Implementing best-practice burn first-aid in emergency care: a type III hybrid effectiveness–implementation study protocol in emergency department and prehospital settings

Abstract

Introduction

Dissemination of evidence-based burn first-aid is critical for improving clinical outcomes for patients with acute burn injuries. The overarching goal of this research is the successful and sustainable translation of 20 min of cool running water (20CRW), administered within 3 hours of a burn, as a first-aid treatment for acute thermal injuries within emergency departments (EDs) and emergency medical services (EMSs). Despite the well-established benefits of 20CRW, this treatment is not included in relevant USA burn first-aid guidelines and has not been adopted in clinical settings as a standard first-aid treatment.

Methods and analysis

This protocol outlines an investigation using an effectiveness-implementation hybrid type III design to evaluate the effectiveness of 20CRW implementation into ED and EMS settings in Sacramento, California. The principal aim of this research is to implement 20CRW as a first-aid treatment for acute thermal burn injuries within participating ED and EMS settings. We will assess adherence to 20CRW guidelines and provision following implementation into routine clinical practice. In addition, we will evaluate the clinical effectiveness of 20CRW in improving patient outcomes, and the acceptability of 20CRW as a burn first-aid treatment, considering both clinician and burn survivor perspectives. This research will generate critical evidence on the implementation and clinical impact of 20CRW in US emergency care settings. It will also evaluate whether the co-designed implementation strategies effectively support adoption of 20CRW within the US ED and EMS settings.

Ethics and dissemination

Institutional Review Board (IRB) approval has been awarded for this research (IRB ID: 18834-5) from the University of California Davis Office of Research Ethics Committee. Results of this investigation will be disseminated across participating hospital and EMS organisations, presented at national and international conferences and published in open access peer-reviewed journals.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• We are using an effectiveness–implementation hybrid type III design to evaluate the implementation of 20 min of cool running water (20CRW) within emergency department and emergency medical services settings.

• The research addresses a critical evidence–practice gap by evaluating the implementation of 20CRW, a well-supported burn first-aid intervention not currently included in US burn first-aid guidelines.

• This work is embedded in real-world emergency care settings, allowing assessment of 20CRW delivery under routine clinical conditions.

• Multiple data sources will be used to assess implementation processes, clinical effectiveness and acceptability of the 20CRW intervention.

• This investigation will be conducted in a single metropolitan region, which may limit the generalisability of findings to dissimilar settings.

Introduction

Recommended first-aid for acute thermal burn injuries consists of 20 min of cool running water (20CRW) applied within the first 3 hours of burns.¹ Burn care organisations worldwide endorse this practice, including the British Burn Association,² European Burns Association³ and the Australian and New Zealand Burn Association.^{4 5} The American Burn Association also recommends cool running water for acute burns, but specifies a minimum duration of 5 min.⁶

Cool running water has several beneficial effects on burn injuries through various possible mechanisms. It halts the burning process by reducing subdermal temperatures below the threshold that causes cellular damage.⁷ Moreover, cool running water limits burn depth progression by preventing cells in the zone of stasis from undergoing progressive necrosis 24–48 hours post-burn.⁸ It also decreases cellular metabolism, supporting cells in the zone of stasis, allowing their survival in the hypoxic wound environment. Numerous human and animal studies have demonstrated that the best clinical outcomes occur when patients receive cool running water for a total duration of 20 min.^9–16 Cool water is defined in this context as tap water around 15°C (59°F), with a range of 8°C–25°C (46.4°F–77°F).^17–21 In a large paediatric cohort investigation, 20CRW minimised burn wound depth, shortened time to re-epithelialisation, reduced the need for skin grafting and other surgical interventions and decreased inpatient admissions.⁹ Similar benefits have been observed in adults with burns, where those receiving 20CRW within 3 hours of injury exhibited lower risks of requiring skin grafts, fewer intensive care unit (ICU) admissions and reduced length of stay.¹²

Successful and sustainable translation of research findings into clinical practice remains a longstanding and well-documented challenge in healthcare.^{22 23} Studies examining the implementation of healthcare interventions consistently highlight barriers at multiple levels, including organisational constraints, intervention-related barriers, individual and broader system-level obstacles.²⁴ Determinants such as leadership, workplace culture and professional group attitudes and norms substantially shape whether implementation efforts succeed.^{23 24} Research findings should not simply be transferred directly from academic settings into routine clinical care; instead, their relevance and feasibility must be assessed locally, and the evidence-based intervention often needs to be adapted, operationalised and integrated into existing workflows to achieve meaningful and sustained impact.

Advantages of 20CRW include its low cost, accessibility and simplicity. In the USA, emergency medical services (EMS) and professional organisation guidelines do not universally include 20CRW application within 3 hours of burns. Instead most burn first-aid guidelines stipulate 3–5 min of cooling,²⁵ at least 5 min of cooling⁶ or the use of wet or dry dressings.²⁶ Our investigation will engage multiple relevant clinical stakeholders throughout the trial and aims to implement 20CRW into standard practice across two clinical settings: the University of California (UC) Davis Health Emergency Department (ED) and the prehospital setting with the Sacramento Fire Department.

Aims and objectives

We aim to implement 20CRW as a first-aid treatment for acute thermal burn injuries, alongside co-designed and tailored implementation strategies, within the ED at UC Davis Health and the prehospital setting Sacramento Fire Department. We will assess adherence to 20CRW guidelines postimplementation into clinical practice and determine the clinical effectiveness of 20CRW on burn patient outcomes. This study also aims to assess the acceptability of 20CRW as part of standard clinical practice in participating organisations 28 months after the implementation of this burn first-aid treatment.

To achieve the above-mentioned aims, we have the following objectives:

1. Determine adherence to 20CRW as a burn first-aid treatment for acute thermal burn injuries.

   1. Adherence is defined as the proportion of eligible patients with acute thermal burn injuries that received 20CRW as a first-aid treatment within 3 hours of sustaining their burns (eg, the extent to which 20CRW was delivered as intended).

   2. The proportion of eligible patients presenting with acute burn injuries that received any duration of cool running water as a first-aid treatment will be determined as a comparator.

2. Using an effectiveness-implementation hybrid type III design, examine the effectiveness of 20CRW implementation as a burn first-aid treatment on improving clinical patient outcomes (eg, reducing skin grafting requirements, hospital admissions, surgical requirements, improving time to re-epithelialisation).

3. Using online questionnaires and semistructured interviews, evaluate the acceptability of 20CRW as a burn first-aid treatment within participating organisations 28 months postimplementation, and determine local contextual factors influencing the uptake and translation of 20CRW into standard clinical practice.

Hypotheses

Primary hypothesis

20CRW administration within the first 3 hours of a burn, in parallel with co-designed and tailored implementation strategies, will be implemented and integrated into clinical practice within the ED at UC Davis and prehospital setting within Sacramento Fire Department. This implementation will be demonstrated via increased rates of adherence to 20CRW provision over a 28-month period for eligible thermal burn patients.

Secondary hypothesis

20CRW will significantly improve clinical outcomes for burn patients by reducing rates of skin grafting, improving time to re-epithelialisation, decreasing hospital admissions and length of stay and minimising the number of outpatient appointments and surgeries.

Ancillary hypothesis

20CRW as a burn first-aid treatment will be accepted by ED, burns, and EMS clinicians, as well as by adult burn survivors (≥18 years) and caregivers of paediatric burn survivors (<18 years), within participating organisations 28 months after implementation.

Methods and analysis

Setting

This investigation will be conducted at UC Davis Health, a major tertiary US adult and paediatric hospital located in Sacramento, California. UC Davis Health houses the American Burn Association verified Firefighters Burn Institute Regional Burn Center, which serves as the designated statewide referral centre for adult burn patients. This investigation will also involve the Sacramento Fire Department, a comprehensive fire department that responds to medical emergencies in Sacramento and is responsible for providing advanced life support services, initial first-aid to patients who have sustained burns and transporting burn patients to the UC Davis ED. Data collection and participant recruitment for this research commenced on 31 January 2024 and will conclude on 1 June 2026.

Trial design

This investigation will be conducted using an effectiveness–implementation hybrid type III study design. Within hybrid study designs, research questions assessing both the clinical effectiveness of an intervention and the effectiveness of its implementation are examined.²⁷ Type III designs refer to studies in which the principal focus is the assessment of implementation strategies and their impact on implementation outcomes (eg, adherence to the intervention), while clinical effectiveness data are collected concurrently.²⁸ Intervention adherence and clinical outcomes will be evaluated in one clinical setting – the ED at UC Davis Health. Acceptability of 20CRW will be assessed within the UC Davis ED (among both ED clinicians and burn survivors/families), the Firefighters Burn Institute Regional Burn Center and the Sacramento Fire Department. This investigation will cover a retrospective period of 28 months before and a prospective period of 28 months after the implementation of 20CRW within the UC Davis ED and the Sacramento Fire Department.

Intervention

The implemented intervention will be 20CRW as a first-aid treatment for acute thermal burn injuries, delivered in parallel with co-designed implementation strategies and tailored resources. Co-designed educational materials are provided in online supplemental files 1–4. Regarding intervention timeframes, cool running water must be administered to patients with acute thermal injuries for a duration of 20 min and must be applied within the first 3 hours after a burn. If cool running water is ceased prior to the minimum timeframe, the reasons for protocol deviation will be documented.

Data collection

To examine treatment adherence to 20CRW guidelines, patient electronic medical record (EMR) data from the UC Davis ED, as well as prehospital records from the Sacramento Fire Department (uploaded to the UC Davis EMR), will be extracted (see table 1). These data will be used to assess the percentage of eligible patients with thermal burn injuries who received 20CRW as a first-aid treatment within 3 hours of sustaining their burns. The percentage of eligible burn patients who received any duration of cool running water will also be examined. To assess the impact of 20CRW on clinical outcomes (eg, time to re-epithelialisation, skin graft requirements, hospital admissions and surgical requirements), EMR data from the UC Davis Firefighters Burn Institute Regional Burn Center will be extracted to examine improvements in these clinical outcomes. Resource use that may be impacted by the 20CRW intervention in relation to clinical patient outcomes (eg, reduction in skin grafting requirements, hospital admissions, improved re-epithelialisation rates, fewer dressing changes and decreased surgical requirements) will also be assessed via EMR data from the UC Davis Firefighters Burn Institute Regional Burn Center for informing future cost-effectiveness modelling.

Table 1. Overview of timing of data collection instruments.

Phase	Instrument	Principal investigators	ED, burns and EMS clinicians	Burn survivors	Health records	Burns registry
Phase 1: Co-design Pre-20CRW Implementation	Electronic questionnaires		X
	Semistructured interviews	X	X
Phase 2: Implementation	Meeting logs	X	X		X	X
Phase 3: Evaluation Post-20CRW Implementation	Electronic questionnaires		X	X
	Semistructured interviews	X	X	X	X	X

Phase one of this investigation has been completed. This aided in the identification of barriers and facilitators to the implementation of 20CRW across ED and EMS settings. Moreover, co-designed and tailored implementation strategies to address identified barriers and leverage key facilitators were developed in phase one in collaboration with relevant clinicians and stakeholders. Results from phase one have been published.

20CRW, 20 min of cool running water; ED, emergency department; EMS, emergency medical service.

Data on the acceptability of 20CRW will be obtained from online questionnaires and semistructured group interviews with relevant ED, burn and EMS clinicians, as well as with burn survivors and caregivers of paediatric burn survivors (<18 years) 28 months postimplementation of this burn first-aid treatment. The acceptability of 20CRW as a burn first-aid treatment will be assessed using online questionnaires and then further explored within semistructured interviews, using interview guides based on components of the Theoretical Framework of Acceptability (TFA) (20). The TFA is a validated framework developed to assess the acceptability of healthcare interventions from the perspective of those delivering or receiving the intervention. It defines acceptability as a multidimensional construct reflecting the extent to which people consider an intervention acceptable, based on their anticipated or experienced cognitive and emotional responses to it.²⁹ The TFA comprises seven constructs: affective attitude (how individuals feel about the intervention), burden (the perceived effort required to participate), ethicality (the extent to which the intervention aligns with personal values), intervention coherence (understanding of the intervention), opportunity costs (benefits or values foregone), perceived effectiveness (belief in the intervention’s efficacy) and self-efficacy (confidence in engaging with the intervention). This framework supports a systematic and theoretically informed approach to assessing implementation outcomes and is increasingly used in qualitative health research to explore stakeholder perspectives across different stages of intervention development and delivery.

Patient electronic medical records

20CRW adherence

Prehospital and ED data will be accessed retrospectively to examine the level of 20CRW adherence, which will be measured via review of patient EMR data 28 months postimplementation of 20CRW in clinical practice. Two measures will be used to examine 20CRW adherence:

1. Evidence of 20CRW (yes/no).

2. Evidence of cool running water but for <20 min (yes/no).

Figure 1 illustrates data collection timepoints. EMR data will be extracted from two clusters of patient records–from periods before and after (T1 and T2) the implementation of 20CRW. It is expected that a total of N=774 medical record reviews will be performed, n=387 in T1 and n=387 in T2.

Figure 1. Data collection time points.

Patient outcomes and resource use

Outlined below are required data points to determine the effect of the 20CRW intervention on clinical outcomes and healthcare resource use:

1. Patient and burn characteristics.

2. First-aid interventions and prehospital care.

3. Skin grafting requirements.

4. Other surgical procedures and interventions.

5. Hospital admission rates and length of stay.

6. ICU admission rates and ICU lengths of stay.

7. Number of outpatient appointments.

8. Number of outpatient dressing changes.

9. Time to 95% burn wound re-epithelialisation (defined as ≥95% of the original burn wound area has re-epithelialised, and the patient no longer requires definitive dressings).

10. Scar management referrals and requirements.

11. Re-admission data and burn wound complications (eg, infection).

12. Mortality.

Adult burn patients transported to the UC Davis ED via Sacramento Fire Department, or who self-present to UC Davis ED, are typically admitted to the UC Davis Firefighters Burn Institute Regional Burn Center following initial management in the ED. Essential burn patient data required for this investigation are routinely collected and stored in EMRs within UC Davis Health. Prehospital burn patient data from Sacramento Fire Department EMS flow sheets are routinely uploaded to UC Davis EMRs–the UC Davis Electronic Health Record Program Interoperability and Compatibility system. Our aim is to access EMR data from 28 months before and 28 months after the implementation of 20CRW to assess adherence to this burn first-aid practice. These data will also be used to detect a change in clinical patient outcomes, as well as healthcare related resource use. Based on sample size calculations, a total number of 774 patient records will be required. Prior to protocol development, formal pilot data were not collected; however, local site investigators confirmed the availability and accessibility of all data elements required for the primary and secondary outcomes through direct review of existing record systems.

Implementation outcome data collection

To establish 20CRW implementation effectiveness at an organisational level, online questionnaires and semistructured interviews with relevant clinical stakeholders will be conducted at 28 months postimplementation:

1. Clinical participants from the UC Davis ED and Firefighters Burn Institute Regional Burn Center will comprise healthcare professionals involved in the treatment of burn patients presenting to the hospital, including ED physicians, burn surgeons, nurses and technicians.

2. Adult burn survivors and caregivers of paediatric burn survivors presenting to the UC Davis ED will also be invited to participate in these online questionnaires and semistructured interviews.

3. Clinical participants from the Sacramento Fire Department will include variable levels of officers and non-officers, all of whom are either firefighter paramedics or firefighter emergency medical technicians.

Questionnaires and interviews will assess the acceptability of 20CRW, alongside the co-designed and tailored implementation strategies, as well as participants’ overall experience delivering or receiving this first-aid treatment. Additional insights into barriers and facilitators to 20CRW implementation will also be sought.

Clinician and patient questionnaires (post-implementation feedback)

An electronic questionnaire will be developed for ED and burn clinicians to complete following the provision of 20CRW (eg, one questionnaire completed each time 20CRW is administered to a patient). Questionnaires will examine how difficult/easy 20CRW was to administer to that specific patient, ongoing contextual barriers and enablers to 20CRW administration since the burn first-aid treatment was implemented into clinical practice and if the co-designed implementation strategies and tailored resources (developed in phase one of this investigation) are suitable to healthcare professionals or require further refining. Questionnaires will also be developed and distributed to adult burn survivors and caregivers of paediatric burn survivors who presented to the UC Davis ED for acute burn management. Questionnaires will ascertain how well the intervention was accepted, its perceived effectiveness and potential different views on implementation barriers or enablers.

Interviews (28 months post-implementation)

Participants (ED clinicians, burn clinicians, burn patients and caregivers of paediatric burn patients) who complete the electronic questionnaire will be invited to take part in an optional follow-up interview to provide more in-depth perspectives on the factors influencing their acceptability ratings. In addition, EMS clinicians from the Sacramento Fire Department will be identified using purposive sampling methods. Local investigators will assist in identifying potential EMS participants based on their roles and availability. A minimum of 10 face-to-face interviews will be conducted with ED, burn and EMS clinicians, as well as burn survivors and caregivers of paediatric burn survivors, 28 months postimplementation of 20CRW as a first-aid treatment for acute burn injuries. These semistructured interviews will collect additional data to determine overall acceptability of 20CRW, alongside the co-designed and tailored implementation strategies. The interview guide will be informed by both the TFA and preliminary questionnaire findings, enabling exploration of each of the seven TFA domains, Affective Attitude, Burden, Ethicality, Intervention Coherence, Opportunity Costs, Perceived Effectiveness and Self-efficacy, in greater depth. Interviews will be conducted via videoconference or face-to-face, audio-recorded with participant consent and transcribed verbatim.

Participant selection and enrolment

Inclusion criteria

Patient EMR data will be accessed for all patients with acute thermal burns presenting or transported to UC Davis ED and admitted to UC Davis Firefighters Burn Institute Regional Burn Center, or discharged home from the ED and referred to Burn Outpatient care at UC Davis.

Exclusion criteria

Data from patients with non-acute burn injuries (eg, burns sustained >3 hours prior) will not be included. Patients with non-thermal burns including chemical, electrical and friction injuries will also be excluded from this trial. Furthermore, the following patient factors were identified as exclusion criteria for 20CRW provision during co-design interviews with relevant clinical stakeholders in phase one:

1. Patients with burn total body surface area (TBSA) percentages ≥30%.

2. Facial burns and/or suspected inhalation injuries.

3. Intubated patients.

4. Hypothermia <36°C (<96.8°F).

5. Non-responsive or critically unwell patients.

6. Patients requiring urgent escharotomies.

Patient and public involvement

Healthcare professionals from participating sites contributed to the design of this investigation through regular multidisciplinary meetings hosted via Microsoft Teams, site visits and email correspondence. No patients or members of the public were directly involved in the design of this research. However, as part of this investigation, adult burn survivors and caregivers of paediatric burn survivors will be invited to participate in electronic questionnaires and semistructured interviews to assess the acceptability of the 20CRW intervention, describe their firsthand experiences and identify any additional resources needed to improve implementation efforts and support ongoing sustainment.

Outcome measures

Primary implementation outcome

Adherence to 20CRW guidelines and provision of at least 20% 28 months after the implementation of 20CRW as a first-aid treatment for acute thermal burn injuries in the ED at UC Davis.

Secondary implementation outcomes

Acceptability of 20CRW implementation within participating ED and EMS settings. The acceptability of 20CRW will be assessed using online questionnaires and semistructured interviews with adult burn patients, caregivers of paediatric burn patients, ED clinicians, burn clinicians and EMS clinicians.

Primary effectiveness outcome

Difference in skin grafting requirements (eg, 10% reduction of skin grafting requirements) 28 months after the implementation of 20CRW as a first-aid treatment for acute thermal burn injuries in the ED at UC Davis.

Secondary effectiveness outcomes

Improvement in burn patient morbidity and outcomes (eg, reduction in surgical interventions, hospital admission rates and length of stay, ICU admission rates and ICU length of stay, number of outpatient appointments, number of outpatient dressing changes, time to 95% burn wound re-epithelialisation, scar management referrals and requirements, re-admission data and burn wound complications and mortality) postimplementation of 20CRW as a burn first-aid treatment.

Statistical plan

Consistent with the multiple types of information planned for collection as part of this research, the statistical analyses will also vary. Proposed statistical analytic methods for the different data sources are outlined below.

Sample size determination

To determine the prevalence of adherence to 20CRW at each of the time periods to within ±5% we require 387 observations in each period (alpha=0.05). This figure assumes the most conservative adherence prevalence (in terms of width of 95% CI) of 0.5. A computer-generated randomised information subset of patients will be selected from each group (from the above sample) to compare adherence between groups at T1 and T2 (eg, 28 months preimplementation and 28 months postimplementation). Based on data from the participating burn centre, between 50% and 60% of patients treated for burns will require skin grafting. The sample size is estimated based on the primary patient outcome of a 10% reduction of skin grafting requirements with an α of 0.05 and power of 80%. With these assumptions, a sample size of N=774 patients (n=387 T1 and n=387 T2, figure 1) will be required. This total sample size of N=774 will be sufficient to conduct multivariable modelling if required and provide sufficient power for secondary outcomes: admission rates, length of stay, outpatient visits, surgical procedures and ICU requirements.

Analysis plan

Quantitative analysis of the primary (20CRW adherence rates) and secondary outcomes (effectiveness of intervention on patient outcomes, including skin graft rates, admission rates, length of stay, ICU admission, ICU length of stay, surgical procedures, mortality) will be undertaken at the two main time periods. Descriptive statistics will include means (SD) and frequency (percentage) to describe the two cohorts. Discrepancies between groups will be tested with regards to demographics (age, gender, ethnicity), injury severity (TBSA% and depth of burn) and comorbidities using regression models. The association between time-period (preimplementation/postimplementation) and the primary implementation outcome (receipt of 20CRW) will be investigated using a mixed-effects logistic regression model with time-period included as the main effect and potentially confounding variables (eg, presentation month, patient’s age) included as covariables. The site (treating ED/EMS) will be included in the regression model as a random effect. The association between the 20CRW intervention and clinical outcomes will be investigated using mixed-effects regression models, with time-period (pre and post) included as the main fixed-effect and site included as a random effect. Potential confounders (eg, injury severity) will be included as appropriate. For outcomes with continuous data, we will use linear models, for binary outcomes we will use logistic models and for count outcomes we will use Poisson or negative binomial models depending on dispersion.

Online questionnaire data

Responses to Likert-scale items will be summarised using descriptive statistics. Categorical data will be presented as frequencies and percentages, while continuous or ordinal data will be reported using means and SD or medians and IQRs, as appropriate. Free-text response data will be analysed using reflexive thematic analysis.³⁰ A hybrid inductive-deductive approach will be employed–initial coding will be guided by the TFA to capture responses related to intervention acceptability across its seven constructs,²⁹ while also allowing novel themes to emerge inductively from the data.

Interview data

Interviews will be conducted via videoconference or face-to-face, audio-recorded with participant consent and transcribed verbatim. Transcripts will be analysed using reflexive thematic analysis, following the approach described by Braun and Clarke.³⁰ Coding will be both inductive and deductive, allowing themes to emerge from the data (to capture novel or context-specific elements) while also mapping responses to the TFA domains.²⁹ NVivo software (QRS International, Doncaster, USA) will be used to assist with data management and coding. Then key barriers will also be mapped against the Consolidated Framework for Implementation Research, identifying supportive implementation strategies to inform phase 4 of the project.

Ethics and dissemination

Institutional Review Board (IRB) approval has been awarded for this research (IRB ID: 18834-5) from the UC Davis Office of Research Ethics Committee. Results of this investigation will be disseminated across participating hospitals and EMS organisations, presented at national and international conferences, and published in open access peer-reviewed journals.

Participant consent

Local site investigators will aid in the identification of participants within ED, Burn and EMS settings. For participation in electronic questionnaires, a consent-to-continue approach (also referred to as implied consent) will be used. At the beginning of the REDCap questionnaire, participants will be provided with information outlining the scope and purpose of the questionnaire, along with a statement indicating that by continuing to complete the questionnaire, they are providing consent to participate and for their responses to be used in the investigation. For participation in semistructured interviews, verbal consent will be obtained from all participants. Participants will be informed that consent includes agreement to take part in the interview and to allow audio and video recording of the session. Regarding access to patient medical records, a waiver of consent has been approved to permit access to patient medical record data for this investigation.

Safety considerations

All researchers involved in the trial will have current Good Clinical Practice research training and follow applicable university policies (eg, UC Davis Hospital Policy 1313, UCDHS P&P 2300-2499) to ensure the highest research practice integrity. Ultimately, the implementation of 20CRW could benefit anyone with an acute burn. The project poses minimal to no risk or direct benefits to anyone involved. The implementation of 20CRW will supplement already existing best practice guidelines within UC Davis ED and Sacramento Fire Department.

Unanticipated problems and adverse events

Due to loss of thermoregulatory control, hypothermia is a risk for patients with severe burns >30% TBSA, especially in those with inhalation injuries and who were intubated in the prehospital environment. Few studies have explored the association between cool running water first-aid provision and the onset of hypothermia. One study identified a correlation between hypothermia and the duration of water cooling in adult patients with burns covering more than 20% TBSA.³¹ In contrast, an investigation conducted in 2010 found no such association between prehospital first-aid cooling with water and the development of hypothermia in both adult and paediatric burn patients.³² This investigation poses minimal to no risk to burn patients, as it builds on well-established, best-practice burn first-aid guidelines that are advocated and used in many countries worldwide. One, if not the only, risk of 20CRW implementation could be hypothermia, which has been associated with severe burns >20% TBSA, patient age and the presence of inhalation injuries.³³ This study excludes patients with >30% TBSA burns, and patients with suspected inhalation injuries.

Data management and storage

Participant names or identifiers will not be associated with any published results. Data obtained from participants will be held strictly confidential in locked facilities and password protected computers locally at the participating site. Data will be backed up on the secure Griffith University Data Storage Service for final analyses. Participants will not be identified by name, and confidentiality will be preserved. A data monitoring committee (DMC) will be established and will comprise a mix of expert clinical specialists, an external biostatistician with clinical trial expertise and a health economist with prior DMC experience from both Australia and California. The DMC will meet three times over the trial’s duration via a videoconference (such as Microsoft Teams). Monitoring will consist of a completeness check, adverse events and linkage quality. We do not anticipate any interim data analysis to be required.

Confidentiality

Data obtained from participants will be held strictly confidential in locked facilities and password protected computers. Trained researchers will enter pertinent information into the database using REDCap with secure servers used to transfer data. Paper workflow observer notes will be transcribed and entered into the secure REDCap or similar secure online database. Data obtained from participants will be held strictly confidentially in locked facilities and password protected computers at each participating site. Trained researchers will enter pertinent information into the database using REDCap or a similar secure online database with secure servers used to transfer data between study sites. Each researcher will be restricted to only the data they collect or have a need to access. Once data are linked it will be de-identified and shared with the biostatistician in Australia for analysis. Identifying information, namely date of birth and sex will be collected only for linkage purposes at California’s Office of Statewide Health Planning and Development. All patient information will be deidentified when sent to investigators. A linking key will be kept at the participating site’s burn research centre and destroyed after data analysis is complete.

Record retention

Data will be backed up on the secure Griffith University Data Storage Service. Participants will not be identified by name, and confidentiality will be preserved. All participants’ details will be entered in coded format, and the confidentiality of participants will be maintained unless disclosure is required by law. Access to the data collection form will only be available to necessary members of the research team and stored in accordance with data storage best practices. Any data exported from REDCap will be de-identified, and no identifiable information data will be published. Consistent with IRB procedures, the study records will be maintained for 6 years after completion of the study. Thereafter, paper and electronic records will be destroyed or erased using data overwriting software and confidential methods (shredding/confidential recycling) per University policy. The study is not subject to record retention or inspection requirements of any other regulatory agencies.

Discussion

This protocol outlines an effectiveness–implementation hybrid type III investigation designed to support and evaluate the translation of 20CRW into routine burn first-aid practice. Although the clinical benefits of 20CRW are well established,^9–12 its absence from US burn first-aid guidelines and its limited uptake in emergency care settings highlight a persistent evidence-to-practice gap. This research aims not only to increase adherence to this evidence-based first-aid treatment but also to understand the contextual factors that influence its adoption and acceptability, as well as to evaluate the clinical effectiveness of 20CRW in improving burn patient outcomes.

This investigation has several strengths. The selected hybrid type III design, in addition to the inclusion of co-design research methods, offers several advantages. Hybrid study designs provide simultaneous examination of how an intervention is implemented and how it performs under routine clinical conditions, often accelerating the translation of evidence-based healthcare interventions into standard clinical practice.³⁴ Involving ED, EMS and burn clinicians as co-design partners in planning and shaping implementation strategies enhances the contextual fit, acceptability and sustainability, ultimately increasing the likelihood that 20CRW will be successfully integrated into routine practice.³⁵

A limitation of our effectiveness–implementation hybrid type III design is that it is not intended to provide robust causal estimates of the effect of 20CRW on patient outcomes, and instead has a primary focus on implementation considerations consistent with the study aims. Moreover, the implementation context of a single ED and its associated EMS agencies within one US state (Sacramento, California) may limit the generalisability of our findings to dissimilar systems and services. This has particular relevance for the co-designed implementation strategies, which were developed in collaboration with local ED and burn clinicians and may not be appropriate for dissimilar contexts. Findings from this research are expected to inform scalable, context-responsive implementation strategies and generate empirical evidence that enhances the uptake and translation of 20CRW into clinical practice and guide future efforts to close this evidence-to-practice gap in acute burn care.