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Anti-coagulation therapy using Warfarin

How to GuideThis guide has been produced to enable GP Practices and their teams to successfully implement a series of care bundles in a timely manner and

apply the Model for Improvement when monitoring patient’s

anticoagulation therapy The former Public Health Wales Primary Care Quality Team, now incorporated within the Primary and Community Care Development and Innovation Hub, developed a series of quality improvement toolkits to assist practices in collating and reviewing information. From information received, practices still find these toolkits useful, therefore they will remain on this webpage for your ease of reference. Please note, however, that the date of publication is clearly stated in the toolkit and that the evidence within may have changed since publication.

Public Health Wales 1000 lives + Anticoagulation H2G

FinalOctober 2013

Acknowledgements

This ‘How to Guide’ has been produced by the Public Health Wales, Primary Care Quality with input from Dr Chris John, Dr Paul Myres and Martin Holloway of Public Health Wales, Primary Care Quality and with contribution from Tessa Lewis and Professor Philip Routledge of the Welsh medicines partnership.

We would like to thank Health Boards and GP Practices in Wales and their teams for their endeavours in implementing these interventions and also feeding back lessons and experiences gained

1000 Lives Plus is run as a collaborative, involving the National Leadership and Innovation Agency for Healthcare (NLIAH), National Patient Safety Agency (NPSA), Public Health Wales, Primary Care Quality and the Clinical Support and Development Unit (CSDU)

We wish to thank and acknowledge the Institute for Healthcare Improvement (IHI) and the Health Foundation for their support and contribution to 1000 Lives Plus

Date of publication and Proposed Review Date This guide was published in October 2013 and will be reviewed in October 2015. The latest version will be available online on the programme’s website: www.1000livesplus.wales.nhs.uk

Purpose of the GuideThis guide has been produced to enable GP Practices and their teams to successfully implement a series of ‘what we do’ (bundles) when initiating and monitoring patients undertaking warfarin therapy, to promote safer prescribing.

This ‘How to Guide’ must be read in conjunction with the following:

Leading the Way to Safety and Quality Improvement

Date: October 2013 Version: 1 Page: 2 of 41

http://www.1000livesplus.wales.nhs.uk/


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How to Improve The Quality Improvement Guide

Further information is also available to support you in your improvement work:PCQIS site http://howis.wales.nhs.uk/sitesplus/888/page/34030

Deanery siteThe new GP Appraisal & CPD website can be found here; https://nhswalesappraisal.org.uk/

Foreword Warfarin is being used in the management of increasing numbers of patients and conditions including patients with atrial fibrillation, DVT pulmonary embolism, valve replacements and other disorders1,3. While it is a very effective drug in these conditions, it can also have serious side effects.

This guide, and its associated collaborative programme, aims to minimise the number of patients who encounter such events by encouraging and supporting primary medical care teams to examine the care they provide, reflect on their services and try different approaches as necessary to improve.

The 1000 lives plus approach requires practices to design their processes to meet the needs of their patients in ways appropriate to their circumstances by considering their own data and comparing it with what they would wish it to be. It encourages practices to compare themselves with others and learn from what others have done. Similarly it asks participating practices to share their learning with others.

This How to Guide is specifically aimed at general medical practice. It is concerned with this service where we know collectively we can do better. It relies on us to work constructively with our secondary care colleagues. It puts responsibility on all of us in the general medical practice team to improve.

Paul MyresPrimary Medical Care Lead1000 lives plusChairRoyal College of GPs Wales


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Making Patient Safety a priority The 1000 Lives Campaign has shown that by working as a collaboration it encompasses not only health services within secondary care organisations but also community based alliances from health clinics and associated general practices who together support mutual aims: the avoidance of unnecessary harm, improvement to services that are delivered and an evidence-informed approach with patient safety as a priority.

The enthusiasm, energy and commitment of teams to improve patient safety by following a systematic, evidence-based approach have resulted in many examples of demonstrable safety improvement.

However, as we move forward with 1000 Lives Plus, we know that harm and error continue to be a fact of life and that this applies to health systems across the world. We know that much of this harm is avoidable and that we can make changes that reduce the risk of harm occurring. Safety problems can’t be solved by using the same kind of thinking that created them in the first place.

In General Practice the field of patient safety has tended to focus on adverse events and on the development of specific solutions aimed at preventing these events. We know that much of the harm is avoidable and that changes in practice and procedures can reduce the risk of harm occurring. Developing a positive safety culture depends on communication between all members of the health care organisation. The health care organisation needs to:

Acknowledge the scope of the problem and make a clear commitment to change.

Recognise that most harm is caused by bad systems and not bad people.

Acknowledge that improving patient safety and outcomes requires everyone on the health care team to work in partnership with one another, patients and families.

The national vision for NHS Wales is to create a world-class service by 2015; one which minimises avoidable death, pain, delays, helplessness and waste. The guide



is grounded in practical experience and builds on learning from organisations across Wales. The National Patient Safety Agency Seven Steps to patient safety in general practice guide describes the key steps for a general practice to take to avoid harming the patients they care for. http://www.nrls.npsa.nhs.uk/resources/collections/seven-steps-to-patient-safety/?entryid45=59804


http://www.nrls.npsa.nhs.uk/resources/collections/seven-steps-to-patient-safety/?entryid45=59804

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Contents Page

Introduction 6

Driver Diagram 9

Getting Started 10

Drivers and Interventions 11

How do we introduce changes to processes? 13

How do we measure for Improvement? 17

References 22

Appendices

Setting up your team 23

The Model for Improvement 25

How to test change 26

Process Measures with descriptors 28

Helpful Resources 32



Introduction

Aim: To ensure the safe prescribing and monitoring of patients taking warfarin

Warfarin is being used in the management of increasing numbers of patients and conditions including patients with atrial fibrillation, DVT pulmonary embolism, valve replacements and other disorders1,3. While it is a very effective drug in these conditions, it can also have serious side effects, e.g. haemorrhage. The NHS Litigation Authority has reported that medication errors involving anticoagulants fall within the top ten causes of claims against NHS Trusts2. A number of factors account for these problems including:-

Complexity of dosing and monitoring Patient compliance Biological variation in response to treatment Numerous drug interactions Dietary interactions affecting drug levels such as alcohol consumption

The existing 1000 lives how to guide cites considerable evidence of harm in the use of anticoagulants.

The 1999 SIGN Guidelines4 note that there is “considerable scope for audit of anti-thrombotic therapy, in both primary care and hospital settings”. They continue by identifying a range of review areas such as;

indication for anticoagulation, screening investigations, risk factors for anticoagulation, management plans, anticoagulant drug and dose, alternative appropriate therapy, anticoagulant control, follow-up, Patient held records.

This guide is not aimed at practices who only prescribe without monitoring. If a practice is providing prescriptions without carrying out the monitoring and dosing, it should be satisfied the process is safe and be clear who has clinical responsibility and accountability for ensuring the correct dosing and appropriate monitoring.

The impact of delivering evidence-based careThe NPSA safer practice recommendation for oral anticoagulants has identified safer practice2. The 2007 Patient safety alert 18 offered guidance regarding the safe monitoring of anti-coagulation therapy. Accompanying this document is an audit checklist that includes a review of training and competence, procedures and protocols, safety indicators and a checklist that can be used to record all patient safety incidents reported during a twelve months period. All primary and secondary care providers in Wales have or are in the process of implementing these measures. The all Wales prescribing advisors group (AWPAG) had also used its 2008/09 incentive scheme to further spread this audit in a


http://www.npsa.nhs.uk/site/media/documents/2436_Anticoag_alert_FINAL.pdf


modified output. This audit had been embedded in the national primary care data quality tool Audit +.

Data Quality System (DQS) in Wales and Audit+

In November 2007, the Welsh Government’s Primary Care Informatics Programme (now part of NHS Wales Informatics (NWIS) launched the Data Quality System.

This was a natural progression from previous initiatives with the aim of providing an efficient, automated and consistent software tool, primarily to support General Medical practices and as a by-product support the bigger picture within Wales.The DQS comprises of a General Practice based tool, ‘Audit+’ and a secure central NHS Wales-based web repository ‘Audit Web’ which receives scheduled automated aggregate data submissions from Audit+.

Participation in the DQS within Wales is voluntary; Audit+ is provided free to all General Practices in Wales irrespective of their clinical information system and is now deployed in 97% of General Practices. To ensure continued acceptance from practices, reflected in continued high level of participation, the development and implementation of all modules is discussed with GPC (Wales) representatives to guarantee ongoing professional approval. NWIS works closely with Public Health Wales and other key NHS organisations to produce modules within Audit+ including amongst others:

INR Monitoring Minor Surgery Learning Disabilities Near Patient Testing QOF age/sex standardised prevalence Flu vaccinations Pneumococcal vaccinations Communicable diseases CHD National Service Framework Diabetes National Service Framework / Directed Enhanced Service

As is the case with any software product the results produced are only as good as the source data supplied. Audit+ therefore contains specific searches within other modules to encourage General Practices to improve the data quality within their clinical system that supports their day-to-day activities. Audit+ modules to support cardiovascular risk will also contain such searches to ensure that the data required to undertake risk calculations is as complete as possible.

Registration process

The Audit+ product collects data from all practices who have signed up to its use. The Practice or service provider will be undertaking testing and measurement of ideas using the improvement methodology as part of a collaborative, made up of themselves and other practices or service providers. The precise size and form of the collaborative will be determined over the coming months.

It will be a voluntary subscription to undertake the interventions described in this improvement guide. In order to filter data from the Audit + tool, to feed back to practices who have subscribed to the collaborative(s), the 1000 Lives Plus programme will need to identify who has subscribed to which collaborative



(defined by its improvement focus e.g.anti-coagulation therapy ). In order to do this, the practice, once signed up to a collaborative, will need to register and accepted that they have agreed to take part in the particular collaborative(s). The registration will take place using the existing “Public Health Wales, PCQ Quality Improvement Tools”, which will be familiar to many GP practices because it hosts the all Wales clinical governance self assessment tool. There will be 1000 Lives Plus collaborative registration form available at this site. Practice Registration Form

Purpose of the Registration FormThe Registration Form will allow practices and other providers to register their subscription to one or more of a number of quality improvement collaboratives covering a range of clinical practice issues, starting with a choice of

Chronic Heart Failure (Left Ventricular Systolic Dysfunction) Atrial Fibrillation Anti coagulation therapy using warfarin

Practices or other service providers will be able to sign up to one or more of thesecollaborative. The registration tool will allow practices to add data that the Audit + tool is not collecting but is important to the subject matter. It will also allow practices to annotate issues or constraints associated with their audit/measurement ranging from internal practice issues, practice development issues identified or lack of services that may prevent the implementation of evidence based quality improvements. It will also provide summary data collection forms for those not signed up to the Audit+ tool.

The issues identified from data collected from the registration form will allow any analysis to be qualified with constraints and caveats to promote a more effective discussion of quality improvement within collaborative learning sessions.

Improving the safety of prescribing warfarin Driver Diagram


Aim Driver ‘What should we be doing?’

http://nww.nphs-cgtool.wales.nhs.uk/



Initiation

Care Bundle 1 Create a register containing Patient

demographics and Clinical indication recorded – reason for taking warfarin e.g. AF ,MI etc (See appendix A)

Record Target INR Record duration of therapy Give patient hand held record and information

leaflet (explanation in main guide, ie yellow book / print out from RAT, other etc)

Check PT/APTT/ FBC/LFT/U&E before starting warfarin;

Identify any contraindications Undertake full risk assessment on likely benefits

and harm from anticoagulation

Care Bundle 2 Record who is responsible for the monitoring ie

primary/ secondary/ shared Record Latest INR Check if INR in target range. If too high or too

low, take appropriate action Check BP in those with hypertension or those

>75 at least annually Record adverse events related to

anticoagulation Undertake annual full risk reassessment If anticoagulation no longer indicated, remove

from prescribing list

Care Bundle 3 Check that latest INR and next test

due date known Ensure the daily dose is written

down and the information given in writing to the patient

Monitoring

Prescribing

To ensure the safe prescribing and monitoring of patients taking warfarin


Getting StartedThe practice needs to think about their current local systems and processes and use this guide as a starting point to think creatively about ideas to test.

The practice needs to think about their current local systems and processes and use this guide as a starting point to think creatively about ideas to test.

Engage the rest of the practice team and ensure effective communication systems are in place for safe prescribing and monitoring of patients taking warfarin

Assign roles and responsibilities around anti-coagulation therapy using warfarin Reflect and review, as a team, on what you are doing (integral to PDSA method). Involve the practice nurse (eg. assessing patients for risk factors, using

information management systems to identify and recall patients, setting up health displays to encourage patient education so that patients ask about managing their condition, provide patient hand held records to all patients receiving warfarin )

Involve administration staff (eg. using information management systems to identify and recall patients)

Setting Up your team:

Identify a clinical lead (Lead GP)

Identify a managerial lead (GP, Practice Manager, Practice Nurse)

Clarify who is responsible for day to day leadership (Practice Manager)

See Appendix A for further information

Do you and your team understand how to apply the Model for Improvement?

The Model for Improvement is a fundamental building block for change and you need to understand how to use it to test, implement and spread the interventions in this guide. For further details on the Model for Improvement (See page 14) and the ‘How to Improve’ Guide.

What should we be doing?PCQIS has used the evidence gathered to produce the driver diagram to summarise desired outcomes and how they can be achieved.

The driver diagram will help the practice translate a high level improvement goal into a logical set of underpinning, evidence-based goals (‘drivers’). It captures an entire change programme in a single diagram and also provides a measurement framework for monitoring progress.

Care Bundles


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The driver diagram details a series of 3 care bundles. Care Bundles are elements of evidence based research which can be delivered to a selected group of patients. It provides a systematic approach to care delivery to ensure a uniformity of implementation. When performed collectively, reliably and continuously, the bundles have been proven to improve patient outcomes (See page 9).

How are you going to measure process reliability?In order to improve outcomes for your patients you need to demonstrate you are using these interventions reliably. This means that all the interventions within each bundle MUST be complied with to achieve successful completion of that bundle. You need to do this by using the process measures in this guide.

See the ‘How to Improve’ Tools for Improvement guide and Appendix D for a summary of all process measures.

Drivers and Interventions - Supporting Evidence

This section details the evidence that underpins the driver diagram to ensure the safe prescribing and monitoring of patients taking warfarin.

As a practice (or at least one GP and one other staff member), choose an area where you feel you need improvement in order that your practice is in line with the evidence. Choose an area where there is likely to be a significant gap between what you currently do and what the evidence based guidelines suggest you do or where your level of delivery is below what you would wish.

Where the recommendations diverge from usual practice explore these recommendations in more detail.

Remember The care bundles within the driver diagram is a series of interventions related to the safe prescribing and monitoring of patients taking warfarin and when implemented together, will achieve significantly better outcomes than when implemented individually.

Care bundle one rationale – Register and initiation of warfarin The enhanced service specification1 funds the development of a register and suggests it should include indicating patient name, date of birth, the indication for, and length of, treatment, including the target INR. SIGN guidelines4 also identifies this information. The process measure requires that three key pieces of information are required as a proxy that the register contains appropriate information (clinical indication target INR and duration of treatment). The clinical indication is required to establish the target INR. A patient should have the three elements recorded to count to this process measure.

The enhanced service1 identifies that once initiated the patient should be educated regarding the treatment and this would include the issue of a patient held booklet. As a proxy measure of this activity the recording of the issue of the patient held booklet is to be used. The NPSA and British Society for Heamatology



booklet is a good example of such a record. Click below for an image of this document.www. npsa .nhs. uk /EasysiteWeb/getresource.axd?AssetID=2222&type

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=61761&..

SIGN guidelines4 identifies that a patient should have a full risk assessment prior to initiation, including medication review to eliminate any contra indications if possible. Patients should have a base line blood sample taken to establish range biochemistry. The evidence based process measures for risk and biochemistry indicate a range of activities. Practices will record a patient has had a risk assessment and if the practice has an issue with adverse events they may wish to examine the elements of the risk assessment.

Care bundle two rationale – monitoring of warfarin SIGN4 indicates that monitoring can be undertaken in a number of settings. It will be important to establish who has the responsibility for monitoring. The responsibility for monitoring should be recorded.

The latest INR should be maintained in the patient record to establish the appropriate dosage of warfarin and to ensure that the patient is maintained within the target range. SIGN4 suggests that from audits only 30% of INRs are within range at any one point in time. SIGN4 indicates if the INR is greater than five that warfarin should be stopped and recommenced once the INR has fallen below five. If a patient’s INR reaches eight again warfain should be stopped until it returns to below five5 and dose vitamin K should be considered4. INRs at these level are dangerous2 hence the process measures. These should be recorded as a snap shot at the time of the audit.

The enhanced service 1 indicates that adverse events should be recorded. The main risk from warfarin therapy is uncontrolled bleeds so those with hypertension are at particular at risk hence the need to record blood pressure, in particular those with uncontrolled hypertension6. Blood pressure should also be recorded in those over 754. Patients should have an annual review1,4. Practices will wish to review the quality of this if outcomes show a number of adverse events.

Care bundle three rationale – prescribing of warfarin Warfarin needs to be prescribed with care as anticoagulants are one of the classes of medicine most frequently identified as causing preventable harm when prescribing the latest INR should be available2. This is shown in care bundle one, however the daily maintenance dose is usually between 3 and 9 mg5.

The average daily dose should be 5mg however there is great variation between patients and within the same patient so it is important to record the daily dose required to achieve the desired INR range4. SIGN4 also cites that the date of the next visit should also be documented.

How do we introduce changes to processes?


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Making improvements to products, systems or services requires change. Although change can seem threatening or overwhelming for busy people, it can be successfully managed if well planned.

The Model for ImprovementThe Model for Improvement provides a framework for developing, testing and implementing changes. It helps to break down the change effort into small, manageable chunks which are then tested to ensure that things are improving and that no effort is wasted. It is always worth remembering that while every improvement is certainly a change; every change is not an improvement.



The Model for Improvement consists of two equal parts; the first part, the ‘thinking part’, consists of three fundamental questions to guide improvement work:

• What are we trying to accomplish?• How will we know that a change is an improvement?• What changes can we make that will result in an improvement?

The second part, the ‘doing part’, is made up of rapid, small ‘plan, do, study, act’ (PDSA) cycles to test and implement change in real work settings. The PDSA cycle provides a framework for testing ideas and assessing the results to determine if the change is an improvement and shares many attributes with the classic audit approach.

PDSA is a model for testing ideas that you think may create improvement in a situation. It can be used to test ideas for improvement quickly and easily based on existing knowledge, research, feedback, theory, review, audit, or by adapting practical ideas that have been proven to work elsewhere.

The answer (or answers) to the third fundamental question: ‘What changes can we make that will result in an improvement?’ will form the ‘change ideas’ (or objectives) to lead each PDSA cycle. It is important to remember that a project will usually be broken down into a number of PDSA cycles.



There are many things to consider and techniques to employ, which are captured in the ‘Appendix B– The Model for Improvement Driver Diagram.

See Appendix C for further guidance on PDSA cycles to assist you to make changes in your practice that can be used to support the implementation of the warfarin Driver Diagram.

Successful improvement initiatives don’t just happen – they need careful planning and execution

In any improvement initiative you need to succeed in three areas. You need to generate the Will to pursue the changes, despite difficulties and competing demands on time and resources. You need the good Ideas that will transform your service. Finally you need to execute those ideas effectively to get the change required.

WillThe interventions you need to build Will are explained in the ‘Leading the Way to Safety and Quality Improvement’ and ‘How to improve’ guides. They concentrate on raising the commitment levels for change and then providing the project structure to underpin improvement approaches. Spreading changes to achieve transformative change across the whole health system requires strong leadership.

We need to create an environment where there is an unstoppable will for improvement and a commitment to challenge and support teams to remove any obstacles to progress.

IdeasThe interventions in this guide describe ideas which evidence shows to be effective for achieving changes that result in improvements. It gives examples from organisations that have achieved them and also advice based on their experience. Methods and techniques for generating new ideas or innovative ways to implement the evidence can be found in the ‘How to Improve’ guide and other improvement literature

ExecutionHowever, to bring these ideas into routine practice in your organisation, it is essential that you test the interventions and ensure that you have achieved a reliable change in your processes before attempting to spread the change more widely.

How will we know that a change is an improvement?

In order to answer this, practices will need a defined process measure (such as compliance with all elements of a care bundle) which is evidently linked to an outcome measure (such as an increase in the numbers of referrals for echocardiograph). Both process and outcome data which are linked are essential to evaluate the effectiveness of change.

The data the practice collects in real time can be used to tell the improvement story and build the case and/or argument to change practice in order to improve outcomes.3



To improve outcomes for patients the practice needs to demonstrate that they are using the interventions in the driver diagram reliably. This means that all the elements of the interventions are performed correctly on 95% or more of the occasions when they are appropriate (A lower limit may be acceptable in small population sizes or where there are variable that are beyond control).

NoteThere should be a measure of compliance with each main indicator.

How do we measure for Improvement?



Start collecting the data and using it for local decision making using the Seven Steps to Measurement:

In this anti-coagulation therapy Guide, steps 1-3 have been established:

Step 1 - What are we trying to accomplish?An aim needs to be Specific, Measurable, Achievable, Realistic andTime-bound (SMART). Everyone involved in the change needs to understand what this is and be able to communicate it to others: To improve the safe prescribing and monitoring of patients taking warfarin.

Step 2 - How will we know that change is an improvement?It is essential to identify what data is needed to answer this question and how to interpret what the data is telling us.

Step 3 – Define measuresThey have been defined and are listed in appendix D (Page 28).


1 Decide aim

2 Choose measures

3 Define measures

6 Review measures

5 Analyse & present

7 Repeat steps

4-64 Collect data


Practices now need to implement steps 4-7-(CAR) collect, analyse, and review data.

The key is to go round the Collect-Analyse-Review cycle frequently: Collect your data Analyse - turn it into something useful like a run chart Review - meet to decide what your data is telling you and then take

action. Successful improvement projects all have clear aims, robust measurement and well-tested ideas. Use the ‘How to Improve’ guide to ensure your projects have all three.

Step 4 – Collect your data

The practice will need to know their baseline before they can track the progress of their goal against it.

Continuous data collection will be collected mainly via the Audit+ software within your practice. Data will be analysed and fed back to practices and local networks by Public Health Wales, Primary Care Quality.

The first collection of your data will provide a ‘baseline’ of current performance. Thereafter running and reviewing the data collection at an agreed frequency will give you a more regular idea of how well you are doing.

Practices may wish to allocate their own standards to the recommended process measures following a review of their baseline data from PCQIS

By starting measurement and plotting points the practice will be able to create their baseline. To create a baseline or identify a trend the practice can start using a run chart.

A run chart is a simple line graph which is used to track the performance of one (or more) steps in the process targeted for improvement across a defined period of time.

“Practices may be able to develop their own run charts from Audit + data at the practice which will be available more frequently than the PCQIS reporting”

Run charts are the visual expression of the process measure developed. Plotting the dots’ is very effective because it will help the practice spot trends and patterns displayed about 25 data points are ideal. However, 20 data points will provide a robust representation. One way to get more points is to measure more frequently. Often the data needed to measure is not being collected. If so, the practice should start collecting data straight away. But the practice does not have to wait to start making small changes. They will not affect the overall situation so you can be doing those while creating the practice baseline.

Run charts can: Help improvement teams formulate aims by depicting how well, or poorly, a

process is performing.



Help in determining when changes are truly improvements by displaying a pattern of data that the practice can observe as they make changes.

Give direction as work on improvement and information about the value of particular changes.

Further information on the construction, interpretation displaying time series data and analyses of run charts can be found at How to Improve’ Guide. http://www.1000livesplus.wales.nhs.uk/home

Why collect data? How can the practice compare, quantify or record changes if the practice

have not captured any data. Without measurable data the practice is at the mercy of anecdote. If the

practice make an assumption based on anecdote rather than data, it will nearly always be wrong because people remember the unusual, not the mundane.

How will the practice know that any changes they have made will result in an improvement?

Note: Continuous data collection will be collected mainly via the Audit+ software. Data will be analysed and fed back to practices and local networks.

Step 5 - Analyse Improvement takes place over time. Therefore, determining if improvement has really happened and if it is lasting requires observing patterns over time.

Step 6 – Review your data to decide what it is telling youIt is vital that the practice set time aside to look at what the measures are telling them. The frequency with which the practice collect, analyse and review their data sets the pace for change for improvement.

How will the practice know that a change is an improvement?1. By understanding the variation that lives within the data.2. By making good decisions on improvement choices (i.e. don’t overreact to a special cause and don’t think that random movement of your data up and down is a signal of improvement).

One of the key strategies in improvement is to control variation- Further reading on Variation, as a measure of quality can be accessed at

How to Improve’Guide http://www.1000livesplus.wales.nhs.uk/home

Step 7 – Repeat steps 4 to 6This is an iterative process. The purpose of measurement is to lead the practice to making the right decisions about their improvement project. Even if the practice are consistently meeting their goals they should still look to see if there are further improvements that could be made. If the practice aimed for 0% or 100% and are meeting it reliably the practice should still continue to measure so that any deviations are picked up and acted upon quickly.

In these cases the practice may decide to measure less frequently, however be aware that the process of measuring does have a positive effect in keeping awareness high and demonstrating that the goals measured is important to the practice.


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Remember:

Plot data over time - Tracking a few key measures over time is the single most powerful tool a team can use.

Seek usefulness, not perfection. Remember, measurement is not the goal; improvement is the goal. In order to move forward to the next step, a team needs just enough data to know whether changes are leading to improvement.

Use sampling. Sampling is a simple, efficient way to help a team understand how a system is performing.

Integrate measurement into the daily routine. Useful data are often easy to obtain without relying on information systems.

Use qualitative and quantitative data. In addition to collecting quantitative data, be sure to collect qualitative data, which often are easier to access and highly informative.

Understand the variation that lives within your data. Don’t overreact to a special cause and don’t think that random movement of your data up and down is a signal of improvement

How to successfully introduce change and Build the will to make improvements

After testing a change on a small scale, learning from each test, and refining the change through several PDSA cycles, the change is ready for implementation on a broader scale-for example, for an entire practice population or on an entire unit.

Achieving change will require consistently applying a range of improvement initiatives into the daily work of the practice.

Strong leadership within the practice is critical to building the will to change Setting clear improvement aims and monitoring progress against them is a

primary task for the practice Commitment to develop practice staff at all levels in the skills needed to lead

and deliver improvement initiatives.

Implementation is a permanent change to the way work is done and, as such, involves building the change into the practice. It may affect documentation, written policies, hiring, training, and aspects of the practice infrastructure that are not heavily engaged in the testing phase. Spreading Changes

Spread is the process of taking a successful implementation process from a pilot unit or pilot population and replicating that change or package of changes in other parts of practice organization.



During implementation, teams learn valuable lessons necessary for successful spread, including key infrastructure issues, optimal sequencing of tasks, and working with people to help them adopt and adapt a change. Locality based Learning sessions

Pockets of excellence exist in our Primary Care health care systems, but knowledge of these better ideas and practices often remains isolated and unknown to others.

A schedule of local learning events (Primary Care collaborative) will be delivered within each Health Board locality to share data/learning issues emanating from practices. This communication method will provide an opportunity for adopters to ask questions, explore solutions among colleagues, share learning, and deepen their understanding of the changes the practices are making.

1References

1. British Medical Association. 2003. GMS contract. National enhanced service Anti-coagulation monitoring: supplementary doc. London BMA

2. National Patient Safety Agency 2007. Patient Safety Alert 18 - Actions that can make anticoagulant therapy safer. Webpage (Cited 15th Dec 2007)



London NPSA. Available from http://www.saferhealthcare.org.uk/NR/rdonlyres/803E1141-B655-4B0A-B378-BB2F48001DD2/2435/Anticoag_alert_FINAL.pdf

3. British Committee for Standards in Haematology. 2005 Guidelines on oral anticoagulation (warfarin): third edition. London BCSH

4. Scottish Intercollegiate Guidelines Network 1999. Guideline 36; Antithrombotic Therapy. Edinburgh SIGN

5. Royal Pharmaceutical Society of Great Britain; British National Formulary 2005. London RPS

6. David A Fitzmaurice, Andrew D Blann, Gregory Y H Lip. 2002; Bleeding risks of anthithrombotic therapy. BMJ ; 325: pp 828-831

7. Andrew D Blann, David Fitzmaurice, Gregory Y H Lip 2003. Anticoagulation in Hospitals and general practice. BMJ: 326:153-156

8. Royal College of General Practitioners 2004. In Safer Hands. Special focus – Warfarin; London RCGP

9. British Journal of Haematology. 1998 Vol 101 No 2. pp374 - 387; Guidelines on oral anti-coagulation. Blackwell Publishing

10.Ryan et al 1989; Warfarin therapy: maximum recall periods during maintenance therapy. BMJ: 299, pp120 –1209

11.Portway Surgery Porthcawl 2006. Counselling Points for Warfarin Patients: Portway Surgery

12.British Hypertension society : Guidelines for management of hypertension: report of the fourth working party of the British Hypertension Society, 2004—BHS IV http://www.bhsoc.org/pdfs/BHS_IV_Guidelines.pdf

Appendix A - Setting up your team

Achieving improvements that reduce harm, waste and variation at a whole organisation level needs a team approach: one person working alone, or groups of individuals working in an uncoordinated way will not achieve it and this applies equally at all organisational levels.


http://www.bhsoc.org/pdfs/BHS_IV_Guidelines.pdf

http://www.saferhealthcare.org.uk/NR/rdonlyres/803E1141-B655-4B0A-B378-BB2F48001DD2/2435/Anticoag_alert_FINAL.pdf

http://www.saferhealthcare.org.uk/NR/rdonlyres/803E1141-B655-4B0A-B378-BB2F48001DD2/2435/Anticoag_alert_FINAL.pdf


Whether your improvement priorities relate to 1000 Lives Plus content areas, national intelligent targets or other local priorities, you need to consider three different dimensions in putting your team together:

Identify a clinical lead (Lead GP, Practice Nurse)

Identify a managerial lead (GP, Practice Manager, Practice Nurse)

Clarify who is responsible for day to day leadership (Practice Manager)

There may be one or more individuals on the team working in each dimension, and one individual may fill more than one role, but each component should be represented in order to achieve sustainable improvement.

Clinical lead (GP, Practice Nurse)A senior clinician should always be given delegated accountability for a specific content area and all practice staff working on the changes should know who this is. This individual needs sufficient influence and authority to allocate the time and resources necessary for the work to be undertaken at the practice. It is essential that this individual has full authority over the areas involved in achieving the improvement aims. It is essential that practice staff have an understanding of the improvement methodology and to base conversations around the interpretation of improvement data. Reporting of progress to higher organisational levels should also use a consistent data format so that the Executive level leader can report to the Board on progress.

Managerial lead (GP, Practice Manager or Practice Nurse)A clinical or technical expert is someone who has a full professional understanding of the processes in the content area. It is critical to have at least one such champion on the team who is intimately familiar with the roles, functions, and operations of the anti-coagulation therapy of warfarin content. This person should be interested in driving change in the practice. (Identify individuals who are not afraid to try changes).

Patients can provide expert advice to the improvement team within the practice, based on their experience of the system and the needs and wishes of patients. A patient with an interest in the improvement of the system can be a useful member of the team. Additional technical expertise may be provided by an expert on improvement methodology, who can help the team to determine what to measure, assist in the design of simple, effective measurement tools, and provide guidance on the design of tests.



Day to day leadership (GP, Practice Manager or Practice Nurse)

Frontline leaders will be the critical driving component of the practice team, assuring that changes are tested and overseeing data collection. It is important that this person understands not only the details of the system, but also the various effects of making changes in the system. They should have skills in improvement methods. This individual must also work effectively with the technical expert. They will be seen as a bridge between the organisation leadership and the day-to-day work and ensuring accurate and timely data collection for process and outcome measures related to the content area (Anti-coagulation therapy).

Characteristics of a good team memberIn selecting team members, you should always consider those who want to work on the project rather than trying to convince those that do not. Some useful questions to consider are the following:

Is the person respected for their judgment by a range of staff? Do they enjoy a reputation as a team player? What is the person’s area of skill or technical proficiency? Are they an excellent listener? Is this person a good verbal communicator within and in front of groups? Is this person a problem-solver? Is this person disappointed with the current system and processes and

passionately want to improve things? Is this person creative, innovative, and enthusiastic? Are they excited about change and new technology?



Appendix B – Model for Improvement Driver Diagram



Appendix C - PDSA Cycle - How to test change

PDSA cycles are a process to assist you to make changes in your practice that can be used to support the implementation of the anti-coagulation therapy Driver Diagram.

It is recommended to start small – one person, one setting, and one service provider.

Even if something has been shown to work in other settings, take the time to do a small-scale trial. There are almost no ‘plug and play’ solutions that work in all situations. Testing allows us to adapt actions to particular settings. To test a new procedure or technique, the practice need to ‘plan, do, study and act’ as explained below.

PlanPlan what you are going to do differently i.e., as a practice (or at least one GP and one other staff member), Choose an area where there is likely to be a significant gap between what you currently do and what evidence based guidelines suggest you do.

Where the recommendations are consistent with your practice spend little or no time reading these, but where they diverge from usual practice explore these recommendations in more detail.

DoCarry out the plan and collect information on what worked well and what issues need tackling.

The first data collection will provide a ‘baseline’ of current performance (the starting part). The practice should plot the results on a chart, this will provide an ideal number of points to create a baseline or identify a trend. One way to get more points is to measure more frequently. The practice may find the information needed is not currently being collected. If so, start collecting the relevant information straight away.

Displaying Observed Data in a time SequenceA run chart is a simple line graph which is used to track the performance of one (or more) steps in the process targeted for improvement across a defined period of time. Run charts are the visual expression of the process measure developed. Plotting the dots’ is very effective because it will help the practice spot trends and patterns displayed.

For more on Run charts go to: http://www.1000livesplus.wales.nhs.uk/methodology ‘How to Improve’ document mentioned in the last paragraph has a section on run charts.

StudyGather relevant team members as soon as possible after the test for a short informal meeting. Analyse the information gathered and review the aim of the new procedure or technique against what actually happened. Questions that need to be asked include:

‘What is the information telling us?’ What worked and what didn’t work?’


http://www.1000livesplus.wales.nhs.uk/methodology


‘What should be adopted, adapted, or abandoned?’

ActUse this new knowledge to plan the next test. Agree the changes and amend the outcome measures if necessary. Continue testing in this way, refining the new procedure or technique, until it is ready to be fully introduced. But, do it quickly (think in days, not weeks)


Appendix D-Process Measures To assess the application of the driver diagram interventions, the following search criteria (as per audit + software) will be collected and analysed by PCQIS and reported back to individual practices.

Criteria: InitiationAudit +

DescriptorTotal %

Care

Bun

dle

One

Number of Patients recorded as taking Warfarin

1Adenominator

All patients with a warfarin prescription within the last 6 months

Number of Patients within an clinical indication recorded

1E Of 1A, patients have a clinical indication recorded within 3mths of initiation eg MI, AF etc (see appendix E)

Number of Patients with Target INR recorded

1G Of 1A, patients have INR target recorded within 3mths months before or after initiation

Number of Patients with a planned duration of therapy recorded

1I Of 1A, patients have a planned duration of treatment recorded within three months before or after initiation

Number of patients with a patient held record issued

1K Of 1A, patients have a patient held record issues within 3mths before or after initiation (explanation in main guide, ie yellow book / print out from RAT, other etc)

Number of new patients (in last 6 and 12 months) received an initial warfarin assessment 1L

1L1

New patients requiring initial warfarin assessment (to discuss likely benefits / harm) before prescribed warfarin

Number of new patients taking NSAID have NSAID risk assessment recorded

1N denominator New Patients(last 12 months) taking NSAIDs have received a NSAID risk assessment before prescribed warfarin

Number of new patients within Alcohol consumption recorded

1O New patients (last 12 months) have alcohol consumption recorded within the last 12mths prior to warfarin initiation

Number of new patients (last 12 months) who have PT/APTT/ FBC/LFT/U&E recorded.

1M New patients (last 12 months) have had PT and APTT and FBC and LFT and U&E before prescribed warfarin


Criteria: MonitoringAudit+

DescriptorTotal %

Care

Bun

dle

Two

Number of Patients recorded as taking Warfarin

1Adenominator


Number of Patients recorded with locus of care recorded

2A Of 1A, Patients taking warfarin have the locus of care recorded ie responsible for monitoring primary care / secondary care / shared care

Number of Patients who have latest INR recorded in the last 3 months

2D Of 1A Patients taking warfarin have the latest INR recorded in the last 3mths

Number of Patients who have latest INR in target range

2E Of 2D, Patients taking warfarin and have a latest INR test in the last 3mths is recorded within range

Number of Patients who have latest INR > 5

2F Of 2D, Patients taking warfarin and have a latest INR test in the last 3mths is equal or greater than 5

Number of Patients who have latest INR > 8

2G Of 2D, Patients taking warfarin and have a latest INR test in the last 3mths is equal or greater than 8

Number of patients with an adverse event recorded associated to anticoagulation

2K Of 2A, Patients taking warfarin who have an adverse event associated with warfarin recorded in last 12mths

Patients taking warfarin for more than 12 months

2Ldenominator

Patients taking warfarin for more than 12months

Number of patients taking warfarin for have an annual assessment recorded

2M Of 2L Patients taking warfarin for more than 12mths have had an annual assessment recorded

Number of patients taking warfarin and diagnosed with hypertension:

BP recorded in the last 12mths

Latest BP > 180/100

2O

2P

2R

Of 2A, Patients taking warfarin and diagnosed with hypertensionOf 2O, Hypertensive patients taking warfarin BP recorded in the last 12mthsOf 2P, Hypertensive patients taking warfarin latest BP > 180/100

Number of patients taking warfarin aged 75 years or over:

BP recorded in the last 12 mths

2S Of 2A, Patients over 75 and are taking warfarin

Of 2S Patients over 75 and are taking warfarin and have had a BP recorded in the last 12 months



Criteria : Prescribing Audit+ Descriptor

Total %

Care

Bun

dle

Thre

e

Number of Patients recorded as taking Warfarin within the last 6 months

1Adenominator


Number of Patients with current daily dose recorded after most recent INR Test

3A Of 1A Patients with a current daily dose of warfarin recorded after the most recent INR

* Ensure the daily dose is written down and the information given in writing to the patient

Number of Patients taking warfarin with the date of next due INR test recorded

Of 1A Patients on warfarin with the date of their next due INR test recorded


Practice Reflection Sheet

“A mind that is stretched by a new experience can never go back to its old dimensions.” –Oliver Wendall Holmes

What did the practice learn from carrying out this quality improvement review?

What changes, if any have the practice agreed to implement as a result?

What collective strengths and weakness did the practice recognise that would enable the practice to enhance the service it provides to patients?

What collective strengths and weakness did the practice recognise that would enable the practice to develop the skills of others?


Annex A : Clinical Indication summaryClinical indication for anticoagulation Target INR

range READ Code

Atrial fibrillation 2.0 – 3.0 G5730

Coronary angioplasty / stent

(insertion of Coronary artery stent / Iliac artery stent)

2.5 – 3.5 79294 / 7A443

MI / Coronary artery / venous thrombo-embolism

(Only Mural Thrombosis is routinely anti-coagulated)

2.0 – 3.0 G30..%

Phlebitis and thrombophlebitis Pregnant women should not receive warfarin beyond the 7th week. Replace with low molecular heparin

2.0 – 3.0 G80..%

External resuscitation (Cardioversion) 2.0 – 3.0 OR 2.5 – 3.5

7L1H.%

Venous complications of pregnancy and the puerperium

Not indicated by BSH

L41..%

Ischaemic stroke / Transient ischaemic attack

Only consider warfarin in the presence of other predisposing factors or recurrent episodes

2.0 – 3.0 G65..%

Other heart valve disease 2.0 – 3.0 791..%

Mitral valve diseases 2.0 – 3.0 G11..%

Pulmonary embolism 2.0 – 3.0 G40..%

Valves of heart and adjacent structures operations see Appendix C, table2

791..%

Diseases of mitral and aortic valves 2.0 – 3.0 G13..%

Retinal vein thrombosis Not indicated by BSH

F4238

Other chronic rheumatic endocardial disease

(Most of these patients will also have AF which poses the greater risk of stroke)

Not indicated by BSH

G14..%

Prophylaxis DVT post op (general surgery) 2.0 – 2.5

Prophylaxis DVT post op (hip surgery, fractures) 2.0 – 3.0

No Indication but warfarin indicated n/a 8BG7.



NB - Mechanical replacement heart valves require lifelong anti-coagulation. Allograft and Xenograft valve replacements may only require short term anti-coagulation. Insertion of coronary and iliac artery stents would usually require use of aspirin and short term clopidogrel rather than warfarin

Adverse events –Read codesBelow is a suggested list of read codes that code be used by the practice to record Adverse Events and Contra-indications for patients taking warfarin:

Adverse Events CODE Contra-indication CODE

Stomach BleedsGastrointestinal Haemorrhage J68.. H/O Warfarin allergy 14LP.

Haematemesis J680. Warfarin side effects 66Q3.

Melaena J681. Warfarin contraindicated 8125.Gastrointestinal haemorrhage unspecified J68z. Anticoagulation

contraindicated 812R.

Gastric haemorrhage NOS J68z0 Warfarin declined 813E.

Chronic gastric ulcer with haemorrhage J1111 Anticoagulation declined 813d.

Acute gastric ulcer with haemorrhage J1101 Warfarin not indicated 8165.

Brain Haemorrhage Anticoagulation not indicated 816N.

Intra-cerebral haemorrhage G61.. Warfarin not tolerated 8171.

Cortical haemorrhage G610. Anticoagulation not tolerated 817A.

Internal capsule haemorrhage G611. Adverse reaction to anticoagulants TJ42.

Basal nucleus haemorrhage G612. Adverse reaction to heparin TJ420

Cerebellar haemorrhage G613. Adverse reaction to warfarin TJ421

Pontine haemorrhage G614. Adverse reaction to nicoumalone TJ422

Bulbar haemorrhage G615. Adverse reaction to phenindione TJ423

External capsule haemorrhage G616. Adverse reaction to anticoagulants NOS TJ42z

Intra-cerebral haemorrhage, intra-ventricular G617. Anticoagulant causing adverse

effects in therapeutic use U6042Intra-cerebral haemorrhage, multiple localized

G618. Personal history of warfarin allergy

ZV14AFalls O/E Bruising



Recurrent Falls 16D1. Spontaneous bruising 16B3.Bruising symptom 16B..

Specification for a national enhanced service – anticoagulation monitoring 1

(i) The development and maintenance of a register. Practices should be able to produce an up- to-date register of all anti-coagulation monitoring service patients, indicating patient name, date of birth, the indication for, and length of, treatment, including the target INR (ii) Call and recall. To ensure that systematic call and recall of patients on this register is taking place either in a hospital or general practice setting(iii) Professional links. To work together with other professionals when appropriate. Any health professionals involved in the care of patients being monitored are appropriately trained.(iv) Referral policies. When appropriate, to refer patients promptly to other necessary services and to the relevant support agencies using locally agreed guidelines where these exist.(v) Education and newly diagnosed patients. To ensure that all newly diagnosed patients (and / or their carers and support staff when appropriate) receive appropriate management of, and prevention of, secondary complications of their condition including the provision of a patient-held booklet.(vi) An individual management plan. To prepare with the patient an individual management plan, that gives the diagnosis, planned duration and therapeutic range to be obtained.(vii) Clinical procedures. To ensure that at initial diagnosis and at least annually an appropriate review of the patient’s health is performed including checks for potential complications and, as necessary, a review of the patient’s own monitoring records. To ensure that all clinical information related to the NES is recorded in the patient’s own GP held lifelong record, including the completion of the “significant event” record that the patient is on warfarin.(viii) Record-keeping. To maintain adequate records of the performance and result of the service provided, incorporating appropriate known information, as appropriate. This may include the number of bleeding episodes requiring hospital admission and deaths caused by anti-coagulants.(ix) Audit. To carry out clinical audit of the care of patients, matched against the above criteria, including any untoward incidents. This should also review the success of the practice in maintaining its patients within the designated INR range as part of quality assurance.(x) Training. Each practice must ensure that all staff involved in providing any aspect of careunder this scheme have the necessary training and skills to do so.(xi) Review. All practices involved in the scheme should perform an annual review which could include:

(a) Information on the number of patients being monitored, the indications of anticoagulation, i.e. deep vein thrombosis (DVT) etc, and the duration of treatment.

(b) brief details as to arrangements for each of the aspects highlighted above.

(c) details of any computer-assisted decision-making equipment used and arrangements for internal and external quality assurance.

(d) details of any near-patient testing equipment used and arrangements for internal and

external quality assurance.

(e) details of training and education relevant to the anti-coagulation monitoring service received by practitioners and staff.



(f) details of the standards used for the control of anti-coagulation.

Anti-coagulation monitoring guidance

Table.1 Therapeutic recommended uses and associated international normalised ratios (INR)

Indication INR LevelProphylaxis of postoperative deep vein thrombosis (general surgery) 2.0-2.5

Prophylaxis of postoperative deep vein thrombosis in hip surgery and fractures 2.0-3.0

Myocardial infarction: prevention of venous thrombo-embolism 2.0-3.0

Treatment of venous thrombosis (DVT) 2.0-3.0

Treatment of pulmonary embolism (PE) 2.0-3.0

Transient ischaemic attacks 2.0-3.0

Tissue heart valves 2.0-3.0

Atrial fibrillation 2.0-3.0

Valvular heart disease 2.0-3.0

Recurrent deep vein thrombosis and pulmonary embolism 3.0-4.5

Arterial disease including myocardial infarction 3.0-4.5

Mechanical prosthetic valves (see table 2)

Recurrent systemic embolism 3.0-4.5

Intravascular stent 2.5-3.5



Table.2 Recommended INR for prosthetic valves

Sinus rhythm normal left atrial size (i.e. most aortic valve replacement patients)

Atrial fibrillation enlarged left atrium (i.e. most mitral valvereplacement patients)

Low thrombo-genicity prosthesis

2.0 - 3.0 2.5 – 3.5

Other prostheses 3.5 - 4.5 3.5 – 4.5

British Journal of Haematology. 1998 Vol 101 No 2. pp374 - 387; Guidelines on oral anti-coagulation

Table.3 warfarin loading scheduleDay INR Warfarin dose (mg)

First <1.4 10Secon

d <1.8 101.8 1

>1.8 0.5Third <2.0 10

2.0-2.1 5

2.2-2.3 4.5

2.4-2.5 4

2.6-2.7 3.5

2.8-2.9 33.0-3.1 2.53.2-3.3 2

3.4 1.53.5 1

3.6-4.0 0.5>4.0 0

Predicted maintenance doseFourth <1.4 >8

1.4 8

1.5 7.5

1.6-1.7 7

1.8 6.5

1.9 6

2.0-2.1 5.5

2.2-2.3 5

2.4-2.6 4.5

2.7-3.0 43.1-3.5 3.53.6-4.0 3



4.1-4.5 Miss out next day’s dose then give 2mg

>4.5 Miss out 2 days dose then give 1mg

British Journal of Haematology. 1998 Vol 101 No 2. pp374 - 387; Guidelines on oral anti-coagulation

Table.4 warfarin therapy: maximum recall periods during maintenance therapy* (not initiation)

Indication Recall period

One INR high:recall in 7-14 days (stop treatment for 1-3 days)(maximum 1 week in prosthetic valve patients)

One INR low: recall in 7-14 days

One INR therapeutic: recall in 4 weeks

Two INR therapeutic: recall in 6 weeks (maximum for prosthetic valve patients)

Three INR therapeutic:

recall in 8 weeks, apart from prosthetic valve patients

Four INR therapeutic: recall in 10 weeks, apart from prosthetic valve patients

Five INR therapeutic: recall in 12 weeks, apart from prosthetic valve patients

NB; Patients seen after discharge from hospital with prosthetic valves may need more frequent INR in the first few weeks 10

Tablet1 strength table



Gwent risk assessment for patients on anti-coagulation therapy
