West MidlandsService specification
for the management of
Stroke Thrombolysis and Acute Care
(Hyper-acute)
Version / 3.10 25 November 2009
Status / Valid from 25 November 2009 until 24 November 2010
From / David Sandler, Consultant Physician in Elderly Medicine, Heart of England NHS Foundation Trust
To / Regional Acute Stroke Steering Group (RASSG)
PCTs covered by the specification / All 17 West Midland PCTs
Networks covered by this specification / Black Country
Birmingham, Sandwell and Solihull
Coventry and Warwickshire
Hereford and Worcester
Shropshire and Staffordshire
Agreement process / RASSG - 5 December 2008
RASSG – 13February 2009
RASSG – 1 May 2009
RASSG – 28 August 2009 (clinicians not present)
RASSG – 30 October 2009

Scene Setting

The Operating Framework has identified the implementation of the national stroke strategy as one of its core priorities.

The SHA’sInvesting in Health Programme, Care PathwaysGroup, has, on behalf of the Chief Executives of the 17 PCTs, charged Paul Maubach with leading a West Midland wide group to agree a consistent set of standards, supporting the development of 24/7 access to stroke thrombolysis for eligible patients.

This document consists of a series of standards that can used to designate acute trusts as centres for the managment of patients with the initial, acute phase of their stroke, with special focus on thrombolysis.

It is important to note that some of these standards may not be achieved initially, but they act as a framework for the ongoing development of a quality service.

The document identifies a series of critical outcome measures and quality indicators that will be able to demonstrate the delivery of thrombolysis stroke care – the delivery of increasingly early stroke thrombolysis in eligible patients.

Quality indicators, whilst specifying targets, can be used to continually drive up service quality, and therefore can be adjusted to meet specific local requirements as identified by the PCTs.

Section A - Context

  1. Introduction

This document provides a framework for the development and continual quality improvement of acute stroke care. It provides a series of standards that not only act as the basis for safe service delivery, but also provides some flexibility to continually raise the bar.

  1. Underpinning principles
  • Safe, speedy access is of paramount importance (time is brain)
  • Quality measurement and benchmarking is an integral part of ongoing service development/improvement - with consistent information collection
  • Underpinned by best evidence/consensus clinical commitment
  1. The burden of disease

The stroke strategy launched in December 2007 identified that approximately 110,000 strokes occur in England annually and is the third highest cause of death (11%) with 900,000 people currently living in England who have had a stroke with one third having a moderate to severe disability.

In terms of costs, total spend is £7B a year:-

a)£2.8B direct costs to NHS

b)£2.4B informal care costs

c)£1.8B in income lost in productivity and disability.

It is suggested that the cost per capita equates to €69,(£54) which is the second highest cost per head in the EU, second only to the Netherlands (€ 79- £62)[1]

Stroke is estimated to cost the EU economy over €38 billion a year – equating to one fifth of the total cost of CVD. Of this total, 49% is attributed to direct health care costs, 23% to productivity losses and 29% to the informal care of people with stroke.[2]

Despite the high level of spend, it is suggested that outcomes in the UK compare poorly internationally with long lengths of stay, avoidable disability and mortality.[3]

3.1Local position

Prevalence of stroke in the West Midlands by PCT (source:- ASSET 11)

PCT / Estimate total strokes / Estimated prevalence / Stroke admissions / Deaths
BLACK COUNTRY
Dudley Beacon and Castle / 250 / 2176 / 153 / 157
Dudley South / 440 / 3838 / 298 / 203
Walsall / 550 / 4826 / 359 / 221
Wolverhampton / 530 / 4579 / 406 / 259
BSSCSN
Eastern Birmingham / 430 / 3696 / 371 / 247
Heart of Birmingham / 330 / 2999 / 300 / 168
North Birmingham / 380 / 3250 / 259 / 157
Oldbury and Smethwick / 180 / 1567 / 181 / 145
W’bury and W. Brom / 230 / 2048 / 204 / 126
RR and Tipton / 190 / 1666 / 124 / 112
Solihull / 460 / 4021 / 252 / 169
South Birmingham / 740 / 6348 / 475 / 354
SHROPS AND STAFFS
Cannock Chase / 260 / 2287 / 195 / 102
East Staffordshire / 250 / 2168 / 158 / 107
North Stoke / 280 / 2420 / 189 / 137
ShropshireCounty / 720 / 6197 / 447 / 428
South Stoke / 260 / 2240 / 197 / 129
Staffordshire Moorlands / 250 / 2192 / 142 / 122
Telford and Wrekin / 290 / 2604 / 231 / 176
BLT / 310 / 2709 / 149 / 146
S/W Staffordshire / 480 / 4140 / 279 / 218
COVENTRY AND WARKS
Coventry / 620 / 5351 / 385 / 278
North Warwickshire / 380 / 3366 / 247 / 180
Rugby / 200 / 1735 / 90 / 104
South Warwickshire / 590 / 5047 / 330 / 247
HE'FORD AND WORCS
Hereford / 470 / 4015 / 275 / 278
Redditch and B’grove / 350 / 3063 / 224 / 145
South Worcestershire / 680 / 5864 / 431 / 336
WyreForest / 250 / 2130 / 130 / 148
  1. Strategic Context

National stroke strategy (2007) – quality marker 7 – All patients with suspected acute stroke are immediately transferred to hospital providing hyper-acute stroke services (where a stroke triage system, expert clinical assessment, timely imaging and the ability to deliver intravenous thrombolysis are available throughout the 24 hour period).

NICE (June 2007) - Alteplase for the treatment of acute ischaemic stroke

Investing for health (November 2007) - NHS West Midlands has identified as one of its pathway projects to ensure 24/7 thrombolysis coverage

High quality care for all – NHS next stage review (July 2008) - guarantee patients access to the most clinically and cost effective drugs and treatment

National Collaborating Centre for chronic conditions (July 2008) - National clinical guideline for the diagnosis and initial management of stroke and transient ischaemic attack.

NICE (July 2008) – Diagnosis and initial management of stroke and transient ischaemic attack.

Operating framework (200/10) - Implementation of the stroke strategy

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NB/All designated stroke units should adhere to standards identified in normal text

Standards in italics relate to centres designated as thrombolysis centres only

Page 1 of 20

Section B – Service Standards

  1. Time is brain

Speed of access to thrombolysis and early rehabilitation are crucial to reducing the risk of both mortality and functional disability.

Whilst NICE and current license indication is for thrombolysis within three hours of onset of symptoms to lysis and ECASS 3 has shown benefit up to 4.5 hours,the optimum onset of symptom to needle time is 90 minutes.

It is crucial to note that the WM aims to achieve a call to lysis time of 120minutes, with a year on year review of targets with the aim of achieving the exemplar standard of 90 minutes.

  1. Scope of the specification

The specification commences with the first contact with medical practitioners and ends 24 hours following the onset of symptoms. This definition is in alignment with clinical practice.

The specification is intended to be used by commissioners to designate centres for the administration of thrombolysis. It is important to note, however, that a significant proportion of patients will not be eligible for thrombolysis, but fundamental to their management is access to early rehabilitation within designated stroke facilities.

All patients irrespective of their eligibility for thrombolysis should receive high quality, consistent care irrespective of the trust of admission.

Clearly, WMAS have an integral role in the assessment of patients eligibility for thrombolysis and the swift transit of patients to these designated facilitates.

In summary, this specification is intended to be used by commissioners to designate centres to deliver acute care within the first 24 hours of presentation, including the designation of centres for the administration of thrombolysis.

It is important to note that this specification cannot affect the time taken to recognise the onset of symptoms and the contact then made to NHS services. Public awareness of the importance of early response is outside the scope of this specification.

  1. High level service access

______

NB/All designated stroke units should adhere to standards identified in normal text

Standards in italics relate to centres designated as thrombolysis centres only

Page 1 of 20

National Collaborating Centre for chronic conditions (July 2008)

*To enable thrombolysis to be given in 6 hours, ambulances should bring patients to the hyper acute stroke centre within 5 hours from onset of symptoms; this will allow 1 hour for assessment and treatment.

______

NB/All designated stroke units should adhere to standards identified in normal text

Standards in italics relate to centres designated as thrombolysis centres only

Page 1 of 20

  1. PCT Commitment

8.1PCTs will work to ensure the spread of principle of the importance of calling early for help by ensuring the promotion of the FAST test to all primary care staff, and across the whole of the economy

8.2Primary care will ensure that should a patient be assessed as a positive FAST test, then the patient should be treated as a clinical emergency and 999 called

  1. Pre-admission (ambulance service)

Standards will be included within the contract with WMAS to ensure that:-

9.1Upon receipt of a call, WMAS will dispatch aresponse of the appropriate category, the outcome of the advanced medical priority dispatch system (AMPDS). Category A calls will be despatched for patients who, upon triage are considered to be potentially eligible for thrombolysis. Category B calls will be dispatched for all other stroke patients.

9.2WMAS will assure commissioners that the AMPDS system is based upon conveyance logic that will ensure that emergency responders are not despatched to patients who are suspected to have had a stroke – when transportation ensures early intervention

9.3Emergency responders will only be considered acceptable when WMAS have concerns of the patients vital signs (the caller indicates concern regarding conscious level, airway maintenance or circulatory issues)

9.4WMAS will aim to achieve a call to door time that does not exceed 60 minutes for patients that are eligible for further assessment for thrombolysis as per the checklist(Appendix 1).

9.5Any FAST positive patient who can be taken to a thrombolysis service within 5 hours of stroke onset (or when last seen well) whatever the time of day should be rapidly transferred there with pre-alert (recognising that at the current time, out-of-hours the 4 – 5 hour attenders will neither get treatment or entered into IST3 unless at UHNS).

9.6All patients with signs and symptoms of a suspected stroke will be assessed using the FAST test

9.7Paramedics will assess patients for their eligibility for thrombolysis using WMAS documentation/checklist.

9.8Patients who are considered eligible for thrombolysis will be transferred to the nearest designated thrombolysis centre

9.9Patients who are not considered eligible for thrombolysis will be transferred to the nearest trust with a designated acute stroke unit

9.10Paramedics will ensure the decision making process is accurately captured on WMAS documentation

9.11WMAS will obtain details regarding the onset of symptoms and ensure it is recorded on and patient report form (PRF)

9.12WMAS will alert the nearest designated thrombolysis centre when a patient is suspected of having a stroke and is in transit, providing an expected time of arrival

9.13The alert call will encompass the time of onset of symptoms where this is known

9.14On handover, paramedics will stress the time of the onset of symptoms

9.15WMAS will agree with designated centres a consistent method of the identification of the arrival (door time) – ideally using satellite clocks visible in handover areas in A+E departments

  1. Provider Agreement

Trusts aiming to be designated as a thrombolysis centre must:-

  • Adhere to the standards identified herein
  • Sign up to the process of peer, network co-ordinated assessment and subsequent designation
  • Agree to the collection of data in line with local networks’core data set[4]
  • Trusts will work towards achieving stroke thrombolysis in 10% of all strokes within their catchment area
  1. Provider Competences

11.1In order to be a designated thrombolysis centre, providers will be capable of the assessment, diagnosis and administration of lysis 24 hours a day

11.2Providers will host a stroke unit that provides:-

  • physiological monitoring
  • imaging available 24/7
  • swallow screening/assessment available on admission
  • rehabilitation assessment within 24 hours and treatment started if clinically appropriate
  • Senior medical ward rounds/review will occur at least 5 times per week

11.3In order to be considered as a designated thrombolysis centre, trusts need to be able to demonstrate that it has well organised rotas, educational and training systems to enable adherence to the following elements:-

  • Trusts will ensure on call rotas are in place to enable on call coverage by expert clinicians and radiographers
  • Rotas will be developed in line with statutory workforce requirements
  • Have systems in place that enable the rapid attendance by expert clinical staff to A+E departments/stroke unit for the rapid assessment of patients for eligibility for stroke thrombolysis

Expert medical staff

11.4Each trust will have an identified stroke clinical lead. He/she will be responsible for the identification of suitable competent clinicians to participate in the stroke thrombolysis on call rota.

11.5To be included on the rota, expert clinicians must have experience in the management of patients with strokes, specifically the clinical assessment of new cases/patients.

Expert nursing staff

11.6To be designated a thrombolysis centre, trusts must demonstrate that nursing staff are trained in the monitoring for complications associated with stroke thrombolysis

11.7Stroke units will ensure coverage of staff that are assessed as competent in the completion of swallowing screening 24 hours a day, seven days a week

11.8In addition to the above, providers will review the patient pathway within their organisation and will identify the staff groups ideally placed to complete swallow screening assessments, ensuring all have received appropriate training to be competent in this intervention.

12Patient Pathway

12.1Designated centres will have systems in place that will enable the prompt alert of radiology to ensure preparedness for patient arrival and assessment

12.2Upon arrival at A+E, patients will be triaged as an urgent case, with the recording of vital signs. This will include the ROSIER test

12.3Trusts will have systems in place that enable significant effort/focus to constantly monitor/count down time between onset of symptoms and progress through the pathway to enable optimum opportunity to be eligible for stroke thrombolysis (ie time is brain)

12.4An accurate history/clinical assessment should be taken by an expert clinician who is designated as a specialist in the management of acute stroke care

Immediate Intervention

12.5Brain imaging should be performed immediately for people with acute stroke if any of the following conditions apply:-

  • Indications for thrombolysis or early anti-coagulation treatment
  • On anti-coagulation treatment
  • A known bleeding tendency
  • A depressed level of consciousness (Glasgow coma scale below 13)
  • Unexplained progressive or fluctuating symptoms
  • Papilloedema, neck stiffness or fever
  • Severe headache at onset of stroke symptoms

12.6Patients that miss the opportunity for stroke thrombolysis due to delays in access to CT scan will be reported (identified in governance section)

12.7Investigations will be encouraged to investigate the factors that predisposed the delays and action plans produced to prevent re-occurrence.

12.8Designated centres will have systems in place to enable expert reportingand recommendation for intervention immediately

12.9The decision to thrombolyse will be taken by a consultant designated by the thrombolysis centre as having the required competences

12.10Stroke thrombolytic agents will be administered in line with criteria specified within the NICE guidance (Alteplase for the treatment of acute ischaemic stroke) specifically within three hours of the onset of symptoms, unless trusts are participating in the IST-3 trial where administration up to six hours is permitted

It appears that general practice based on ECASS 3 is for thrombolysis up to 4.5 hours which is NOTspecifically in the context of IST 3 or other trial enrolment

12.11The administration of thrombolytic agent will be given in line with trust policy

Urgent Management

12.12Patients that have symptoms that are outside the conditions identified above will have same day scanning, not exceeding 24 hours of the onset of symptoms continually working to improve the door to scan times – with the eventual aim of achieving a target of within 4 hours.

12.13All patients should have an initial dose of 300mg of aspirin either orally, or rectally as tolerated, and continued into the acute phase (unless contra-indicated or unless haemorrhage is shown on CT or is clinically likely)

12.14An alternative anti-platelet agent should be commenced within 24 hours if aspirin is contra indicated

Transfer of Care

12.15Trusts should have internal systems in place to ensure the ring fencing of beds in stroke units to ensure patients suspected of having a stroke are transferred for intensive monitoring and ongoing functional assessmentwithin four hours of admission.

12.16All trusts will ensure the adherence of vital signs by avoiding the transfer of patients with suspected or confirmed stroke to medical assessment units (aiming for not less than 80% of patients will spend 90% of their stay in a stroke unit)

12.17Acute trusts need to have physiological monitoring systems in place for acute stroke patients to include continuous ECG, oxygen saturation and BP monitoring during their acute illness

Swallowing assessment

12.18Trusts should have protocols in place that enable the screeningof patient’s ability to swallow prior to the administration of any drinks, food or oral medication

12.19If the admission screening indicated problems with swallowing, then specialist assessment of swallowing should be performed with 24 hours of admission

12.20Patients who are not able to take adequate oral fluid and nutrition will receive tube feeding

  1. Acute intra-cerebral haemorrhage or malignant cerebral oedema

Providers will be able to demonstrate the existence of monitoring protocols and urgent referral pathways into neuro-surgery for patients that, on imaging have or require:-

  • Symptomatic hydrocephalus
  • Decompression hemicraniotomy

Section C – Governance and Performance

  1. Governance

14.1Trusts will be able to demonstrate internal systems to assure the accuracy of assessment and administration of stroke thrombolysis

14.2Trusts will have systems in place to ensure the collection and reporting of patient reported outcome measures both to commissioners and internally to current patients and their carers

14.3Trusts will agree action plans with host PCT to rectify service gaps identified in the PROMs

14.4Designated thrombolysis centres should participate in research – being active members of the WM stroke research network

14.5Trusts will be required to participate in the real time audit (DH lead) ensuring accurate collection of all fields in line with national data set in line with national roll out

14.6Until this service is up and running, trusts will be required to work collectively in the agreement of an interim data set – the network will work to ensure this is in alignment with the real time audit standards wherever possible