Bypassing nearest hospital for more distant neuroscience care in head-injured adults with suspected traumatic brain injury: findings of the head injury transportation straight to neurosurgery (HITS-NS) pilot cluster randomised trial.

OBJECTIVE: Reconfiguration of trauma services, with direct transport of patients with traumatic brain injury (TBI) to specialist neuroscience centres (SNCs)-bypassing non-specialist acute hospitals (NSAHs), could improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) may worsen outcomes when compared with selective secondary transfer from nearest NSAH to SNC. We conducted a pilot cluster randomised controlled trial to determine the feasibility and plausibility of bypassing suspected patients with TBI -directly into SNCs-producing a measurable effect. SETTING: Two English Ambulance Services. PARTICIPANTS: 74 clusters (ambulance stations) were randomised within pairs after matching for important characteristics. Clusters enrolled head-injured adults-injured nearest to an NSAH-with internationally accepted TBI risk factors and stable ABC. We excluded participants attended by Helicopter Emergency Medical Services or who were injured more than 1 hour by road from nearest SNC. INTERVENTIONS: Intervention cluster participants were transported directly to an SNC bypassing nearest NSAH; control cluster participants were transported to nearest NSAH with selective secondary transfer to SNC. OUTCOMES: Trial recruitment rate (target n=700 per annum) and percentage with TBI on CT scan (target 80%) were the primary feasibility outcomes. 30-day mortality, 6-month Extended Glasgow Outcome Scale and quality of life were secondary outcomes. RESULTS: 56 ambulance station clusters recruited 293 patients in 12 months. The trial arms were similar in terms of age, conscious level and injury severity. Less than 25% of recruited patients had TBI on CT (n=70) with 7% (n=20) requiring neurosurgery. Complete case analysis showed similar 30-day mortality in the two trial arms (control=8.8 (2.7-14.0)% vs intervention=9.4(2.3-14.0)%). CONCLUSION: Bypassing patients with suspected TBI to SNCs gives an overtriage (false positive) ratio of 13:1 for neurosurgical intervention and 4:1 for TBI. A measurable effect from a full trial of early neuroscience care following bypass is therefore unlikely. TRIAL REGISTRATION NUMBER: ISRCTN68087745.

Cross-sectional study of the hospital management of adult patients with a suspected seizure (EPIC2).

OBJECTIVE: To determine the clinical characteristics, management and outcomes of patients taken to hospital by emergency ambulance after a suspected seizure. DESIGN: Quantitative cross-sectional retrospective study of a consecutive series of patients. SETTING: An acute hospital trust in a large city in England. PARTICIPANTS: In 2012-2013, the regions' ambulance service managed 605 481 emergency incidents, 74 141/605 481 originated from Sheffield (a large city in the region), 2121/74 141 (2.9%) were suspected seizures and 178/2121 occurred in May 2012. We undertook detailed analysis of the medical records of the 91/178 patients who were transported to the city's acute hospital. After undertaking a retrospective review of the medical records, the best available aetiological explanation for the seizures was determined. RESULTS: The best available aetiological explanation for 74.7% (68/91) of the incidents was an epileptic seizure, 11.0% (10/91) were psychogenic non-epileptic seizures and 9.9% (9/91) were cardiogenic events. The epileptic seizures fall into the following four categories: first epileptic seizure (13.2%, 12/91), epileptic seizure with a historical diagnosis of epilepsy (30.8%, 28/91), recurrent epileptic seizures without a historical diagnosis of epilepsy (20.9%, 19/91) and acute symptomatic seizures (9.9%, 9/91). Of those with seizures (excluding cardiogenic events), 2.4% (2/82) of patients were seizing on arrival in the Emergency Department (ED), 19.5% (16/82) were postictal and 69.5% (57/82) were alert. 63.4% (52/82) were discharged at the end of their ED attendance and 36.5% (19/52) of these had no referral or follow-up. CONCLUSIONS: Most suspected seizures are epileptic seizures but this is a diagnostically heterogeneous group. Only a small minority of patients require emergency medical care but most are transported to hospital. Few patients receive expert review and many are discharged home without referral to a specialist leaving them at risk of further seizures and the associated morbidity, mortality and health services costs of poorly controlled epilepsy.

Multiple triangulation and collaborative research using qualitative methods to explore decision making in pre-hospital emergency care.

BACKGROUND: Paramedics make important and increasingly complex decisions at scene about patient care. Patient safety implications of influences on decision making in the pre-hospital setting were previously under-researched. Cutting edge perspectives advocate exploring the whole system rather than individual influences on patient safety. Ethnography (the study of people and cultures) has been acknowledged as a suitable method for identifying health care issues as they occur within the natural context. In this paper we compare multiple methods used in a multi-site, qualitative study that aimed to identify system influences on decision making. METHODS: The study was conducted in three NHS Ambulance Trusts in England and involved researchers from each Trust working alongside academic researchers. Exploratory interviews with key informants e.g. managers (n = 16) and document review provided contextual information. Between October 2012 and July 2013 researchers observed 34 paramedic shifts and ten paramedics provided additional accounts via audio-recorded 'digital diaries' (155 events). Three staff focus groups (total n = 21) and three service user focus groups (total n = 23) explored a range of experiences and perceptions. Data collection and analysis was carried out by academic and ambulance service researchers as well as service users. Workshops were held at each site to elicit feedback on the findings and facilitate prioritisation of issues identified. RESULTS: The use of a multi-method qualitative approach allowed cross-validation of important issues for ambulance service staff and service users. A key factor in successful implementation of the study was establishing good working relationships with academic and ambulance service teams. Enrolling at least one research lead at each site facilitated the recruitment process as well as study progress. Active involvement with the study allowed ambulance service researchers and service users to gain a better understanding of the research process. Feedback workshops allowed stakeholders to discuss and prioritise findings as well as identify new research areas. CONCLUSION: Combining multiple qualitative methods with a collaborative research approach can facilitate exploration of system influences on patient safety in under-researched settings. The paper highlights empirical issues, strengths and limitations for this approach. Feedback workshops were effective for verifying findings and prioritising areas for future intervention and research.

Cross-sectional study of the prehospital management of adult patients with a suspected seizure (EPIC1).

OBJECTIVES: Suspected seizures are a common reason for emergency calls to ambulance services. Prehospital management of these patients is an important element of good quality care. The aim of this study, conducted in a regional ambulance service in the UK, was to quantify the number of emergency telephone calls for suspected seizures in adults, the associated costs, and to describe the patients' characteristics, their prehospital management and their immediate outcomes. DESIGN: Quantitative cross-sectional study using routinely collected data and a detailed review of the clinical records of a consecutive series of adult patients (≥ 16 years). SETTING: A regional ambulance service within the National Health Service in England. PARTICIPANTS: Cross-sectional data from all 605,481 adult emergency incidents managed by the ambulance service from 1 April 2012 to 31 March 2013. We selected a consecutive series of 178 individual incidents from May 2012 for more detailed analysis (132 after exclusions and removal of non-seizure cases). RESULTS: Suspected seizures made up 3.3% of all emergency incidents. True medical emergencies were uncommon but 3.3% had partially occluded airways, 6.8% had ongoing seizure activity and 59.1% had clinical problems in addition to the seizure (29.1% involving injury). Emergency vehicles were dispatched for 97.2% of suspected seizures, the seizure had terminated on arrival in 93.2% of incidents, 75% of these patients were transported to hospital. The estimated emergency management cost per annum of suspected seizures in the English ambulance services is £45.2 million (€64.0 million, $68.6 million). CONCLUSIONS: Many patients with suspected seizures could potentially be treated more effectively and at lower cost by modifying ambulance call handling protocols. The development of innovative care pathways could give call handlers and paramedics alternatives to hospital transportation. Increased adoption of care plans could reduce 999 calls and could increase the rates of successful home or community treatment.

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study.

BACKGROUND: Reconfiguration of trauma services, with direct transport of traumatic brain injury (TBI) patients to neuroscience centres (NCs), bypassing non-specialist acute hospitals (NSAHs), could potentially improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) and the difficulties in reliably identifying TBI at scene may make this practice deleterious compared with selective secondary transfer from nearest NSAH to NC. National Institute for Health and Care Excellence guidance and systematic reviews suggested equipoise and poor-quality evidence - with regard to 'early neurosurgery' in this cohort - which we sought to address. METHODS: Pilot cluster randomised controlled trial of bypass to NC conducted in two ambulance services with the ambulance station (n = 74) as unit of cluster [Lancashire/Cumbria in the North West Ambulance Service (NWAS) and the North East Ambulance Service (NEAS)]. Adult patients with signs of isolated TBI [Glasgow Coma Scale (GCS) score of < 13 in NWAS, GCS score of < 14 in NEAS] and stable ABC, injured nearest to a NSAH were transported either to that hospital (control clusters) or bypassed to the nearest NC (intervention clusters). PRIMARY OUTCOMES: recruitment rate, protocol compliance, selection bias as a result of non-compliance, accuracy of paramedic TBI identification (overtriage of study inclusion criteria) and pathway acceptability to patients, families and staff. 'Open-label' secondary outcomes: 30-day mortality, 6-month Extended Glasgow Outcome Scale (GOSE) and European Quality of Life-5 Dimensions. RESULTS: Overall, 56 clusters recruited 293 (169 intervention, 124 control) patients in 12 months, demonstrating cluster randomised pre-hospital trials as viable for heath service evaluations. Overall compliance was 62%, but 90% was achieved in the control arm and when face-to-face paramedic training was possible. Non-compliance appeared to be driven by proximity of the nearest hospital and perceptions of injury severity and so occurred more frequently in the intervention arm, in which the perceived time to the NC was greater and severity of injury was lower. Fewer than 25% of recruited patients had TBI on computed tomography scan (n = 70), with 7% (n = 20) requiring neurosurgery (craniotomy, craniectomy or intracranial pressure monitoring) but a further 18 requiring admission to an intensive care unit. An intention-to-treat analysis revealed the two trial arms to be equivalent in terms of age, GCS and severity of injury. No significant 30-day mortality differences were found (8.8% vs. 9.1/%; p > 0.05) in the 273 (159/113) patients with data available. There were no apparent differences in staff and patient preferences for either pathway, with satisfaction high with both. Very low responses to invitations to consent for follow-up in the large number of mild head injury-enrolled patients meant that only 20% of patients had 6-month outcomes. The trial-based economic evaluation could not focus on early neurosurgery because of these low numbers but instead investigated the comparative cost-effectiveness of bypass compared with selective secondary transfer for eligible patients at the scene of injury. CONCLUSIONS: Current NHS England practice of bypassing patients with suspected TBI to neuroscience centres gives overtriage ratios of 13 : 1 for neurosurgery and 4 : 1 for TBI. This important finding makes studying the impact of bypass to facilitate early neurosurgery not plausible using this study design. Future research should explore an efficient comparative effectiveness design for evaluating 'early neurosurgery through bypass' and address the challenge of reliable TBI diagnosis at the scene of injury. TRIAL REGISTRATION: Current Controlled Trials ISRCTN68087745. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 1. See the NIHR Journals Library website for further project information.

A qualitative study of systemic influences on paramedic decision making: care transitions and patient safety.

OBJECTIVES: Paramedics routinely make critical decisions about the most appropriate care to deliver in a complex system characterized by significant variation in patient case-mix, care pathways and linked service providers. There has been little research carried out in the ambulance service to identify areas of risk associated with decisions about patient care. The aim of this study was to explore systemic influences on decision making by paramedics relating to care transitions to identify potential risk factors. METHODS: An exploratory multi-method qualitative study was conducted in three English National Health Service (NHS) Ambulance Service Trusts, focusing on decision making by paramedic and specialist paramedic staff. Researchers observed 57 staff across 34 shifts. Ten staff completed digital diaries and three focus groups were conducted with 21 staff. RESULTS: Nine types of decision were identified, ranging from emergency department conveyance and specialist emergency pathways to non-conveyance. Seven overarching systemic influences and risk factors potentially influencing decision making were identified: demand; performance priorities; access to care options; risk tolerance; training and development; communication and feedback and resources. CONCLUSIONS: Use of multiple methods provided a consistent picture of key systemic influences and potential risk factors. The study highlighted the increased complexity of paramedic decisions and multi-level system influences that may exacerbate risk. The findings have implications at the level of individual NHS Ambulance Service Trusts (e.g. ensuring an appropriately skilled workforce to manage diverse patient needs and reduce emergency department conveyance) and at the wider prehospital emergency care system level (e.g. ensuring access to appropriate patient care options as alternatives to the emergency department).