Date: October 2013 / Version: 1 / Page: 1 of 14
Public Health Wales / 1000 lives + Anticoagulation H2G
Anti-coagulation therapy using Warfarin
Rapid Improvement Guide
This 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 patients on anti-coagulation 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.
Final
October 2013
The purpose of this guide
This Rapid guide has been developed byPrimary Care Quality, Public Health Wales and the 1000Lives Improvement Unit team to support general practices in improving their current processes for providing warfarin therapy in order to ensure safe prescribing and monitoring.
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.
How do practices get involved?
This Quality Improvement development is a voluntary subscription to undertake the interventions described in this improvement guide.
In order to filter data from the Audit + software in practice, 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.
Therefore PCQT have set up an online registration process for practices who wish to engage in any of the primary care 1000 Lives + topics, please click on the following webpage to register your interest:
This document is not intended to be a complete reference manual. This guide should be used alongside the 1000 Lives + ‘How to Guides’ to support the successful implementation of the programme’s interventions:
1. What are we trying to accomplish?
To improve the safety of prescribing warfarin
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
1. Complexity of dosing and monitoring
2. Patient compliance
3. Biological variation in response to treatment
4. Numerous drug interactions
5. Dietary interactions affecting drug levels such as alcohol consumption
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;
1. Indication for anticoagulation,
2. Screening investigations,
3. Risk factors for anticoagulation,
4. Management plans,
5. Anticoagulant drug and dose,
6. Alternative appropriate therapy,
7. Anticoagulant control,
8. Follow-up,
9. Patient held records.
What should we be doing?
PCQ has used the evidence gathered to produce a, Improving the safety of prescribing warfarin Driver Diagram (See page5) tosummarise desired outcomes and how they can be achieved.
The following driver diagram will help the practice translate a high level improvement goals into a logical set of underpinning goals (‘drivers’). It captures an entire change programme in a single diagram and also provides a measurement framework for monitoring progress
2. How will we know that a change is an improvement?
In order to answer this you will need a defined process (such as compliance with all elements of a care bundle) which is evidently linked to an outcome. 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.
Practices may wish to allocate their own standards to the recommended process measures following a review of their baseline data from PCQT.
Improving the safety of prescribing warfarin Driver Diagram
3. What change can we make that will result in improvement?
PDSA (Plan, Do, Study, Act) cycles are a process to assist with making changes in your practice to support the implementation of theDriver Diagram. Essential questions that form the basis for the Model for Improvement are;
- What are we trying to accomplish?
- How will we know when we have accomplished what we set out to do?
- What will we test/try in order to produce the improvement we aim to achieve?
Even if something has been shown to work in other settings, take the time to do a small-scale test of change (or pilot). 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. (How to Improve Guidefor more information).
Use the following PDSA (Plan, Do, Study, Act) cycle to test, implement and replicate each intervention within the driver diagram.
Plan - what you are going to do differently?
In other words as a practice (or at least one GP with one other staff member), choose an area where you know or think there may be a significant gap between what you currently do and what evidence based guidelines suggest you do or where you feel that optimum care is not being provided to all those who may benefit.
Where the guidelines and your practice are consistent, spend little or no time on them.
However, where they are different from your usual practice, explore these guidelines/recommendations in more detail. Work out (i.e. plan) how and what you could test/try that would make the differences smaller.
Do - Carry out the plan and collect information on what worked well and what hasn’t worked so well.
Continuous data collection will be collected mainly via the Audit+ software. Data will be analysed and fed back to practices and local networks by the Public Health Wales Primary Care Quality Team (PCQT).See data measures on Page 10-15.
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 be able to develop their own run charts from Audit + data at the practice, which will be available more frequently than the PCQT reporting.
Further information on the construction, interpretation displaying time series data and analyses of run charts can be found at How to Improve’ Guide.
Remember:
- Plot data over time - Tracking a few key measures over time is the single most powerful tool a team can use. 4
- 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. 4
- Use sampling. Sampling is a simple, efficient way to help a team understand how a system is performing. 4
- Integrate measurement into the daily routine. Useful data are often easy to obtain without relying on information systems. 4
- 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. 4
- 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 4
For example
The practice may find the information/data needed is not currently being collected in an easily retrievable format (or coding). If so, you may wish to use standard coding or use of a template as your first test of change.
Study - Gather relevant team members as soon as possible after the test (Do) for a short informal meeting. Analyse the information gathered and review the expected outcome the new process or technique against what actually happened. Questions that will help you include the following4:
‘What is the information telling us?’
‘What worked and what didn’t work?’
‘What should be adopted, adapted, or abandoned?’
Act - Use this new knowledge (information, data and study) to plan the next test. Agree the changes. If you feel the outcome measures are no longer appropriate, please contact Primary Care Quality.
Continue testing in this way, refining the new procedure or technique. Once all the interventions are being applied to 90% of eligible patients, share your ideas and actions with other practices.
References
- British Medical Association. 2003. GMS contract. National enhanced service Anti-coagulation monitoring: supplementary doc. London BMA
- 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
- British Committee for Standards in Haematology. 2005 Guidelines on oral anticoagulation (warfarin): third edition. London BCSH
- Scottish Intercollegiate Guidelines Network 1999. Guideline 36;Antithrombotic Therapy. Edinburgh SIGN
- Royal Pharmaceutical Society of Great Britain; British National Formulary 2005. London RPS
- David A Fitzmaurice, Andrew D Blann, Gregory Y H Lip. 2002; Bleeding risks of anthithrombotic therapy. BMJ ; 325: pp 828-831
- Andrew D Blann, David Fitzmaurice, Gregory Y H Lip 2003. Anticoagulation in Hospitals and general practice. BMJ: 326:153-156
- Royal College of General Practitioners 2004. In Safer Hands. Special focus – Warfarin; London RCGP
- British Journal of Haematology. 1998 Vol 101 No 2. pp374 - 387; Guidelines on oral anti-coagulation. Blackwell Publishing
- Ryan et al 1989; Warfarin therapy: maximum recall periods during maintenance therapy. BMJ: 299, pp120 –1209
- Portway Surgery Porthcawl 2006. Counselling Points for Warfarin Patients: Portway Surgery
- British Hypertension society : Guidelines for management of hypertension: report of the fourth working party of the British Hypertension Society, 2004—BHS IV
Date: October 2013 / Version: 1 / Page: 1 of 14
Public Health Wales / 1000 lives + Anticoagulation H2G
Process Measures Care Bundle One
To assess the application of the driver diagram interventions, the following search criteria (as per audit + software) will be collectedand analysed by PCQT and reported back to individual practices.
Criteria: Initiation / Audit + / DescriptorTotal / %
Care Bundle One / Number of Patients recorded as taking Warfarin / 1A / denominator / All patients with a warfarin prescription within the last 6 months
Number of Patients within an clinical indication recorded / 1E / Of 1A, patientshave 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 monthsbefore 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
Process Measures Care Bundle Two
Criteria: Monitoring / Audit+ / DescriptorTotal / %
Care Bundle Two / Number of Patients recorded as taking Warfarin / 1A / denominator / All patients with a warfarin prescription within the last 6 months
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 / 2L / denominator / Patients taking warfarin for more than 12months
Number of patients taking warfarin who 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
2P
2R / Of 2A, Patients taking warfarin and diagnosed with hypertension
Of 2O, Hypertensive patients taking warfarin BP recorded in the last 12mths
Of 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
Of 2S Patients over 75 and are taking warfarin and have had a BP recorded in the last 12 months
Process Measures Care Bundle Three
Criteria : Prescribing / Audit+ / DescriptorTotal / %
Care Bundle Three / Number of Patients recorded as taking Warfarin / 1A / denominator / All patients with a warfarin prescription within the last 6 months
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
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Public Health Wales / 1000 lives + Anticoagulation H2G
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 thatwould enable the practice to enhance the service it provides to patients?
What collective strengths and weakness did the practice recognise thatwould enable the practice to develop the skills of others?
Annex A : Clinical Indication summary
Clinical indication for anticoagulation / Target INR range / READCodeAtrial 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
(Allograft / Xenograft valve replacements) / 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
Date: October 2013 / Version: 1 / Page: 1 of 14