Summary

12.1. Introduction: the characteristics of clinical pathways

Clinical pathways (CPWs) are tools used to guide evidence-based healthcare; their use has been widespread since the 1980s. CPWs aim to translate clinical practice guideline recommendations (see Chapter 9) into clinical processes of care within the unique culture and environment of the healthcare institution, thereby maximizing patient safety and clinical efficiency.

CPWs should be developed based on the best available evidence, such as clinical practice guidelines or a systematic review. Thus, they have the potential to streamline clinical practice for a specific group of patients with a particular diagnosis or undergoing a particular procedure. In other words, CPWs can be described as structured multidisciplinary care plans which detail essential steps in the care of patients with a specific clinical problem.

In daily practice and research, widespread confusion exists as to what constitutes a CPW and there is a lack of agreement regarding an internationally agreed CPW definition. In fact, a recent study revealed 84 different terms that may refer to a CPW, including (among others) care map, critical pathway, protocol and integrated care pathway (De Bleser et al., 2006).

However, several definitions vary in the content criteria described. See Box 12.1 for the European Pathways Association (EPA) definition of a CPW.

Box 12.1

EPA Definition of a clinical pathway.

The EPA definition lacks specificity, i.e. it does not allow CPWs to be distinguished from similar concepts or strategies. Such a distinction is necessary when addressing the issue of effectiveness of the strategy.

Independent of the terminology used, the concept of CPWs is defined by the characteristics and content of the strategy. Based on a synthesis of published definitions and descriptions, an operational definition of CPWs has been proposed (Kinsman et al., 2010; Rotter et al., 2010; Rotter et al., 2013).

Therefore, a CPW is a structured multidisciplinary care plan with the following characteristics:

1. It is used to translate guidelines or evidence into local structures.
2. It details the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol or other “inventory of actions” (i.e. the intervention has time-frames or criteria-based progression).
3. It aims to standardize care for a specific clinical problem, procedure or episode of healthcare in a specific population.

In theory, CPWs could be implemented in any area of healthcare, i.e. preventive, acute, chronic and palliative care. They mainly focus on processes in relation to effectiveness, patient-safety and/or patient-centredness. CPWs are strongly linked to recommendations from clinical guidelines (see Chapter 9), if available for the specific condition.

This chapter follows the common structure of all chapters in Part 2 of this book. The underlying rationale of why CPWs should contribute to healthcare quality is described, along with an overview of what is being done in European countries in respect to the specific quality strategy, while the following section provides an overview of the available evidence with regard to the effectiveness and cost-effectiveness of the specific strategy. The next section addresses questions of implementation, and the final section provides conclusions for policy-makers, bringing together the available evidence and highlighting lessons for implementation of the strategy.

12.2. Why should clinical pathways contribute to healthcare quality?

The main aim of clinical pathway implementation is to align clinical practice with guideline recommendations (see Chapter 9) in order to provide high-quality care within an institution. CPWs may serve as useful tools to reduce variations in clinical practice, thereby maximizing patient outcomes and clinical efficiency. They have the capacity to promote safe, evidence-based care by providing locally oriented recommendations for the management of a specific condition, disease or reason to demand healthcare (Kiyama et al., 2003; Aizawa et al., 2002; Choong et al., 2000; Delaney et al., 2003; Marelich et al., 2000). CPWs also contribute to the reduction of complications and treatment errors (Rotter et al., 2010).

CPWs structure the flow of services for a group of patients with a particular diagnosis or undergoing a particular procedure and they guide the patient through the treatment process. They also support the translation of clinical guideline recommendations or evidence available in other forms into local protocols and clinical practice (Campbell et al., 1998). Whilst clinical guidelines provide generic recommendations, CPWs institutionalize best practices to bring evidence to the bedside for all the health professionals involved (Campbell et al., 1998; Kinsman et al., 2010). (For more information on professionals’ education, see Chapter 5.)

As an example, a clinical guideline recommendation for an outpatient rehabilitation programme will be implemented locally in a clinical pathway in much more detail, such as when to submit the referral and to whom it should be submitted. Thus CPWs aim to standardize clinical processes of care within the unique culture and environment of the healthcare institution. As a result of standardizing clinical practice according to evidence-based clinical practice guidelines, CPWs have the potential to reduce treatment errors and improve patient outcomes.

An example of a CPW for the management of elderly inpatients with malnutrition is provided in Fig. 12.1.

Fig. 12.1

A clinical pathway for the management of elderly inpatients with malnutrition.

Another rationale (for policy-makers and healthcare institutions) for implementing and using CPWs is that they have also been proposed as a strategy to optimize resource allocation and cost-effectiveness. Within the trend towards the economization of healthcare, as evidenced by the prevalence of case mix (CM) systems worldwide, there is also evidence of the increased promotion of clinical pathway interventions to tackle these dramatic changes in healthcare reimbursement methods (Delaney et al., 2003).

12.3. What is being done in Europe?

The use of CPWs has been growing in Europe since the 1990s, beginning in the UK (Zander, 2002), and spreading to most European countries (Vanhaecht et al., 2006; Knai et al., 2013).

The European Pathways Association (EPA), the world’s largest CPW professional organization, was founded in 2004 with the aim of supporting the development, implementation and evaluation of clinical/care pathways within Europe (see Box 12.2). In 2018 the EPA reported members in more than 50 countries, covering both national health systems and SHI systems (EPA, 2018a). CPWs are being used in countries with public not-for-profit and with private for-profit healthcare providers.

Box 12.2

The European Pathways Association (EPA).

In 2006 the EPA network published its first international survey and overview on the reported use and dissemination of CPWs in 23 countries (Vanhaecht et al., 2006). CPW prevalence was defined as the number of individual patients reported to be on a pathway. The study found that reported estimates of CPW use were low and that when CPWs were used it was mainly in acute care settings. Pathway utilization was low (1–5%) in Belgium, the Netherlands, Germany and Spain, whereas in Wales and Scotland it was found to be higher (6–10%), and in the rest of the UK the estimate was 11–15% (Vanhaecht et al., 2006). The investigation concluded that CPWs were primarily used as an inter-professional tool to improve the quality of care.

The cross-sectional survey (n = 76 respondents) reflects limited representation and is at high risk of self-selection bias (Vanhaecht et al., 2006), so this information should be considered with caution.

In 2013 the EPA network published a follow-up cross-sectional survey. The investigators collected 163 responses from 39 countries with a 25% response rate (Knai et al., 2013). In this update the authors clearly stated that it was not a representative survey and no prevalence estimates were reported (Knai et al., 2013). Neither survey addressed the issue of which pathway conditions were reported and included in the responses.

In some European countries (see below) there are increasing activities in the development and implementation of CPWs. The examples show that there is an increasing number of activities in this field, but little can be said about the actual usage and content of the CPWs.

12.4. The effectiveness and cost-effectiveness of clinical pathways

Effectiveness

As with any other intervention in healthcare, the question is whether CPWs achieve what they aim for, whether they ultimately contribute to improve the outcomes of healthcare, and at what cost this is achieved. Rotter et al. (2012) addressed the effects of CPWs on professional practice, patient outcomes, length of stay and hospital costs for the hospital setting in a Cochrane systematic review (Rotter et al., 2012). The methodology of the review is summarized in Box 12.3. The review represents the most comprehensive database in terms of the available quantitative literature; an update has been submitted to the Cochrane Library for publication.

Box 12.3

Methodology of systematic review.

Rotter et al. (2012) observed considerable clinical and methodological heterogeneity, with a broad range of disparate outcomes measured, many different settings in which care is delivered, and a wide range of diagnoses and types of patient included in the different study designs. Study outcomes reported were in-hospital complications, in-hospital mortality, hospital readmission, length of stay and hospital costs (Kinsman et al., 2010).

Out of the 3214 studies identified, 27 involving 11 398 participants met the Effective Practice and Organization of Care (EPOC) eligibility and study quality criteria for inclusion. Twenty studies compared CPWs with usual care and seven studies compared CPWs as part of a multifaceted intervention with usual care. Nineteen randomized controlled trials (RCTs) and eight non- randomized controlled trials met the selection criteria and many different hospital settings were included in the systematic review. The majority of studies (13) were conducted in the United States (Bauer et al., 2006; Bookbinder et al., 2005; Brook et al., 1999; Delaney et al., 2003; Falconer et al., 1993; Gomez et al., 1996; Johnson et al., 2000; Kim et al., 2002; Kollef et al., 1997; Marelich et al., 2000; Philbin et al., 2000; Roberts et al., 1997; Tilden & Shepherd, 1987), four in Australia (Choong et al., 2000; Doherty & Jones, 2006; Dowsey et al., 1999; Smith et al., 2004), three in Japan (Aizawa et al., 2002; Kiyama et al., 2003; Usui et al., 2004), two each in the United Kingdom (Sulch et al., 2000, 2002; Chadha et al., 2000) and Canada (Cole et al., 2002; Marrie et al., 2000), and one each in Thailand (Kampan, 2006), Taiwan (Chen et al., 2004) and Norway (Brattebo et al., 2002).

Due to the high level of clinical and statistical heterogeneity (I square), length of stay (LOS) and hospital cost data were not suitable for pooling among those studies.

Table 12.1 depicts the main results of the meta-analysis of primary studies, which compared care with and without CPWs.

Table 12.1

Effectiveness of CPWs compared to usual care.

Despite the different settings and investigations included in the systematic review, it was striking that the majority of studies reported reductions in both length of stay and hospital costs for the CPW group(s) compared with usual care. Meta-analysis showed that CPWs are associated with a reduction in in-hospital complications and two studies reported on improved professional documentation (see Table 12.1).

In-hospital complications were measured in five studies of pathways for invasive interventions (both elective and non-elective), concerning a total of 664 participants. All studies reported improved outcomes for the CPW group (Aizawa et al., 2002; Choong et al., 2000; Delaney et al., 2003; Kiyama et al., 2003; Marelich et al., 2000). Fig. 12.2 provides details about the meta-analytic comparison. Aizawa et al. (2002) tested a clinical pathway for transurethral resection of the prostate (TURP), Choong et al. (2000) assessed a CPW for femoral neck fracture, Delaney et al. (2003) tested a CPW for laparotomy and intestinal resection, Kiyama et al. (2003) a CPW for gastrectomy, and Marelich et al. (2000) a clinical pathway for mechanical ventilation. In-hospital complications assessed were wound infections, bleeding and pneumonia (Aizawa et al., 2002; Choong et al., 2000; Delaney et al., 2003; Kiyama et al., 2003; Marelich et al., 2000). The results indicate that in order to avoid one hospital complication it would be necessary to include 18 patients in a CPW (i.e. number needed to treat = 18).

Fig. 12.2

Clinical pathway vs. usual care, outcome: in-hospital complications. Sources: Rotter et al., 2012; Review-Manager 2008

However, both groups did not differ for in-hospital mortality and hospital readmission within six months after discharge (the longest follow-up period reported.) Significant variations across studies prevented further meta-analysis and limited conclusions. In terms of the transferability and generalizability of the review results, four RCTs were conducted in medical units (Brook et al., 1999; Cole et al., 2002; Kampan, 2006; Philbin et al., 2000), three RCTs in surgical units (Aizawa et al., 2002; Delaney et al., 2003; Kiyama et al., 2003), three RCTs in medical or surgical intensive care, two RCTs in emergency departments (Kim et al., 2002b; Roberts et al., 1997), two RCTs in stroke rehabilitation wards (Falconer et al., 1993; Sulch et al., 2000) and five RCTS in other hospital settings (Bauer et al., 2006; Chen et al., 2004; Dowsey et al., 1999; Johnson et al., 2000; Marrie et al., 2000).

12.4.1. Cost-effectiveness

Hospital cost data were reported as direct hospital costs and as total costs (direct costs and indirect costs) including administration or other overhead costs. Due to the low number of high-quality studies evaluating hospital costs, the study investigated all objective cost data available, such as hospital charges (i.e. DRGs) or country-specific insurance points (Rotter et al., 2010). This highly variable set of reported cost measures precluded further economic evaluation and we concentrated therefore on the direct cost-effects of CPWs rather than their cost-effectiveness. Table 12.2 presents an overview of the costing method used and which costs/charges were included and excluded in the calculations (as far as reported).

Table 12.2

Evidence on cost-effectiveness of CPWs.

Most studies reported a reduction in in-hospital costs. The adjusted cost effects (weighted mean difference in US dollars standardized to the year 2000) ranged from additional costs of US$261 per case for a protocol-directed weaning from mechanical ventilation (Kollef et al., 1997) to savings of US$4 919 per case for an emergency department-based protocol for rapidly ruling out myocardial ischemia (Gomez et al., 1996). Significant clinical and methodological heterogeneity prevented a meta-analysis of the reported cost results. In summary, CPWs are associated with improved patient outcomes and could play an important role in patient safety, but considerable clinical and methodological heterogeneity prohibited further economic investigation of the reported effect measures and benefits.

It should be noted that the development and implementation of CPWs consumes a considerable amount of resources. This corresponds to the fact that truly achievable cost savings depend on the number of cases (volume) of the condition targeted by the pathway. According to a cost analysis from Comried (1996), inflation-adjusted costs for the development and implementation of the pathway for the indication “Caesarian section” amounted to more than US$26 000 while the costs for the development and implementation of a CPW for the indication “uncomplicated vaginal delivery” were estimated at approximately US$10 000 (Comried, 1996). However, since normally 20% of diagnoses cover 80% of cases (Schlüchtermann et al., 2005), a considerable percentage of medical services can be dealt with using a relatively small number of CPWs.

12.5. How can the strategy be implemented? What are the organizational and institutional requirements?

The implementation of CPWs needs to be an active process that considers barriers to clinician usage of the CPW. While any change to processes and systems has its challenges, there is particular resistance to the implementation of CPWs as they are often described as “cook-book medicine” by clinicians who may fear a loss of autonomy. However, check-lists and CPWs are being increasingly demonstrated as improving professional practice and patient outcomes (Rotter et al., 2010; de Vries et al., 2010) so strategies to enhance clinician compliance with CPWs need to be considered and built into implementation strategies.

Passive, top-down approaches to CPW implementation have little or no impact (Kinsman & James, 2001) as opposed to a growing evidence-base for participative implementation processes. These processes include use of an implementation team and “local champions”. Identifying barriers to change, clinician involvement in design and implementation, identification of local evidence-practice gaps, optimizing the evidence-base of the CPW content, adaptation of evidence to the local circumstances, staff education sessions, incorporation of reminder systems, and audit and feedback (see Chapter 10) regarding CPW compliance and outcomes are key success factors (Cluzeau et al., 1999; Doherty & Jones, 2006; Grimshaw, 1998; Grimshaw et al., 2001; Kinsman, James & Ham, 2004).

12.6. Conclusions for policy-makers

This chapter has shown that although the clinical pathway concept is not a “silver bullet” for improving healthcare practice in Europe, it has the potential to promote quality of care and to maximize clinical efficiency. From a patient perspective, CPWs provide better guidance and understanding of what patients should expect throughout the care episode.

CPWs may also act as a managerial intervention to tackle the challenges associated with the globalization of case-mix systems (i.e. DRGs) in healthcare reimbursement. Therefore, CPWs may be promoted for reasons relating to management or cost-containment even though clinicians may have negative attitudes in terms of standardization of healthcare practice (Evans-Lacko et al., 2010). In fact, the clinical pathway concept is a tool to translate guideline recommendations and to organize clinical care differently but it does not necessarily interfere with clinical decision-making.

Many countries and professional bodies embrace the clinical pathway concept. Examples are the United Kingdom, Canada and Australia (EPA, 2018b; Huckson & Davies, 2007; Grimshaw et al., 2007). CPWs may serve as useful and evidence-based management tools to reduce variations in clinical practice and to decrease costs and length of stay. The reported effects on in-hospital complications are promising and the pathway concept seems to be effective for large groups of patients, especially those receiving invasive procedures. Thus CPW implementation is likely to become increasingly emphasized in Europe (Evans-Lacko et al., 2010) although much more experience with CPW implementation is needed to fully understand this quality improvement concept.

Evidence on successful clinical pathway implementation is sparse and varies significantly in how healthcare organizations implement CPWs. Successful CPW uptake and implementation is a complex process and requires careful consideration about facilitators and barriers in order to change provider behaviour (Grimshaw et al., 2001). The clinical pathway concept is by definition a multidisciplinary approach and should include all involved professions. Passive, top-down strategies to promote and implement CPWs have little or no impact. Engagement of both clinical and management staff in the development and adoption of CPWs is required and multifaceted strategies should be used to implement this concept. It is pivotal to carefully select the targeted group of patients and a setting-specific and tailored implementation strategy is most likely to be effective (Evans-Lacko et al., 2010). The planned implementation strategy could be also adopted from complementary studies investigating clinical practice guidelines or surgical checklists (Bosch et al., 2007). Compliance with clinical guideline recommendations should always be measured prior to CPW development and implementation in order to improve clinical practice.

CPWs are not new and are complementary to clinical practice guidelines, disease-management programmes (DMPs) and clinical checklists or protocols. They are based on clinical guidelines and available evidence and are tailored to suit the organizational requirements. It is also striking that similar interventions such as DMPs often include CPWs, and that their successful implementation strategies also refer to an implementation team, audit and feedback, patient involvement and education sessions.

For local healthcare providers and policy-makers, the choice of implementing clinical pathway strategies should be also based upon considerations of the expected costs and benefits of pathway interventions. It should be noted that the development and implementation of CPWs consumes a considerable amount of resources. This corresponds to the fact that truly achievable cost savings depend on the number of cases (volume) of the condition targeted by the pathway.

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