Chapter 4. Producing health
Tanya Claridge and Gary Cook
Introduction
This chapter discusses the characteristics and use of clinical pathways as commonly used tools in healthcare delivery to organise and manage, sometimes previously tacit, clinical processes into a more seamless and patient-oriented production system. Care is organised around clinical case types, for example patients with chronic obstructive airways disease; thus the ‘pull’ rather than the ‘push’ philosophy embodied within clinical pathways means that the production system is defined by the evidence-based needs and the expectations of the patient population instead of the ‘push’ from the healthcare system. Clinical pathways contribute to the production system by integrating low-tech patient-related activities with healthcare technology, information technology and social and management practices. Well-designed clinical pathways have the potential to reduce or eliminate wasted time, money and energy in healthcare, contributing to systems that produce safe, efficient, effective, and continuously improving and responsive healthcare.
From push to pull – moving from individual practitioner-based care to a co-produced service
Healthcare as a system
An evolution has occurred in the understanding of and emphasis given to the provision of healthcare. This evolutionary change shifts healthcare from an individually orientated pattern (with rudimentary batching and queuing of patients with different treatment needs grouped in ‘individual silos’) of delivery (see Figure 4.1), to one of a multidisciplinary systems-orientated pattern of patients grouped by similar conditions, treatments or healthcare needs (Figure 4.2). This evolution relates to the conceptualisation of healthcare as an industry comprised of complex systems and subsystems of healthcare organisation and delivery that incorporate dynamic and goal-orientated processes. In the first model, each different service manages a variation as if it were unique to each process and each (differently shaped) patient with little generalisation to similar patients or processes. In the second, variations are managed for populations of patients that stabilises the process, integrates the change and applies it to all subsequent patients treated for that particular case type (same shape).
In this context, healthcare delivery should be viewed as transdisciplinary and integrative. This conceptualisation of healthcare is underpinned by the assumption that reducing or removing a process from the whole system reduces the system’s overall effectiveness. This view stresses the interdependence between groups of individuals, structures and processes that enable the organisation to function and hence to result in a ‘co-produced’ service. Primacy is given to these interrelationships, and not, as with more traditional models of healthcare delivery (that centre on the effectiveness of individual practitioners, structures and departments), to the separate elements of the system.
All systems are determined by their inputs, outputs, processes, feedback and control mechanisms and environmental factors. This chapter explores how and why management of clinical processes within a healthcare system is needed to ‘produce health’, in terms both of improving process flow and of managing process variation.
Why manage clinical processes?
The development of organisational capability to deliver sustainable, accountable, patient-focused and quality-assured, safe healthcare is the aim of healthcare systems and organisations worldwide (Nicholls et al 2000, WHO 2000). However the context of healthcare delivery is complex and healthcare systems are subject to myriad pressures.These pressures include:
▪ changing patterns of supply and demand (Frankel et al 2000)
▪ the cost of innovation
▪ changing organisational structures
▪ patient and public expectations
▪ the diverse and complex nature of healthcare delivery.
At its simplest, clinical process management enables healthcare organisations to respond to these pressures by putting procedures in place to ensure individual practitioners/teams or services execute critical activities required to concurrently measure, improve or sustain the productivity, quality (Lilford et al 2007) and safety of care and guarantee a level of control to best manage and evaluate the system. Process management in any system can involve managing the ‘flow’, managing any variance in the process or both.
Managing process flow – lean thinking
The flow of work through healthcare systems is complex and costly, although the actual work involved is often routine. By delineating, standardising, synchronising and managing every step in the process of healthcare delivery, both in patient-focused systems and in wider networks of care (Keen et al 2006), the work can flow in line with actual demand. This is the premise of ‘lean thinking’. Lean thinking is not currently widely associated with healthcare organisations though the encouraging results produced in a variety of sectors all round the world have generated interest in the healthcare community (Institute of Health Care Improvement 2005). While the ideology was developed in Japanese manufacturing (Eisert 2006) it is just as applicable in healthcare, where waste (of time, money and supplies) is common, as it provides an opportunity to increase productivity, reduce waiting times, lower costs and improve services by improving processes.
Managing process variance – critical pathways
Critical Path Method (CPM) or Critical Path Analysis was developed in the 1950s for managing maintenance projects (DuPont Corporation and Remington Rand Corporation) and formalised within social science in the 1960s (Lucas 2001). It is now commonly used with many forms of projects that involve concurrent interdependent activities in diverse sectors including construction, research and engineering. CPM is essentially an algorithmic method for scheduling project activities. It produces, in diagrammatic form, the longest path of planned activities to the end of a project, the process of development determining both ‘critical activities’ and those that have ‘total float’ (i.e. can be delayed without making the project longer). Thus project managers can either prioritise actions to ensure the project is completed effectively, ‘fast track’ (by performing more activities concurrently) or direct resources (e.g. staff or equipment) to the critical path from activities that have ‘total float’. This is known as ‘crashing the critical path’.
Critical pathways are administrative models with close links to CPM, utilised in industry (Industrial Engineering 1992, Kallo 1996) as tools to improve the efficacy of production by streamlining work processes (Every et al 2000). Any variance on a production line in industry will have an effect on its efficacy. Using critical pathways to define and time processes enables the identification of problematic areas, the measurement of any variation and hence allows improvements to be made.
Identifying clinical processes
In order for clinical processes to be managed within the production systems of a health organisation they have to be identified. This is usually done by identifying the processes that support different ‘core services’. A core service of a healthcare organisation could be as generic as a patient appointment with a doctor. However if considered in the context of population-based healthcare, a core service of a healthcare organisation would be the provision of care for patients based on clinical case types. This approach to identifying ‘core population-based services’ of health organisations is just as relevant to primary care services as it is to secondary and tertiary care. Examples of some core services offered by healthcare organisations can be found in Table 4.1.
| Core product | Example |
|---|---|
| Assessment | of the psychosocial wellbeing of women in the early postnatal period (Yelland et al 2007) |
| Education | of caregivers of patients with dementia (Kazui et al 2004) |
| Surgery | Total joint replacement (Ho & Huo 2007, Saufl et al 2007) |
| Oesophagectomy (Low et al 2007) | |
| Prevention | of primary bacteraemia (Juan-Torres & Harbarth 2007) |
| Diagnosis and treatment | of septic arthiritis (Merino Muñoz et al 2007) |
| Support and signposting | of pregnant teenagers (Logsdon & Koniak-Griffin 2005) |
| Multidisciplinary identification and treatment | of distress in palliative care (Vitek et al 2007) |
| Public health | Preventive dental care (Tay et al 2006) |
| Management | of the technology-dependant child in the community (see example later in chapter) |
Pause for reflection
Healthcare economies are subject to multiple pressures including rapid technological advances, changing demographics and concerns about the quality and safety of the care received by patients. In response to these pressures there has been a shift from individual practitioner-led healthcare delivery to the co-production of care using a population-based systems approach that incorporates dynamic and goal-orientated processes. Process management techniques allow the management of flow, management of variance or management of both thus increasing standardisation and predictability within the system. Why is this important in managing healthcare?
Managing clinical processes – protocol-based care
Developing and implementing rules is one of the most common ways to manage behaviour in complex organisations (Hopwood 1974) to promote the uptake of clinical management practices. Promoting both quality and safety is one area of organisational behaviour in which rules feature heavily. For instance, Reason’s (1995) model of organisational safety indicates that rules, in the form of procedures, protocols and guidelines, are one of the principal defences necessary to ensure a safe organisation. In recent years there has been a proliferation of formal or semi-formal rules in healthcare worldwide, often in the form of policies, protocols, guidelines or clinical pathways in order to standardise and manage clinical processes both to improve the quality and measurability of healthcare systems and to try to ensure the safety of patients receiving care.
One of the key features of organised society is the development of a system of social rules and behavioural norms. The principal functions of such systems are to reflect societal and cultural values, and to safeguard things of value. Rules come in many different forms, including conventions, laws and social norms. Some are based on fundamental moral principles (it is wrong to commit murder), while others serve as a form of social control, proscribing antisocial behaviour (it is wrong to drop litter). Many rules exist purely in order to ensure that social affairs run smoothly. For example, driving on the right-hand side of the road is not intrinsically safer than driving on the left, but in many countries there is a rule (in this case, with the force of law) that all drivers will keep to the right. This rule has been imposed as a way of introducing standardisation and increasing predictability in a complex system.
Semi-formal and formal rules in various guises have been used for a number of years in all sectors of healthcare to regulate safety-critical ancillary processes (for instance storage of controlled and prescription drugs (Yee 1998) and hand washing (McCarthy et al 1999)). They have also been used with reference to clinical processes, for instance, guidelines on clinical technique and history taking are often presented in handbooks on clerking patients (Swash & Hutchinson 2001) and within the nursing process (Roper et al 1983). However, in recent years healthcare policy worldwide has begun to focus on the use of rules embodied in clinical pathways as a way of managing both quality and safety.
The implementation of evidence-based medicine (EBM), the doctrine that professional clinical practice should be based on sound research evidence (Sackett et al 2000), is one area in which rules governing clinical processes have been used as a vehicle for improving quality. Previously, even when clinical effectiveness was supported by apparently rigorous evidence, this proved insufficient to produce related changes in practice. For example, Schuster et al (1998) postulated that 30–40% of patients do not get treatment of proven effectiveness and 20–25% patients get care that is not needed or is potentially harmful. In response to the slow pace of progress towards evidence-based practice (EBP), policy interest increased in the use of rules to promote it (Grol 2001). For instance, the UK National Health Service (NHS) Plan (Department of Health 2000:86) specified that ‘by 2004 the majority of NHS staff will be working under agreed protocols’ and that there will be ‘a major drive to ensure that protocol-based care takes hold throughout the NHS’.
In terms of patient safety, there is also a move internationally towards using rules to regulate clinical processes and the behaviour of healthcare professionals (Kohn et al 2000). In 2002 the World Alliance for Patient Safety was formed and passed a resolution urging the World Health Organization to take the lead in developing global norms and standards. The assumption is that, as in other high-risk industries, patient safety can be improved by increasing standardisation and predictability in the system.
The drive for quality improvements, coupled with increased awareness of patient safety issues in recent years, has seen a proliferation of formal (active) or semi-formal (passive) rules, developed in order to standardise and manage the behaviour of healthcare professionals. The most common type of rule in healthcare is a protocol, which is essentially a set of instructions that can be formatted in a variety of different ways and used in many different clinical contexts.
Passive protocols (Coiera 2003) such as guidelines are semi-formal. They do not direct patient management, but provide guidance and add to the information resources available. Passive protocols are accessed or used at the discretion of the healthcare professional. In contrast, active or formal protocols (clinical pathways) are prescriptive, actively managing clinical processes. Active protocols are fundamentally different from passive protocols, in that they are central to the way the patient is managed, rather than an optional accessory. The way protocols are formatted also varies. Active protocols can be computer based and include alerts when there is deviation from the protocol (e.g. GP prescribing software). However, the majority of active protocols are paper based, allowing their effect on actual practice to be evaluated through audit of adherence and outcomes. Protocols in any format are seen by their exponents as ‘tools that ensure service development is driven by evidence of clinical or cost effectiveness, for improving the safety of and consistency of care, and for coordinating health services’ (Dillon & Hargadon 2003). In other words, protocols are tools that manage clinical processes within healthcare systems that should lead to improvements in the quality of care and in patient safety.
Managing clinical processes – clinical pathways
Clinical pathways (underpinned by an ideology similar to critical pathways described above) have been used worldwide (Hindle & Yazbeck 2005) for over a decade to systemise and support a process-centred vision of healthcare delivery. Clinical pathways have been variously known as anticipated recovery paths (ARPs), CareMaps®, multidisciplinary pathways of care (MPC), care protocols, integrated care management, pathways of care, care packages, collaborative care pathways, critical care pathways, care profiles and integrated care pathways. They are mass customisation disease- or symptom-specific case management plans that display goals for patients based on their clinical presentation and provide the sequence and timings of key elements of care based on EBM necessary to achieve these goals with optimal efficiency (Pearson et al 1995). They are generally conceptualised as vehicles for implementing collaboratively developed (multidisciplinary) care programs focused on population-based and patient-centred care. In theory fragmentation and duplication of care and treatment are therefore reduced, and coordination and communication are improved (De Bleser et al 2006, National Electronic Library for Health 2006).
Clinical pathways provide the opportunity to manage both clinical process flow and variance using lean thinking and critical pathway ideologies. They are developed by mapping and modelling clinical and non-clinical processes related to specific clinical case types or client groups. Opportunities for multidisciplinarity and skill mixing are identified based on roles, competencies and responsibilities rather than on individual disciplines alone. Both priorities and sequencing of actions are identified and processes and outcomes are incorporated (adapted from Venture Training 2005). The documentation – either paper or electronic – that supports the clinical pathway is designed to capture variations between the clinical processes planned and those experienced by the patient. The presence and implications of any variance can be analysed and assessed. Changes can then be made to the clinical process if necessary.
Clinical pathways and outcomes
Programs to develop and introduce clinical pathways aim to improve a range of clinical and financial parameters through decreased length of stay, preventing readmissions and reducing resource use (Vanounou et al 2007). There are few papers describing rigorous financial testing of clinical pathways. Those that are available tend to use algorithms to estimate savings based on the above objective process, throughput and outcome measures. Vanounou et al (2007) described a new model to evaluate the clinical and economic impact of clinical pathways. They used deviation-based cost modelling to determine the contribution of clinical pathway implementation itself to cost savings beyond usual secular trends in measuring improvements in care. The core product of the system involved in their study, a pancreaticoduodenectomy, was delivered using clinical processes that shortened length of stay, reduced resource use and decreased costs compared with before the clinical pathway was introduced. However, in a review of several case studies Lee & Anderson (2007) found that only one out of five clinical pathways implemented showed an association with a statistical significance in decreasing the length of stay. In another study an acute inpatient clinical pathway for psychosis and depression was trialled for a 12-month period and discontinued after it failed to demonstrate any improvement in terms of either clinical or financial parameters (Emmerson et al 2006). The authors suggested that the complexity, individuality and variability of mental disorders meant that clinical pathways were not beneficial in mental health settings.
It is difficult to establish whether or not all clinical pathways will have a direct impact on patient and/or financial outcomes. It may therefore be more important to explore the impact clinical pathways can have on clinical processes themselves. This involves ceasing dependence on inspecting clinical outcomes to achieve quality and eliminating the need for inspection on a mass basis by building quality into the process in the first place and monitoring the processes themselves (adapted from Deming 2000, Lilford et al 2007).
It is a natural assumption to make that a clinical pathway designed to delineate a pre-determined, evidence-based clinical process will have an effect on that process. It may also be reasonable to assume if the anticipated process is delivered to the expected standard then the desired outcomes will also be achieved. However, there are few tools available to assess how a clinical pathway influences clinical processes in the production of core healthcare services (Vanhaecht et al 2007). This may be due to a general lack of clarity about the concept of clinical pathways, but also related to the preoccupation of healthcare organisations with achieving financially motivated targets, for instance length of stay and readmissions. Vanhaecht et al (2007) have developed a care process self-evaluation tool designed to assess the organisation of the clinical processes embedded in an acute clinical pathway. The tool allows an assessment of the impact of a clinical pathway on clinical processes in terms of multiple domains including the coordination of care, cooperation with primary care and monitoring of the clinical process.
Clinical pathways are thus a potentially effective instrument in ensuring high-quality, effective and safe clinical processes because, in theory, they decrease process variability and improve process flow. This is because they are tools that can be used both at a macro level to delineate system design and integration and at a micro level to influence and regulate the behaviour of healthcare professionals at the patient care interface. The role of clinical pathways in ensuring effective clinical processes at these different levels of a system is discussed in more detail below.
Influencing system design – supporting patient focus and coordination of care
Developing a clinical pathway requires mapping the current state of the process critical to the delivery of the ‘core service’ under scrutiny (Hunter & Segrott 2007). This is often where ‘lean thinking’ can facilitate changes in the process to place the patient at the centre and to better coordinate care, removing unnecessary steps, even before the clinical pathway has been produced. Consider the case study in Box 4.1 and the diagrammatic representation in Figure 4.3.
Box 4.1
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