Conference Report

TOWARDS A UNIFIED APPROACH
'Standards, Stoke and Thrombolysis'

Proceedings of the Joint Royal Colleges Ambulance Service Liaison Committee Conference - 3 November 2000.

The Joint Royal Colleges Ambulance Liaison Committee’s (JRCALC) annual conference at the Royal College of Physicians was attended by over 70 delegates from across the United Kingdom despite the flooding and transport difficulties that meant that some had started their journeys at 2am to get to London. Towards a unified approach was this year’s theme with specific focus on clinical standards, stroke and thrombolysis.

Welcome and introduction

Welcoming and congratulating those who had made it despite the weather, Chairman Professor Douglas Chamberlain reminded the audience that JRCALC had been born in 1989 from the vision of a small group of like minded clinicians and ambulance managers. Its original aim was to act as the national liaison body between the various colleges and the ambulance service and to provide an interface with hospital and primary care. During the past decade the committee has played a leading part in developing paramedic training, improving clinical standards, supporting professional registration, facilitating the use of prescription only medicines, encouraging audit, promoting proposals for practitioners in emergency care and introducing treatment protocols and guidelines.

As paramedic practice has developed those tasks have increased in importance and recent developments, particularly current extensions to the prescriptions only medicine (POMS) list, allow ambulance staff to do much more to help the patient. Trusts may also use drugs not on the POMS list under Patient Group Directions, but all these developments make better training and stronger audit vital in order to maximise patient benefit and minimise risk. That is particularly true in respect of thrombolysis where the inevitable adverse effects of giving the drug to some patients will be immediately apparent whilst the benefit will not be. Producing and then maintaining good clinical guidelines and developing better audit were major areas of work for JRCALC and an important theme of this conference.

New national clinical guidelines

Dr Iain McNeil, chairman of the `guidelines’ sub-committee presented new national clinical guidelines that had been revised and endorsed by JRCALC for use in the UK’s ambulance services. These are to be available on the JRCALC web site <www.jrcalc.org.uk>

He reminded the audience that the public rightly expects the same high standard of pre-hospital care wherever and whenever they might need it and that it has to be recognised that there is currently little standardisation, ability to benchmark, or define best practice. There is also a general lack of research in pre-hospital care and very little evidence to support many current practices. With the development of clinical governance and risk management these deficiencies were important managerially as well as clinically and whilst programmes like Panorama may have been unduly critical they did highlight a very real deficiency.

Much has already been done to produce training manuals and local guidelines, but JRCALC firmly believe that national guidelines are now essential and was asked by the Department of Health to help develop a standard approach. Building on the extensive work already carried out by Drs Carney, Scott and others, these new guidelines are not claimed to be perfect, but rather a good start at producing a living document which belongs to the ambulance service. A greater degree of standardisation is clearly desirable, but at present these guidelines can only be advisory and Ambulance Paramedic Steering Committees or Medical Directors may choose to deviate from them at a local level. However, clinical governance would suggest a need to explain deviations and it would be helpful if Services shared the reasons behind any change. We must seek to overcome local prejudices and the whole intention is to maintain and refine the guidelines, develop a scientific and rigorous evidence base and produce practical and measurable clinical standards supported by audit tools and programmes. As such, Dr McNeil would particularly welcome feedback, comments and suggestions.

He also emphasised that producing and maintaining evidence- based guidelines was a time consuming, lengthy, expensive and continuous process - akin to painting the Forth bridge. For the future, solely relying on the good will and commitment of a small number of volunteers is not a practical approach, to do the job properly will take investment. Initial funding had been secured from the Ministry of Defence, which is also interested in areas of this work. But to develop the guidelines and supporting audit programmes ambulance services and the Department of Health, JRCALC and the ASA must now accept the need for investment to produce better patient care. In summary Dr McNeil emphasised that the interim guidelines are now ready, the evidence base is still to be developed, that task requires funding and there is a need to work better together in order to improve standards and practice.

Clinical guidelines- from paper to best practice

West Country Ambulance Clinical Effectiveness manager Graham Brown welcomed the availability of the new clinical guidelines and explored the challenges of putting them into practice. Differentiating between a system intended to guide and assist to make better decisions (guidelines) and that which sets out standard procedures to be followed step by step (protocols); he believed that guidelines were much better suited to the pre-hospital environment given the diversity of situations which confront ambulance staff. Over 30 years ago some research indicated that only 10-20% of all clinical interventions were proven to be clinically effective and beneficial, more recent research has estimated that only 25-33% could be shown to do more good than harm. As few can be shown to do more harm than good, most are in the unknown category and with much of what is currently done pre-hospital based on consensus and experience, most is also in that area.

He stressed that there are good reasons for looking at variances between treatments in ambulance services as surveys have shown inexplicable differences between drug dosages and treatment regimes. But we also have to recognise that such variances are not necessarily bad and are also common in other areas of clinical practice. Existing guidelines themselves vary in effectiveness with some - for example those of the European Resuscitation Council - being widely adopted. Others - such as the British Heart Foundation’s guidelines for acute myocardial infarction - are not so well followed and the lack of published research evidence remains a major concern.

Mr Brown suggested that effective guidelines need to be owned by and not imposed upon, the ambulance service. Translating them into action will take political and managerial commitment, persistence and energy. They need to be credible and valid, acceptable to the practitioner, actually change practices and demonstrate that health gain is achieved. Overcoming resistance and gaining ownership are critical and that requires the guidelines to be sold to staff not just published and disseminated. They must be in a simple accessible format, well explained to crews and supported by training, evaluation and monitoring. Implementation may also involve the use of incentives and ultimately sanctions and takes time to achieve.

Collecting the right data from the right forms at the right time

Stuart Nicholls, the manager of the Ambulance Service Association’s clinical effectiveness project described its main aims as facilitating and linking the work of individual ambulance services and bringing together the jigsaw pieces to create and support clinically effective practice. An important reason for the programme was to gather uniform data for the national service framework for coronary heart disease but the approach could equally be adopted for other clinical areas. Collecting accurate and timely data is essential and he asked how what is desirable could be made possible. A unified approach needs to be co-ordinated from a central point and for clinical audit the ASA project provides such a focus, linking to the joint JRCALC /ASA clinical effectiveness committee and beyond to the National Institute for Clinical Excellence. It also has data collection links with the Royal College of Physicians’ clinical evaluation unit, which is organising the national in-hospital audit the management of myocardial infarction (MINAP) and in turn to the central cardiac arrest database.

He emphasised that clinical audit was central to the process of continuing improvement in patient care and data collection the key to audit. A minimum data set will allow for comparative clinical audit between ambulance services and across integrated care pathways would provide the framework for clinical risk management. Accurate information is essential to provide a patient record, measure quality of care, establish best practice and implement clinical governance. The backbone of a minimum data set in ambulance services is the patient report form, but design varies and they do not provide an audit tool or all the information required. Surveys have shown that patient report forms do not provide all the information required by the coronary heart disease framework and only 17% of all ambulance services routinely collate data from all of them. The development of electronic patient report forms, data transfer, common definitions, agreed coding system and similar improvements would all help to address those deficiencies.

Mr Nicholls stressed that clinical audit can no longer be regarded as an option, but an essential and the key to professionalism. The project is planning work which includes a code of practice for pre-hospital record keeping and data collection, a review of the minimum data set including its compliance and the development of a rolling programme of clinical audit built around the national guidelines and service frameworks.

What does the ambulance service need from JRCALC in the new millennium?

Was the question posed to ASA President Barry Johns. He described how the organisation of ambulance services was changing, the various managerial and clinical issues that face the service and the continuing debate as to whether it is the health arm of the emergency services or the emergency arm of the health services. Recognising that the training and skills of ambulance staff had come a long way since professional training was first introduced in the 1970’s, he saw paramedic registration as the latest step forward and explored the future role of the service and its staff in the context of the wider changes in health services.

The ASA has commissioned a strategic review of the role and structure of the service, which is due to report by the end of the year. That will look at many of these issues and help set future direction. The service’s future role will largely determine the skills and education required by operational staff and the scope of their practice may well widen if it becomes more involved in the delivery of primary care and rotation into hospital settings. Proposals for practitioners in emergency care have already captured the imagination and support of the NHS and may well be the next logical stage of development. Technology and communications systems will also change the way in which they work.

Mr Johns concluded that although ambulance trusts now have numerous sources of clinical advice, the ASA sees JRCALC as continuing to have the expertise, status and experience to provide national clinical leadership and believes it must remain as the focal point for authoritative clinical advice for the UK’s ambulance services.

Pre lunch debate

A lively debate followed the morning contributions, the audience discussing a range of topics including: whether additional risks and responsibilities would be welcomed by ambulance staff - were there are any pay and reward issues - who assumes liability- the lack of an academic department of pre-hospital care in a UK university- the shift from protocol driven to evidence based care through education- decision support systems - the size of the proposed guidelines - what if any thinking had already been done to introduce them to the service.

A rapid ambulance protocol for acute stroke

Dr Gary Ford, Consultant Physician at the Freeman Hospital Newcastle, described the development of the first comprehensive stroke service in the UK established at the Freeman Hospital at Newcastle in 1993. He emphasised that the diagnosis of stroke patients was often wrong and that early intervention and rehabilitation can make a significant difference to outcome. Having established a specialist stroke service, the admission of patients via various A&E departments in Newcastle hospitals did not seem to work well, therefore a protocol was developed allowing ambulance crews to bring suitable 999 patients direct to the specialist emergency reception suite at the unit. A specific Face Arm Speech Test (FAST) has been developed as a diagnostic aid and paramedics are trained in stroke recognition. The test asks the paramedic to look for, facial weakness, arm weakness or speech disturbance (either dysarthria or dysphasia) in context. The paramedics inform the hospital via control when a stroke is suspected and providing the patient is not in a coma can proceed direct to the Freeman. There is no criticism in respect of errors.

Dr Ford reported that initially the numbers of direct admission were fairly small but as crews gained confidence that improved greatly with 45% of the unit’s patients now arriving directly. Results over the first 15 months confirm that the paramedics have the diagnostic skills to make the right decisions, that the time to definitive treatment has been significantly reduced compared to other admission routes and that there has been patient benefit. Of 123 patients in a study the diagnosis had been correct in 102 cases, the paramedics ability to recognise stroke compared well with GP’s and A&E departments and there had been no significant scene delays. He did not consider that pre hospital thrombolysis was likely to be a practical pre-hospital option for stroke victims. But as with the heart, the concept in acute stroke should be that `time is brain’ and the use of neuroprotective agents out of hospital may well be an area that will develop in the future.

Setting up a stroke protocol needs commitment from senior ambulance managers, agreement with clinical colleagues, a suitable stroke identification instrument included in the patient report form, simple and unambiguous protocols, a blame free culture, ambulance staff involvement in the audit programme and a recognition that change takes time. Ambulance services have an increasingly important role to play in the early identification and triage of acute stroke patients and Dr Ford believes that the Newcastle model could work equally well elsewhere, particularly in urban settings. He is perfectly willing to share the training package developed for the project with interested parties and can be contacted via the Wolfson Unit at the University of Newcastle on Tyne.

Pre-hospital thrombolysis in Sweden

With continuing debate on the balance of benefit and risk in pre hospital thrombolysis Dr Lars Engerstone - an anaesthetist and director of the emergency department and ambulance services at Falun Central Hospital in the County of Darlana - shared experience from Sweden where the approach has already developed.

He explained that there were 85 emergency hospitals in Sweden, 65 of them able to receive ECG’s transmitted from an ambulance. 38 have a protocol for pre-hospital thrombolysis, most using Reteplase. A national data base for prehospital thrombolysis has been established this year and so far about 500 patients are believed to have received pre hospital thrombolysis so far, 100 of them in Dalecarlia County. Dr Engerstone’s hospital serves a large rural area with poor road conditions and some long travel times. A national reduction in numbers of emergency hospitals is leading to longer transportation and more critical care transfers. More and different types of ambulances are required, staff training had to be improved and better communications technology is increasingly important. Ambulance paramedics all have three years nurse training and an additional year’s practice in hospital before working in the pre-hospital arena. Nurses also work in the call centre to assist decision making and reliable conventional communication between the ambulance and hospital presents some difficulties.

Patients are assessed in the ambulance and the ECG and data then transmitted by mobitext or mobimed keyboard. Cardiologists at the hospital decide whether the patients should receive thrombolysis and where they are then to be taken. As well as ambulance personnel, medical, nursing and call centre staffs have been given additional education in the thrombolysis protocol. The total additional training for ambulance personnel was about 10 hours. During 1999, 518 patients were referred to Falum hospital with myocardial infarction, 152 of them with ST elevation and of those 60% had been given pre hospital thrombolysis. Pre-hospital contraindications are deliberately strict so treatment is conservative. Initial indications are that `pain to needle’ time has reduced from about 3.5 to 2.5 hours since the programme started in 1998. There were three diagnostic errors, but no pre -hospital deaths, among the 78 thrombolysed, but the numbers are too small to draw any valid conclusions regarding impact on outcome at this stage.

Pre-hospital thrombolysis in the UK - looking ahead

Professor Richard Vincent a cardiologist in Brighton reminded the audience of the persuasive case for pre-hospital thrombolytics, but that it had to be balanced against the inevitable risks. Time is muscle and persuasive clinical trials have shown that there is a huge benefit early on, with a potential to save 65 lives per 1000 patients in those eminently suitable for thrombolysis. Benefit lessens rapidly with time - but is not a linear fall off- and the potential depends heavily on the patient’s response to their symptoms. That remains the biggest and probably the most important cause of delay. Logistically, minimising professional delay will mean thrombolysis outside hospital and the enthusiasm of the few can now be combined with improved practicality, new thrombolytic agents, better technology, built–in decision support systems, telemetry and above all permission from the Government through the NHS Plan to make progress.

He discussed the merits and deficiencies of the various possible approaches proposed by JRCALC, but emphasised the need to guard against downgrading care for those not considered suitable for pre-hospital thrombolysis. Defibrillation of patients in VF will still save far more lives. How each agency interacts and which takes responsible for delivering this kind of care raises interesting issues that will require agreement and trust between each partner. The JRCALC survey showed a spread of interest by ambulance trusts in the possible options, but inevitably we should start with those patients whose infarct is `barn door’ because of risk benefit - which may not justify investment in sophisticated decision support systems. There is a real determination to make this development successful, but to do that we will need to be discerning about choice of model and have particular regard for time to hospital.

Professor Vincent also reminded the audience that there are going to be mistakes, as there are in hospitals, but they are likely to be more exposed in the pre-hospital setting. Even with a reasonable diagnostic accuracy of about 85% we will need to be careful about how those problems are handled. Agreeing local or regional protocols across a health community, deciding on ownership and responsibility, ensuring the required standard of training and competency amongst paramedic staff and strengthened audit programmes are still issues needing further attention. But he suggested that how the benefits and risks are perceived by ambulance staff is likely to prove equally important.

In training paramedics to deal with an acute infarct the theme must still be that ventricular fibrillation continues to be an early problematic and fatal condition. Treatment is therefore mandatory and to treat VF with a shock basically requires that you diagnose death and have an appropriate ECG. There are few contraindications to a shock and if successful there will be an obvious, immediate and visible benefit. The patient can’t really get worse and can suffer no real harm.

But treating acute myocardial infarction is going to be significantly different. It will require many more questions, the recognition of subtler ECG changes and constant awareness of some important contraindications. The message is already that you should not thrombolyse in many situations and paramedics are likely to think of more as variations on those set restrictions. The benefits are also more theoretical -perhaps 3 or 4 per 100 patients treated might survive who would otherwise not have done so- and those benefits are also invisible unless there is some follow up. So there is little immediate feedback, satisfaction or appreciation. Patients can get worse from cerebral haemorrhage, bruising, major internal haemorrhage, allergy, immediate hypotension or bradycardia - although these may not develop early. All these factors make the use of thrombolytics significantly different to the paramedic’s current treatment regimes and failing to recognise these psychological aspects could influence their willingness to participate. In closing, Professor Vincent urged the audience to maintain their enthusiasm but to take a broad view of these issues in constructing the systems, guidelines and directions which will enable pre-hospital thrombolysis to be done and done well.

Subsequent discussion covered: - the various practical risks - delays in moving the patient to hospital - the position of the British Cardiac Society - the role of telemetry- the cost/benefits of the focus on cardiac arrests - the wider potential impact on general patient care and how to reduce the pain to call time. All speakers and participants were thanked for their contribution and Dr Engerstone presented with a college plate as a reminder of his visit.

The next annual conference is to be held at the College on 2 November 2001 with a special meeting on the practical aspects of delivering thrombolysis to be held on 12 March 2001. Further details will be published on the JRCALC web site as they become available.

ENDS.


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