Award Title: Randomised trial of clinical and cost effectiveness of Administration of Prehospital fascia Iliaca compartment block for emergency Pre-Hospital hip fracture care Delivery (RAPID 2)
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Background_x000D_
Hip fractures are a very common injury for elderly people. About one in three patients who break their hip die within one year and many patients lose mobility and independence. Pain relief before the patient reaches hospital is often inadequate and causes side effects which may slow down recovery. We have recently completed a small study testing whether a local anaesthetic injection into the hip area called Fascia Iliaca Compartment Block (FICB) given by paramedics at the scene of injury is safe and acceptable. We met all the criteria that we set at the beginning of the study, and concluded that it is feasible to undertake a full trial._x000D_
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Aim_x000D_
We aim to find out whether the local anaesthetic injection reduces pain, is safe, and improves patient health outcomes, as well as how much it costs the National Health Service (NHS). _x000D_
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Design_x000D_
We will carry out a trial where paramedics give patients either the new treatment - local anaesthetic injection or usual care (often morphine). Patients will be allocated to one or other treatment by a random process (similar to tossing a coin) to ensure a fair comparison between treatments._x000D_
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Methods_x000D_
We will provide training for the paramedics who take part in the trial, so that they can perform the local anaesthetic injection safely. When a trained paramedic attends a patient he or she assesses as having a hip fracture, (s)he will use a scratchcard to decide which treatment to give the patient. We will compare patients’ pain levels, other outcomes and costs between those allocated to the new local anaesthetic injection and those allocated to receive usual care. The other outcomes we will compare between the two groups during their initial care and up to four months following injury are: length of stay in hospital, deaths, quality of life, ability to walk, and satisfaction with care. We will also monitor safety by identifying any concerning health-related events in each group. We will work out the costs of NHS care in each group. _x000D_
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We will carry out the trial in areas within five ambulance services in England and Wales, where a local Emergency Department (ED) has agreed to participate in the research. We will recruit and train 44 paramedics in each ambulance service. We aim to recruit 1400 patients to the study, so that we can detect a difference in improvement in levels of pain of about 10%, which the public and clinical members of our research team agreed would be important to patients._x000D_
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We will train and support paramedics and triage nurses in ED to record patient reported pain levels throughout the trial._x000D_
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Patient and public involvement_x000D_
Two members of the public have helped us to plan this bid and two patient groups (approximately 40 individuals) reviewed our ideas. Members of the public will continue to be involved throughout this research. During the research, members of the public will attend meetings, help to write information sheets for patients, and help to write up the findings from this research. Members of the public will also sit on our oversight committee to ensure the research is carried out properly, and be part of local implementation teams at sites to ensure the patient voice is heard throughout our research. _x000D_
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Sharing our results_x000D_
We will publicise the results of the research using scientific journals, social and professional media and conferences, in the UK and worldwide. Our findings will be incorporated into ambulance service guidelines in the future.

Lay Abstract: Research question_x000D_
Is Fascia Iliaca Compartment Block (FICB) administered by paramedics in the prehospital setting as pain relief for patients with hip fracture safe, effective and cost-effective?_x000D_
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Background_x000D_
Approximately 75,000 people fracture a hip each year in the UK. This excruciatingly painful injury can be devastating  – with a high associated mortality rate - and those who survive likely to be more dependent and less mobile than before their injury. Patients with hip fracture occupy 2.5% of all hospital beds at any time and cost the NHS £2 billion each year. Pain relief at the scene of injury is known to be inadequate. Intravenous morphine is usually given to patients by paramedics but opioids are less effective for dynamic pain and can cause serious side effects, including nausea, constipation, delirium and respiratory depression. These may delay surgery, require further treatment and worsen patient outcomes._x000D_
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We have recently completed a feasibility study testing whether paramedic provided FICB is safe and acceptable; whether our trial design worked in the prehospital setting, and whether we could collect data needed in a full trial. This initial study - the RAPID trial (now published) - showed that a full trial is feasible, as assessed against pre-specified progression criteria._x000D_
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Aim_x000D_
To test safety, clinical and cost-effectiveness of paramedic provided FICB as pain relief to patients with suspected hip fracture in the prehospital environment._x000D_
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Methods_x000D_
We will conduct a multi-centre individually randomised parallel-group trial, with a 1:1 allocation ratio between usual care and FICB. Hospital clinicians in five sites (paired ambulance services and receiving hospitals) will train 220 paramedics to administer FICB. We will use individually issued, sequentially numbered scratchcards to conceal randomisation allocation. The primary outcome for this trial is change in pain score from pre-randomisation to arrival at the Emergency Department (ED). We will use the SAIL (Secure Anonymised Information Linkage) databank (in Wales) and NHS Digital (in England) to follow up processes and outcomes using routine anonymised linked data in an efficient study design; and questionnaires to capture patient reported outcomes at 1 and 4 months. 1400 patients are required to find a clinically important difference in primary outcome (standardised statistical effect ~ 0.2; 90% power, 5% significance). Secondary outcomes include mortality; length of stay in hospital; prehospital medications including morphine; presence of hip fracture; satisfaction; mobility; and costs to the NHS. We will assess safety through capture of Serious Adverse Events in each trial arm._x000D_
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Timelines_x000D_
This research will take 5 years and 2 months to prepare, conduct, analyse and report. This includes time to complete ethics and governance processes; train paramedics; recruit patients over 24 months and follow up outcomes. We have included a six month period without cost to allow for the time lag in retrieving routine anonymised outcomes. _x000D_
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Public and/or patient members have been involved throughout trial development and we will supplement existing PPI membership across trial management and oversight groups._x000D_
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Impact and dissemination_x000D_
We will disseminate our results widely, using high impact peer-reviewed journals and conferences, in the UK and worldwide. We expect trial findings to be incorporated into relevant national and international practice guidelines.

Research Activity Codes: 6.1 PHARMACEUTICALS
Health Categories: INJURIES AND ACCIDENTS