached by local research nurse and delivered a participant information and consent form (PICF) prior to participation in either i) interview, ii) focus group and/or iii) questionnaire. Parent and caregivers, as well as burns and ED clinicians from the four partnering sites, will complete electronic surveys and participate in phone or onsite focus group interviews. The surveys will be completed online in their own time and in an environment of their choice. Phone interviews will be scheduled to suit the parent, caregiver, or clinicians and co-design focus group will be conducted on site at the Centre for Children’s Health Research in South Brisbane, with COVID-19 safe approaches. The co-design process is anticipated to occur via weekly one-hour workshops, conducted over a two-month period across each state. Ten one-hour focus group interviews with consumers (patients and parents/carers) are to be conducted during the pre-implementation phase, and will take around 1 – 2 months. Questionnaires disseminated to both clinical and consumer stakeholders (patients and parents/carers) will take 20 minutes to complete, and only need to be completed once during the study period. Regarding implementation, consensus focus group workshop are anticipated be to 2 hours in duration with one to two rounds depending on level of agreement reached – and will take approximately 3 – 6 months to complete. Intensive face-to-face workshops are anticipated to be one hour and occur twice a week for 6 weeks. Lastly, parents and caregivers will be sent surveys (20 minutes in duration to complete) for a period of 6 months (post-implementation) for all patients who were eligible for NPWT. Purposive sampling will be used to select healthcare professionals and parent/carer stakeholders. Semi-structured interviews will be conducted using maximum variation sampling (until saturation is reached) to ensure representation of different perspectives including emergency and burns clinicians (medical/nursing, metropolitan/regional, novice/experienced, various states) and consumers (parents/carers of NPWT patients) across all states. Interviews will be audio recorded using a semi-structured approach with open-ended questions about current and desired approaches to NPWT application in paediatric burns patients. The intervention will involve (delivered via a stepped wedge randomised controlled trial) the implementation and evaluation of the INPREP Pathway’s effect on clinical and implementation outcomes from four major Australian paediatric hospitals - The Children’s Hospital at Westmead, Perth Children’s Hospital, Queensland Children’s Hospital, and Royal Children’s Hospital Melbourne. All participating hospitals will start the trial in the control phase (usual care/standard silver dressings) with baseline measurements taken. Following this control phase, one site will randomly step up (computer-generated, centralised randomisation) to implementation every six weeks over 13-months, until saturation of the implementation intervention across all sites. Intervention establishment will involve the research nurses (ReNs) collaborating with a NPWT advisory group (comprising of burns and ED clinicians and parents and caregivers of children who have previously engaged with the burns service). The project manager and ReNs will also collaborate with local champions to promote the INPREP Pathway and delivering the companion implementation strategies. An internal process evaluation will be undertaken guided by the Consolidation Framework for Implementation Research (CFIR) to establish: 1. INPREP Pathway adherence: rate of patients who received NPWT according to eligibility and duration of application defined within the INPREP Pathway 2. Appropriateness of the INPREP Pathway – clinician and patient carer perspective of pathway and procedure 3. Acceptability of the INPREP Pathway – clinician and patient carer perspective of pathway and procedure 4. Feasibility of the INPREP Pathway – clinician and patient carer perspective of pathway and procedure. A project manager at the Queensland Children’s Hospital (lead site) will develop a study manual and training schedule for research nurses, monitor data integrity, maintain an intervention fidelity log, collaborate with the team (ReNs and chief investigators) to promote intervention fidelity, and work with local site investigators at participating hospitals to address any issues that arise during the study period. Implementation education will provide evidence-based advice, but treating clinicians will determine definitive care (e.g., inpatient versus outpatient care) based on patient needs and healthcare priorities.