6
The Patient as a Catalyst for Change

OVERVIEW

There is a growing appreciation for the centrality of patient involvement as a contributor to positive healthcare outcomes, and as a catalyst for change in healthcare delivery. This chapter presents the views of several individuals involved with programs that look to empower patients through improvements in access to health information as well as methods to make the patient an equal partner in health decision making. The era of the Internet and the personal health record greatly expands the types of information and evidence available to patients, but in a truly learning healthcare system, learning is bidirectional such that it works not only to better inform patients but also to ensure that patient preference is incorporated into “best care.” These contributions only introduce the complexities and possibilities of a truly patient-centered healthcare system, but they represent important shifts towards a system that seeks to learn from patients and provide the means for their collaboration in the delivery of care. In the first essay, Janet Marchibroda reviews a number of recent public and private initiatives promoting the use of health information technology and health information exchange and widespread adoption of the electronic health record (EHR). These initiatives are aimed at improving the quality, efficiency, and value of care, in part by providing better information to consumers and patients. Also outlined by Marchibroda are results of a recent survey by eHealth Initiative and others to determine consumer perceptions and expectations for these technologies. While there is overestimation of the current use of health IT and of interoperability, there is also growing interest in using



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The Learning Healthcare System: Workshop Summary 6 The Patient as a Catalyst for Change OVERVIEW There is a growing appreciation for the centrality of patient involvement as a contributor to positive healthcare outcomes, and as a catalyst for change in healthcare delivery. This chapter presents the views of several individuals involved with programs that look to empower patients through improvements in access to health information as well as methods to make the patient an equal partner in health decision making. The era of the Internet and the personal health record greatly expands the types of information and evidence available to patients, but in a truly learning healthcare system, learning is bidirectional such that it works not only to better inform patients but also to ensure that patient preference is incorporated into “best care.” These contributions only introduce the complexities and possibilities of a truly patient-centered healthcare system, but they represent important shifts towards a system that seeks to learn from patients and provide the means for their collaboration in the delivery of care. In the first essay, Janet Marchibroda reviews a number of recent public and private initiatives promoting the use of health information technology and health information exchange and widespread adoption of the electronic health record (EHR). These initiatives are aimed at improving the quality, efficiency, and value of care, in part by providing better information to consumers and patients. Also outlined by Marchibroda are results of a recent survey by eHealth Initiative and others to determine consumer perceptions and expectations for these technologies. While there is overestimation of the current use of health IT and of interoperability, there is also growing interest in using

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The Learning Healthcare System: Workshop Summary these tools to connect with providers and to manage care. Andrew Barbash then discusses possibilities to build on patient interests to connect with care and move toward true patient-provider collaboration. He notes that while the primary focus has been on building the tools that allow patients to take on new roles and responsibilities in managing personal health, equal effort should be put into thinking about new information models that can provide the types of information needed to appropriate users and into developing new rules of engagement for how accountability for the integrity of data, communication and response, and safeguarding privacy might be governed. Understanding how to develop an evidence base that can incorporate patient preference is an important move toward a patient-centered system. James Weinstein’s and Kate Clay’s work at the Dartmouth-Hitchcock Medical Center has helped to develop the concepts of informed choice and shared decision making as a way to get the “right rates of treatment” and “catalyzing a patient-driven change of the healthcare system.” This approach is particularly useful in cases where there is no clear “best” treatment option because such conditions are particularly value sensitive with a clear role for patient preference. Implicit in such an approach will be the use of high-quality decision aids and evidence-based information. THE INTERNET, eHEALTH, AND PATIENT EMPOWERMENT Janet M. Marchibroda eHealth Initiative Over the last five years, there has been a growing consensus among recognized experts, including many of the nation’s leading providers, employers, health plans, and patient groups; members of both the House and the Senate; leaders in nearly every federal agency involved in health care; and state and local policy makers, that healthcare information technology, and specifically mobilizing health information exchange electronically, will contribute to significant improvements in the quality, safety, and efficiency of health care. Because of the highly fragmented nature of the U.S. healthcare system, information about the patient is stored in a variety of locations, often in paper-based forms and is not easily accessed. As a result, clinicians often do not have comprehensive information about the patient when and where it is needed most—at the point of care—and those responsible for managing and improving the health of populations do not have the information they need to measure progress and facilitate improvement. In addition, those responsible for protecting the public’s health don’t have access to the information

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The Learning Healthcare System: Workshop Summary they need to identify threats and manage their response. Finally, those who are driving new research don’t have effective access to the information they need to support the creation and monitoring of the effectiveness of both evidence-based guidelines and new, more effective therapies to improve health and health care for Americans. Interoperable health information technology (HIT) and health information exchange—or the mobilization of clinical information electronically— facilitates access to and retrieval of clinical data, privately and securely, by different entities involved in the care delivery system, to provide safer, more timely, efficient, effective, equitable, patient-centered care. There are several drivers for the use of HIT and health information exchange in health care, including concerns about quality and safety, driving various incentive or “pay for performance” programs as well as programs designed to drive public reporting or transparency of measures related to quality; concerns about rising healthcare costs, driving transparency in pricing; and consumerism. These drivers have led the federal government, Congress, state leaders, and many members of the private sector to take action to increase the use of HIT in health care. This paper highlights environmental drivers, including those emerging at the national, state, and local levels, for the use of HIT in health care and explores the role of the patient as a catalyst for change for these efforts. Rapidly Emerging Policy Advancements Related to the Use of HIT to Address Healthcare Challenges In response to the fragmented healthcare system, and the quality and safety issues that result, reports from the Institute of Medicine (IOM), the Department of Health and Human Services (HHS), and several private sector groups have been pointing toward the need for an electronic, interoperable healthcare system to get information where it is needed, when it is needed, in an efficient manner. In addition to considerable leadership demonstrated in the private sector, a number of initiatives are now under way funded by HHS to address standards harmonization, application certification, prototype development, and privacy and confidentiality issues related to a nationwide health information network. On August 22, 2006, an Executive Order was issued calling for healthcare programs that are administered or sponsored by the federal government to promote quality and efficient delivery of health care through the use of HIT and to utilize HIT systems and products that meet recognized interoperability standards. As recently as December 8, 2006, HHS announced its intent to advance a “nationwide health information network initiative,” “bringing together the significant expertise and work achieved this year by the current efforts with state and local health information exchanges” to “begin to construct

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The Learning Healthcare System: Workshop Summary the network of networks that will form the basis of the NHIN.” While details are currently under development with the announcement of a Request for Information (RFI) process in the spring of 2007, HHS appears to be interested in conducting “trial implementations of the NHIN [National Health Information Network]” that are likely to leverage its investments made to date, including those related to the development of an NHIN architecture prototype, which include, among other things, functional requirements, security approaches, and needed standards. In addition to activities in the administration, Congress is also playing a considerable role. Over the last three years, much legislation has been introduced by Democrats and Republicans alike in both the House and the Senate, addressing the role of government in driving adoption of HIT, the need for standards, funding, and a host of other issues. On July 27, 2006, the U.S. House of Representatives passed the Health Information Technology Promotion Act (H.R. 4157), which was anticipated to be conferenced in the 109th Congress with the Senate version of the bill passed in November 2005. Despite considerable momentum, talks were suspended and this issue will be taken up in the 110th Congress as part of the Democratic agenda of economic, foreign policy, and healthcare reforms. A number of states are also moving forward—in parallel with federal efforts—to develop and adopt policies for improving health and health care through HIT and electronic health information exchange. State legislators are increasingly recognizing the role of HIT in addressing healthcare challenges, with 121 bills introduced in 38 states since 2005—64 of which were introduced in the first seven months of 2006. Thirty-six of such bills in 24 states were passed in the legislature and signed into law (eHealth Initiative 2006). State legislatures are not the only policy makers driving change in states—U.S. governors are increasingly recognizing the value of HIT in addressing their healthcare goals. To date, 12 U.S. governors have issued an executive order designed to drive improvements in health and health care through the use of information technology (IT). At the same time, the number of collaborative health information exchange initiatives at the state, regional, and community levels has grown considerably over the last three years. In September 2006, the eHealth Initiative (eHI) released the results of its Third Annual Survey of Health Information Exchange at the State, Regional and Community Levels, analyzing results from 165 responses from initiatives in 49 states, the District of Columbia, and Puerto Rico. Primarily nonprofit, multistakeholder organizations, these initiatives are beginning to mobilize health information electronically to support primarily services related to the delivery of care, such as those related to clinical results delivery, providing alerts, et cetera. About 20 percent of those surveyed reported that they were currently exchanging data types such as laboratory results, dictation or transcrip-

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The Learning Healthcare System: Workshop Summary tion data, inpatient and outpatient episodes, and enrollment and eligibility information. Federal Efforts Toward Value-Based Health Care Are Also Likely to Have Impact Concerns about cost and quality are also driving the federal government to take action on initiatives designed to drive value-based health care. In addition to requiring healthcare programs that are administered or sponsored by the federal government to utilize HIT systems and products that meet recognized interoperability standards, the August 22, 2006, Executive Order called for such programs to make available cost and quality information to their beneficiaries. Secretary of Health and Human Services Leavitt has spoken frequently to public audiences, calling for action to drive better care and lower costs through four cornerstones, which are detailed in the HHS Prescription for a Value-Driven Health System (Leavitt 2006): Connecting the system: Every medical provider has some system for health records. Increasingly, these systems are electronic. Standards need to be set so that all health information systems can quickly and securely communicate and exchange data. Measure and publish quality: Every case, every procedure, has an outcome. Some are better than others. To measure quality, we must work with doctors and hospitals to define benchmarks for what constitutes quality care. Measure and publish price: Price information is useless unless cost is calculated for identical services. Agreement is needed on what procedures and services are covered in each “episode of care.” Create positive incentives: All parties—providers, patients, insurance plans, and payers—should participate in arrangements that reward both those who offer and those who purchase high-quality, competitively priced health care. Several large employer groups are exploring similar measures designed to drive value-based health care. The Business Roundtable and several other employer groups joined Secretary Leavitt on November 17, 2006, to discuss taking steps similar to that of the administration’s Executive Order, utilizing an “employer toolkit” to drive implementation across markets in the United States. In September 2006 the IOM released a report entitled Rewarding Provider Performance: Aligning Incentives in Medicare, which provided a series of recommendations related to pay for performance, recognizing that

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The Learning Healthcare System: Workshop Summary “existing (payment) systems do not reflect the relative value of healthcare services in important aspects of quality, such as clinical quality, patient-centeredness, and efficiency” (IOM 2006). To add strength to fast-moving federal initiatives, on December 8, 2006, Congress passed the Tax Relief and Health Care Act of 2006 (H.R. 6408) as the 109th Congress came to a close. Among other things, the bill creates a quality reporting system for the voluntary reporting by eligible professionals of data on quality measures specified by the HHS secretary starting in July 2007. Beginning in 2008, quality measures used for data reporting will be measures adopted or endorsed by a consensus organization (such as the National Quality Forum or the AQA [Ambulatory Care Quality Alliance]), and it is specified that measures will include structural measures such as the use of electronic health records and electronic prescribing technology. A majority of emerging policies and initiatives within both the public and the private sectors, related to what has most recently been termed “value-based health care” introduce the notion that the use of HIT and health information exchange can play an integral part in increasing the likelihood that improvements in quality and efficiency will result from these initiatives. Efforts are now under way to articulate specifically how HIT and health information exchange can play a critical role in rapidly emerging quality and efficiency-focused programs. Some value-based healthcare efforts incorporate structural measures designed to promote the adoption of interoperable EHRs. Nearly all such efforts currently require or plan to require the reporting of performance measures by clinicians, which will be difficult without the existence of a either a data warehouse or a health information exchange network. Exploring the Role of the Consumer as a Catalyst for Change Consumer activation can play a key role in driving improvements in quality and efficiency, as well as the use of HIT. This section explores consumer perceptions regarding the value of HIT and health information exchange, as well as their concerns. According to research conducted by the Markle Foundation, there is a widespread overestimate of the current use of health IT and of interoperability: 40-65 percent of the public believes their doctor now has electronic health records, and 25 percent believes the emergency department can access their health record. Recent public opinion research sponsored by the eHealth Initiative Foundation further supports this overestimation, indicating that of Gulf state citizens, 29 percent believe that their doctors keep their records electronically, and 54 percent believe that backup copies of their health information are kept in electronic form, which is simply not the

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The Learning Healthcare System: Workshop Summary case. In fact, according to a recent study conducted by David Blumenthal, only 17 to 25 percent of physician offices have EHRs, with 17 percent being the best estimate based on high-quality surveys (Blumenthal 2006). According to research conducted by the eHealth Initiative Foundation in June 2006, 70 percent of Americans on the Gulf Coast favor the creation of secure, electronic health information (eHealth Initiative Foundation 2006). A similar survey by the Markle Foundation also found considerable support for the creation of a nationwide health information exchange network that has the following attributes: access to information controlled in secure online accounts; requirement for patient permission for medical information to be shared through a network; patient control of which information is made available to other physicians; and information held and maintained by individual physicians instead of a central database (Markle Foundation 2005). A survey by Public Opinion Strategies in September 2005, on the behalf of the Markle Foundation, found significant interest in using EHR-related tools: 65 percent of Americans are interested in accessing their records online, a service that could be enabled by a creation of the NHIN. While younger Americans are most likely to express interest, more than half of those 60 and older (53 percent) are interested in seeing their health information online (Markle Foundation 2005). When asked about perceived benefits, the research indicates that for the most part, consumers believe a great deal of value emerges from the use of electronic health records, HIT, or health information exchange. For example, according to the Markle Foundation, 60 percent of Americans support the creation of a secure online “personal health record” service, and a substantial number of consumers would use this tool to check and refill prescriptions (68 percent); get results over the Internet (58 percent); check for mistakes in individual medical records (69 percent); and conduct secure and private e-mail communication with physicians (57 percent) (Markle Foundation 2005). A recent report released by the Markle Foundation offers similar insights. According to this report, the public feels that access to personal electronic health records would have the following benefits: ability to see what their doctors write down (91 percent); ability to check for mistakes (84 percent); and reduction in the number of repeated tests and procedures (88 percent) (Markle Foundation 2006). Despite these benefits, there are some concerns about the use of HIT and health information exchange. According to the Markle Foundation (2006) report, while Americans see many benefits of electronic personal health information, they express concern that such information would be used for purposes other than their own care; some of the concern expressed include identity theft or fraud (80 percent) and marketing firms (77 percent), employers (56 percent), or health insurance companies (53 percent) gaining access to their records.

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The Learning Healthcare System: Workshop Summary Opportunities for Consumer Engagement Initiatives are beginning to emerge that engage the consumer, including personal health record services offered by private organizations such as WebMD, initiatives led by health plans such as that announced by America’s Health Information Plans and the Blue Cross and Blue Shield Association, and those supported by some of the nation’s largest employers—including Intel and Wal-Mart. Such initiatives—primarily national in nature—are designed to empower consumers, giving them the ability to access health information—that to date is primarily claims-based information—to help them navigate the health system. At the same time, efforts to connect clinical data and information across disparate systems are beginning to take place at the state, regional, and community levels—where health care is delivered—in many parts of the country. The eHealth Initiative Foundation survey, however, indicates that only 6 percent of such efforts are currently interfacing with consumers or patients. Data services that support provision of information to clinicians—whether in their practices, in the emergency room, or in the hospital—are ordinarily the first step for these initiatives. As efforts at the national, state, and local levels continue to mature and expand, there exists an enormous opportunity to engage consumers, who—according to research—are increasingly interested in accessing their information online. By connecting national efforts that are now beginning to interact directly with the consumer with claims-based information, to primarily state and local efforts that mobilize clinical information residing in laboratories, hospitals, and physician offices, the U.S. healthcare system has the opportunity to take a giant leap forward, bringing information not only to those who provide care and pay for care—but most importantly, to those receiving care. JOINT PATIENT-PROVIDER MANAGEMENT OF THE ELECTRONIC HEALTH RECORD Andrew Barbash, M.D. Apractis Solutions The increasing adoption of the electronic health record across a variety of settings will bring new roles and responsibilities to all those involved. As patients, family members, clinicians, and other caregivers begin to view, use, contribute to, and interact with information in the EHR, a new set of “rules of engagement” will evolve, in which accountability for integrity of data, for acting on reminders, for guardianship of privacy, and for responsible communication will require a new level of collaboration. The EHR

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The Learning Healthcare System: Workshop Summary is increasingly considered a tool that will allow for personal ownership of health information, which by necessity means that we will move away from the “institution” creating the data as a single system into a more collaborative environment that crosses the boundaries of a clinical practice, organizations, the individual patient, and the family. This paper outlines some pragmatic aspects of this for the present and future. Considering patient-provider collaboration and the electronic health record opens a new paradigm for how to think about decision support. Medical decision making is a difficult process and is even more difficult to translate into something that is easily understood by patients in general. Many medical decisions are akin to complex statistical computations and factor in likelihood of risk and benefit, with the overall issue of our confidence in the data superimposed on these elements. Does the average consumer have any concept of how to make a risk-based decision? Looking at some of the considerations, does the healthcare decision-making equation mimic any other daily decision? For example, consider: % risk of benefit − % risk of adversity × N (confidence in the data) + cost of making the choice − chance of car accident on way to the test As patients and family members gain ownership and control of more information, either through the EHR or through the vast resources now available to anyone with a computer and an Internet connection, they are asked to take a larger role in this complex process of medical decision making. Asking them to do this simply because they have the information at hand is not sufficient, and we need to think about ways to foster collaborative decision making. There are large-scale efforts under way to achieve collaboration between consumers, patients, and doctors using online resources. In addition, there is a large and growing field that examines the decision-making behavior of consumers and the internal processes that drive these decisions. Many organizations are involved in getting consumers engaged through portals, products, software, and communication processes, such as the Veterans Health Administration, Kaiser Permanente, Regional Health Information Organizations, and the Centers for Medicare and Medicaid Services (CMS), as well as commercial vendors and small practices. The true goal of these initiatives is ultimately to move toward a consumer-centered world in terms of interaction with information. However most people in the healthcare sector don’t consider collaboration tools that have been used in other indus-

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The Learning Healthcare System: Workshop Summary tries as useful in health care because fundamentally, the healthcare system as it exists today lacks a culture of collaboration. The opportunities to use EHRs as a basis for increased collaboration between patient and provider are immense. One major consideration in everyday health care is medication list management. This is a truly important area because we are caught in a paradigm where there is a disconnect between what a physician thinks a patient is taking and what the patient is taking in reality. In this case, patients have the opportunity to play a critical role in the translation of everyday information to their provider through the utility of tools such as EHRs. Currently, however, few patients think it is their responsibility to keep track of what they are actually taking. These new tools present an opportunity to change the culture that fosters this disconnect for both the patient and the provider. Another opportunity centers around the ability to update conditions and status. There is a lot of work being done on interactive patient portals where patients can manage personal health records. This will require a better understanding of how patients view their own condition relative to how a health professional would characterize them, but nonetheless has significant opportunity to benefit the patient, make disease states more understandable to the provider, and provide a means to generate information for the healthcare system. One of the key elements of EHRs is the ability to facilitate automatic alerts and reminders for physicians and patients. There are problems with assuming that this will be a great solution across the board though, because many busy providers will turn off these systems unless they are geared to be germane and timely. Alerts and reminders delivered to patients will perhaps have to have an even higher level of accuracy than they do for doctors. For example, at Mayo there only needed to be a couple of alerts sent out for an annual mammogram for patients who had had bilateral mastectomies to embarrass the whole system. There is a level of sophistication that needs to occur before something that seems so straightforward can be enacted in reality. On the other end of the spectrum, disease management and prevention are clearly areas where the role of the patient in receiving messages and the role of providers in receiving reminders to notify the patient create an important, and beneficial, communication interaction. Health care, while often talked about as a data problem, is fundamentally just as much a communication problem. Communication, on an organizational level, is highly nonpersonalized and noncustomizable. The solutions emerging are the organization’s view of how to communicate with patients, but this is very different from the patient’s perspective of what level of communication is actually desired. On the organizational level, we view patient centeredness as one context for the EHR, but in reality for patients, this is just one piece of an otherwise large puzzle. From the

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The Learning Healthcare System: Workshop Summary patient perspective, there are many other components that are part of this picture, including legal documents and financial records. Thus, we must be cognizant of the real context of EHRs, which is the reality that health care and health records are only a fraction of the multitude of factors the consumer deals with each day. Patients, families, clinicians, and care coordinators are all dealing with changing technologies, changing demographics, changing knowledge, and changing rules. We have to be highly cognizant that as patients and doctors are trying to collaborate around order management, results management, alerts management, and preventive reminders, the technology in many cases moves faster than the ability to keep up with it, which creates a very complex dynamic. Looking at patient-provider collaboration, we have key, common tasks that each entity shares at some time; they communicate, collaborate, decide, document, and validate or authenticate information. True patient-provider(s) collaboration is the same set of intersections, but with consumers playing a bigger role. For instance in MyHealtheVet, which is an interactive portal for Veterans Administration (VA) patients, patients will have access to their personal health information. If they see errors, what is their role, their responsibility, and who do they communicate with on these issues? Each entity also plays different roles at different times and the EHR needs to accommodate inquiries and searches, transforming information, ordering and requesting, communicating, documenting, and responding. Different information models are also needed. What do different users need to know and how can we best convey this to them? Agreement that everyone plays a role in even something as simple as a common shared medication list might be reasonable, but what are the relative values of similar accuracy for other “shared information?” Understanding the role of the consumer is complex enough and will be compounded by issues related to EHRs. Suppose that instead of thinking heath record collaboration specifically being oriented around the EHR, thinking shifts to collaboration in health care in general, about how consumers think about how they collaborate, and assigning tasks for different emerging “roles.” For example, most doctors do not think of themselves as collaborators online. In addition, current focus is “web-centric” but perhaps becoming “communication-centric” will allow better leveraging of the web as a communication vehicle. Finally, consumers (patients and providers) need to be more educated about the changing tools they are being confronted with that could put them at the center of their own health management. There is tremendous opportunity to begin to tackle these issues. Collaboration, occurring online, will provide insights into what new evidence is needed to move forward: what level of adoption or critical mass creates the transition point for stakeholders; how dependent “compliance” is on

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The Learning Healthcare System: Workshop Summary them at the point of care for use in the clinical encounter, and reaches an informed choice that is agreed on by patient and clinician and acted upon. Doing What Works: Evidence-Based Medicine Archie Cochrane, whose contributions to epidemiology are best known through the Cochrane Collaboration, offered the challenge of evidence-based medicine. In particular, he advocated that “because resources would always be limited, they should be used to provide equitably those forms of health care which had been shown in properly designed evaluations to be effective” (The Cochrane Collaboration 2006). Today there are numerous Cochrane groups around the world synthesizing the literature on effective care. Most are attempted meta-analyses based on inadequate studies, and nearly all suggest that more studies are needed. This is not a criticism of investigations or investigators of the past; randomized trials are difficult at best, especially in the surgical disciplines (Carragee 2006; Flum 2006; Weinstein et al. 2006b; Weinstein et al. 2006c). Yet both patients and physicians would do well to understand that at this point, medicine, in many cases, is truly more art than science, and the struggle to keep up with unproven scientific innovations threatens to overwhelm patient care. In the continuum of science and technology, the objective is to follow the trail of new evidence as it evolves and to act accordingly. Many beneficial treatments and processes in current practice are underutilized, as demonstrated by the tremendous variation in the use of such things as aspirin and beta blockers after myocardial infarction (MI), prophylactic antibiotics before surgery, and protection against deep vein thrombosis (DVT). Basing clinical practice on evidence will adjust underuse of beneficial care and overuse of preference-sensitive care that is recommended by clinicians but not preferred by patients. The Learning Healthcare System The United States is lagging behind in providing meaningful support for clinical excellence. The British National Health Service (NHS) has taken the lead in fostering a learning healthcare system by creating the National Institute for Health and Clinical Excellence (NICE). The essential components of such a system are multidisciplinary evidence-based clinical practice and a process for learning from errors (Sheaff and Pilgrim 2006). The institute is tasked with advising healthcare professionals on how to provide patients the highest standards of care. NICE is using a three-pronged approach: an appraisals program, a guidelines program, and an interventional procedures program (Rawlins 2004). It is charged with assessing clinical and cost-effectiveness of drugs, devices, and diagnostic tools. Based on these

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The Learning Healthcare System: Workshop Summary assessments, practice guidelines provide advice on whether and how these should be used. To date, NICE has produced reports on nearly 250 products. As in the Cochrane model, its work is grounded in systematic reviews of randomized trials (and observational studies when appropriate) in order to estimate the true effect size more accurately. The guidelines are developed by independent, unpaid advisory boards drawn from the NHS, academia (including economics), professional societies, and patients and patient groups; the NHS has a legal obligation to provide the resources necessary for implementation. It is fully intended that physician pay will be linked to the quality of care. Paul Shekelle, M.D., described this as “an initiative … that is the boldest such proposal attempted anywhere in the world…. With one mighty leap, the NHS has vaulted over anything being attempted in the US, the previous leader in quality improvement initiatives” (Roland 2004). Patient surveys are another new tool for the NHS. Physicians are rewarded, not for the scores, but for having surveyed the patients and then acted on the results by discussing them with patients. Physicians are now beginning to compare practices using these scores. This is a learning healthcare system in action. Rather than asking patients to learn from providers about healthcare options and recommendations, they are asked to let providers learn from them and to partner with providers in an exchange of information used to make an informed choice in real time during the clinical encounter. The use of patient surveys in the United Kingdom is a strategy that has been in place within the Spine Center at the Dartmouth-Hitchcock Medical Center (DHMC) in Lebanon, New Hampshire, since 1997 (Weinstein et al. 2000), and in the Comprehensive Breast Program at DHMC since 2004. In the late 1990s, both the Spine Center (SC) and the first Center for Shared Decision-Making (CSDM) in the United States opened at DHMC. The Spine Center was designed to be a high-performing micro-system of care that incorporates a feed forward-feed back model at the point of care. The Spine Center Patient Summary Report uses patient self-reported data “commonly used for measurement of outcomes (feedback) to the clinician for use in clinical assessment (feed forward)”(Weinstein and Clay [submitted 2006]). This design was based in part on a trial done in the early 1990s, which found that after patients viewed a shared decision-making CD on treatment choices, procedure rates changed; patients chose lower rates of surgery for herniated disc and slightly higher rates for spinal stenosis (Ciol et al. 1996; Deyo et al. 1998). The face validity of this trial was consistent with the best evidence available at the time, which called for different rates of intervention than were being observed. It was this knowledge that inspired the pursuit of the “patient as a catalyst for change” using shared decision making as the vehicle. This has become the Spine Center Learning Microsystem.

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The Learning Healthcare System: Workshop Summary Validated measurement tools are used at Dartmouth to give a snapshot of how each patient is doing in comparison to the last visit, so that care plans can be tailored by taking into account self-ratings and treatment preferences. Planning for DHMC institution-wide use of patient self-reported intake questionnaires for all patients at all points of care is well under way. This approach remains limited to pockets of excellence, because the U.S. healthcare system does not offer incentives for such patient-focused innovations, which is a significant barrier to their widespread use. Doing What Works: Shared Decision Making A minority of current healthcare practices are grounded in evidence-based information. As a profession and a system we have experienced some costly mistakes, such as recommending hormone replacement therapy to reduce cardiovascular risk in women. Millions of women were treated largely for the indication of cardiovascular health before a randomized trial demonstrated no benefit (Rossouw et al. 2002). Yet only a limited number of treatment recommendations are based on high-quality clinical trial evidence of efficacy. Decisions in health care do not, in general, have clear answers. The risk-benefit ratios are either scientifically uncertain or unknown, and their presentation to patients has not incorporated the role of values in weighing risks or benefits (Weinstein and Clay [submitted 2006]). How do we approach healthcare decision making in cases where good evidence exists and also where it does not? There is a growing movement toward the concept of shared decision making as a process that can lead clinicians and patients to an informed choice based on a clear understanding of clinical evidence or lack thereof. Shared decision making is the collaboration between patients and clinicians to come to an agreement about a healthcare decision. The process is especially useful when there is no clear “best” treatment option. Clinicians and patients share information with each other in order to understand the likely outcomes of the options at hand, think about values as they relate to the risks and benefits of each option, and participate jointly in decisions about medical care. Not all healthcare decisions are amenable to the shared decision-making process. In cases where there is strong evidence for the effectiveness of a treatment (e.g., treating a hip fracture or bacterial pneumonia), there is usually strong agreement among both clinicians and patients that these are valued interventions. However, many conditions, such as chronic low back pain, early-stage breast or prostate cancer, benign prostate enlargement, or abnormal uterine bleeding, are value sensitive. Reasons to consider higher-risk options in these cases are less clear and fall more under the purview of the patient. In such cases, the path of watchful waiting may be an option

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The Learning Healthcare System: Workshop Summary worth considering, and the valuing of risks and benefits becomes individual and personal (Weinstein et al. 2006b; Weinstein et al. 2006c). In such decisions, the best choice should, in fact, depend on a patient’s values with regard both to benefits and harms and to the scientific uncertainty associated with alternative treatment options. There is tremendous geographic variation in the use of value-sensitive options in our country. Low back pain treated with fusion is one example. Fusion surgery rates vary more than twentyfold and are dependent on where one lives and who one sees (Weinstein et al. 2006a). The rates of spine fusion rose more than 300 percent from 1992 to 2003, and the cost increased nearly 500 percent. In this example, lack of evidence-based medicine to support treatment decisions reveals significant scientific uncertainty expressed as increased regional variation and cost. Where there is significant regional variation, it is often the case that the proposed doctrine of informed choice is not considered. In such environments, the patient is the recipient of physician-based information rather than a partner in the decision-making process. Another example is insurer-based limitation of information. Recently CMS, for the first time, made a decision not to pay for a new artificial disk technology, despite Food and Drug Administration (FDA) approval. Patients should know about this option; when they are engaged in informed choice and given a balanced presentation of all options and the evidence of efficacy (or lack thereof), patients tend to make the right decisions that set the benchmark for the right rates of surgeries and medical treatments (Ciol et al. 1996; Deyo et al. 1998; Deyo et al. 2000; O’Connor et al. 2004; Weinstein 2005). Doing What Works: Patient Decision Aids One good way to ensure the provision of balanced, evidence-based information is to integrate high-quality decision aids into the informed choice process whenever possible. Numerous randomized trials indicate that decision aids improve decision quality and prevent overuse of treatments that informed patients do not value (O’Connor et al. 2004). Research has shown that the use of a patient decision aid (PtDA) as part of the process of making a treatment choice has unique value. Decision aids are defined as “interventions designed to help people make specific and deliberative choices among options (including the status quo) by providing (at the minimum) information on the options and outcomes relevant to a person’s health status” (O’Connor et al. 2004). Thirty-four randomized trials have shown that decision aids improve decision-making by: Improving knowledge of the options, pros and cons; Creating more realistic expectations;

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The Learning Healthcare System: Workshop Summary Lowering decisional conflict; Reducing uncertainty about what to choose; Enhancing active participation in decision making; Decreasing the proportion of people who are undecided; and Improving agreement between values and choices (O’Connor et al. 2004). Patients who use decision aids at DHMC rate them as having the right amount of information, being balanced in presenting information about the options, and being helpful in making their decisions, and say they would recommend the videos to others who are facing the same decision (see Table 6-1). Doing What Works: Informed Choice Focusing on patients changes the doctrine of informed consent, now antiquated and inadequate to meet the need of the current doctor-patient TABLE 6-1 Treatment Intention Before and After Video Decision Aid for Spinal Stenosis, Herniated Disc, Knee, and Hip Osteoarthritis       After Video Intention (N) Video Decision Aid Before Video Intention N Unsure Nonsurgical Surgery Spinal stenosis Unsure 65 31 30 4   Nonsurgical 91 8 80 3   Surgery 42 4 1 37   Total 198 43 111 44 Herniated disc Unsure 38 21 12 5   Nonsurgical 91 6 83 2   Surgery 45 2 3 40   Total 174 29 98 47 Knee osteoarthritis Unsure 17 7 4 6   Nonsurgical 14 0 12 2   Surgery 93 4 2 87   Total 124 11 18 95 Hip osteoarthritis Unsure 8 5 0 3   Nonsurgical 3 0 3 0   Surgery 49 2 0 47   Total 60 7 3 50 SOURCE: Author’s summary of self-reported patient questionnaires.

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The Learning Healthcare System: Workshop Summary relationship to share information in a partnership. The patient-based doctrine of informed choice transforms informed consent with the addition of shared decision-making and the use of decision aids as an impartial source of information. This process includes the following: Provision of balanced, evidence-based information on all options; Discussion of benefits and risks of each option and the likelihood that they will occur, using framing and language understandable to the patient; Elicitation of patient values and preferred role in decision making; and Arriving at a treatment decision through discussion between clinician and patient. Using these steps in the clinical encounter has been shown to actively engage patients in decision making and to arrive at a treatment choice that is the right choice because it is based on good information and on the patient’s values. Barriers to Doing What Works As with any intervention that is perceived to alter the usual doctor-patient relationship, recommendations for basing patient-focused care on evidence and fully engaging the patient in decision making can be threatening and become a barrier to implementation. The first hurdle to overcome is the resistance that comes with any change at the level of the clinician-patient encounter. In addition to resistance on the part of clinicians, there are barriers to implementing these strategies at other levels: health plans, health systems, even patients, some of whom just want the doctor to decide. Current practice incentives (e.g., fee-for-service model) are not aligned for the patient and are certainly not aligned to provide the best health care has to offer. The lack of appropriate incentives represents an important barrier to utilizing novel approaches to catalyze meaningful change. Overcoming Barriers— Value-Added Proposition for Clinicians and Patients How do we incorporate informed choice into the flow of a busy physician’s practice? How do we make decisions based on evidence and real knowledge, whether it comes from practical, pragmatic, observational, or randomized trials (Weinstein et al. 2000)? Remember, informed choice is by definition the process of interacting with patients and arriving at informed, values-based choices when options have features that patients value dif-

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The Learning Healthcare System: Workshop Summary ferently. We all value risks and benefits differently, so a one-size-fits-all approach will not work. Any new approach must be integrated easily into the normal workflow; it must improve clinical care and it must help the doctor or the doctor won’t be an advocate for it. The Spine Patient Outcomes Research Trial (SPORT) (Weinstein et al. 2006c; Weinstein et al. 2006b; Birkmeyer et al. 2002) is one example of how these barriers can be addressed in clinical practice (Weinstein et al. 2000). SPORT is a novel, practical clinical trial that utilized shared decision making as part of a generalizable, evidence-based enrollment strategy. It also took advantage of the computer as a technology partner in healthcare delivery (Birkmeyer et al. 2002; Arega et al. 2006). The SPORT multicenter trial enrolled patients at 13 centers in 11 states. It was not an add-on to the practice; it was usual care with systems already in place and shared decision making as part of the enrollment process. Patients who were eligible for SPORT viewed one of two shared decision-making videos: Treatment Choices for Low Back Pain: Herniated Disc or Treatment Choices for Low Back Pain: Spinal Stenosis. They were then offered trial enrollment and selected either the randomization cohort or the observational (preference) cohort, which allowed us to look at generalizability of the randomized arm versus the observational arm (Weinstein et al. 2006b; Weinstein et al. 2006c). The randomization cohort was randomly assigned surgical or medical management; the preference cohort chose surgery or the alternative. Using data from SPORT, we will be able to share probabilities with our patients so they have better information about their treatment options and the treatment outcomes. The issues of numeracy and patient understanding of risk-benefit information are well known and are not insignificant; thus we need to work on how we frame and transmit information to our patients and how patients interpret information so they can better understand it and make truly informed choices. An added benefit may be that patient decision aids enhance minority enrollment in clinical studies. The SPORT protocol and its use of shared decision making may have facilitated enrollment across racial groups into SPORT (Arega et al. 2006). While previous studies have demonstrated low rates of minority participation in randomized trials, SPORT investigators discovered that this likely has more to do with treatment preference than with an unwillingness to randomize (Arega et al. 2006). Preference-based trials may be a mechanism to enhance enrollment of minority populations necessary for broader indications and use in clinical practice. In a paper for Health Affairs, the principles of preference-sensitive care were applied to health economics (Weinstein et al. 2004). Data analysis showed that residents of Florida are much more likely to have surgical procedures if they live on the west coast rather than the east coast. In Florida, as in the United States in general, “geography is destiny.” From

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The Learning Healthcare System: Workshop Summary a healthcare policy perspective, this speaks not only to the quality and costs of health care, but to the value of care delivered. Employing shared decision-making tools and the informed choice process on the west coast of Florida is an opportunity in waiting, to adjust surgery rates so they are driven by patient preference rather than zip code (Weinstein et al. 2006a; Weinstein et al. 2004). In summary, resources must be redeployed utilizing best evidence and shared decision making. By allowing patients to be active partners in their healthcare decisions, there will be better prospects for resolving the economic crisis now faced. The patient as a catalyst for change is, in fact, where real change can be leveraged. Studies utilizing shared decision making for spine surgery showed a reduction in herniated disk surgery of about 30 percent (Deyo et al. 1998; Ciol et al. 1996). These tools work across the board; about 25 to 30 percent of our patients who have formed a “naïve” treatment preference actually change their preference when informed via shared decision making and tend to prefer the less aggressive procedure. Given the change in demand for procedures based on patient preferences, here is an opportunity to suggest that less is more (Fisher and Welch 2000, 1999). In a system wherein the evidence is mixed at best, why not respect patients and their values? If the evidence does not suggest a detrimental outcome, why not let our patients be the guide? Given that patients tend to be risk-averse, there is much to be gained by partnering with our patients: trust, better outcomes, better quality, and compliance. Of course, the cost of care also will be less. Now we can provide more of what really works to all of those truly in need. What we are talking about is not new; patients and doctors have always been part of the same system. We need to shift from an independent doctor-patient relationship to a relationship where we are on the same team, shifting our roles so we are coaching each other and helping each other to improve health care for each individual patient. In this respect it is important to keep in mind a quote from a factory worker who said, “If we always do what we have always done, we will always get what we have always gotten.” It is time to adopt a doctrine of evidence-based informed choice, utilizing our patients as partners and catalysts to change health care. We must not ration health care but rationalize it based on best evidence. We must adopt and implement technologies that provide the evidence necessary for best clinical practice to help all at the expense of none.

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The Learning Healthcare System: Workshop Summary REFERENCES Arega, A, N Birkmeyer, J Lurie, T Tosteson, J Gibson, B Taylor, T Morgan, and J Weinstein. 2006. Racial variation in treatment preferences and willingness to randomize in the Spine Patient Outcomes Research Trial (SPORT). Spine 31(19):2263-2269. Birkmeyer, N, J Weinstein, A Tosteson, T Tosteson, J Skinner, J Lurie, R Deyo, and J Wennberg. 2002. Design of the Spine Patient Outcomes Research Trial (SPORT). Spine 27(12):1361-1372. Blumenthal, D. 2006 (September 12). Institute for Health Policy, Massachusetts General Hospital/Harvard Medical School, Presentation to the Department of Health and Human Services American Health Information Community. Washington, DC. Carragee, E. 2006. Surgical treatment of lumbar disk disorders. Journal of the American Medical Association 296(20):2485-2487. Ciol, M, R Deyo, E Howell, and S Kreif. 1996. An assessment of surgery for spinal stenosis: time trends, geographic variations, complications, and reoperations. Journal of the American Geriatric Society 44:285-290. The Cochrane Collaboration. 2006. The Name Behind the Cochrane Collaboration (accessed November 30, 2006). Available from http://www.cochrane.org/docs/archieco.htm. Deyo, R, E Phelan, M Ciol, D Cherkin, J Weinstein, and A Mulley. 1998. Videodisc for Back Surgery Decisions: A Randomized Trial. HS08079, Agency for Health Care Policy and Research, National Institutes of Health, Washington, DC. Deyo, R, D Cherkin, J Weinstein, J Howe, M Ciol, and A Mulley Jr. 2000. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Medical Care 38(9):959-969. eHealth Initiative. 2006 (August). States Getting Connected: State Policy Makers Drive Improvements in Healthcare Quality and Safety Through IT. Washington, DC: eHealth Initiative. eHealth Initiative Foundation. 2006 (October). Gulf Coast Health Information Technology Services Project. Funded by DHHS. Fisher, E, and H Welch. 1999. Avoiding the unintended consequences of growth in medical care: how might more be worse? Journal of the American Medical Association 281(5):446-453. ———. 2000. Is this issue a mistake? Effective Clinical Practice 3(6):290-293. Flum, D. 2006. Interpreting surgical trials with subjective outcomes: avoiding UnSPORTsman-like conduct. Journal of the American Medical Association 296(20):2483-2485. Greenspan, A. 2004 (August 27). Remarks by Chairman Alan Greenspan (accessed April 3, 2007). Available from http://www.federalreserve.gov/boarddocs/speeches/2004/20040827/default.htm. Hawker, G, J Wright, P Coyte, J Williams, B Harvey, R Glazier, A Wilkins, and E Badley. 2001. Determining the need for hip and knee arthroplasty: the role of clinical severity and patients’ preferences. Medical Care 39(3):206-216. IOM (Institute of Medicine). 2006. Rewarding Provider Performance: Aligning Incentives in Medicare. Washington, DC: The National Academies Press. Leavitt, M. 2006. Better Care, Lower Cost: Prescription for a Value-Driven Health System. Washington, DC: Department of Health and Human Services. Markle Foundation. 2005 (October). Attitudes of Americans Regarding Personal Health Records and Nationwide Electronic Health Information Exchange: Key Findings From Two Surveys of Americans. Conducted by Public Opinion Strategies. Available from http://www.phrconference.org/assets/research_release_101105.pdf (accessed April 4, 2007).

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The Learning Healthcare System: Workshop Summary ———. 2006 (November). National Survey on Electronic Personal Health Records. Conducted by Lake Research Partners and American Viewpoint. Available from http://www.markle.org/downloadable_assets/research_doc_120706.pdf (accessed April 3, 2007). O’Connor, A, D Stacey, V Entwistle, H Llewellyn-Thomas, D Royner, M Holmes-Royner, V Tait, V Fiset, M Barry, and J Jones. 2004. Decision aids for people facing health treatment or screening decisions. Cochrane Library. Available from http://decisionaid.ohri.ca/cochsystem.html (accessed October 17, 2006). Rawlins, M. 2004. NICE work—providing guidance to the British National Health Service. New England Journal of Medicine 351(14):1383-1385. Roland, M. 2004. Linking physicians’ pay to the quality of care: a major experiment in the United Kingdom. New England Journal of Medicine 351(14):1448-1454. Rossouw, J, G Anderson, R Prentice, A LaCroix, C Kooperberg, M Stefanick, R Jackson, S Beresford, B Howard, K Johnson, J Kotchen, and J Ockene. 2002. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. Journal of the American Medical Association 288(3):321-333. Sheaff, R, and D Pilgrim. 2006. Can learning organizations survive in the newer NHS? Implementation Science 1:27. Weinstein, J. 2005. Partnership: doctor and patient: advocacy for informed choice vs. informed consent. Spine 30(3):269-272. ———. 2006. An altruistic approach to clinical trials: the national clinical trials consortium (NCTC). Spine 31(1):1-3. Weinstein, J, and K Clay. Submitted 2006. Informed patient choice: assessment of risk/benefit tradeoffs for surgical procedures and medical devices. Health Affairs. Weinstein, J, P Brown, B Hanscom, T Walsh, and E Nelson. 2000. Designing an ambulatory clinical practice for outcomes improvement: from vision to reality: the Spine Center at Dartmouth-Hitchcock, year one. Quality Management in Health Care 8(2):1-20. Weinstein, J, K Bronner, T Morgan, and J Wennberg. 2004. Trends and geographic variations in major surgery for degenerative diseases of the hip, knee, and spine. Health Affairs (Millwood) Supplemental Web Exclusive:VAR81-9. Weinstein, J, J Lurie, P Olson, K Bronner, and E Fisher. 2006a. United States’ trends and regional variations in lumbar spine surgery: 1992-2003. Spine 31(23):2707-2714. Weinstein, J, J Lurie, T Tosteson, J Skinner, B Hanscom, A Tosteson, H Herkowitz, J Fischgrund, F Cammisa, T Albert, and R Deyo. 2006b. Surgical vs. nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. Journal of the American Medical Association 296(20):2451-2459. Weinstein, J, T Tosteson, J Lurie, A Tosteson, B Hanscom, J Skinner, W Abdu, A Hilibrand, S Boden, and R Deyo. 2006c. Surgical vs. nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. Journal of the American Medical Association 296(20):2441-2450.

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