Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000166774
Ethics application status
Approved
Date submitted
30/11/2021
Date registered
1/02/2022
Date last updated
27/01/2023
Date data sharing statement initially provided
1/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of Negative Pressure for Acute Paediatric Burns
Scientific title
Implementation effectiveness of a co-designed negative pressure wound therapy pathway for paediatric burns: A multisite, stepped wedge randomised controlled trial
Secondary ID [1] 305866 0
None
Universal Trial Number (UTN)
Trial acronym
INPREP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Burns 324415 0
Paediatric Burns 324416 0
Condition category
Condition code
Emergency medicine 321907 321907 0 0
Other emergency care
Injuries and Accidents 321909 321909 0 0
Burns
Skin 321910 321910 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322264 0
Treatment: Devices
Comparator / control treatment
Emergency departments/burns centres will be randomised to varying lengths of baseline in a stepped-wedge design, where no intervention will be delivered during the baseline period. Sites will randomly step up to receive the intervention at 6-week intervals until saturation of the implementation intervention across all sites.
Control group
Active

Outcomes
Primary outcome [1] 329656 0
INPREP Pathway Adherence: Rate of patients who received NPWT

INPREP Pathway Adherence will be assessed by audit of electronic medical records of paediatric patients receiving care for burns injuries at the four partnering sites.
Timepoint [1] 329656 0
13 months post-intervention implementation at the last site
Secondary outcome [1] 403333 0
Appropriateness – Clinician and patient carer perspective of INPREP pathway and procedure

Appropriateness will be assessed using the Intervention Appropriateness Measure, and Consolidated Framework for Implementation Research (CFIR) observation/field notes.

Patient- and clinician-rated appropriateness will be assessed using 5-point Likert scales within self-report questionnaires and structured interviews (30-minute, audio-recorded focus group interviews with approximately 5 participants in each group or via telephone interview.).
Timepoint [1] 403333 0
13 - 30 months post-baseline data collection (control phase)
Secondary outcome [2] 404412 0
Acceptability: Clinician and patient carer perspective

Acceptability, from the perspective of both the clinician and patient carer, will be assessed using the Acceptability of Intervention Measure, as well as CFIR observation and field notes.

Patient- and clinician-rated acceptability will be assessed using 5-point Likert scales within a self-report questionnaires and structured interviews (30-minute, audio-recorded focus group interviews with approximately 5 participants in each group or via telephone interview.).
Timepoint [2] 404412 0
13 - 30 months post-baseline data collection (control phase)
Secondary outcome [3] 404413 0
Feasibility: Clinician and patient carer perspective

Feasibility, from the perspective of both the clinician and patient carer, will be assessed using the Feasibility of Intervention Measure (5-point Likert scale) and CFIR observation/field notes.

Patient- and clinician-rated feasibility will be assessed using 5-point Likert scales within a self-report questionnaires and structured interviews (30-minute, audio-recorded focus group interviews with approximately 5 participants in each group or via telephone interview.).
Timepoint [3] 404413 0
13 - 30 months post-baseline data collection (control phase)
Secondary outcome [4] 404414 0
Healing outcomes: i)Time/days to re-epithelialisation (blinded photo assessment), ii) rate of skin grafting, iii) blister fluid, iv) number of dressing changes, v) adverse events.

Healing outcomes will be assessed via audit of electronic medical records of paediatric patients receiving care for burns injuries at the four partnering sites.
Timepoint [4] 404414 0
36 - 48 months post-baseline data collection (control phase)
Secondary outcome [5] 404415 0
Operating theatre requirements: i) proportion patients requiring an operation (%), ii)operations required per patient, iii) operative procedures performed (e.g., skin graft)

Operating theatre requirements will be assessed via audit of electronic medical records of paediatric patients receiving care for burns injuries at the four partnering sites.
Timepoint [5] 404415 0
36 - 48 months post-baseline data collection (control phase)
Secondary outcome [6] 404416 0
Hospital requirements 12 months post-injury: i) rate of patients needing =1 admissions to hospital (% & length of days stay), ii) number of outpatient appointments, iii) number of scar clinic appointments

Hospital requirements (such as rate of patient admissions to hospital, number of outpatient appointments, and number of scar clinic appointments) will be assessed via audit of electronic medical records of paediatric patients receiving care for burns injuries at the four partnering sites.
Timepoint [6] 404416 0
36 - 48 months post-baseline data collection (control phase)
Secondary outcome [7] 404421 0
Health care resource use for study interventions (e.g. time to apply NPWT, cost of device, other dressings, procedures, unexpected return to hospital ii) implementation costs (e.g. change facilitator, staff time for training, resources & materials).

Health care resources will be assessed via audit of electronic medical records of paediatric patients receiving care for burns injuries at the four partnering sites.
Timepoint [7] 404421 0
36 - 48 months post-baseline data collection (control phase)

Eligibility
Key inclusion criteria
Phase 1 (Co-Design Pathway) Inclusion Criteria:
• Clinicians from the ED and/or burns service who are responsible for burns care
• Parents and caregivers of children who have had a burn injury within the last year

Phase 2 (Implementation) Inclusion Criteria:
Participants will include paediatric patients (aged less than 18 years) presenting to the CHW, PCH, QCH, or RCHM with an acute burn. Specific eligibility criteria (inclusion and exclusion criteria) for the use of NPWT in children with acute burns will be established during Phase 1 of this investigation. Broad inclusion criteria will include children presenting to one of the four participating tertiary hospitals with an acute thermal burn injury requiring treatment from the Burns Service.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following initial set up, all participating sites will start the trial in control phase with the baseline measures taken, and then one site will randomly step up (computer-generated, centralised randomisation) to implementation every 6 weeks, until saturation of the implementation intervention across all sites.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Following the development and co-design of the INPREP Pathway, NPWT will be implemented and integrated across four major paediatric Australian hospitals using a hybrid type III effectiveness-implementation design to test the INPREP Pathway implementation strategies and patient outcomes, via a multi-centre, prospective, pragmatic, stepped-wedge RCT at four partnering hospitals. The stepped-wedge RCT suits scenarios where simultaneous rollout is unfeasible. We aim to evaluate the impact of the INPREP Pathway on implementation outcomes and patient outcomes over three periods (control, implementation, and sustainability).

Our project follows a pragmatic design to best allow the NPWT Pathway intervention to be tailored to the site context. All sites will start the trial in control phase with the baseline measures taken, then one site will randomly be allocated (i.e., NPWT implemented across the site) (using computer-generated, centralised randomisation) to implementation every 6 weeks, until the new intervention has been implemented across all sites at 13 months. At 13 months after implementation has occurred across all sites, adherence sustainability will be measured to inform implementation effectiveness.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size & Statistical Power:
Using a stepped-wedge study design, and four sites with a minimum of 100 individuals recruited from each site (recruiting patients until the capacity of the site is reached), we would be able to detect a difference of 10% in adherence rate with 94% power (5% alpha). We expect an improvement of 10% in adherence from 10% in controls to 20% in the treatment. A greater difference in adherence, with the same parameters otherwise, will result in higher power and thus the above is the minimum numbers expected. Calculations were performed with the shiny app from Hemming et al. (2015). We anticipate a minimum of 120 potential patients per site, which will be more than the above estimate and thus the power of this study is expected to be >94%.

Statistical Analysis:
Generalised Linear Mixed Models (fitting a random intercept to account for clustering, random effect) and Generalised Estimating Equations (using the individual as the clustering unit) will be used to compare the effect of switching from the usual care to INPREP condition on primary and secondary outcomes. Specifically, an appropriate protocol for model selection based on Zuur et al. (2009) will be applied. This analysis approach is able to account for potential temporal trends, using time as a covariate, in addition to clinical explanatory variables (total body surface area, age, gender), which will be included in each model. It should be noted that other covariates, such as time, could be used as random effects in the mixed models.

Implementation Evaluation:
We will use a previously described approach informed by the Consolidated Framework for Implementation Research (CFIR) (Keith et al., 2017). We will collate data from focus groups, questionnaires as well as field notes of clinicians, taken by the ReNs documenting feedback at the time of the intervention implementation. The transcribed interviews and field notes will be analysed using a deductive qualitative content analysis technique recommended for CFIR. The analysis will be performed by two researchers independently using the CFIR NVivo template [QSR International Pty Ltd. (2020)] pre-populated with construct codes. The outputs of the analysis will be actionable recommendations to optimise the pathway and improve implementation.

Cost Effective Analysis:
We will record data, analyse, and report cost-effectiveness findings following guidelines for trial-based cost-effectiveness analyses, including reporting resource use and costs (healthcare perspective) for each trial condition. Healthcare utilisation data will be costed using actual costs (e.g., device costings) when available or market rates. Intervention provision costs to deliver usual care or INPREP during the trial (12-month time-horizon for patients) will be recorded and applied at a per-patient level. A trial-based incremental cost-effectiveness ratio (ICER) will be estimated for the incremental cost per additional patient successfully completing NPWT. ICER=[(Cost NPWT) minus (Cost usual care)] / [(Effect NPWT minus Effect usual care)]. Due to the potential for uncertainty and non-normal distributions, 95%CIs (for costs and effect estimates) and a 95% confidence ellipse (for ICER) will be derived from bootstrap resampling. In addition, Markov modelling (5-year time-horizon) will be used to extend these cost-effectiveness findings by generating estimates for the consequences (on costs and patient outcomes listed above) of implementing INPREP at all specialist paediatric hospitals in Australia using data from this trial and prior studies as well as health service and population profile data (e.g. Australian Bureau of Statistics). In addition to probabilistic sensitivity analyses, we will assess sensitivity of results to variation in measured resource use, unit costs, effectiveness, time-horizon, and discounting (one way and multi-way sensitivity analyses).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
8/08/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
400
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 21232 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 21234 0
Perth Children's Hospital - Nedlands
Recruitment hospital [3] 21235 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 21236 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 36103 0
2145 - Westmead
Recruitment postcode(s) [2] 36105 0
6009 - Nedlands
Recruitment postcode(s) [3] 36106 0
4101 - South Brisbane
Recruitment postcode(s) [4] 36107 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 310218 0
Government body
Name [1] 310218 0
National Health and Medical Research Council
Country [1] 310218 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road, Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 311368 0
Hospital
Name [1] 311368 0
Queensland Children's Hospital
Address [1] 311368 0
501 Stanley St, South Brisbane QLD 4101
Country [1] 311368 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309901 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 309901 0
Ethics committee country [1] 309901 0
Australia
Date submitted for ethics approval [1] 309901 0
22/11/2021
Approval date [1] 309901 0
21/12/2021
Ethics approval number [1] 309901 0
HREC/21/QCHQ/81002

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

Contacts
Principal investigator
Name 115770 0
Dr Bronwyn Griffin
Address 115770 0
Level 4, Centre for Children’s Health Research
62 Graham St,
South Brisbane QLD 4101
Country 115770 0
Australia
Phone 115770 0
+61 404 892 517
Fax 115770 0
Email 115770 0
bronwyn.griffin@griffith.edu.au
Contact person for public queries
Name 115771 0
Maleea Holbert
Address 115771 0
Level 4, Centre for Children’s Health Research
62 Graham St,
South Brisbane QLD 4101
Country 115771 0
Australia
Phone 115771 0
+61 426 842 261
Fax 115771 0
Email 115771 0
m.holbert@griffith.edu.au
Contact person for scientific queries
Name 115772 0
Bronwyn Griffin
Address 115772 0
Level 4, Centre for Children’s Health Research
62 Graham St,
South Brisbane QLD 4101
Country 115772 0
Australia
Phone 115772 0
+61 404 892 517
Fax 115772 0
Email 115772 0
bronwyn.griffin@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data (IPD) for this trial (including data dictionaries) will not be available as a condition of ethics approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14253Study protocol  bronwyn.griffin@griffith.edu.au Please email Dr Bronwyn Griffin for additional sup... [More Details]
14254Informed consent form  bronwyn.griffin@griffith.edu.au Please email Dr Bronwyn Griffin for additional sup... [More Details]



Results publications and other study-related documents

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