Title: Promoting Effective And Rapid Stroke care (PEARS)
Funder: Department of Health and Social Care

Abstract: The programme comprises two interconnected strands of work focused on improving the effectiveness, efficiency and speed of the early management of patients with acute stroke and major disabling symptoms. A key focus of our work will be improving and integrating working between pre-hospital (ambulance paramedics, general practitioners) and hospital teams (Emergency Department, Acute Stroke, Radiology, Neuroradiology) to achieve more rapid delivery of intravenous thrombolysis for major disabling strokes (objective 1) and define the role of intra-arterial thrombectomy in the management of major disabling stroke (objective 2). Objective 1 will develop and evaluate a novel enhanced paramedic protocol to expedite immediate brain imaging and drive forward the hospital assessment of stroke patients who can benefit from rapid treatment, specifically thrombolytic therapy. Paramedics will pre-notify the hospital team with details that justify urgent imaging, transfer the patient directly to the scan room on arrival and use a standard checklist to co-ordinate rapid delivery of thrombolysis if indicated. The objective consists of six phases. Output from the pre-trial phases 1-3 (months 0-20) will be a systematic review of enhanced paramedic roles, qualitative description of professional and public views to shape the intervention, training materials and a tested protocol. Phase 4 (months 21 &ndash; 54) will evaluate the enhanced protocol by cluster randomized controlled trial across three regions (North East, North West and South Wales) and qualitative examination of professional and public experiences. Phase 5 (months 24&ndash;60) is a within-trial economic evaluation to estimate cost-effectiveness of the enhanced protocol versus usual care. If the enhanced protocol is effective and affordable, dissemination of results and training materials would quickly lead to wider adoption (phase 6; months 55-60). Objective 2 will determine the clinical effectiveness, costs, cost effectiveness and affordability of delivering intra-arterial therapy (IAT) for acute ischaemic stroke patients to the English population. We will model alternative means of provision of (IAT) for stroke across NHS services as part of the cost effectiveness/affordability analyses. Objective two will increase understanding of the evidence of IATs effectiveness, how effectiveness might vary across patient groups, the requirements for and barriers to providing an acute intra-arterial stroke therapy nationally across the NHS. This information will then be used to develop a model that can be used to explore how such a service would best be organised. The model reflects the complete patient pathway and will include the enhanced role of paramedics outlined in objective one in the potential redirection of suitable patients to centres providing acute intra-arterial therapy. As a model of effective and cost-effectiveness, the outputs will include the resource implications from an NHS perspective. The objective consists of five phases: (months 0-12) a conceptual model of care pathways intra-arterial therapy and an understanding of the feasibility and requirements of providing a 24hr IA service obtained from a survey of stakeholders; (months 13-36) creating a validated mathematical model capable of running simulations of a population of stroke patients; (months 25-30) consulting with stakeholders about possible configurations of service provision; (months 37-54) modelling and reporting on the configurations being considered and consulting on and disseminating the results of the objective (months 48-60). The two objectives each address a critical and under-researched area of the emergency care pathway of patients with acute stroke symptoms. Each involves the evaluation of potentially large changes in services and by addressing them in one programme of work facilitates joined-up thinking about the wider implications of change to a service both individually and collectively. Critically this approach also allows consideration of unforeseen consequences flowing from the changes evaluated in one objective on other objectives and other parts of the service. Furthermore, by addressing each objective simultaneously clinical and methodological expertise can be shared as can the data.

Lay abstract: Acute stroke care has improved dramatically in recent years with implementation of clot busting drugs to treat moderate/severe stroke, and rapid access to specialist acute services. This proposal addresses two areas where the early management of people with stroke could be improved through better working between ambulance services and hospital services. First, time from patients contacting 999 to receiving clot busting drugs is too long. Second, a new treatment where a radiologist inserts a tube into a brain artery to remove the clot causing a severe stroke is very promising but it is unclear how NHS services would be best organised to offer this treatment as currently it is available in fewer than 30 specialist centres in England. We will improve outcomes of people with acute stroke through two related work packages by: 1: Developing an enhanced paramedic role to transfer the patient directly to the scan room and stay with the patient to speed up brain scans, assessment by the stroke team, and consequently reduce delays in treatment with clot busting drugs. We will then conduct a trial in three ambulance services comparing the benefits and costs of this new enhanced model of care to current practice, where paramedics leave immediately after patient handover. 2: Determining the likely effectiveness of the new technique of clot removal by analysing existing datasets and working out how many people could benefit from treatment. Analysis will take into account travel times and the availability of specialist teams. We will estimate costs, and make recommendations about how the treatment could be provided by the NHS.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: STROKE