CHAPTER 7 Undertaking a clinical audit
7.2 Introduction
Evidence-based healthcare has made huge inroads over recent years. There have been a number of bodies formed to produce and disseminate best evidence, and as a result a massive discourse has grown around the topic. Resources for quick access to information on best practice are plentiful and readily available to both practitioners and consumers. Yet, despite this mass of activity and expenditure in producing evidence, it has become clear that putting it into practice has been less successful. Indeed, uptake of evidence remains one of the key challenges facing nurses internationally (Borbasi et al 2008). The literature is full of interventions and ideas to help enhance the uptake of evidence into clinical practice. However, Thompson and Learmonth (2002:236) suggest that interventions such as didactic study days, and passively disseminated clinical guidelines and protocols, have ‘little or no effect on practice’.
One tool that has been effective in advancing evidence-based practice (EBP) is the clinical audit. The clinical audit has been situated primarily in the final (fifth) phase of the evidence-based cycle and concerns evaluation. (The clinical audit follows after the first four phases of the evidence-based cycle, which are: formulating a clinical question; locating the evidence; critically appraising the evidence; and applying the evidence to bring about change.) Evaluation determines the effect of an intervention on clinical practice and patients. Thus, clinical audit is a tool to evaluate care and, with evaluation, the EBP cycle begins again (Mason 2002). Indeed, as noted by Mason (2002:295), any audit should be completed by follow-up audits.
7.3 What is a clinical audit?
Clinical audit is a tool used by healthcare professionals to examine their practice and compare the outcomes either with quality standards, clinical guidelines or best practice evidence. In effect, clinical audit is a quality improvement process that aims to identify how to improve clinical practice, or to demonstrate that best practice standards are being met through current methods of care provision (Kinn 1995).
… quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual, team or service level and further monitoring is used to confirm improvement in healthcare delivery (NICE 2002).
Clinical audit then is a quality improvement and a change process based on the evaluation of current practice. Morrell and Harvey (1999:10) describe four main stages of clinical audit. The process begins by clearly defining best practice (stage 1); once this is established there is a move to implement best practice (stage 2), so bringing about change. This is followed by monitoring (stage 3) and comparing actual practice and outcomes against best practice standards (stage 4). Findings from this stage should lead to action to improve practice.
The National Institute for Health and Clinical Excellence (NICE; 2002:101–4) presents principles for best practice in clinical audit that incorporate an additional fifth stage. In addition to the steps described by Morrell and Harvey (1999), NICE (2002) include a stage for sustaining the improvements resulting from the practice change component of audit. The emphasis on sustainable change is valid and important given the varying effectiveness of ensuring worthwhile, long-term practice change in the care of patients (Walshe & Spurgeon 1997). The steps described by NICE involve preparing for audit, selecting criteria, measuring the level of performance, making improvements and sustaining improvement. These steps provide a framework rather than actual instructions for how to conduct an audit; hence, a detailed example is provided later in this chapter.
Shakib (2003) describes audit as a tool for determining the current state of a situation and, once results are determined, for bringing about change to best practice. Morrell and Harvey (1999) on the other hand refer to audit as a tool used to monitor and evaluate best practice after best practice has been implemented. Their model involves the development and implementation of best practice standards into care that is then followed up by audit. Either way, it can be seen that audit is really all about improving patient care. It is never static; both of the models described above include a need for continual re-audit. Audit is also a useful tool to establish a baseline for later comparison when considering change in practice. Baseline audits assist in identifying and prioritising areas of guideline-related practice that require change (Perry 2007).
After change has been implemented, repeat audits serve to evaluate whether there have been any gains from it. Perry (2007) points out that audit may be a way of convincing staff of the need for change, as it offers promise of evaluation, which is something clinicians often complain is not forthcoming. However, Thompson and Learmonth (2002:230) warn that on its own, clinical audit is probably not a sufficient mechanism for bringing about sustained change and that a number of multifaceted strategies for change should be put in place. These may include electronic or paper-based reminders and educational programs (Thompson & Learmonth 2002:236).
Though many clinical audits are conducted locally, Mason (2002) advocates national audits over and above local audit projects, which he claims, for a variety of reasons, tend not to produce better health outcomes. He states, ‘the future of clinical audit, as a major agent of change, lies with nationally organised projects associated with national priorities’ (Mason 2002:296). UK national audits have included the Myocardial Infarction National Audit Project and the National Sentinel Audit for Stroke, both of which have used the latest in information technology, rapid feedback to stakeholders and re-audit. Other national clinical audits undertaken in the UK include the management of elderly people who have had falls, the management of violence in mental-health settings, the management of patients with venous leg ulcers and audit of the use of caesarean section (NICE 2002:94).
7.4 How does a clinical audit relate to the quality improvement movement?
In an effort to improve the quality of clinical practice over the past few years, a number of initiatives have emerged, the names of which have changed as ‘new groups of management gurus’ have refashioned and reshaped former ideas (Mason 2002:294). Thus, terminology surrounding the notion of providing best care is dynamic. For example, until recently, clinical effectiveness has been popular, but now the wider concept of clinical governance has come into vogue. In the UK, Morrell and Harvey (1999:10) see clinical audit as part of clinical effectiveness and quality improvement, whereas Mason (2002) states that clinical audit has become an integral component of the clinical governance processes within the National Health Service (NHS). Both are correct. Clinical governance is the framework through which clinical effectiveness takes place, and is intended as an accountability model focused on creating environments that seek to safeguard high standards of care and continuously improve them (Gaston 2003).
Clinical effectiveness has been defined as:
… applying the best available knowledge, derived from research, clinical expertise and patient preferences, to achieve optimum processes and outcomes of care for patients (Royal College of Nursing 1996, cited in Morrell & Harvey 1999:11).
Clinical audit is regarded as an integral part of any clinical effectiveness program (Morrell & Harvey 1999:156), whereas clinical governance is seen as:
… a system through which… organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish (Scally & Donaldson 1998:61).
It divides quality into four aspects:
NICE in the UK believe ‘clinical audit is at the heart of clinical governance’ (NICE 2002:vi). NICE have produced a book called Principles for best practice in clinical audit, which can be downloaded free from the NICE website (see www.nice.org.uk).
As described in Chapter 1, the National Institute of Clinical Studies (NICS) was established by the Australian Federal Government in 2000, and commenced operations in 2001. The primary purpose of the NICS is to champion continuous improvement in the quality and delivery of clinical practice to the Australian community. The methods by which this is to be achieved are based on partnership with consumers, health professionals, health organisations, researchers and governments. In collaboration with these groups, the NICS seeks to close the gaps between evidence and clinical practice in those areas that will effect significant change for the Australian community. It seeks to do this by providing practitioners and health organisations with systems that will assist them to improve the health outcomes of those within their care.
The methods used in the NICS projects vary according to the topic in question, although the focus across all projects is the implementation of evidence in practice. Evaluations of projects and programs initiated by the NICS reflect similarity to audit programs in that there are distinct barriers and facilitators to change. The challenge to address these in context-specific ways has been taken on by the NICS through the development of reference groups with the role of establishing a coordinated national approach to implementation. The parallels with optimal audit program design include use of multidisciplinary approaches, use of broad-based programs to target key clinical problems identified via research, and then use of multiple methods to close the gaps between evidence and practice. Details of some of the work of the NICS were presented in Appendix 1.1 in Chapter 1.
7.5 What do clinical audits measure?
The UK-based NICE describes clinical audit as a strategy to monitor the use of particular interventions or care received by patients against agreed standards (NICE 2002). Effectiveness is the degree to which an intervention does what it is meant to do in normal circumstances (Thomas 1999). In assessing effectiveness, evidence is needed to determine if intended outcomes were achieved. The clinical audit process is a way of ascertaining the achievement or failure of intended outcomes. It allows the identification of departure from best practices so they can be examined in an effort to understand and act upon the causes (NICE 2002).
Thomas (1999:41) differentiates clinical audit from medical audit by defining the former as being concerned with the ‘total package of care offered to patients’, rather than focusing only on medical care. The clinical audit focuses on nursing care, service provision and management, as well as physical and environmental issues (Thomas 1999). This positions the clinical audit as an essentially multidisciplinary activity, which is in keeping with the fact that the provision of health services is also a multidisciplinary activity (Closs & Cheater 1996).
7.6 Audit or research?
Nurses have been evaluating their work for years but have not actually called that process audit (Kinn 1995). In nursing circles, what began as medical audits have now become clinical audits (Mason 2002), and clinical audits have come to be viewed as an important aspect of professional accountability (NICE 2002:8). There is some contention over whether or not clinical audits are research and therefore require approval from an institutional ethics committee (IEC). Scott (2000) is convinced clinical audit is research, whereas CRAG (Clinical Resource and Audit Group) in Scotland categorically takes the view that because research is about establishing new knowledge, audit is not research (cited Morrell & Harvey 1999:3).
Balogh (1996) also points out that research is concerned with extending knowledge, whereas audits are concerned with making sure that best current knowledge is being applied in practice and promoting positive practice change. However, Balogh (1996) acknowledges the similarities between audit and research, in that they both engage in a process of inquiry, and both employ similar strategies for gathering and analysing information (similarly Mead & Moseley 1996). Closs and Cheater (1996) highlight further differences in the two processes, in that audit is theorised as a repeating, circular process, whereas with some exceptions, research is more often conceptualised as linear in nature. Furthermore, whereas much research aims to be generalisable, audits are carried out in local environments and therefore reflect practices in a particular setting (Balogh 1996). The nature of the clinical audit can be likened to the action research cycle, which also focuses on local solutions to local problems and engages in a process of data collection to facilitate practice change. The University Hospitals Bristol NHS Foundation Trust, through their Clinical Audit Central Office, has produced a series of short papers on different aspects of clinical audit, including one called How to apply ethics to clinical audit (see www.uhbristol.nhs.uk/healthcare-professionals/clinical-audit/how-to-guides.html).
No matter where one sits in the debate, it is clear that undertaking a clinical audit can contribute to research by drawing attention to areas requiring further research, as well as raising new researchable areas (Balogh 1996). Audit is a mechanism by which the gap between research and practice can be closed by comparing the two, identifying any inconsistencies, and guiding the development of methods to improve practice in the light of research findings. Despite the controversy, it is clear that clinical audits do raise ethical issues (e.g. use of patient records to gather information). Therefore, clinical audits should adhere to the same ethical principles common to any sphere of clinical practice, investigation or research, and require approval from an institutional body specifically set up to assess such proposals, such as an IEC (Morrell & Harvey 1999:105, NICE 2002).
7.7 Why are clinical audits useful in practice development?
There are a number of advantages to clinical audit. Ideally the audit should be a routine part of care (Closs & Cheater 1996) and so produce a constant spiral of intervention–monitoring–review of clinical care. Kinn (1995:36) notes that raising standards of care can only benefit patient outcomes and that the provision of care will be more efficient, which should enhance the job satisfaction of staff. Audit is seen to be educational and a useful tool for fostering interdisciplinary teamwork and communication. Morrell and Harvey (1999:158) state that clinical audit provides an avenue for reflection on work by healthcare workers, which, in turn, facilitates the development of their practice, knowledge and attitudes. The development of practice and the development of practitioners are regarded as inextricably linked (Morrell et al 1995, cited in Morrell & Harvey 1999:158).
NICE (2002) point out that effective clinical audit is important for a range of stakeholders, including health professionals, health service managers, patients and the public. They explain that audits:
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