Anti-Coagulation Therapy Using Warfarin

Public Health Wales / 1000 lives + Anticoagulation H2G
Date: October 2013 / Version: 1 / Page: 1 of 40
Public Health Wales / 1000 lives + Anticoagulation H2G

Anti-coagulation therapy using Warfarin

How to 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 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.

Final

October 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:

Purpose of the Guide

This 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

How to Improve

The Quality Improvement Guide

Further information is also available to support you in your improvement work:

PCQIS site

Deanery site

The new GP Appraisal & CPD website can be found here;

Foreword

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 Myres

Primary Medical Care Lead

1000 lives plus

Chair

Royal College of GPs Wales

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 patientsafety by following a systematic, evidence-based approach have resulted in manyexamples of demonstrable safety improvement.

However, as we move forward with 1000 Lives Plus, we know that harm anderror continue to be a fact of life and that this applies to health systems acrossthe world. We know that much of this harm is avoidable and that we can makechanges that reduce the risk of harm occurring. Safety problems can’t be solvedby 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.

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

References22

Appendices

Setting up your team 23

The Model for Improvement25

How to test change26

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 care

The 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 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 Form

The 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 these

collaborative. 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 formwill allow any analysis to be qualified with constraints and caveats to promotea more effective discussion of quality improvement within collaborative learning sessions.

Improving the safety of prescribing warfarin Driver Diagram

Getting Started

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 aclinical 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 tosummarise 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

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 bundleMUST 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.