ADVANCE CLINICAL HEALTHCARE MANAGEMENT (HCM 403)USES OF QUALITATIVE AND QUANTITATIVE TOOLS TO MONITOR AND IMPROVE PERFORMANCES: The necessity for quality and safety improvement initiatives permeates health care.1, 2 Quality health care is defined as “the degree to which health services for individuals and Populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge’3 (p. 1161). According to the Institute of Medicine (IOM) report, To Err Is Human the majority of medical errors result from faulty systems and processes, not individuals. Processes that are inefficient and variable, changing case mix of patients, health insurance, differences in provider education and experience, and ‘numerous other factors contribute to the complexity of health care. With this in mind, the [OM also asserted that today's health care industry functions at a lower level than it can and should, and it put forth the following six aims of health care: effective, safe, patient-centered, timely, efficient, and equitable 2 The eims of effectiveness and safety are targeted through process-of-care measures, assessing whether providers of health care perform processes that have been demonstrated to achieve the desired aims and avoid those processes that are predisposed toward harm. The goals of measuring health care quality are to determine the effects of health care on desired outcomes and to assess the degree to which health care adheres to processes based on scientific evidence or agreed to by professional consensus and is consistent with patient preferences. More than 40 years ago, Donabedian27 proposed measuring the quality of health care by observing its structure, processes, and outcomes. Structure measures assess the accessibility, availability, and quality of resources, such as health insurance, bed capacity of a hospital, and number of nurses with advanced training. Process measures assess the delivery of health care services by clinicians and providers, such as using guidelines {or care of diabetic patients. Outcome measures indicate the final result of health care ‘and can be influenced by environmental and behavioral factors. Examples include mortality, patient satisfaction, and improved health status. Twenty years later, health care leaders borrowed techniques from the work of Deming28 in rebuilding the manufacturing businesses of post-World Wer II Japan. Deming the father of Total Quality Management (TQM), promoted “constancy of purpose” and systematic analysis and measurement of process steps in relation to capacity or outcomes. The TQM model is an organizational approach involving organizational management, teamwork, defined processes, systems thinking, and change to create an environment for improvement. This approach incorporated the view that the entire organization must be committed to quality and improvement to achieve the best results.29 In health care, continuous quality improvement (CQ) is used interchangeably with TQM.CQI has been used as a means to develop clinical practice30 and is based on the principle that there is an opportunity for improvement in every process and on every ‘occasion.31 Many inhospital quality assurance (QA) programs generally focus on issues identified by regulatory or accreditation organizations, such as checking documentation, reviewing the work of oversight committees, and studying credentialing processes.32 There are several other strategies that have been proposed for improving clinical practice. For example, Horn and colleagues discussed clinical practice improvement (CPI) as a * multidimensional outcomes methodology that has direct application to the clinical ‘management of individual patients~33 (p. 160). CPI, an approach lead by cinicians that attempts a comprehensive understanding of the complexity of health care delivery, uses a team, determines @ purpose, collects data, assesses findings, and then translates those findings into practice changes. From these models, management and clinician commitment and involvement have been found to be essential for the successful implementation of change.34~36 From other quality improvement strategies, there has been particular emphasis on the need for management to have faith in the project, communicate the purpose, and empower staff. PROCESS IMPROVEMENT Hospital systems across the country face a number of pressing problems: clinical variation, preventable medical errors, hospital acquired infections, delays in patient discharge, and dwindling cash flow. While health systems need to consistently innovate in order to tackle these problems, many quality improvement projects fail to deliver on ROL. While there are many different definitions of quality improvement, the Health Resources and Services Administration (HRSA) defines it as “systematic and continuous actions that lead to measurable improvement in health care services and the health status of targeted patient groups.” In addition to a practical definition, health systems need a roadmap to help guide successful quality improvement projects forward. Health Catalyst has focused on helping health systems identify, prioritize, and succeed in tacking quality improvement projects since 2008. With the right evidence, analytics, and methods, providers and improvement teams can transform healthcare, improving the quality of care delivered to the patients they serve and the bottom line. Health Catalyst offers a roadmap to use best practice, adoption, and analytics together to drive outcomes improvement. This article provides examples of quality improvement in healthcare that may help others in their journey. Clinical Examples of Quality improvement in Healthcare Healthcare systems working to improve clinical quality face the difficult challenge of aligring changes across the organization. But health systems can learn from successful clinical quality improvement projects and implementing key principles of their success. Below are three successful clinical examples of quality improvement in healthcare covering a wide range of issues facing many health systems today.1. Pharmacist-led Medication Therapy Management Reduces Total Cost of Care The first example is a recent project to improve patient outcomes and reduce cost where Allina Health leveraged their analytics system to demonstrate the impact of their pharmacistled medication therapy management (MTM) in reducing the total cost of care. In order to reduce medication-related adverse events the health system initially considered expanding the involvement of pharmacists performing medication therapy management (MTM) to a group of Medicaid patients covered by a shared-tisk contract. Before making this decision and developing a comprehensive business plan, the health system wanted to better demonstrate the unique impact pharmacists were making on patient outcomes. The health system leveraged its analytics platform and Health Catalyst professional services to perform a comprehensive analysis. The analysis demonstrated the unique, positive impact pharmacist medication therapy management program is making on patient outcomes in the six-month period following the pharmacist MTM. This program is effectively reducing the total cost of care. 2. Optimizing Sepsis Care Improves Early Recognition and Outcomes The second example of a clinical quality improvement project deals with an issue wellknown to hospital systems. Sepsis is a major driver of mortality in the U.S.~it's estimated that up to half of all hospital deaths are linked to the infection. Identifying sepsis early can be challenging, as the patient’ s physical response presents as a syndrome of non-specific symptoms, which delays recognition, diagnosis, and treatment ~all of which increases mortality rates Mission Health, North Carolina's sixth largest health system, had previously implemented evidence-based sepsis care bundles. However, their processes for identifying patients with sepsis and initiation of care was fragmented and varied widely across the system, negatively impacting outcomes. By using a comprehensive data-driven approach to facilitate early sepsis identification and standardize the treatment of sepsis, including the addition of evidence-based alerts, Mission Health gained insights into sepsis performance to drive improvements. Using this comprehensive approach for early recognition and treatment, they achieved substantial improvements in sepsis outcomes, including the following: 1% relative reduction in mortality for patients with severe sepsis and septic shock 9% relative difference in mortality for patients that received the evidence based protocols compared to those who did not —the evidence-based protocols substantially reduce mortality 4% relative reduction in emergency department (ED) length of stay (LOS) for patients with severe sepsis and septic shock. Four percent relative reduction in ICU LOS for patients with severe sepsis and septic shock admitted from the ED. The health system will continue to use this proven plan to improve sepsis outcomes andenhance care for patients with sepsis and they are laying the groundwork to move the early identification screening tools to the outpatient setting, including urgent care centers and physician offices. 3. Boosting Readiness and Change Competencies Key to Successfully Reducing Clinical Variation This example of clinical quality improvement in healthcare comes from UnityPoint Health, a healthcare system serving lowa, westem Illinois, and southern Wisconsin. System leaders recognized the importance of reducing clinical variation and the need to have strong physician champions and robust analytics to effectively support improvement efforts. However, they also realized that without understanding organizational strengths and weaknesses related to adopting change and improving outcomes, they would struggle to successfully implement initiatives that delivered the desired benefits and sustained improvements over time. By consistently integrating information from a readiness assessment, an opportunity analysis, and expert resources, the health system was able to esteblish a prioritization and implementation approach to outcomes improvement that produced the following results: Variable costs were reduced by more than $1.75 million based on the deployment of interventions in sepsis alerts, order sets, and other clinical decision support tools. Reductions in length of stay have allowed patients to return home earlier and spend more than 1,000 additional nights in their homes. lions of clicks have been reduced for clinicians based on deployment of new sepsis screening tools. 36% increase in sepsis screenings completed in the emergency department (ED). Sepsis order set utilization in the ED has increased by more than 185 percent. The health system plans to continue identifying large improvement opportunities aligned with its strategic planning cycle and the priorities identified by clinical and operational leadership.4. New Generation Activity Based Costing Accelerates Timeliness of Decision Support The first example comes from UPMC, an academic medical center affiliated with the University of Pittsburgh. Health system leaders recognized that the common denominator to addressing threats to sustainability is to fully understand and effectively manage costs. To address this, they implemented activity-based costing (ABC), facilitated by the Health Catalyst CORUS™ Suite, to deliver detailed and actionable cost data actoss the analytics environment, and support service line reporting, contract modeling, and clinical process improvement. They used this capability to effectively drive cost savings and improve clinical outcomes in many of its service lines, including Surgical Services, Women's Health, Orthopedics, and Cardiovascular.5. Systematic, Data-Driven Approach Lowers Length of Stay and Improves Care Coordination The second example comes from Memorial Hospital at Gulfport. The hospital was faced with declining revenue due to changes in Medicare and Medicaid reimbursements.Hospital leaders knew additional methods of providing more efficient and costeffective quality care were needed to maintain long-term success. Improving and reducing length of stay (LOS) improves financial, operational, and clinical outcomes by decreasing the costs of care for a patient. It can also improve outcomes by minimizing the risk of hospital-acquired conditions. DEFINITION AND SOURCES OF PROCESS VARIATION All manufacturing and measurement processes exhibit variation. For example, when we take sample data on the output of a process, such as critical dimensions, oxide thickness, or resistivity, we observe that all the values are NOT the same. This results in a collection of observed values distributed about some location value. This is what we call spread or variability. We represent variability numerically with the variance calculation and graphically with a histogram. The standard deviation (square root of the variance) gives insight into the spread of the data through the use of what is known as the Empirical Rule. This rule (shown in the graph below) is: Approximately 60-78% of the data are within a distance of one standard deviation from the average (x"-s,x"+8). Approximately 90-98% of the data are within a distance of two standard deviations from the average (x"-2s,x"+2s). More than 99% of the data are within a distance of three standard deviations from the average (x"-3s,x"+3s). This observed variability is an accumulation of many different sources of variation that have occurred throughout the manufacturing process. One of the more important activities of process characterization is to identify and quantify these various sources of variation so that they may be minimized There are not only different sources of variation, but there are also different types of variation. Two important classifications of variation for the purposes of PPC are controlled variation and uncontrolled variation. CONTROLLED VARIATION Variation that is characterized by a stable and consistent pattem of variation over time. This type of variation will be random in nature and will be exhibited by a uniform fluctuation about a constant level. UNCONTROLLED VARIATION Variation that is characterized by a patter of variation that changes over time and hence is unpredictable. This type of variation will typically contain some structure. This concept of controlled/uncontrolled variation is important in determining if @ process is stable. A process is deemed stable if it runs in a consistent and predictable manner. This means that the average process value is constant and the variability is controlled. If the variation is uncontrolled, then either the process average is changing or the process variation is changing or both. The first process in the example above is stable; the ‘second is not. In the course of process characterization we should endeavor to eliminate all sources ofuncontrolled variation. Sources of Variation Statistics: the Language of Variation We have statistics to describe the variation that occurs in our world. Statistics is the language of variation. if each of your produced products were identical in every way to all products produced, with no variability, we wouldnt be concerned with the effect of variation on the performance and reliability of our designs. Yet, variation does happen and we have a range of tools to identify and minimize the naturally occurring variation. One of the roles of a reliability engineer is to identify and minimize variation that increases the probability of failure. Let's look a that occurs. generic manufacturing process to identify the various sources of variation Total process spread ~ is the accumulated variations from all sources, Lot to lot variation - is the differences that occur from one batch of material or processing to the next The equipment we use, the raw materials, and processing conditions are all different for each lot, even when everything else is the same, lot to lot variation reflects the variation of the incoming materials and stability of the process. Stream to stream variation ~ is the differences that occur from one process stream (sequence of equipment or tools) to the next. Even in the same factory with two production lines of the same equipment models and process steps will produce products that are consistently different. Even factors like the different in temperature and humidity due to different physical location may be sufficient to cause the variation. Also, the differences in equipment and processing between the two lines contribute to stream to stream variation Time to time variation ~ reflects the difference over time. This is within or between lots, or within or between streams, just time will change equipment. Daily or seasonal variations in temperature may be sufficient to cause changes. Also, consider the physical changes to equipment over time (wear, corrosion, etc.) along with changes in how the people change (experience, attention, etc.) as it impacts product consistency. Piece to piece variation ~ Even controlling or minimizing all the above sources of variability no two items, even produced one right after the other on a production line, are the same. They have physically different material as @ minimum, yet often do exhibit arange of variations that may include welding joint strength differences due to slight changes in material, changes in coatings, due to small differences in surface contamination or material roughness, etc. Within piece variability - captures the variation across the product. For example, the coating on a steel tube may vary in thickness along the length of the tube. The steel also varies along the length in thickness, composition, and strength, for example. Very few materials have absolutely uniform material properties over the area or volume used in products, while often an acceptably small variation, it sometimes becomes important. Inherent error of measurement ~ in order to detect differences we make measurements. Measurement error includes both human and equipment components and left uncontrolled may dominate the sources of variability. Often measurements actually change the product being measured, thus there is a variation from measurement to measurement due to physical changes caused by the measurement. Considering and minimizing measurement error (and damage) is a great starting point to then focus on which next source of variability to improve next. Variation happens and it's with an understanding of the sources of variation along with adequate measurement techniques that we can work to create products consistently and avoid product failures. METHODS USED IN MONITORING AND MANAGING PROCESS VARIATION One size fits all. It's an attractive notion for those of us who like the idea of a quick fix. In my experience, however, whether it’s a cap, a pair of socks, or a business process - the likelihood of one mould suiting everyone is seldom the case. For some organizations, business processes vary by geography, by industry, or due to legal requirements. And yet, good business practice dictates that process standardization can increase efficiency, clarify expectations and optimize productivity. While standardized processes have been proven to save time and minimize errors, sometimes a cookie-cutter approach to the execution of tasks can cause more problems than it solves. Expect there to be variations in your processes Increased globalization and advancements in technology see businesses constantly reinventing themselves. With the universal adoption of ecommerce, even the smallest of companies can now do business with customers and vendors in regions that are temoved from their headquarters. Yet those that take advantage of these types of opportunities are required to deal with a range of variables which inherently conflict with process standardization, and can include country-specific product attributes, customer characteristics, regulations and legislations.To operate effectively despite these challenges, organizations would do well to start by capturing those variations that differ from their core processes — adaptations of the standard processes that take the relevant variables into account, while still aiming for the same outcome. For example, a U.S. company that produces food products for domestic use as well as for export to Canada will need a standard process that uses the customary system as a weight unit for the U.S. and a process variation that uses the metric system as a weight unit for Canada. 3 pitfalls to avoid While the need for a flexible approach to managing process variations is obvious, executing on the requirement is often challenging, Over time | have seen organizations frequently approach process variations in one of the following three ways: + Create high-level standard processes: Standard processes are defined only at a high level and aren't functional as practical guidance. This situation is often found in newly-founded companies. + Create mega-processes: Often encountered during change initiatives and in technical teams, this scenario involves the meticulous, detailed documenting of every possible process variation. Due to the complexity of the documentation, this system often fails. + Create individual process variations: In more mature organizations, management often allows this approach, which leads to siloed processes and process sprawl. It ‘compromises the organization's ability to change and complicates administration. Clearly, these three methods fail to deliver the efficiency, productivity and visibility ‘organizations are looking to achieve with process standardization 7 ways to effectively manage process variations It is possible for organizations to effectively handle their need for variations outside of their core processes, Here are seven steps to keep in mind: 1. Create a global standard process as a foundation for all variations. With a centralized governance team that consists of global process owners, you can use global processes as benchmarks against which the variations can be measured. 2. Establish local vatiations where necessary. Local process variations can be cteated by process variant experts, who must ensure their differences are highlighted against the standard processes.3. Ensure all process variations are visible. All variations on every process need to be carefully reviewed and compared to standard processes. 4, Make sure teams have easy access to the relevant variations. Leverage a platform that automatically routes teams to those process variations that apply to their business unit, location or other characteristic. Alternatively, provide a list from which they can select the relevant variations. 5. Notify owners of process variations or changes to the standard processes. They can review the changes and either incorporate them into their specific variations or reverse them and keep their variations unchanged. 6. Implement global reporting. Global process owners can review and consequertly reject or approve variations. 7. Gather and analyze cost and time data. With this information, you can compare the effectiveness of process variations against standard processes, and determine their efficiency. ADVOCATE FOR THE NECESSITY OF THE ALWAYS ORGANIZING CARE BASED ON VALUE CREATION FOR THE BENEFITS OF PATIENT AND CITIZENS ‘Another way to facilitate clinical decision-making and patient centeredness in health care is to organize the process of care around the concept of value: a health care system based on value has as a key component, the enhancement of patient ~ doctor communication, and the use of SDM. In accordance with this, a study showed that 69% of patients with lung cancer and 81% of patients with colorectal cancer experienced some difficulties in understanding the goals of their treatments and, consequently, they were ‘not able to make aware decisions. 30 Between 2006 and 2013 at the Institute for Strategy and Competitiveness, based at the Harvard Business School, Porter and Teisberg developed and proposed @ new health care system based on value, “a breakthrough framework for redefining health care competition based on patient value."31 According to value-based principles, a health care system should co-create and measure outcomes that are meaningful for patients with similar needs along the whole care pathway.32 A value-based health system should refer to three important principles. 33 First, its proper goal should be the value it provides to the patient. In health care, the meaning of value varies along a continuum where psychological and physical outcomes meet costs. In fact, we can refer to value either from a psychological or from an economic perspective. Following Porter's idea, value is expressed as the best “health outcomes achieved perdollar spent."34 By “health outcomes”, it is meant the health results that matter for the patient's condition over the care cycle, and by “costs”, they refer to the total costs of care {or patient's condition over the care cycle. ‘Second, treatment delivery should be based on medical conditions, and on the course of treatment, a patient has to undergo treatment and, finally, outcomes should be measurable and recorded.35 Data must be collected along the entire patient cycle of care because the outcomes achieved are more effective measures than the number of services delvered - that we could not previously know if they ere properly and successfully used. Moreover, outcomes should be interpreted on the basis of the true costs effectively delivered across the full care cycle because cost reduction without considering outcomes is dangerous and self-defeating. Value-based approaches consider cost measurement in a similar way to outcomes measurement, that is, around individual patients for all their care, rather than the cost of each organization delivering care. A value-based system goes hand in hand with patient centeredness: today's fragmented health care system should move toward what patients want, considering and respecting their feelings in clinical procedures. Health care management is clearly moving toward a patient-centered system (PCS), where outcomes achieved and units organized around the patient's needs are the main guidelines for the delivery of high-value care 32,40 In fact, the IOM defines patient-centered care as “care that is respectful of and respective to individual patient preference, needs and values, and ensure that patient values guide all clinical decisions. * 41,42 Biological information must be integrated with beliefs and cognitive dispositions to empower patients and make them active participant in the treatment process.43 These features are also stressed by the PS medicine approach to build a medicine that involves both medical and psycho-cognitive aspects. The health care system is moving toward a P5 medicine, which is a predictive, personalized, preventive, participatory, and psycho-cognitive medicine. The fifth P refers to an integration among needs, values, cognitive dispositions, and medical information, between psychological and biological aspects.41 The necessity of a psychological and cognitive profile, instead of a mere diagnostic patient's classification, leads to an assessment with psychomettic tools that include cognitive, decision-making, and mental aspects, as well as clinical ones. The consideration of all these aspects is important to empower the patient, improve his/her QoL, and move toward their becoming an active decision-maker.43 To obtain a complete evaluation of medical treatment and to determine its value, it is necessary both balancing the costs with the benefits and considering the range of patient preferences or costs offsets: only with a careful assessment of all these aspects, high-value care will be provided. If we do not keep in mind outcomes, safety, and patient satisfaction, we could tun into unexpected costs and lower level of care. Nowadays, different studies and updated clinical practice guidelines underline the importance of heeding both costs and values if we want a health care system effectively patient centered. New normativeguidelines should include value and cost to achieve best performance measures and improve all health care system, as we can read on the report of American College of Cardiology/AHA statement on cost/value methodology6 These guidelines should give ‘some important recommendations for appropriate exercise testing in patients with cardiovascular disease.44 On the basis of these recommendations, a recent randomized trial45 regarding diagnostic testing in women with suspected coronary artery disease demonstrated how the only difference between two groups (treadmill exercise electrocardiographic testing Ys exercise myocardial perfusion imaging) was costs and not outcomes: the first intervention was more cost-effective and less invasive than the second one. This example shows how cost considerations can be informed by patient's values. ‘A good physician should be able to communicate in the right way with patients and to assess their health literacy and comprehension regarding different treatment options, possible benefits, and harm.46 These features are fundamental in the clinical decision-making process and are a cornerstone in a value-based health system. Indeed, ‘one of the main recommendations to implement a value-based health system is to actively involve the patient in his or her process of care.33 At the same time, medicine and the whole health care system are facing a shift toward the patient empowerment paradigm that is linked with different aspects of patient Participation. Although there is no unanimous agreement, current studies define this paradigm as a multidimensional concept where communication, decision, and health care system combined together and converge in the enhancement of the patient 47,48 Every definition emphasizes a specific aspect of the empowerment process: awareness, responsibility, participation in the care process, SDM, and patient-doctor communication. ‘An empowered patient has developed specific abilities to interact with the health care system and to make better choices that include value for him or her. An empowerment process allows the patient to be an active and effective participant in their process of care and to look for valuable and useful information for their health. This is why empowerment should be considered in each step of the value chain and should influence the decision-making process in a PCS. These features are also prominent in the value health care model and attach importance to psychological aspects influencing the process of care because empowered patients become effective people, able to choose valuable paths of care and of life.