Inequalities in birth before arrival at hospital in South West England: a multimethods study of neonatal hypothermia and emergency medical services call-handler advice.

OBJECTIVES: To examine inequalities in birth before arrival (BBA) at hospitals in South West England, understand which groups are most likely to experience BBA and how this relates to hypothermia and outcomes (phase A). To investigate opportunities to improve temperature management advice given by emergency medical services (EMS) call-handlers during emergency calls regarding BBA in the UK (phase B). DESIGN: A two-phase multimethod study. Phase A analysed anonymised data from hospital neonatal records between January 2018 and January 2021. Phase B analysed anonymised EMS call transcripts, followed by focus groups with National Health Service (NHS) staff and patients. SETTING: Six Hospital Trusts in South West England and two EMS providers (ambulance services) in South West and North East England. PARTICIPANTS: 18 multidisciplinary NHS staff and 22 members of the public who had experienced BBA in the UK. RESULTS: 35% (64/184) of babies conveyed to hospital were hypothermic on arrival. When compared with national data on all births in the South West, we found higher percentages of women with documented safeguarding concerns at booking, previous live births and 'late bookers' (booking their pregnancy >13 weeks gestation). These women may, therefore, be more likely to experience BBA. Preterm babies, babies to first-time mothers and babies born to mothers with disability or safeguarding concerns at booking were more likely to be hypothermic following BBA. Five main themes emerged from qualitative data on call-handler advice: (1) importance placed on neonatal temperature; (2) advice on where the baby should be placed following birth; (3) advice on how to keep the baby warm; (4) timing of temperature management advice and (5) clarity and priority of instructions. CONCLUSIONS: Findings identified factors associated with BBA and neonatal hypothermia following BBA. Improvements to EMS call-handler advice could reduce the number of babies arriving at hospital hypothermic.

Which elements of hospital-based clinical decision support tools for the assessment and management of children with head injury can be adapted for use by paramedics in prehospital care? A systematic mapping review and narrative synthesis.

OBJECTIVE: Hospital-based clinical decision tools support clinician decision-making when a child presents to the emergency department with a head injury, particularly regarding CT scanning. However, there is no decision tool to support prehospital clinicians in deciding which head-injured children can safely remain at scene. This study aims to identify clinical decision tools, or constituent elements, which may be adapted for use in prehospital care. DESIGN: Systematic mapping review and narrative synthesis. DATA SOURCES: Searches were conducted using MEDLINE, EMBASE, PsycINFO, CINAHL and AMED. ELIGIBILITY CRITERIA: Quantitative, qualitative, mixed-methods or systematic review research that included a clinical decision support tool for assessing and managing children with head injury. DATA EXTRACTION AND SYNTHESIS: We systematically identified all in-hospital clinical decision support tools and extracted from these the clinical criteria used in decision-making. We complemented this with a narrative synthesis. RESULTS: Following de-duplication, 887 articles were identified. After screening titles and abstracts, 710 articles were excluded, leaving 177 full-text articles. Of these, 95 were excluded, yielding 82 studies. A further 14 studies were identified in the literature after cross-checking, totalling 96 analysed studies. 25 relevant in-hospital clinical decision tools were identified, encompassing 67 different clinical criteria, which were grouped into 18 categories. CONCLUSION: Factors that should be considered for use in a clinical decision tool designed to support paramedics in the assessment and management of children with head injury are: signs of skull fracture; a large, boggy or non-frontal scalp haematoma neurological deficit; Glasgow Coma Score less than 15; prolonged or worsening headache; prolonged loss of consciousness; post-traumatic seizure; amnesia in older children; non-accidental injury; drug or alcohol use; and less than 1 year old. Clinical criteria that require further investigation include mechanism of injury, clotting impairment/anticoagulation, vertigo, length of time of unconsciousness and number of vomits.

How do emergency department staff respond to behaviour that challenges displayed by people living with dementia? A mixed-methods study.

OBJECTIVES: To investigate staff experiences of, and approaches to behaviour that challenges displayed by patients with dementia in the emergency department (ED). Behaviour that challenges is defined as 'actions that detract from the well-being of individuals due to the physical or psychological distress they cause within the settings they are performed', and can take many forms including aggressive physical actions, shouting and verbal aggression and non-aggressive behaviour including repetitive questioning, inappropriate exposure and resistance to care. DESIGN: Mixed-methods study consisting of an online survey and semistructured telephone interviews. Quantitative data were analysed and presented using descriptive statistics. Qualitative data were analysed thematically. SETTING: The EDs of three National Health Service (NHS) Hospital Trusts in Southwest England. PARTICIPANTS: Multidisciplinary NHS staff working in the ED. RESULTS: Fifty-two online survey responses and 13 telephone interviews were analysed. Most (24/36, 67%) survey respondents reported that they had received general training in relation to dementia in the last 2-5 years, however, less than a fifth (4/23, 17%) had received any ED-specific dementia training. All (48/48) felt that behaviour that challenges could potentially be prevented, though resource constraints and practice variation were identified. Four main themes emerged from the qualitative data: (1) the 'perfect storm' of the ED; (2) behaviour that challenges is preventable with the right resources; (3) improvisation and (4) requirement for approaches that are specific to the ED. CONCLUSIONS: The findings of this study suggest that ED staff do not feel that they are prepared to respond effectively to behaviour that challenges displayed by people living with dementia. Future work could adapt or develop an intervention to support ED staff in responding to behaviour that challenges.

Factors that influence the administration of tranexamic acid (TXA) to trauma patients in prehospital settings: a systematic review.

OBJECTIVE: In the UK there are around 5400 deaths annually from injury. Tranexamic acid (TXA) prevents bleeding and has been shown to reduce trauma mortality. However, only 5% of UK major trauma patients who are at risk of haemorrhage receive prehospital TXA. This review aims to examine the evidence regarding factors influencing the prehospital administration of TXA to trauma patients. DESIGN: Systematic literature review. DATA SOURCES: AMED, CENTRAL, CINAHL, Cochrane Database of Systematic Reviews, Conference Proceedings Citation Index-Science, Embase and MEDLINE were searched from January 2010 to 2020; searches were updated in June 2022. CLINICALTRIALS: gov and OpenGrey were also searched and forward and backwards citation chasing performed. ELIGIBILITY CRITERIA: All primary research reporting factors influencing TXA administration to trauma patients in the prehospital setting was included. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers performed the selection process, quality assessment and data extraction. Data were tabulated, grouped by setting and influencing factor and synthesised narratively. RESULTS: Twenty papers (278 249 participants in total) were included in the final synthesis; 13 papers from civilian and 7 from military settings. Thirteen studies were rated as 'moderate' using the Effective Public Health Practice Project Quality Assessment Tool. Several common factors were identified: knowledge and skills; consequences and social influences; injury type (severity, injury site and mechanism); protocols; resources; priorities; patient age; patient sex. CONCLUSIONS: This review highlights an absence of high-quality research. Preliminary evidence suggests a host of system and individual-level factors that may be important in determining whether TXA is administered to trauma patients in the prehospital setting. FUNDING AND REGISTRATION: This review was supported by Research Capability Funding from the South Western Ambulance Service NHS Foundation Trust and the National Institute for Health Research Applied Research Collaboration South West Peninsula. PROSPERO REGISTRATION NUMBER: CRD42020162943.

Do general practitioners working in or alongside the emergency department improve clinical outcomes or experience? A mixed-methods study.

OBJECTIVES: To examine the effect of general practitioners (GPs) working in or alongside the emergency department (GPED) on patient outcomes and experience, and the associated impacts of implementation on the workforce. DESIGN: Mixed-methods study: interviews with service leaders and NHS managers; in-depth case studies (n=10) and retrospective observational analysis of routinely collected national data. We used normalisation process theory to map our findings to the theory's four main constructs of coherence, cognitive participation, collective action and reflexive monitoring. SETTING AND PARTICIPANTS: Data were collected from 64 EDs in England. Case site data included: non-participant observation of 142 clinical encounters; 467 semistructured interviews with policy-makers, service leaders, clinical staff, patients and carers. Retrospective observational analysis used routinely collected Hospital Episode Statistics alongside information on GPED service hours from 40 hospitals for which complete data were available. RESULTS: There was disagreement at individual, stakeholder and organisational levels regarding the purpose and potential impact of GPED (coherence). Participants criticised policy development and implementation, and staff engagement was hindered by tensions between ED and GP staff (cognitive participation). Patient 'streaming' processes, staffing and resource constraints influenced whether GPED became embedded in routine practice. Concerns that GPED may increase ED attendance influenced staff views. Our quantitative analysis showed no detectable impact on attendance (collective action). Stakeholders disagreed whether GPED was successful, due to variations in GPED model, site-specific patient mix and governance arrangements. Following statistical adjustment for multiple testing, we found no impact on: ED reattendances within 7 days, patients discharged within 4 hours of arrival, patients leaving the ED without being seen; inpatient admissions; non-urgent ED attendances and 30-day mortality (reflexive monitoring). CONCLUSIONS: We found a high degree of variability between hospital sites, but no overall evidence that GPED increases the efficient operation of EDs or improves clinical outcomes, patient or staff experience. TRIAL REGISTRATION NUMBER: ISCRTN5178022.

Does the presence of general practitioners in emergency departments affect quality and safety in English NHS hospitals? A retrospective observational study.

OBJECTIVES: Emergency departments (EDs) in NHS hospitals in England have faced considerable increases in demand over recent years. Most hospitals have developed general practitioner services in emergency departments (GPEDs) to treat non-emergency patients, aiming to relieve pressure on other staff and to improve ED efficiency and patient experience. We measured the impact of GPED services on patient flows, health outcomes and ED workload. DESIGN: Retrospective observational study. Differences in GPED service availability across EDs and time of day were used to identify the causal effect of GPED, as patients attending the ED at the same hour of the day are quasi-randomly assigned to treatment or control groups based on their local ED's service availability. PARTICIPANTS: Attendances to 40 EDs in English NHS hospitals from April 2018 to March 2019, 4 441 349 observations. PRIMARY AND SECONDARY OUTCOMES MEASURED: Outcomes measured were volume of attendances, 'non-urgent' attendances, waiting times over 4 hours, patients leaving without being treated, unplanned reattendances within 7 days, inpatient admissions and 30-day mortality. RESULTS: We found a small, statistically significant reduction in unplanned reattendances within 7 days (OR 0.968, 95% CI 0.948 to 0.989), equivalent to 302 fewer reattendances per year for the average ED. The clinical impact of this was judged to be negligible. There was no detectable impact on any other outcome measure. CONCLUSIONS: We found no adverse effects on patient outcomes; neither did we find any evidence of the hypothesised benefits of placing GPs in emergency settings beyond a marginal reduction in reattendances that was not considered clinically significant.

Potential impacts of general practitioners working in or alongside emergency departments in England: initial qualitative findings from a national mixed-methods evaluation.

OBJECTIVES: To explore the potential impacts of introducing General Practitioners into Emergency Departments (GPED) from the perspectives of service leaders, health professionals and patients. These 'expectations of impact' can be used to generate hypotheses that will inform future implementations and evaluations of GPED. DESIGN: Qualitative study consisting of 228 semistructured interviews. SETTING: 10 acute National Health Service (NHS) hospitals and the wider healthcare system in England. Interviews were undertaken face to face or via telephone. Data were analysed thematically. PARTICIPANTS: 124 health professionals and 94 patients and carers. 10 service leaders representing a range of national organisations and government departments across England (eg, NHS England and Department of Health) were also interviewed. RESULTS: A range of GPED models are being implemented across the NHS due to different interpretations of national policy and variation in local context. This has resulted in stakeholders and organisations interpreting the aims of GPED differently and anticipating a range of potential impacts. Participants expected GPED to affect the following areas: ED performance indicators; patient outcome and experience; service access; staffing and workforce experience; and resources. Across these 'domains of influence', arguments for positive, negative and no effect of GPED were proposed. CONCLUSIONS: Evaluating whether GPED has been successful will be challenging. However, despite uncertainty surrounding the direction of effect, there was agreement across all stakeholder groups on the areas that GPED would influence. As a result, we propose eight domains of influence that will inform our subsequent mixed-methods evaluation of GPED. TRIAL REGISTRATION NUMBER: ISRCTN51780222.

Limit of detection of troponin discharge strategy versus usual care: randomised controlled trial.

INTRODUCTION: The clinical effectiveness of a 'rule-out' acute coronary syndrome (ACS) strategy for emergency department patients with chest pain, incorporating a single undetectable high-sensitivity cardiac troponin (hs-cTn) taken at presentation, together with a non-ischaemic ECG, remains unknown. METHODS: A randomised controlled trial, across eight hospitals in the UK, aimed to establish the clinical effectiveness of an undetectable hs-cTn and ECG (limit of detection and ECG discharge (LoDED)) discharge strategy. Eligible adult patients presented with chest pain; the treating clinician intended to perform investigations to rule out an ACS; the initial ECG was non-ischaemic; and peak symptoms occurred <6 hours previously. Participants were randomised 1:1 to either the LoDED strategy or the usual rule-out strategy. The primary outcome was discharge from the hospital within 4 hours of arrival, without a major adverse cardiac event (MACE) within 30 days. RESULTS: Between June 2018 and March 2019, 632 patients were randomised; 3 were later withdrawn. Of 629 patients (age 53.8 (SD 16.1) years, 41% women), 7% had a MACE within 30 days. For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98). No patient with an initial undetectable hs-cTn had a MACE within 30 days. CONCLUSION: The LoDED strategy facilitates safe early discharge in >40% of patients with chest pain. Clinical effectiveness is variable when compared with existing rule-out strategies and influenced by wider system factors. TRIAL REGISTRATION NUMBER: ISRCTN86184521.

Cost-effectiveness of advanced life support and prehospital critical care for out-of-hospital cardiac arrest in England: a decision analysis model.

OBJECTIVES: This research aimed to answer the following questions: What are the costs of prehospital advanced life support (ALS) and prehospital critical care for out-of-hospital cardiac arrest (OHCA)? What is the cost-effectiveness of prehospital ALS? What improvement in survival rates from OHCA would prehospital critical care need to achieve in order to be cost-effective? SETTING: A single National Health Service ambulance service and a charity-funded prehospital critical care service in England. PARTICIPANTS: The patient population is adult, non-traumatic OHCA. METHODS: We combined data from previously published research with data provided by a regional ambulance service and air ambulance charity to create a decision tree model, coupled with a Markov model, of costs and outcomes following OHCA. We compared no treatment for OHCA to the current standard of care of prehospital ALS, and prehospital ALS to prehospital critical care. To reflect the uncertainty in the underlying data, we used probabilistic and two-way sensitivity analyses. RESULTS: Costs of prehospital ALS and prehospital critical care were £347 and £1711 per patient, respectively. When costs and outcomes of prehospital, in-hospital and postdischarge phase of OHCA care were combined, prehospital ALS was estimated to be cost-effective at £11 407/quality-adjusted life year. In order to be cost-effective in addition to ALS, prehospital critical care for OHCA would need to achieve a minimally economically important difference (MEID) in survival to hospital discharge of 3%-5%. CONCLUSION: This is the first economic analysis to address the question of cost-effectiveness of prehospital critical care following OHCA. While costs of either prehospital ALS and/or critical care per patient with OHCA are relatively low, significant costs are incurred during hospital treatment and after discharge in patients who survive. Knowledge of the MEID for prehospital critical care can guide future research in this field. TRIAL REGISTRATION NUMBER: ISRCTN18375201.

General practitioners and emergency departments (GPED)-efficient models of care: a mixed-methods study protocol.

INTRODUCTION: Pressure continues to grow on emergency departments in the UK and throughout the world, with declining performance and adverse effects on patient outcome, safety and experience. One proposed solution is to locate general practitioners to work in or alongside the emergency department (GPED). Several GPED models have been introduced, however, evidence of effectiveness is weak. This study aims to evaluate the impact of GPED on patient care, the primary care and acute hospital team and the wider urgent care system. METHODS AND ANALYSIS: The study will be divided into three work packages (WPs). WP-A; Mapping and Taxonomy: mapping, description and classification of current models of GPED in all emergency departments in England and interviews with key informants to examine the hypotheses that underpin GPED. WP-B; Quantitative Analysis of National Data: measurement of the effectiveness, costs and consequences of the GPED models identified in WP-A, compared with a no-GPED model, using retrospective analysis of Hospital Episode Statistics Data. WP-C; Case Studies: detailed case studies of different GPED models using a mixture of qualitative and quantitative methods including: non-participant observation of clinical care, semistructured interviews with staff, patients and carers; workforce surveys with emergency department staff and analysis of available local routinely collected hospital data. Prospective case study sites will be identified by completing telephone interviews with sites awarded capital funding by the UK government to implement GPED initiatives. The study has a strong patient and public involvement group that has contributed to study design and materials, and which will be closely involved in data interpretation and dissemination. ETHICS AND DISSEMINATION: The study has been approved by the National Health Service East Midlands-Leicester South Research Ethics Committee: 17/EM/0312. The results of the study will be disseminated through peer-reviewed journals, conferences and a planned programme of knowledge mobilisation. TRIAL REGISTRATION NUMBER: ISRCTN51780222.

Randomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department: study protocol.

INTRODUCTION: Observational data suggest a single high-sensitivity troponin blood test taken at emergency department (ED) presentation could be used to rule out major adverse cardiac events (MACE) in 10%-60% of ED patients with chest pain. This is done using an 'undetectable' cut-off (the Limit of Detection: LoD). We combined the LoD cut-off with ECG findings to create the LoDED strategy. We aim to establish whether the LoDED strategy works under real-life conditions, when compared with existing strategies, in a way that is cost-effective and acceptable to patients. METHODS AND ANALYSIS: This is a parallel-group pragmatic randomised controlled trial across UK EDs. Adults presenting to ED with suspected cardiac chest pain will be randomised 1:1. Existing rule-out strategies in current use across study centres, using serial high-sensitivity troponin testing, will be compared with the LoDED strategy. The primary outcome is successful early discharge (discharge from hospital within 4 hours of arrival) without MACE occurring within 30 days. Secondary outcomes include initial length of hospital stay; comparative costs; patient satisfaction and acceptability to patients. To detect a 9% difference between the early discharge rates (assuming an 8% rate in the standard care group) with 90% power, 594 patients need to be recruited, assuming a 95% follow-up rate. ETHICS AND DISSEMINATION: The study has been approved by the Frenchay Research Ethics Committee (reference 18/SW/0038). Results will be published in an international peer-reviewed journal. Lay summaries will be made available to patients. TRIAL REGISTRATION NUMBER: ISRCTN86184521; Pre-results.

How do people with dementia use the ambulance service? A retrospective study in England: the HOMEWARD project.

OBJECTIVES: An increasing number of older people are calling ambulances and presenting to accident and emergency departments. The presence of comorbidities and dementia can make managing these patients more challenging and hospital admission more likely, resulting in poorer outcomes for patients. However, we do not know how many of these patients are conveyed to hospital by ambulance. This study aims to determine: how often ambulances are called to older people; how often comorbidities including dementia are recorded; the reason for the call; provisional diagnosis; the amount of time ambulance clinicians spend on scene; the frequency with which these patients are transported to hospital. METHODS: We conducted a retrospective cross-sectional study of ambulance patient care records (PCRs) from calls to patients aged 65 years and over. Data were collected from two ambulance services in England during 24 or 48 hours periods in January 2017 and July 2017. The records were examined by two researchers using a standard template and the data were extracted from 3037 PCRs using a coding structure. RESULTS: Results were reported as percentages and means with 95% CIs. Dementia was recorded in 421 (13.9%) of PCRs. Patients with dementia were significantly less likely to be conveyed to hospital following an emergency call than those without dementia. The call cycle times were similar for patients regardless of whether or not they had dementia. Calls to people with dementia were more likely to be due to injury following a fall. In the overall sample, one or more comorbidities were reported on the PCR in over 80% of cases. CONCLUSION: Rates of hospital conveyance for older people may be related to comorbidities, frailty and complex needs, rather than dementia. Further research is needed to understand the way in which ambulance clinicians make conveyance decisions at scene.

A systematic review to identify and assess the effectiveness of alternatives for people over the age of 65 who are at risk of potentially avoidable hospital admission.

BACKGROUND/OBJECTIVES: There are some older patients who are 'at the decision margin' of admission. This systematic review sought to explore this issue with the following objective: what admission alternatives are there for older patients and are they safe, effective and cost-effective? A secondary objective was to identify the characteristics of those older patients for whom the decision to admit to hospital may be unclear. DESIGN: Systematic review of controlled studies (April 2005-December 2016) with searches in Medline, Embase, Cinahl and CENTRAL databases. The protocol is registered at PROSPERO (CRD42015020371). Studies were assessed using Cochrane risk of bias criteria, and relevant reviews were assessed with the AMSTAR tool. The results are presented narratively and discussed. SETTING: Primary and secondary healthcare interface. PARTICIPANTS: People aged over 65 years at risk of an unplanned admission. INTERVENTIONS: Any community-based intervention offered as an alternative to admission to an acute hospital. PRIMARY AND SECONDARY OUTCOMES MEASURES: Reduction in secondary care use, patient-related outcomes, safety and costs. RESULTS: Nineteen studies and seven systematic reviews were identified. These recruited patients with both specific conditions and mixed chronic and acute conditions. The interventions involved paramedic/emergency care practitioners (n=3), emergency department-based interventions (n=3), community hospitals (n=2) and hospital-at-home services (n=11). Data suggest that alternatives to admission appear safe with potential to reduce secondary care use and length of time receiving care. There is a lack of patient-related outcomes and cost data. The important features of older patients for whom the decision to admit is uncertain are: age over 75 years, comorbidities/multi-morbidities, dementia, home situation, social support and individual coping abilities. CONCLUSIONS: This systematic review describes and assesses evidence on alternatives to acute care for older patients and shows that many of the options available are safe and appear to reduce resource use. However, cost analyses and patient preference data are lacking.

PAin SoluTions In the Emergency Setting (PASTIES); a protocol for two open-label randomised trials of patient-controlled analgesia (PCA) versus routine care in the emergency department.

INTRODUCTION: Pain is the commonest reason that patients present to an emergency department (ED), but it is often not treated effectively. Patient controlled analgesia (PCA) is used in other hospital settings but there is little evidence to support its use in emergency patients. We describe two randomised trials aiming to compare PCA to nurse titrated analgesia (routine care) in adult patients who present to the ED requiring intravenous opioid analgesia for the treatment of moderate to severe pain and are subsequently admitted to hospital. METHODS AND ANALYSIS: Two prospective multi-centre open-label randomised trials of PCA versus routine care in emergency department patients who require intravenous opioid analgesia followed by admission to hospital; one trial involving patients with traumatic musculoskeletal injuries and the second involving patients with non-traumatic abdominal pain. In each trial, 200 participants will be randomised to receive either routine care or PCA, and followed for the first 12 h of their hospital stay. The primary outcome measure is hourly pain score recorded by the participant using a visual analogue scale (VAS) over the 12 h study period, with the primary statistical analyses based on the area under the curve of these pain scores. Secondary outcomes include total opioid use, side effects, time spent asleep, patient satisfaction, length of hospital stay and incremental cost effectiveness ratio. ETHICS AND DISSEMINATION: The study is approved by the South Central-Southampton A Research Ethics Committee (REC reference 11/SC/0151). Data collection will be completed by August 2013, with statistical analyses starting after all final data queries are resolved. Dissemination plans include presentations at local, national and international scientific meetings held by relevant Colleges and societies. Publications should be ready for submission during 2014. A lay summary of the results will be available to study participants on request, and disseminated via a publically accessible website. REGISTRATION DETAILS: The study is registered with the European Clinical Trials Database (EudraCT Number: 2011-000194-31) and is on the ISCRTN register (ISRCTN25343280).

Randomised comparison of the effectiveness of the laryngeal mask airway supreme, i-gel and current practice in the initial airway management of prehospital cardiac arrest (REVIVE-Airways): a feasibility study research protocol.

INTRODUCTION: Effective cardiopulmonary resuscitation with appropriate airway management improves outcomes following out-of-hospital cardiac arrest (OHCA). Historically, tracheal intubation has been accepted as the optimal form of OHCA airway management in the UK. The Joint Royal Colleges Ambulance Liaison Committee recently concluded that newer supraglottic airway devices (SADs) are safe and effective devices for hospital procedures and that their use in OHCA should be investigated. This study will address an identified gap in current knowledge by assessing whether it is feasible to use a cluster randomised design to compare SADs with current practice, and also to each other, during OHCA. METHODS AND ANALYSIS: The primary objective of this study is to assess the feasibility of a cluster randomised trial to compare the ventilation success of two newer SADs: the i-gel and the laryngeal mask airway supreme to usual practice during the initial airway management of OHCA. The secondary objectives are to collect data on ventilation success, further airway interventions required, loss of a previously established airway during transport, airway management on arrival at hospital (or termination of the resuscitation attempt), initial resuscitation success, survival to intensive care admission, survival to hospital discharge and patient outcome at 3 months. Ambulance paramedics will be randomly allocated to one of the three methods of airway management. Adults in medical OHCA attended by a trial paramedic will be eligible for the study. ETHICS AND DISSEMINATION: Approval for the study has been obtained from a National Health Service Research Ethics Committee with authority to review proposals for trials of a medical device in incapacitated adults. The results will be made publicly available on an open access website, and we will publish the findings in appropriate journals and present them at national and international conferences relevant to the subject field. TRIAL REGISTRATION: ISRCTN: 18528625.

A randomised trial comparing the cost effectiveness of different emergency department healthcare professionals in soft tissue injury management.

OBJECTIVES: To evaluate the cost effectiveness of soft tissue injury management by emergency nurse practitioners (ENPs) and extended scope physiotherapists (ESPs) compared with the routine care provided by doctors in an emergency department (ED). DESIGN: Randomised, pragmatic trial of equivalence. SETTING: A single ED in England. PARTICIPANTS: 372 patients were randomised, 126 to the ESP group, 123 to the ENP group and 123 to the doctor group. Participants were adults (16 years and older) presenting to the ED with a peripheral soft tissue injury eligible for management by any of the three professional groups. INTERVENTIONS: Patients were randomised to treatment by an ESP, ENP or routine care provided by doctors (of all grades). MAIN OUTCOME MEASURES: Economic cost-minimisation evaluation from a funder perspective of the National Health Service, England incorporating analysis of the direct, indirect and tangible costs of care in primary and secondary settings. RESULTS: From a funder perspective in primary and secondary care, ESPs and ENPs are at best equivalent and could not cost less than routine care. Uncertainty in cost arises from ESPs and ENPs incurring greater indirect costs, such as those associated with follow-up appointments and subsequent primary care visits. Comparison from a funder perspective in secondary care, that is, considering those costs incurred in secondary care alone, demonstrates that ENPs are equivalent in cost to routine care, while ESPs are either equivalent or possibly cheaper than routine care. CONCLUSIONS: These results question the notion that training the healthcare workforce to undertake extensions of their role is generally cost effective. While the randomised trial indicated that the three professional groups have equivalent clinical outcomes, this economic analysis suggests that substitution of routine care with a predominantly ESP or ENP workforce could prove more expensive. Further research is required to understand the underlying reasons for this. The trial has been registered with ISRCTN-ISRCTN 70891354.

A randomised trial comparing the clinical effectiveness of different emergency department healthcare professionals in soft tissue injury management.

OBJECTIVES: To evaluate the clinical effectiveness of soft tissue injury management by emergency nurse practitioners (ENPs) and extended scope physiotherapists (ESPs) compared to the routine care provided by doctors in a UK emergency department (ED). DESIGN: Randomised, pragmatic trial of equivalence. SETTING: One adult ED in England. PARTICIPANTS: 372 patients were randomised; 126 to the ESP group, 123 to the ENP group and 123 to the doctor group. Participants were adults (older than 16 years) presenting to the ED with a peripheral soft tissue injury eligible for management by any of the three professional groups. Patients were excluded if they had any of the following: injury greater than 72 hours old; systemic disease; dislocated joints; recent surgery; unable to give informed consent (eg, dementia), open wounds; major deformities; opiate analgesia required; concurrent chest/rib injury; neurovascular deficits and associated fracture. INTERVENTIONS: Patients were randomised to treatment by ESPs, ENPs or routine care provided by doctors (of all grades). MAIN OUTCOME MEASURES: Upper-limb and lower-limb functional scores, quality of life, physical well-being, preference-based health measures and the number of days off work. RESULTS: The clinical outcomes of soft tissue injury treated by ESPs and ENPs in the ED were equivalent to routine care provided by doctors. CONCLUSIONS: As all groups were clinically equivalent it is other factors such as cost, workforce sustainability, service provision and skill mix that become important. This result validates the role of the ENP, which is becoming established as an integral part of minor injuries care, and demonstrates that the ESP should be considered as part of the clinical skill mix without detriment to outcomes. ISRCTN-ISRCTN TRIALS REGISTER NUMBER: 70891354.