The Care Process Organization Triangle: A Framework to Better Understand how Clinical Pathways Work

The Organization of the Care Process

Emphasis on the evaluation and management of health-care quality has shifted over time from structures (having the right things) to processes (doing things right) to outcomes (having the right things happen). ¹⁸ The relationship between structure, process and outcome is also known as Donabedian's paradigm. ¹⁹ Health care is actually seen as processes acting within systems or structures. ¹⁷ The organization of care processes receives increasing attention from clinicians and managers.^{3–14,16,20–22} Many care processes are undergoing change, and although every improvement involves change, not all changes are improvements. To know that change is producing improvement, we need information about what is happening. ¹⁷ Different authors discuss the direct relationship between interventions or organizational changes and outcomes.^18,23–25

Based on Donabedian's paradigm, the realistic evaluation configuration ²⁵ contends that causal outcomes follow from mechanisms acting in a context (context + mechanism = outcome [CMO]). The realistic evaluation approach offers researchers the opportunity to look at evaluation from a realistic perspective, one in which action is not happening in a laboratory environment. The questions posed are ‘What works, for whom, in what circumstances?’ instead of ‘Does this work?’ or ‘What works?’. ²⁵ The basic CMO concern is still, of course, the outcome. However, the explanation first focuses on the mechanism (e.g. the programme that was introduced, known as the process in Donabedian's paradigm) and second on the context (e.g. the characteristics of the organization where the programme was introduced, known as the structure in Donabedian's paradigm). The realistic evaluation configuration has previously been used in a wide range of health-care projects.^26–28 In 1998, Mitchell et al. ¹⁸ indicated that no direct relationship exists between interventions and outcomes. Their quality health outcomes model has four components – system, intervention, client and outcomes – and proposes bidirectional relationships among components, with interventions always acting through characteristics of the system and the clients. In 2007, Batalden and Davidoff ¹⁷ described the linked aims of improvement: better patient outcomes, better professional development and better system performance lead to improvement for everyone. Health-care organizations are professional organizations in which the multidisciplinary team occupies a central place. ²⁰ Health care is a type of service industry in which internal and external customers (known as employees and patients) each play a specific role. ²³ Heskett et al. ²³ describe this relationship as the service triangle, which includes the firm (i.e. the hospital, which is considered to be the structure or context), the frontline employee (i.e. members of the multidisciplinary team, who are considered to be the process or mechanism) and the customer (i.e. patients, who are considered to be the outcome or result). The success of a service company depends on its ability to develop a satisfactory relationship with each of its customers. Since employees play a vital part in promoting and providing the service, during the delivery of care, it is essential that they fully understand their roles and are willing to act as required. Most of the work is designed backstage, out of the sight of the customer, but is performed frontstage, creating ‘a moment of truth’. Teboul ²⁴ states that ‘service is a front stage experience’. The relationship between the design of the process, the role of the multidisciplinary personnel involved and the customers is vital within these processes.^23,29 Quality, therefore, is what the customer determines. ²⁴ No matter how much care is taken in designing the structure or service on paper, in testing it, and in delivering it during the process of care, what customers perceive is quite different from the original proposition. This means that gaps in quality can exist between the three cornerstones –structure, process and outcome – of the service triangle. ²⁴

If one wants to re-organize health care as suggested by the reports of the IOM3, ¹⁶ and more recently by Porter and Olmsted Teisberg^12,13 in 2006 and 2007, the innovation and change should be focused on care, which is the essence of a health-care organization. ¹⁴ This means that care processes will occupy a central place and that organizations will be designed in such a way that the care processes deliver high-quality and efficient care.

Previously described concepts^{12,17–19,23–25} have been integrated into a paradigm specifically intended to help us understand these complex relationships: the care process organization triangle (Figure 1). In this triangle, the relationships between care process structure, multidisciplinary team processes and outcomes are described. Also within this triangle, gaps or chasms between these three cornerstones can occur more frequently than we thought.^16,24 This care process organization triangle – based on Donabedian, ¹⁹ Heskett et al., ²³ Teboul, ²⁴ Batalden and Davidoff, ¹⁷ Mitchell et al., ¹⁸ and Pawson and Tilley ²⁵ – will be the organizing concept of this dissertation.

OPEN IN VIEWER

Figure 1

The care process organization triangle (based on Donabedian and including the terminology used by Pawson and Tilley, Mitchell et al., Batalden and Davidoff, Heskett et al. and Teboul)

The structure

In industry, processes occupy a central place in the management of a company or product line. Different methods are used to systematically plan and follow up these processes. Continuous quality improvement projects, lean management and six sigma or process redesign are examples of methods that continuously improve the efficiency and quality of the product line. Most of the methods are based on Shewhart and Deming's ³⁰ principles of quality improvement. The reduction of variability is the key to quality. Decreasing this variability is the cornerstone of methods introduced by different quality gurus. ³¹ Organizations like the European Foundation for Quality Management (EFQM) and European Quality Awards still base their process survey tools on these concepts.^32,33 Also, in service industries like hotels, consulting, financial institutions and health care, there is an increased focus on primary processes.^14,23,24,29 Hospitals are seriously analysing their operations and are currently using industrial knowledge to optimize work flow. ³⁴

To better understand what is happening in the structure of these primary processes, transparency and standardization are necessary. In industry, the critical pathway method (CPM) and programme evaluation and review technique (PERT) have been used since the 1950s to plan and standardize the structure of processes. ³⁵ CPM and PERT are used to manage complex processes in which different team members or agencies work together towards shared financial and quality goals. Until today, companies and organizations like Motorola, Boeing and NASA are still using these methods. In 1985, this technique was translated into health care in the form of clinical pathways or case management plans. ³⁶

Managers and clinicians have always searched for novel methods to improve the quality and efficiency of health-care processes. As early as the early 1970s, concepts related to pathways were discussed and researched, but the environment for implementation was not receptive. ³⁷ In 1974, for example, Shoemaker stated the following: ‘Routine or patient protocols are useful means to standardise care, to facilitate completeness of services, and to evaluate both the patient's progress and the therapeutic efficacy of the program. They are also an educational tool. In essence, the development of protocols is the first step leading from anecdotal to scientific medicine. ³⁸ Protocols, routines, and other standards do not insure excellence, but sometimes they prevent disasters.'^37,38

The development, implementation and evaluation of clinical pathways represent one of these structured care methodologies.^21,39–45 Clinical pathways are nowadays being implemented in a wide range of health-care systems, primarily to improve the efficiency of hospital care while maintaining or improving quality.^{36,42,44–52} The first systematic use of clinical pathways took place in 1985 at the New England Medical Center in Boston in response to the 1983 introduction of Diagnosis Related Groups (DRGs).^36,41 Typically, a reference length-of-stay (LOS) and a budget are assigned to each DRG. Clinical pathways, as a method for monitoring processes and processing time, were introduced for reducing LOS and managing costs while maintaining quality of care. In the late 1990s, more than 80% of US hospitals used at least some pathways. ⁵³ In the UK, pathways were introduced in the early 1990s.^41,54 Clinical pathways, or integrated care pathways as they are called in the UK, are primarily considered to be tools for designing care processes, implementing clinical governance, streamlining delivered care, improving the quality of clinical care and ensuring that clinical care is based on the latest research.^55–58 From the late 1990s towards the beginning of the 21st century, clinical pathways were disseminated all over the world. ⁴¹ Nowadays, clinical pathways are used worldwide as one of the tools used to structure or design care processes and improve them within the patient-centred care concept.^{41,42,51,52,59} In most countries, the prevalence of pathways is still rather meagre, unless one considers the idea that the care of 60–80% of patient groups in general hospitals should be suitable for pathway use. ⁶⁰

Although they have been in use for 20 years, there is still a great deal of uncertainty surrounding: (i) the definition of pathways; (ii) the actual use of pathways; (iii) the dissemination and knowledge sharing of pathways; (iv) the methods used to develop and implement pathways; and (v) the effect of pathways on outcomes.

A recent literature review ⁶¹ found 84 different definitions in Medline literature published between 2000 and 2003. In the study of De Luc et al., ⁶² 17 different terms were found for this concept. Although the term mostly used is clinical pathway, the equivalent medical subheading (MeSH) term in PubMed is still critical pathway. Fifteen different entry terms are used. In 1996, the National Library of Medicine (NLM) in the USA introduced the term ‘critical pathway’, defining it according to Mosby's Medical Nursing & Allied Health Dictionary: ⁶³ ‘Schedules of medical and nursing procedures, including diagnostic tests, medications, and consultations designed to effect an efficient, coordinated program of treatment’. In an international survey by the European Pathway Association (E-P-A), which included 23 countries, 13 different English synonyms were mentioned. ⁶⁰ The top 10 pathway characteristics that came out of this study were: (i) improvement of quality of care; (ii) improving evidence-based care; (iii) multidisciplinary use; (iv) improving efficiency of care; (v) communication tool between professionals; (vi) standardization of care; (vii) plan to manage the respondent's care; (viii) outcome oriented; (ix) use of guidelines; and (x) communication tool between patient and professional. ⁶⁰ In view of the literature study on definitions, ⁶¹ the E-P-A survey, ⁶⁰ discussions on an Internet forum on pathways, ⁵⁹ and consensus meetings of the board of the E-P-A in 2005 and 2006, ⁶⁰ the E-P-A ⁵¹ defined a care pathway as: ‘A methodology for the mutual decision making and organisation of care for a well-defined group of patients during a well-defined period. Defining characteristics of care pathways includes: An explicit statement of the goals and key elements of care based on evidence, best practice, and patient expectations; the facilitation of the communication, coordination of roles, and sequencing the activities of the multi-disciplinary care team, patients and their relatives; the documentation, monitoring, and evaluation of variances and outcomes; and the identification of the appropriate resources. The aim of a care pathway is to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources’ (www.E-P-A.org).

Pathways are mostly documented in a time-task matrix or Gantt Chart.^44,64 In the UK, pathways are mainly used to replace or to be integrated into the patient record.^65,66 A pathway for hip or knee arthroplasty can be more than 50 pages. However, a pathway for the same procedure in the USA can be only be a few pages. The difference in use is the level of detail that is described in the pathway. With the approach used in the USA, only key interventions and outcomes are written in the pathway document.

The process

A second uncertainty in clinical pathways is that how they are used vary. During the delivery of care, what mechanisms do frontline employees use to organize the care? Zander and Bower,^64,67 emphasize that clinical pathways represent more than written instructions in patients' records, and that the main purpose of pathways is to re-design and follow up care processes, as other structured care methodologies might do. The clinical pathway as a document is probably not its crucial factor. Pathways comprise more than just the structure of the care process. It is even more crucial that the entire process of care is discussed, made explicit and is shared by the multidisciplinary team. Although pathways were introduced in the USA with a focus on cost containment, in 1992, Berwick ⁶⁸ described them as one of the methods employed to promote physician involvement in quality management. Because the process is made explicit, best practices can be discussed, timing and procedures can be planned and scheduled in a better way, desirable outcomes can be set and monitored, and capacity and resources can be provided. ⁴⁴ In an overview article on clinical pathways, Bandolier ⁵⁰ concluded the following: ‘In industry, clinical pathways would be called something else. A mix, perhaps, of good practice and quality control, plus a large helping of ongoing quality improvement. After all, care pathways involve not one action, but many, often in a complex package of care. In these complex packages, it is the combining of individual interventions in a management framework suited to local needs and abilities that is the critical factor.’

A third uncertainty in or weakness of clinical pathways is the variable dissemination and knowledge sharing of pathways. The international survey of the E-P-A revealed that many countries lack knowledge sharing on how care processes are organized. ⁶⁰ Most teams do not share their practical knowledge, sometimes even within the same organization. Some countries have knowledge-sharing networks and use the same pathway methodology.^{42,51,52,60,69} In Belgium and The Netherlands, a Belgian–Dutch Clinical Pathway Network ⁶⁹ was launched in 2000 with eight participating acute hospital trusts. As of 2007, this social capital network (www.nkp.be) had 106 member organizations. In contrast to this knowledge-sharing network comprising different organizations, in most other countries, knowledge-sharing networks consist of individuals that share ideas, discuss methodologies and share results.^51,52,60 In 2004, the E-P-A was launched to help individuals build knowledge-sharing networks within and beyond the borders of the European Union. The E-P-A currently has a contact person in over 25 countries. Knowledge-sharing on how multidisciplinary teams organize these care processes will become an important issue.

A fourth uncertainty in clinical pathways involves the differences in methods used to develop, implement and evaluate a pathway. One of the most glaring weaknesses in pathway methodology is the lack of integration of the latest evidence.^{43,45,60,64,70–73} The development of most pathways is based on only the peer review of pathway content by the multidisciplinary team that develops the pathway. A review by Harkleroad et al. ⁷⁴ revealed a variety of methods for developing and implementing a pathway. In 2003, Wood ⁷⁰ wrote a systematic review on the development and implementation of integrated care pathways in which she found 20 protocols describing pathway methodologies. Even if different methods exist, in all pathway projects the goal of multidisciplinary teams is to develop well-organized care processes. Currently, most pathways are developed by health-care professionals, with little direct input from patients. The increasing focus on patients ¹⁶ may result in a movement towards patient input. ³⁷ Within the Belgian–Dutch Clinical Pathway Network,^69,75 one method used to develop, implement and evaluate pathways is known as the 30-step scenario.^72,73,76 This scenario is based on Deming's ³⁰ Plan–Do–Check–Act cycle for continuous quality improvement, on results of from literature reviews^72,74 and on national and international collaboration.^64,69,75 This methodology is taught to pathway facilitators from the member organizations and is continuously updated and improved.

As stated by Degeling et al., ²¹ a clinical pathway represents a method to achieve a result. A pathway is a tool for empowering clinicians to strike a balance between the clinical and resource dimensions of care, and between the requirements of both clinical autonomy and transparent accountability. The team's perspective is essential. Pathways provide a basis for re-establishing ‘responsible autonomy’ as the primary organizing principle of clinical work. If multidisciplinary teams, including both clinicians and managers, do not work together on the re-organization of health care, all parties will continue to be driven by the distrust and related crises of confidence that pervade the field. ²¹ When teams improve their coordination, or relational coordination as termed by Gittell et al., ⁷⁷ outcomes of care also improve. Recently, the development and implementation of pathways, with a focus on teamwork, transparency and coordination, were also suggested as methods for solving safety problems. ⁷⁷ The process or mechanism of care is therefore essential in understanding how pathways work.

The outcome

Besides uncertainty in the pathway definition, use, dissemination and knowledge sharing, and methodology, the impact of clinical pathways on outcomes remains rather unclear. Several reviews have indicated that clinical pathways are linked to a variety of outcomes.^{43–45,50,71,79–86} In 2004 and 2005, our research team presented an overview of the impact of pathways as part of an introduction on pathways published by Sermeus et al. ⁴⁴ and Van Herck et al. ⁸¹ Although most results in the literature are positive, no changes, and even negative results, have also been described.^44,81

As discussed in previous reviews,^44,81 the methodologies used to assess the effects of clinical pathways are often criticized because of their research designs and sample sizes. Several potential sources of bias are present. Only a few large multicentre studies with an appropriate design are available. The published studies explored the direct relationship between the introduction of a pathway and its effect on outcome. As described in the care process organization triangle (Figure 1), the multidisciplinary process or mechanism plays a vital role in the relationship between the structure and the outcome.^{17,18,23–25} This mechanism, or the way the multidisciplinary team works and evaluates the organization of a care process, is not taken into account in most of the above-mentioned pathway research. Even though a clinical pathway in some situations may not affect patient outcome, the reasons for the lack of an effect should be investigated and understood. Although many papers have been published on the outcome of pathways, most of the pathway knowledge is found in the grey literature. This situation will certainly produce a publication bias in pathway research.

The wide range of outcomes observed can be explained by differences in study design or implementation method. An obvious explanation for these differences in outcomes, however, is the great variability in how researchers define implementation of the ‘clinical pathway’: from implementing a new patient record with minor or no changes in clinical practice (working on only the structure) to totally redesigning care given by a multidisciplinary team (working on the total process). Besides the wide variation in clinical pathway content, all these researchers tended to use the term ‘clinical pathway’ to describe the change they introduced into health care.^{39,44,45,59,79,84}