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A Brief Introduction to the Clinical Audit Cycle INTRODUCTION This guide provides a brief introduction to the principles of undertaking a clinical audit project at UHBristol. Each aspect of the clinical audit cycle is covered in more detail as part of the complete range of ‘How To’ guides as available on the clinical audit website:  What is Clinical Audit?  How To: Choose & Prioritise Topics.  How To: Set an Audit Aim, Objectives & Standards.  How To: Set an Audit Sample & Plan Your Data Collection.  How To: Analyse & Present Data.  How To: Share Your Findings – Clinical Audit Report & Presentation.  How To: Implement Change Successfully.  How To: Engage Patients, Service Users & Carers in Clinical Audit.  How To: Apply Ethics to Clinical Audit. WHAT IS CLINICAL AUDIT “Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria…Where indicated, changes are implemented…and further monitoring is used to confirm improvement in healthcare delivery” Principles for Best Practice in Clinical Audit (2002, NICE/CHI) The main stages of the clinical audit process are: 1) Selecting a topic. Choose 2) Agreeing standards of best practice (audit criteria). topic 3) Collecting data. Agree / 4) Analysing data against standards. review 5) Feeding back results. standards 6) Discussing possible changes. Implement Collect data 7) Implementing agreed changes. change if on current needed practice 8) Allowing time for changes to embed, before re-auditing. 9) Collecting a second set of data. Compare data with 10) Analysing the re-audit data. 11) Feeding back the re-audit results. standards 12) Discussing whether practice has improved. This process is called the Audit Cycle and is summarised in the diagram above. UNDERTAKING A CLINICAL AUDIT PROJECT AT UHBRISTOL Clinical audit at UHBristol is supported by Divisional Clinical Audit Facilitators, centrally located within Trust Headquarters. Before undertaking a clinical audit project, you should discuss your proposed project with the relevant Facilitator and complete the clinical audit project proposal paperwork (available on the clinical audit website - website and contact details are listed at the end of this guide).  2005 - 2017 UHBristol Clinical Audit Team – Version 4 Page 1 of 6 A Brief Introduction to Clinical Audit 1. CHOOSE A CLINICAL AUDIT TOPIC Your topic should be chosen systematically. Clinical audit projects take time and resources so the topic that you choose to address should be of potential benefit to the service as a whole. Clinical audit projects are best focussed on the processes - e.g. investigations, treatments, or procedures - which have been shown to result in the best patient outcomes if followed. Possible sources for your clinical audit project include the:  National Institute of Clinical Excellence (NICE), National Service Frameworks (NSFs), National Confidential Enquiries, Patient Safety Initiatives, or Royal Colleges / national professional bodies.  Publication of conclusive new evidence about clinically effective healthcare; local or regional treatment guidelines, protocols or frameworks; user views or complaints; adverse incident/near miss reporting (aka clinical/critical incident reporting); or identified local priorities or concerns, e.g. areas of high volume, risk or cost. If you would like to carry out a clinical audit project but are unsure about appropriate topics your divisional Clinical Audit Facilitator will be able to help you to identify key subjects in your clinical area. 2. FORM A PROJECT TEAM Clinical audit projects are generally described as being either unidisciplinary (i.e. involving only one staff group) or multidisciplinary (i.e. involving more than one discipline or profession). It is important that a clinical audit project assesses patient care as provided by the whole clinical team, in order to identify how care can be improved. Therefore if your project has implications for a profession or discipline other than your own, whether within or outside the clinical area you work in, it is important to ensure that they are represented on the project team. If your clinical audit project is looking at the patient journey across different care sectors, i.e. ‘interface’ audit, try to include staff representatives from these other care sectors in your project team. An example of an interface audit would be looking at the process of referral into the hospital from primary care. Consider including a patient, service user and/ or carer representative(s) on your project team or gaining their views on what they would like to see from the service. Engagement is important as healthcare is a partnership between clinicians and their patients/ service users. Whilst we strive to provide the best quality of care as we see it, patients/ service users might want something different. Direct engagement is best e.g. through participation of identified individuals on project steering groups or divisional/specialty audit committees. However, indirect engagement is another possibility, e.g. through the completion of a survey, usually administered at the end of an episode of care. It is important that your project is supported by colleagues who have the authority and commitment to see that any necessary changes indicated by the audit results are put into practice. 3. SET THE AIM, OBJECTIVES AND STANDARDS To define the aim of your clinical audit project consider Audit Topic what it is that you hope to achieve, i.e. the overall purpose of the project. The aim can be written as either a Aim statement that about what you want to happen as a result of the audit or as a question that you want your audit to Objective Objective answer. Statements should be phrased positively, to ensure that the audit brings about improvements in Standard Standard Standard practice. 2005 – 2017 UHBristol Clinical Audit & Effectiveness Team – Version 4 Page 2 of 6 A Brief Introduction to Clinical Audit Your aim is then broken down into a series of smaller objectives. Objectives are the steps that you need to take in order to assess whether or not you have achieved your aim. Your objectives can be written as either specific tasks to be undertaken or as the different aspects of quality that your project will address, e.g. appropriateness = right treatment for right patient; timeliness = treatment given at right time; or effectiveness = treatment given in right way or with desired effect S pecific Standards should be SMART and are more specific than objectives. They are quantifiable statements detailing the specific aspects of patient care and easurable management that you intend to measure current practice against. Standards greed should always be based on the strongest, most up-to-date evidence of what elevant constitutes best practice. If standards are available in the form of guidelines, you should base your audit on the most widely applicable guidelines available, e.g. heoretically sound national rather than regional or local guidelines. If guidelines/ protocols do not exist or existing ones are out of date, you will need to undertake a literature search to identify best practice. Assistance with this can be provided by the Library and Information Service, whose contact details are listed at the end of this guide. It is important that there is agreement with your standards locally before you start. You will find it hard to improve practice if there is disagreement as to what constitutes best practice. 4. ETHICS & ENGAGEMENT Unlike research, clinical audit projects do not need to be submitted to a Research Ethics Committee (REC) for ethical approval. This is one of the key reasons why you must ensure that your project is clinical audit rather than research. If you think that there are ethical issues with your project you must discuss these with your divisional Clinical Audit Facilitator. Clinical audit should always be conducted within an ethical framework. This means abiding by the principles of the Data Protection Act; e.g. by ensuring patient and staff confidentiality and by ensuring that data is collected and stored appropriately. If you are including a patient survey as part of your project it must be submitted to the Questionnaire, Interview and Survey (QIS) Group for approval. Contact details for the QIS group are listed at the end of this guide. 5. SELECT AN AUDIT SAMPLE The sample population will be dependent upon your topic. Occasionally an aspect of treatment or care that applies to all patients is audited. However, the majority of clinical audit tends to assess the care of a defined group of patients who share certain characteristics. Typically, the fact that they have the same medical condition, have received the same form of treatment or were seen within a certain time frame. It is not always practical to audit all patients within your population, therefore you will need to select an appropriate sample size. The sample should be large enough so that senior clinicians/managers are willing to implement changes based on your findings. A ‘snapshot’ is often sufficient (roughly 20-50 cases) for process- based audit. It is important that your sample contains current/recent patients. Clinical audit is about improvement. You cannot change the past but you can change the future. 6. PLAN AND CARRY OUT DATA COLLECTION Data should only be collected if it is necessary to enable you to measure current practice against your audit criteria (standards). Any extra data means more time spent on your project without any additional benefit and is contrary to the principles of the Data Protection Act. 2005 – 2017 UHBristol Clinical Audit & Effectiveness Team – Version 4 Page 3 of 6 A Brief Introduction to Clinical Audit If data is routinely recorded either in the patient’s notes or electronically it is possible to carry out a retrospective audit, i.e. assessing past episodes of patient care. If the data is not routinely recorded prospective data collection is required, i.e. assessing the patient care at the time it is given. Data can be collected using an audit form (proforma) or entered directly onto a computer. Before you collect the data for your entire sample it is important to pilot your data collection ‘tool’ (form/ spreadsheet/database). The purpose of the pilot is to try out your tool on a small sample to make sure that it works, especially if someone else is going to be collecting the data for you. The pilot may reveal that some of your instructions on how to complete the tool or the questions asked are ambiguous, that the tool is difficult to complete or that you are simply not getting the information you wanted. 7. ANALYSE THE DATA Number of patients who meet standard Your data analysis should establish which standards are being met and which are not. If a standard is not being met 100 you need to identify why and how practice can be improved x to ensure that the standard is met in the future. You may Number of Number of patients to patients who also consider if there were other, acceptable reasons for the – standard not being met, i.e. an exception not considered whom standard meet any listed during the planning stage. applies exceptions 8. PRESENT THE FINDINGS The findings of your project should be discussed by the project team and presented to colleagues . If full compliance with the standards was not achieved an action plan should be developed to address any issues . Once completed projects should be presented both verbally and written up as a report. Both should address how well the standards are being met and highlight any problems that need to be addressed. The presentation gets the message of your audit across to key staff and should generate discussion and agreement about changes to practice in light of the audit results. Your final report (template available on the clinical audit website, address provided at the end of this guide) acts as the official record of what you have done and contains more detail than the presentation. It should include an Action Plan if improvements are required and all the information needed to plan a re-audit. 9. IMPLEMENT CHANGES AND RE-AUDIT If an audit shows that current practice needs to be improved, making changes is important. The public has the right to expect that practitioners will provide care that is consistent with recognised good practice. Not all changes will be improvements. Do not make changes for change’s sake. At an appropriate time, repeat the audit (re-audit) to ensure that changes have been implemented and that practice has improved. 2005 – 2017 UHBristol Clinical Audit & Effectiveness Team – Version 4 Page 4 of 6 A Brief Introduction to Clinical Audit A FLOW CHART SUMMARISING THE CLINICAL AUDIT PROCESS AT UHBRISTOL Discuss and agree project with divisional Clinical Audit Facilitator Audit topic Form a project team Set the aim, objectives and standards Consider ethics and engagement Select an audit sample Plan your data collection and data collection form Agree project with all areas and staff affected and gain senior clinician support Complete the UHBristol clinical audit proposal paperwork Submit proposal to relevant Clinical Audit Convenor/Facilitator for approval Carry out data collection Analyse the data Share your findings: 1. Presentation 2. Report and action plan Implement changes and re-audit 2005 – 2017 UHBristol Clinical Audit & Effectiveness Team – Version 4 Page 5 of 6 A Brief Introduction to Clinical Audit CONTACT DETAILS / USEFUL INFORMATION CLINICAL AUDIT  The UHBristol Clinical Audit website is available via http://www.uhbristol.nhs.uk/for- clinicians/clinicalaudit/  Contact details for UHBristol Clinical Audit Facilitators are available via http://www.uhbristol.nhs.uk/for-clinicians/clinicalaudit/contacts/  The full range of UHBristol Clinic Audit ‘How To’ guides are available via http://www.uhbristol.nhs.uk/for-clinicians/clinicalaudit/how-to-guides/  Copies of UHBristol Clinical Audit Proposal Form, Presentation Template, Report Template, Summary Form, and Action Form are available via http://www.uhbristol.nhs.uk/for- clinicians/clinicalaudit/carrying-out-projects-at-uh-bristol/  The UHBristol Clinical Audit & Effectiveness Central Office can be contacted on 0117 342 3614 or e- mail: stuart.metcalfe@uhbristol.nhs.uk  Clinical Audit Training Workshops can be booked through the Clinical Audit & Effectiveness Central Office as above. CLINICAL EFFECTIVENESS  For advice on Clinical Effectiveness (NICE, NCEPOD, PROMS, guidelines) matters contact Stuart Metcalfe, Clinical Audit & Effectiveness Manager, 0117 342 3614 or e-mail: stuart.metcalfe@uhbristol.nhs.uk PATIENT EXPERIENCE  For advice on carrying out surveys, interviews and questionnaires please contact Paul Lewis, Patient Experience Lead (Surveys & Evaluations), 0117 342 3638 or e-mail: paul.lewis@UHBristol.nhs.uk  For advice on conducting qualitative and Patient Public Involvement Activities (focus groups, community engagement, co-design, workshops) please contact Tony Watkin, Patient Experience Lead (Engagement & Involvement), 0117 342 3729 or e-mail: tony.watkin@UHBristol.nhs.uk  All surveys that are being carried out for service evaluation or audit purposes should be discussed with Paul Lewis in the first instance. Patient experience surveys will also usually need to be approved by the Trust's Questionnaire, Interview and Survey (QIS) Group. Proposals should be submitted to Paul Lewis using the QIS proposal form. The proposal form and covering letter template is available via http://www.uhbristol.nhs.uk/for-clinicians/patient-surveys,-interviews-and-focus-groups/ RESEARCH For advice on research projects contact the Research & Innovation Department on 0117 342 0233 or e-mail: research@UHBristol.nhs.uk Further information can be found via http://www.uhbristol.nhs.uk/research-innovation/contact-us/ LITERATURE REVIEWS/EVIDENCE For advice on literature reviews, NHS Evidence, article/book requests and critical appraisal contact the Library and Information Service on 0117 342 0105 or e-mail: Library@UHBristol.nhs.uk SAMPLE SIZES  The Sample Size Calculator is available via: http://www.uhbristol.nhs.uk/for- clinicians/clinicalaudit/how-to-guides/ QUALITY IMPROVEMENT Further information about clinical audit and wider quality improvement is available via the Healthcare Quality Improvement Partnership (HQIP) - http://www.hqip.org.uk/ 2005 – 2017 UHBristol Clinical Audit & Effectiveness Team – Version 4 Page 6 of 6