Jenna Bulger

Rapid analgesia for prehospital hip disruption (RAPID): protocol for feasibility study of randomised controlled trial

BackgroundAdequate pain relief at the point of injury and during transport to hospital is a major challenge in all acute traumas, especially for those with hip fractures, whose injuries are difficult to immobilise and whose long-term outcomes may be adversely affected by administration of opiate analgesics. Fascia iliaca compartment block (FICB) is a procedure routinely undertaken by doctors and nurses in the emergency department for patients with hip fracture but not yet evaluated for use by paramedics at the scene of emergency calls.In this feasibility study, we aim to test whether FICB administered by paramedics at the scene of participants’ hip fractures is feasible, safe and acceptable. This will enable us to decide whether to proceed to a fully powered, multi-centre pragmatic randomised trial to evaluate whether the procedure is effective for patients and worthwhile for the NHS.Methods/designIn this study, we propose to recruit ten paramedics in an urban area of South Wales. We will train them to carry out FICB when they attend patients with hip fracture. We will randomly allocate eligible patients to FICB or usual care using audited scratch cards. We will follow up participants to assess measurability of key outcomes including quality of life, pain scores, adverse events, length of stay in hospital, acceptability to patients and compliance of paramedics. We will assess whether the findings meet specified feasibility criteria and, if so, plan a full trial.DiscussionThis study will enable us to recommend whether to undertake a definitive trial of FICB by paramedics for hip fracture.Trial registrationISRCTN60065373

P34 Paramedic trail blazers – why do paramedics take part in prehospital research?

Background Research to improve prehospital treatment and care requires the participation of clinical and managerial staff from ambulance services to test interventions and collect research data. Researchers work closely with individuals and organisations with prehospital clinical, managerial and policy expertise to plan, deliver and disseminate research evidence. A recent trial involved assessing feasibility of paramedics administering Fascia Iliaca Compartment Block (FICB) in place of morphine to patients with suspected hip fracture. Participation in the trial was voluntary. We explored paramedics’ motivation for participating in research through the RAPID (Rapid Analgesia for Prehospital Hip Disruption) trial. Methods We held three focus groups with 11 RAPID trial paramedics serving one district hospital, audio-recorded with participants’ consent. We conducted thematic analysis of interview transcripts. Two researchers, one paramedic and one lay member were in the analysis team. Results Paramedics believed their participation in research had benefits for patients, for them individually and for the paramedic profession. Respondents said that being part of a research project provided an opportunity to increase their skills and provide improved patient care. In the RAPID trial, they understood the potential risks and benefits of different medications and management for patients with suspected hip fracture and welcomed the chance to identify improved pain management for a vulnerable population. They felt proud to be learning and using a procedure usually administered by clinical staff: ‘This is quite specialised, like, hang on, I’m doing a really top job here, dealing with anaesthetics…blunt needles… it’s like ‘up there’. It’s not our everyday thing.’ More generally, respondents identified how research potentially contributed towards widening the scope of paramedic practice by extending their role into clinically specialist areas. They suggested that many paramedics were unwilling to undertake tasks perceived to exceed their pay-grades and shunned the opportunity to learn new techniques which were not routine care. In comparison, these paramedics saw themselves as trail-blazers for the profession, proud to be acquiring extra clinical responsibilities and skills. They also valued the chance to contribute to the evidence base, providing knowledge about using alternative medication which they instinctively felt would cause fewer complications and benefit patient mortality and morbidity. Conclusion Paramedics who take part in research believe they contribute to personal and professional development and potentially improve patient care. Future research with paramedics refusing research participation could explore barriers and different views on skills development, which may also inform implementation of new evidence-based interventions.

Use of scratchcards for allocation concealment in a prehospital randomised controlled trial

Background Rapid Analgesia for Prehospital Hip Disruption was a small study designed to determine the feasibility of undertaking a randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics administering Fascia Iliaca Compartment Block as early prehospital pain relief to patients with a fractured hip. The objective was to devise a simple and effective method of random allocation concealment suitable for use by paramedics while in the emergency prehospital setting. Methods Scratchcards were produced using scratch-off silver stickers which concealed the trial arm allocation. Paramedics were each allocated a unique range of consecutive numbers, used as both the scratchcard number and the patient’s study ID. The cards were designed to allow the paramedic to write on the incident number, date and signature. A small envelope holding the cards was prepared for each paramedic. The study took place between 28 June 2016 and 31 July 2017 in the Swansea area. Results Nineteen trial paramedics used 71 scratchcards throughout the study and reported no problems randomly allocating patients using the scratchcards. Five protocol deviations were reported in relation to scratchcard use. On auditing the scratchcards, all unused cards were located, and no evidence of tampering with the silver panel was found. Conclusion Paramedics can use scratchcards as a method of randomly allocating patients in trials in prehospital care. In the future, a method that allows only the top card to be selected and a more protective method of storing the cards should be used. Scratchcards can be considered for wider use in RCTs in the emergency prehospital setting. Trial registration number ISRCTN60065373; Post-results.

8 Rapid analgesia for prehospital hip disruption (rapid)

Aim Pain relief in prehospital care is a challenge in trauma, especially for those with hip fractures, whose injuries are difficult to immobilise and whose long term outcomes may be adversely affected by administration of opiates. Fascia Iliaca Compartment Block (FICB) is routinely undertaken by hospital clinicians, but has not been fully evaluated for use by paramedics in prehospital care. Method Nineteen paramedics were trained; they randomly allocated eligible patients to trial arms using audited scratchcards. Patients were followed up to assess availability of outcomes including quality of life, length of admission, pain scores, and adverse events. Findings were analysed against pre-specified progression criteria. Results Seventy-one patients were randomised by paramedics (28/6/16 – 31/7/17); 57 consented to follow up. The only outcome which reached a statistically significant difference between groups was the proportion of participants who received morphine (38% difference between groups 95% CI: −61.88 to −15.79). There was a difference of approximately nine days in the length of admission between trial arms (mean difference 9.12 (95% CI: −20.51 to 2.27). Conclusion RAPID met its pre-specified progression criteria; a funding application for a fully-powered RCT will therefore be submitted. We will consider the use of length of stay as the primary outcome, as findings indicated a difference between groups without reaching statistical significance. Conflict of interest None Funding Health and Care Research Wales, Research for Patient and Public Benefit.

VP88 Transient Ischaemic Attack Referral (TIER) Intervention Development

INTRODUCTION: Transient Ischaemic Attack (TIA) is a neurologic event with symptom resolution within 24 hours. Early specialist assessment of TIA reduces risk of stroke and death. National United Kingdom (UK) guidelines recommend patients with TIA are seen in specialist clinics within 24 hours (high risk) or seven days (low risk). We aimed to develop a complex intervention for patients with low risk TIA presenting to the emergency ambulance service. The intervention is being tested in the TIER feasibility trial, in line with Medical Research Council (MRC) guidance on staged development and evaluation of complex interventions. METHODS: We conducted three interrelated activities to produce the TIER intervention: • Survey of UK Ambulance Services (n = 13) to gather information about TIA pathways already in use • Scoping review of literature describing prehospital care of patients with TIA • Synthesis of data and definition of intervention by specialist panel of: paramedics; Emergency Department (ED) and stroke consultants; service users; ambulance service managers. RESULTS: The panel used results to define the TIER intervention, to include: 1. Protocol for paramedics to assess patients presenting with TIA and identify and refer low risk patients for prompt ( 2. Patient Group Directive and information pack to allow paramedic administration of aspirin to patients left at home with referral to TIA clinic 3. Referral process via ambulance control room 4. Training package for paramedics 5. Agreement with TIA clinic service provider including rapid review of referred patients CONCLUSIONS: We followed MRC guidance to develop a clinical intervention for assessment and referral of low risk TIA patients attended by emergency ambulance paramedic. We are testing feasibility of implementing and evaluating this intervention in the TIER feasibility trial which may lead to fully powered multicentre randomized controlled trial (RCT) if predefined progression criteria are met.

PP24 The transient ischaemic attack 999 emergency referral (tier) feasibility trial: development of a complex intervention

Background Transient Ischaemic Attack (TIA) is a neurologic event with symptom resolution within 24 hours. Early specialist assessment of TIA reduces risk of stroke and death. NICE (2008) recommends patients with TIA are seen in specialist clinics within 24 hours (if high risk) and seven days (if low risk). We aimed to develop a complex intervention for patients with low risk TIA presenting to the emergency ambulance service. The intervention was then to be used in the TIER feasibility trial, in line with the MRC guidance on staged development and evaluation of complex interventions. Methods We conducted three interrelated activities to produce the TIER intervention: Survey of UK Ambulance Services (n=13) to gather information about TIA pathways already in use Scoping review of literature describing prehospital care of patients with TIA Synthesis of data and definition of the intervention by specialist panel of: paramedics; ED and stroke consultants; service users; ambulance service managers. Results The panel defined the TIER intervention to include: Protocol for paramedics to assess patients presenting with TIA and identify and refer low risk patients for prompt (<7 day) specialist review at TIA clinic Patient Group Directive and information pack to allow paramedic administration of aspirin to patients left at home with referral to TIA clinic Referral process via clinical desk in ambulance control room Training package for paramedics Agreement with TIA clinic service provider to ensure rapid review of referred patients Conclusion We followed MRC guidance to develop a clinical intervention which assesses and refers low risk TIA patients requesting 999 care. We will test feasibility of implementing and evaluating this in the TIER feasibility trial. We will then develop a fully powered randomised multicentre trial, if findings indicate this is appropriate.

PP22 Alternative care pathways for patients with low risk tia attended by emergency ambulance: a national survey

Background Patients presenting to emergency ambulance services with TIA are usually conveyed to the nearest Emergency Department (ED) with subsequent referral to specialist assessment at a TIA clinic within one week if at low risk of stroke. There is the opportunity for paramedics to refer patients with TIA at low risk of recurrent stroke directly to specialist TIA clinic, if such protocols can be shown to be safe and cost effective. We aimed to describe current service developments across the UK for the pre-hospital emergency care of patients with TIA, to inform the development of an intervention for testing. Methods We surveyed all UK Ambulance Trusts (n=13) by email, asking them to identify initiatives related to the management of TIA, and followed up services reporting an alternative TIA pathway by telephone to gather further details. Results Twelve ambulance services responded to our survey. Nine reported that they had no current TIA referral pathway; of these, one had a pathway which was discontinued due to service reconfiguration. Three reported currently using a TIA referral pathway. All (4/4) pathways which had been introduced used the FAST test and ABCD2 tool to screen patients, in line with national guidelines, and classified patients as low risk if the ABCD2 score was 3 or below. All pathways indicated that eligible low-risk TIA patients should be referred by paramedics to specialist care, 2/4 by telephone, and 2/4 by fax. Non-conveyance exclusion criteria varied. Although protocol compliance was audited in an initial pilot in one service, no formal evaluation of effectiveness was reported. Conclusion Several UK ambulance services have introduced referral pathways for low risk TIA patients, avoiding the ED. None have evaluated the safety (subsequent stroke or serious misdiagnosis) or cost effectiveness. A clinical trial to evaluate the safety and effectiveness of alternative care pathways for patients with suspected TIA presenting to emergency ambulance services is indicated.

PP30 Rapid analgesia for prehospital hip disruption (rapid: feasibility study progress)

Background Adequate pain relief at the scene of injury and during transport to hospital is a major challenge in all acute traumas, especially for those with hip fractures, whose injuries are difficult to immobilise and whose long-term outcomes may be adversely affected by administration of opiate analgesics. Fascia Iliaca Compartment Block (FICB) is a procedure routinely undertaken by clinicians in emergency departments for hip fracture patients, but use by paramedics at the scene of emergency calls, is not yet evaluated. We report on study progress following six months of patient recruitment. Methods We undertook a randomised controlled feasibility trial using novel audited scratchcard randomisation to allocate eligible patients to FICB or usual care. FICB is only administered to patients without contraindications. The primary measureable outcome is health related quality of life, measured using SF-12 at 1 and 6 months. Secondary outcome measures include mobility scores at 6 months (using Rivermead Mobility Index); patient satisfaction; pain scores; patient safety and length of hospital stay. Interviews and focus groups will be used to understand acceptability of FICB to patients and paramedics. We will also assess the accuracy of paramedic hip fracture recognition (using sensitivity and positive predictive value as indicators). Results We have developed paramedic pathway to assess patients for hip fracture and FICB paramedic training package, delivered by Consultant Anaesthetist randomisation scratchcards To date we have recruited 19 paramedics; 10 are fully trained and recruiting patients, the remainder are being trained. Twenty-two patients have been randomised and 16 have consented to follow-up. Discussion This study will enable us to recommend whether to undertake a definitive multi-centre randomised controlled trial of FICB by paramedics for hip fracture and the procedure is effective for patients and worthwhile for the NHS.

PRE-HOSPITAL ANALGESIA FOR PATIENTS WITH FEMORAL FRACTURE: A SYSTEMATIC REVIEW OF THE LITERATURE

Objective To identify and estimate the effectiveness of interventions to provide analgesia for patients with femoral fracture in the emergency pre-hospital setting. Methods We searched the Cochrane Library, CINAHL, HMIC, Medline, PubMed, Scopus, Web of Science, grey literature and citations of included studies. We included randomised trials and observational studies that included pain score measurements. We carried out a meta-analysis using Review Manager. Results We identified 858 studies and assessed 36 full articles for eligibility. Ten studies met the inclusion criteria, including 478 patients. Five studies were randomised controlled trials, comparing outcomes between: fascia iliaca compartment block (FICB) with standard care; femoral nerve block with standard care; Transcutaneous Electrical Nerve Stimulation (TENS) with placebo; auricular acupressure with sham acupressure; and simple splints with traction splints. Two cohort studies included comparisons of pain scores with and without FICB. Three uncontrolled observational studies reported effects of FICB. Meta-analysis of four randomised studies with 227 patients showed that, compared with control, proactive interventions reduced pain scores by 1.9 standard deviations (95% CI from 1.1 to 2.7; p<0.0001); but these trials were clinically and statistically heterogeneous. Conclusions Current published research suggests that interventions to enhance the provision of analgesia for femoral fracture in emergency pre-hospital care reduce pain scores significantly more than standard care. However, as only five randomised studies are available with a range of diverse interventions, further research is warranted.