Employing Standardized Clinical Care Pathways to Improve Health Outcomes and Lower Costs



Employing Standardized Clinical Care Pathways to Improve Health Outcomes and Lower Costs


Prakash Jayakumar, MD, PhD

Eugenia Lin, MD

Kenoma Anighoro, MD, MBA

Karl Koenig, MD, MS, FAAOS


Dr. Koenig or an immediate family member serves as a paid consultant to or is an employee of Surgical Directions. None of the following authors or any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this chapter: Dr. Jayakumar, Dr. Lin, and Dr. Anighoro.



INTRODUCTION

Standardized care pathways in orthopaedic surgery offer a pragmatic, evidencebased strategy for operationalizing high-value, integrated care for a range of musculoskeletal problems while reducing unwarranted variation and waste, improving outcomes, and lowering costs. This chapter defines and explores concepts behind standardized clinical pathways (SCPs), tools and technologies enabling SCPs, and the evidence to date for SCPs in orthopaedic practice.


BACKGROUND

The transformation of practice and payment models in the United States from volume to value-based health care – defined as care improving health outcomes benefiting patients relative to cost – has been stimulated by an escalation in health care spending (from 7% gross domestic product in 1970 to 17% in 20191) without a commensurate improvement in population health outcomes.2 Underlying this health care paradox is unwarranted variation, inequity, and poor access to evidence-based treatments and preventive and supportive care, patient harm, and waste.3,4 Unwarranted variation – the variation in utilization of services that cannot be explained by variations in a patient’s condition or preferences – is reflected in widely varying outcomes of care. Inequity and poor access derive from underutilization of evidence-based interventions, especially
for the underserved, the vulnerable, and people of color. Harm relates to undertreatment as well as inappropriate diagnosis, overtreatment, and medical error; and waste involves any factor not enhancing patient outcomes or resources that could provide greater value if applied to another population.4 To date, payers, clinicians, and policymakers in US health care have used various strategies to overcome these challenges including cost containment, capitation, prior authorization of expensive services, introducing penalties, intensifying resources, and implementing new technologies. Although these efforts offer variable levels of benefit, they often fail to achieve better value for patients, tackle the inappropriate utilization of treatments and low-value interventions, or equitably distribute resources across the wider system. This is mostly because such strategies are applied to the existing health care delivery system without an emphasis on fundamentally changing the structure. Although challenging, these problems also spark opportunities to deliver greater value through improvement in the systems and processes involved in health care delivery.

Advances in the science of process improvement within complex systems have revolutionized the business sector and manufacturing industry.5 The application of “systems thinking” uses a holistic approach that focuses on the dynamic interplay between the components of various processes within a system to drive function, the changes in system function over time, and their effects on the wider system. This approach has elevated performance in a variety of fields.6,7 Further, it has been identified that more variation within a system leads to more waste, impeding the ability to consistently deliver better results. Such insights have prompted initiatives to reduce variation and increase standardization.5 Simply put, if it is assumed that every system and its processes are intentionally and optimally designed to achieve the results they get, then to improve results, the system and its underlying processes need to be changed. But how does this relate to high-value orthopaedic care?

Concepts of systems thinking and the science of process improvement have been incorporated within the field of health care quality improvement.8 A series of landmark reports in the 1990s and early 2000s, with findings such as 44,000 to 98,000 deaths occurring annually due to medical errors, brought patient safety and systems improvement to the forefront.9,10,11 When designing optimal systems, there is a need to differentiate between normal and “special cause” (or unwarranted) variation as a way to eliminate waste, mitigate harm, and achieve improved quality, outcomes, and lower costs. Orthopaedic surgery has a strong legacy in standardizing care practices, in part due to the high prevalence of conditions that often have an assortment of viable treatment options.12,13 From prophylactic antibiotics prior to total joint arthroplasty (TJA), to enhanced perioperative management of fragility fractures, the field is a rich source of processes and services that can be redesigned, tested, and standardized for improvement.14

The readiness to adopt standardized care pathways and practices has been mixed among stakeholders in health care and orthopaedics who may view such efforts as precursors of so-called cookbook or cookie-cutter medicine, where there may be a perceived loss of clinician autonomy, opportunity to exercise
professional judgement, and ability to provide individualized, patient-centered care.15,16 Instead, standardization can function as a vehicle for delivering highvalue care for patients through system and process improvements. Systemization of repetitive and broadly applicable tasks and interventions allows the measured application of best evidence and practices to create a standardized pathway that can be tweaked or adjusted to the individual, when necessary, without losing the effectiveness of reproducibility. Although each patient is indeed unique, there are sufficient commonalities and evidence-based, best practices that should be standardized in order to more predictably achieve better outcomes and lower costs.17,18 This chapter defines and explores concepts behind standardized clinical pathways (SCPs), tools and technologies enabling SCPs, and the evidence to date for SCPs in orthopaedic practice.


STANDARDIZED CLINICAL PATHWAYS



The Concept of Integration

SCPs within complex systems invariably require different levels of care integration.4,20,21,22 Integrated care is defined as coordinated care across professionals, facilities, and support systems that is continuous over time and between visits, tailored to patients’ needs and preferences and based on shared responsibility between patients and caregivers while systematically measuring outcomes.22,23 Singer et al21,23 classified integration into structural, functional, normative, interpersonal, and process integration, which dynamically interacts with contextual factors to affect quality, efficiency, and patient outcomes and experiences (Figure 1). Integrated care delivery has also been described as horizontal integration and vertical integration.24,25 Horizontal integration describes the integration of organizations that provide similar services, such as single specialty group practices, multispecialty group practices, virtual physician networks, independent practice associations, or multihospital systems. Vertical integration describes the integration of organizations offering differing levels of care, services, or functions such as hospital ownership of physician practices, physician-hospital organizations, management services, clinically integrated networks, foundation models, and financially integrated healthcare organizations. Vertically integrated systems make the clinical case for taking complete clinical and
financial responsibility for the whole patient while improving patient outcomes and experiences. These systems also make an economic case through economies of scale, broadening patient coverage while simultaneously consolidating delivery and administrative processes (reducing duplication), thereby lowering health care costs resulting from process duplication between organizations.26 Whichever form of integration, SCPs may offer more effective payer and clinician access to health data, analytics to guide management, coordination, and individualized clinical and administrative consumer experiences.27 They also serve to bolster the bottom line around meaningful, real-time communication among different clinicians – a feature that must be incentivized, facilitated, and maintained in order to deliver high-value care.







QUALITY IMPROVEMENT

Quality improvement is a framework for systematically improving care delivery to patients through a continuous and cyclical process in order to achieve predictable and sustainable results.8,28 The landmark article by Donabedian
describes the triad of structure, process, and outcome to evaluate the quality of health care alongside seven pillars of quality that aim to inform efforts to improve care.29 Further, the Model for Improvement framework, developed by the Associates in Process Improvement, provides a powerful tool to accelerate selection, testing, and implementation of changes for improvement5,8,28 (Figure 2). Three core questions are posed prior to testing involving improvement teams (discussed in the next paragraphs). Teams executing improvement projects should include members representing three areas of expertise: clinical system leadership, technical expertise, and day-to-day leadership. Clinical system leadership ensures sufficient authority to support development, testing, implementation, and maintenance of the change. Clinical leaders should anticipate implications and effect on the wider system. Technical expertise affords guidance on what to measure and how to measure using effective tools, data collection, synthesis, and visualization. Technical experts will have a deep understanding of the subject, intended change or intervention, and process(es) involved, with support from implementation scientists and improvement experts as needed. Day-to-day leadership drives the project, ensures adherence to the project plan, implements the changes and tests, and monitors the captured data while maintaining close contact with the clinical champions. The day-to-day leader also needs to have a strong understanding of the system, and how changes can trigger effects in other parts of the system. The working members of the improvement team should also work with a project sponsor – a person or group with executive authority that has access to enterprise-level management, other parts of the network, or strategies to overcome barriers, while maintaining accountability and the overarching goal.








Question 1 (Setting Aims): “What Are You Going to Improve, by How Much, Over What Time, and for Whom?”

The 2001 report, Crossing the Quality Chasm: A New Health System for the 21st Century,11 outlined six aims for improvement for healthcare systems that continue to form the basis of quality improvement: safety (avoiding injury from care intended to help patients); effectiveness (aligning care with science and avoiding overuse of ineffective care or underuse of effective care); patient-centeredness (respecting patient choices, preferences, values, and needs); timeliness (reducing wait times for patients, caregivers, and clinicians); efficiency (reducing waste); and equity (reducing variation and closing racial and ethnic gaps in health status). Aims can be developed using the SMART criteria (ie, aims that are Specific, Measurable, Achievable, Realistic, Timebound). This question relates to affected patient populations as well as systems.


Question 2 (Choosing Measures): “How Will You Know If Change Is An Improvement?”

Measurement is integral to quality improvement. This question helps define whether initiatives are on track to improve the system via reliable, user-friendly measures.8,28 Measures for improvement include outcome, process, and balancing measures. Outcome measures reflect how the system affects the patient as well as other health care stakeholders. Process measures relate to the effect on processes or systems behind the aim. Balance measures view the whole system and whether change designed to improve one or more parts of the system triggers unintended consequences elsewhere in the system. Although there are several commonalities between measurement for learning and improvement compared to measurement for research, improvement measures differ in terms of purpose (ie, knowledge to drive daily practice), process (ie, iterative testing with multiple sequential and observable tests), and practicality (ie, controlling biases from test to test and gathering just enough information to swiftly complete test cycles).


Question 3 (Selecting Changes): “What Changes Can You Make That Will Lead to An Improvement?”

Changes leading to improvement relevant to patients, health care professionals, or administrators usually relate to one or more change concepts—approaches that can develop ideas (both creatively and through application of knowledge and evidence) to inform testable interventions.8

The elimination of waste concept is defined as the removal of non-value—adding activities within organizations. Orthopaedic practices may draw upon the seven wastes exemplified by the Toyota production system in improving their processes and systems: waste of overproduction, waiting, transportation, processing (redundancy), inventory, motion, and production of defective parts or products.30 The workflow improvement concept relates to targeting workflow planning and process components that can lead to better pathways, products, and services. Changes involving the optimization of inventory require a comprehensive understanding of relevant inventory, associated capital investment, storage, handling, tracking,
access, and maintenance before reducing any surplus to minimize waste. Concepts examining change in the working environment may identify real-world opportunities to develop, test, support, and implement changes more effectively. Change concepts improving the producer/customer interface can enable stakeholders to better understand customer needs and expectations before reaping the benefits of products and services. Although many ideas for improvement can come from suppliers (ie, medical device companies, recruitment agencies), customers (ie, patients, surgeons) often provide the most valuable input. Time management concepts offer opportunities to focus on aspects such as reduction in wait times for services, cycle times for various functions and assets, lead time for obtaining supplies and deliveries, and development time for new products. Enhancing this change concept can provide a competitive advantage for practices. Reducing variation is a critical change concept that fosters improvement through increasing the predictability of quality, outcomes, and costs, related to processes and products. Strategies for handling variations often center on evidence and best practices. Error reduction is an important change concept that recognizes factors causing uncertainty within real-world settings (such as human error through handling of multiple tasks sequentially, simultaneously and/or rapidly in clinical situations). Human error is frequently associated with an individual; however, errors often trace back to failures within the system. The number of opportunities to make errors within a system combined with the probability of making an error culminate in a total error frequency. System redesign and implementing specific changes can reduce the probability of individuals making an error for a given opportunity (known as error proofing). Strategies for error proofing include reducing the number of steps within a process, incorporating safety champions and adverse event response teams, instituting periodic safety briefings and safety reporting, integrating technology to automate repetitive tasks, and implementing checks to limit errors from actions performed almost subconsciously within pathways. Finally, focusing on products and services can promote change for improvement beyond targeting processes alone. The three key questions from the Model for Improvement framework are illustrated in the context of various orthopaedic practice scenarios (Figure 3).


PLAN-DO-STUDY-ACT CYCLE

Plan-Do-Study-Act (PDSA) cycles help test change in real-world settings once team members are defined and the aims, measures, and change concepts are established. PDSA frameworks provide a cyclical, iterative, and action-oriented approach to planning, implementing, studying, learning, and acting on changes (Figure 2). “Plan” denotes plans for testing, observation, and data collection; “Do” reflects executing the test at a smaller scale while recording issues and commencing data analysis; “Study” focuses on data analysis and synthesis of results; and “Act” pertains to refinement of changes, defining modifications, assimilating learnings from the test, and preparing for the next test. The team and organization conducting the project then decides whether the change is an improvement, and to adapt, adopt, or abandon the change. After testing, learning, refining, and implementing changes at a smaller scale through several PDSA cycles, the organization

may then choose to implement changes at scale. A PDSA cycle is illustrated in the context of applying a telehealth service within an orthopaedic practice (Figure 4).











Following cycles of testing, learning, and refining changes at a relatively small scale, the change may be ready for wider implementation and spread. Spread is defined as the process of taking effective implementation processes from a pilot population and replicating the change or changes in other areas of the organization or organizational network at a local, regional, or national level. Scaling for an orthopaedic practice may require further adaptations to optimize infrastructure, sequences of tasks, and processes, resources, hiring policies, training, and financial renumeration. A range of techniques including Lean, Six Sigma, and Total Quality Management offer approaches to quality improvement and development of optimal care pathways. Regardless of which techniques are adopted, working rapidly, learning iteratively, and adhering to a systematic process of quality improvement offers the best chances of success.


TOOLS AND TECHNOLOGIES FOR ENABLING SCPs

A variety of quality and process improvement tools and technologies can help enable SCPs in orthopaedic practices. These tools and technologies can be applied to specific phases of the care pathway, to the whole pathway, or to the system in its entirety.12 Assets can be characterized at the patient, physician, and systems level and orthopaedic surgeons should leverage tools at each level in quality improvement efforts and SCP development.31,32 Many of these tools and technologies are discussed elsewhere in this book.


Patient-Facing Tools

Tools enabling the capture of patient-generated health data, defined as health-related data created, recorded, and gathered from patients (or caregivers) to help establish a patient’s health status, are integral to value-based care and SCPs.33,34



Patient-Reported Outcome Measures/Patient-Reported Experience Measures

Patient-reported outcome measures (PROMs) are validated measures of capability, mindset, and circumstances, reported by the patient, enabling quantification of the effect of medical interventions from the patient’s perspective.32,35 Similarly, patient-reported experience measures (PREMs) are subjective measures of patient experiences of healthcare systems ranging from measures of satisfaction with various structural and functional aspects of health care, such as waiting times, access to facilities, and ability to navigate services, to the quality of communication and relationships with health care professionals and teams.34,36,37 Both PROMs and PREMs have made a shift from research settings to clinical practice and policy making as indicators of patient-centered performance improvement. PROMs, for instance, are fast becoming standardized performance measures, administered at designated time points with an established risk-adjusted scoring methodology.38 Such tools will play an increasing role in reimbursement as health care shifts from volume-driven care toward outcomes and value-based care. Because reducing variation remains integral to this transformation, longitudinal data generated by PROMs can be a useful component in tracking, monitoring, and decision support within SCPs.35 Several general health-specific and condition-specific PROMs have been applied across orthopaedic practices, most commonly to measure symptoms and functional outcomes before and after surgical interventions.39 Professional societies such as the American Academy of Orthopaedic Surgeons (AAOS) and International Consortium for Health Outcome Measurement have compiled standardized outcome measures and measurement sets including PROMs for clinical application.40,41 National payers such as the Centers for Medicare & Medicaid Services incentivize PROMs collection through standardized processes of quality reporting and bonus payment initiatives.42 Further, the Consumer Assessment of Healthcare Providers and Systems provide a suite of PREMs developed by the Agency for Healthcare Research and Quality, rating key areas of patient experience related to structural, functional, and interpersonal aspects of care delivery.


Shared Decision Making-Related Outcome Measures and Patient Decision Aids

Shared decision-making (SDM) is a concept that empowers patients to become active participants in developing management plans and selecting appropriate treatments for their condition with clinical teams.43,44 In SDM, informed treatment decisions, aligned with a patient’s preferences, needs and values, are made through expert communication and high-quality patient education. SDM may be incorporated into SCPs to improve patient satisfaction, decision quality, patient outcomes, and appropriate utilization of health care resources. Shared decision making-related outcome measures can be utilized as part of an orthopaedic service’s SDM initiative alongside decision aids. In a manner similar to PROMs, shared decision making-related outcome measures provide a measure of the patient’s perspective in relation to various elements of the decision-making process, from decision
quality, level of collaboration during SDM, preparing for decision making, and decisional conflict, to decision support and satisfaction with the clinical consultation. Patient decision aids (PDAs) are tools designed to facilitate SDM by helping patients better understand evidence-based information, the potential benefits and harms of various treatments, and facilitate communication between patients and clinicians.45,46,47 Importantly, these tools are distinct from patient education materials in that they more actively direct patients toward making an informed choice, aligned with their preferences, between multiple treatment options. In orthopaedic practice, PDAs have been studied most frequently in persistently painful preference sensitive conditions (ie, where multiple valid treatment options exist) such as degenerative disease of the spine and osteoarthritis (OA) of the hip and knee.47,48,49 Decision aids take multiple forms, including written booklets, videos, and interactive digital tools, provided to patients before, during, or after encounters with orthopaedic surgeons. PDAs may also be effective in empowering patients to make informed decisions at a given point in time as well as providing ongoing guidance along different phases of a care pathway. Payers, clinicians, and policymakers are increasingly encouraging the standardization of these value-adding tools in orthopaedic practice.43,44,50 Tools and checklists for the development and application of PDAs are also provided by the International Patient Decision Aid Standards initiative.51


Physician-Facing Tools

Physician-facing tools enabling clinical decision support provide timely and relevant person-specific information to inform clinically oriented decisions that can also improve efficiency, utilization, quality, outcomes and costs of care.52,53 Such tools can be divided into clinical risk assessment tools, web-based orthopaedic personalized predictive tools, standardized clinical checklists, clinical practice guidelines (CPGs), and standardized clinical assessment and management plans (SCAMPs).

Clinical risk assessment tools provide validated metrics that can be utilized by surgeons to better assess the risks associated with a given treatment option. In orthopaedic practice, clinical risk assessment tools such as the Risk Assessment and Predictor Tool, predict length of stay and discharge destination following total joint arthroplasty.54 This function assists patients, clinicians, administrators, and caregivers in taking necessary clinical actions (eg, preparing patient charts and orders), nonclinical actions (eg, preparing for an overnight stay), and allocating resources more effectively. Similar risk assessment tools have been developed for frail, elderly patients with hip fractures to predict postoperative morbidity and mortality.55

Web-based orthopaedic personalized predictive tools provide personalized predictions of clinical outcomes based on the analysis of large volumes of data utilizing algorithmic mathematical modeling and predictive analytics.54,56,57,58,59 A recent study identified 31 discrete web-based orthopaedic personalized predictive tools designed to provide personalized prediction in various orthopaedic specialties including trauma and fracture management, spinal surgery, total joint arthroplasty, and musculoskeletal oncology.60



Standardized Checklists

Standardized clinical checklists in health care and orthopaedics, analogous to those routinely used in the aviation industry, have now become widely adopted.61 The World Health Organization Surgical Safety Checklist, since its introduction in 2008, has transformed perioperative patient safety in surgical care.61 Although this checklist is primarily designed to increase safety awareness and reduce perioperative medical error, it also enhances team communication and consistent execution of procedural steps along the surgical care pathway.62 The AAOS has developed multiple checklists through their appropriate use criteria initiative, which uses a modified Delphi method to create standardized tools, such as a preoperative checklist to facilitate hip fracture management in elderly patients.63 Further, in a move to address the social determinants of health and social unmet needs, a set of checklists and screening tools have also been developed, including the Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences, developed by the National Association of Community Health Centers,64 and the Accountable Health Communities Health-Related Social Needs Screening Tool developed by Centers for Medicare & Medicaid Services.65


CPGs and SCAMPs

CPGs are statements developed by the systematic distillation of high-quality evidence into clinical recommendations to support decision making around specific clinical scenarios.66 SCAMPs are clinician-driven tools, created by multidisciplinary teams, based on iterative and evolving analyses of internally collected data, emerging evidence, best practices, and sound expert opinion when evidence is limited. CPGs are centered on the best available evidence at a point in time and are less frequently updated compared to SCAMPs. Although CPGs provide a more rigid tool where adherence is key and deviations from guidelines are generally discouraged, their design costs are relatively low and adoption less labor intensive. In contrast, SCAMPs are dynamic entities designed around decision tree frameworks where deviations from the care pathway based on a physician’s clinical acumen is encouraged at any stage.67,68 This flexibility assumes higher design and implementation costs and tends to be more labor intensive.

Both CPGs and SCAMPs can help reduce practice pattern variations, optimize resource utilization, reduce costs, and improve patient health outcomes.69,70,71 Professional societies such as the AAOS and American College of Chest Physicians have developed numerous CPGs spanning a range of conditions and interventions69 from venous thromboembolism and antibiotic prophylaxis, to the prevention of surgical site infections.66 However, CPGs have also met with some resistance and disengagement from clinicians due to their rigid dependence on the strength of supporting evidence, the need for repeated updates every few years, and questions around their usability in more diverse patient populations.69,72 In contrast, SCAMPs may serve as a more effective and continuous process improvement tool capable of targeting diverse populations and complex clinical scenarios, as long as resources are sufficient and there is
adequate buy-in from the wider healthcare organization alongside any payers or regulatory agencies with a stake in the system.16,71


System-Level Tools


Electronic Medical Records and Data Analytic Engines

Robust, interoperable, and user-friendly electronic medical records (EMRs) are foundational tools for SCPs that enable advanced administrative and management capabilities, improved learning, and reduction in variation and waste within health systems. EMRs can also standardize care and provide a more holistic, longitudinal view of patients while improving coordination and continuity of care within multidisciplinary teams. The functions of these platforms now extend beyond basic repositories of health information, toward the administration and collection of detailed clinical metrics, patient outcomes, and other forms of data including social determinants of health. EMRs should ideally be supported by a strong data analytics engine, advanced enterprise-level data warehouse, and/or cloud systems. This will often serve as a foundational asset for most orthopaedic practices and quality improvement projects.


Patient Portals

Patient portals facilitating patient education, enabling channels for communication, and continuity of care may be part of the EMR or stand-alone, enhancing patient engagement in the care delivery process. Such portals are usually secure websites that allow patients to access personal health information online using a secure username and password.73,74 These platforms can facilitate patient-centered SCPs and quality improvement projects by providing patients with open access to a standardized set of records related to visits, medication lists, and laboratory results, as well as a secure means of communication with clinicians to request prescription refills, ask questions about their care, and schedule appointments.


Outcome Measurement Platforms

Myriad commercial and research-grade patient outcome measurement platforms exist, enabling electronic capture of PROMs and other forms of patient-generated health data. Digitization enables functionalities (eg, data visualization and analysis) and efficiencies (eg, time saving, automation). Most electronic PROM platforms support remote delivery, allowing patients to complete questionnaires by text, email, smartphone, tablet, or their desktop computers at home.75 In addition, these electronic platforms offer integration into EMRs, enabling the review of information in real time with patients and team members.39


Clinical Registries

Local, regional, and national clinical registries and databases capturing various clinical, process, and patient-level metrics may support efforts to standardize aspects of orthopaedic practices and networks.76 Several registries have been developed in the United States since the Mayo Clinic Total Joint Arthroplasty (TJA) registry in 1969, ranging from those at a regional level, such as the Michigan
Arthroplasty Registry Collaborative Quality Initiative, to national initiatives including the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement registry and the AAOS/American Joint Replacement Registry.77,78,79,80 These registries variably capture PROMs alongside clinical outcomes, including readmission rates, complications, and implant survivorship.39 Other registries, including those sponsored by industry, capture data around medical devices, enabling surveillance for safety and performance.81 The big data housed within many registries offers a powerful source of information for generating substantial clinical insights as well as opportunities for advanced decision support.77,82,83 The UK National Hip Fracture Database provides evidence to drive SCPs, influencing the development of CPGs to influence the standardized management of these common injuries.76 The UK National Joint Registry has been utilized extensively for benchmarking, reporting TJA performance in a standardized fashion, and has more recently been used to develop a patient-facing decision support tool for those considering TJA.84

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Nov 2, 2025 | Posted by in ORTHOPEDIC | Comments Off on Employing Standardized Clinical Care Pathways to Improve Health Outcomes and Lower Costs

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