PatientsChartingCourse

base, as well as helping to ensure the availability and integrity of the clinical data that shape conclusions on evidence.

Approaches are needed that draw effectively on both public and private capacities: Several times in the course of the meeting it was pointed out that although the total investment in clinical effectiveness research in the United States is substantial, it is inefficient because of the absence of a vehicle for common priority setting and coordination of efforts and because the work on effectiveness done by private companies in product development and testing is usually not accessible to the broader community. Several models are in development to establish public–private collaborative efforts to improve the efficiency and effectiveness of the work.

Efficiency and effectiveness compel globalizing evidence and localizing decisions: Reference was made throughout the meeting to work going on elsewhere in the world. This brought clearly into play the need to ensure that, where possible, common work to assess an intervention’s clinical effec- tiveness—or collective work to assess the body of evidence—be collaborative and well-coordinated across boundaries, while also being mindful that different cultural and policy environments may lead to different decisions at the local level.

6. DIGITAL PLATFORM

Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care

Build a shared learning environment: HIT provides an opportunity to change the current environment in which health decisions are made to one of shared input and active participation from patients, caregivers, and the population at large. Approaches to developing­ this shared learning environment discussed include the direct involvement and support of the patients’ and population’s roles in the generation of knowledge through the incorporation of user-generated data; under­ standing the benefits of information use in patient care and population health improvement; and improving patient access to health information to allow for a more active role in care decisions.

Engage health and health care, population and patient: Many participants reiterated that in order to improve health outcomes for the nation, thinking must extend beyond clinical encounters, and even beyond the individual patient,­ to the population as a whole. This shift of scope brought into clearer focus several issues discussed, including: the opportunity to use HIT and its associated information to build a concept of health that is about more than medical care, and draws on seamless interface with information from non-medical health-related sources to generate knowledge that allows for a more inclusive view of population health improvement.

Leverage existing programs and policies: A foundational assumption during the discussions was the advantage provided by building on the substantial recent progress, both nationally and internationally, with an emphasis on the importance of fostering coordination among these efforts to capture efficiencies and prevent unnecessary duplication and waste going forward. Participants often noted that recent policies and legislation have laid a foundation for this work, and that the resulting investments and progress can be leveraged to move toward long-term system goals.

Embed services and research in a continuous learning loop: Meeting participants often underscored that a digital infrastructure that supports both the generation and use of knowledge cannot be effective unless it is integrated seamlessly within the processes from which it draws and is meant to support: care delivery, research, quality improvement, and population health monitoring. Ease of use for health system stakeholders, attention to the effects on workflow, and the delivery of useful decision support at point of care were often mentioned in discussions.

Anchor in the ultra-large-scale (ULS) system approach: One of the most prominent features of the discussions was the notion that the health system is a complex, socio-technical ecosystem, and therefore requires a new way of thinking. Grounding the approach to coordination and integration of the digital infrastructure for the learning health system in the principles of a ULS system approach was suggested by several workshop participants from the computer science community. The term “ultra-large-scale system” refers to the existence of a virtual system of unprecedented scale and complexity, working from multiple platforms and used by multiple participants and stakeholders with cross-cutting common purpose at some level—e.g., improving health and health care. Overall ULS functionality is therefore facilitated by protocols that allow maximum practical flexibility for participants. Incorporating decentralization of data, development, and operational authority and control, this approach fosters local innovation, personalization, and emergent behaviors. Participants felt that this approach was well

suited to the complex adaptive characteristics of the health system, and that it could serve as an anchoring framework for approaching both the social and technical components of the overall infrastructure.

Emphasize decentralization and specifications parsimony: In line with the complex adaptive qualities of the health system outlined in the Quality Chasm (IOM, 2001) report and reiterated during these workshops, both the social and technical components of the digital health infrastructure require a framework that allows for tailoring to specific needs, local innovation,­ and evolvability. In this respect, the commonly repeated refrain was a call for the principle of parsimony and minimizing centralization that might constitute a barrier to entry: specify only the minimal set of standards or requirements necessary for key functional utility, and push the maximum amount of control to the periphery. This approach is in line with strategies under consideration for use of metadata for wrapping individual information packets to facilitate interoperability and health information exchange, in which a primary focus would be on development of the metadata standards.

Keep use barriers low and complexity incremental: Similarly, incentives for broad participation in the digital infrastructure by all stakeholders was discussed as a crucial factor to its success. The proposal to keep the barrier for use of the infrastructure low was articulated by workshop participants in order to allow for maximum participation at a basal level, and allow for incremental complexity and sophistication where possible or necessary.

Foster a socio-technical perspective, focused on the population: From the outset of the discussions, participants pointed out that the major barriers to technical progress often lie in social and cultural domains. Acknowledging and engaging this fact was described as being crucial to success, with discussions centering on an approach that reorients future efforts to engage the patient more directly in the collection and use of information in a way that is most useful to them.

Weave a strong trust fabric among stakeholders: Security and privacy concerns represent a strong threat to participation in, and therefore the success of, the socio-technical ecosystem. Accordingly, they must be dealt with from both the social and technical perspectives. Participants emphasized the need for systems security to comply with all current requirements and regulations and retain an ability to evolve to meet future needs. In addition, honest communication to the public and other involved stakeholders about risks and benefits will be crucial to building a foundation of trust.

Provide continuous evaluation and improvement: A learning system is one that assesses its own performance against a set of goals and uses the results of that evaluation to change future behaviors. Workshop participants articulated the importance that all components of a digital infrastructure must themselves function as learning systems.

7. SYSTEMS ENGINEERING

Engineering a Learning Healthcare System: A Look at the Future

Center the system’s processes on the right target—the patient: Patient-centered care was defined in the 2001 IOM report Crossing the Quality Chasm as providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions. Throughout several sessions, workshop participants emphasized the need to ensure that processes support patients— and patients are not forced into processes. Patient needs and perspectives must be at the center of all process design, technology application,­ and clinician engagement.

System excellence is created by the reliable delivery of established best practice: In health care, establishing practices from the best available evidence and building them as routines into practice patterns, as well as developing systems to document results and update best practices as the evidence evolves, will integrate some of the best elements from the engineering disciplines into healthcare issues. Participants often cited the need for better integration of best practices development, and communication in healthcare systems, as well as process systems to track care details and outcomes, and feedback to inform practice refinement and lead to better patient outcomes.

Complexity compels reasoned allowance for tailored adjustments: Established routines may need circumstance-specific adjustments, either because of differences among individuals in the appropriateness for them of the established healthcare regimens, variations in caregiver skill, the evolving nature of the science base—or all three. Mass customization and other engineer­ing practices can help assure the consistency that can accelerate the

recognition of the need for tailoring and delivering the most appropriate care, with the best prospects for improved outcomes, for the patient.

Learning is a non-linear process: The focus on an established hierarchy of scientific evidence as a basis for evaluation and decision making cannot accommodate the fact that much of the sound learning in complex systems occurs in local and individual settings. Participants cited the need to bridge the gap between dependence on formal trials, such as randomized clinical trials, and the experience of local improvement, in order to speed learning and avoid impractical costs.

Emphasize interdependence and tend to the process interfaces: A system is most vulnerable at links between critical processes. In health care, attention to the nature of relationships and hand-offs between elements of the patient care and administrative processes is therefore vital and a crucial component of focusing the process on the patient experience and improving outcomes.

Teamwork and cross-checks trump command and control: Especially in systems designed to guarantee safety, system performance that is effective and efficient requires careful coordination and teamwork, as well as a culture that encourages parity among all with established responsibilities. During the workshop several examples were cited of other industries that have used systems design and social engineering to better integrate and strengthen their systems processes with great improvements in efficiency and safety.

Performance, transparency, and feedback serve as the engine for improvement: Continuous learning and improvement in patient care requires transparency in processes and outcomes, as well as capacity to capture feedback and make adjustments.

Expect errors in the performance of individuals, perfection in the performance of systems: Human error is inevitable in any system and should be assumed. On the other hand, safeguards and designed redundancies can deliver perfection in system performance. Mapping processes, embedding prompts, cross-checks, and information loops can assure best outcomes, and allow human capacity to focus on what can not be programmed— compassion and individual patient needs. Several workshop presentations shared success stories and lessons learned from other industries, such as automotive and the airline industry, that have effectively incorporated this strategy.

Align rewards on the key elements of continuous improvement: Incentives, standards, and measurement requirements can serve as powerful change

agents. Participants noted that it is vital that incentives be carefully considered and directed to the targets most important to improving the efficiency, effectiveness, and safety of the system and ultimately patient outcomes, as well as taking into consideration the patient and provider experiences.

Development of education and research to facilitate understanding and partnerships between engineering and the health professions: The relevance of systems engineering principles to health care and the impressive transformation brought to other industries speaks to the merits of developing common vocabularies, concepts, and ongoing joint education and research activities that help generate stronger questions and solutions. Workshop participants pointed to the dearth of training opportunities bridging these two professions and spoke of the need to encourage greater collaborative work between them.

Foster a leadership culture, language, and style that reinforce teamwork and results: Positive leadership cultures foster and celebrate consensus goals, teamwork, multidisciplinary efforts, transparency, and continuous monitoring and improvement. In citing examples of successful learning systems, participants highlighted the need for a supportive and integrated leadership.

8. PATIENTS & THE PUBLIC

Patients Charting the Course:

Citizen Engagement and the Learning Health System

Listening: Each patient encounter starts with the patient’s voice fully drawn out on issues, perspectives, goals, and preferences. These patient views should then be used to guide clinical decisions, which often involve choices among multiple treatments, each of which has both benefits and risks. Workshop participants reported that care often improved when staff and providers listened to the concerns of patients and their families. Achieving this goal will require a new focus on patient communication starting early in provider education to ensure that providers have the tools they need to share complex health information with patients and help them with these decisions.

Participatory: Health outcomes improve when patients are engaged in their own care. In addition to improving health outcomes and patient adherence, participants noted that engagement can increase employee satisfaction and financial performance. People are eager to play a strong role in their own health care when given the right tools, as evidenced by the rapid uptake of Web 2.0 health information applications. Yet as one speaker mentioned, surveys indicate that only half of patients receive clear information on the benefits and trade-offs of the treatments under consideration for their condition. Patients’ involvement may be increased by providing them with additional information tools for learning about their health, helping them see the impact of their efforts, and acquainting them with new technologies with which to monitor their health and assist with lifestyle changes. Public participation is not limited to the clinic; the workshop highlighted new initiatives to provide access to health data and allow individuals to create new applications to improve their health.

Reliable: Each patient should expect proven best practice as the starting point in their care. The current variability in medical practice impacts patient­ care and results in uneven quality and safety for patients. Participants described tools that minimize this variation, such as dashboard displays that highlight the interventions that are due, done, or overdue and improve the consistency of the delivery of interventions to patients. Other technologies that show promise include clinical decision support systems that present best practices to clinicians. Participants also noted that, while technologies provide new opportunities, incentives are needed to promote reliability and effectiveness in healthcare organizations and ensure accountability.

Personalized: With proven best practices as the starting point, science-based tailoring is shaped by personal biological traits, circumstances, and preferences. Since the sequencing of the human genome was accomplished, medical science has sought to personalize treatments and standards of care. This effort challenges the traditional approach of giving the highest priority­ to evidence gathered by means of large randomized controlled clinical trials,­ in which treatments are measured in a large population with a diverse genetic­ profile. Using multiple types of complementary evidence could better­ guide medical decisions and account for these personal factors. This new approach focuses on the applicability of results to the clinic, rather than automatically giving priority to the results of randomized controlled trials.

Seamless: Care delivered by multiple providers in multiple settings should be nonetheless expected to be fully integrated and seamless. As patients move among providers and settings, they often encounter communication

problems, which may result in treatment errors and duplicative services. Participants described how team-based care offers the potential to rectify this disconnected care and limit human error. Effective teams are aided by an appropriate information technology infrastructure, which facilitates efficient and effective communication of health information, as well as by collaborative organizational systems, from medical homes to accountable care organizations.

Efficient: Patients, their families, and clinicians should expect care to be appropriate to need, resources, and time required. Participants underscored the fact that currently, much of the care that is delivered is neither necessary nor efficient. Among the chief complaints of patients are increasing out-of-pocket costs and lost time in the care process. This finding is not surprising given that the current incentive structure, focused on volume over value, encourages overuse and waste. As multiple participants noted, the United States spent roughly 17 percent of its gross domestic product on health care last year, yet this investment did not yield the health outcomes commensurate with the costs. To gain greater value, participants stressed, the costs and outcomes of care must be more transparent to patients, and new payment models—ranging from bundling payments for an entire episode of care, to pay-for-performance systems, to global payment—must be implemented.

Accountable: All relevant aspects of the clinical experience, including patient perspectives, should be captured and routinely assessed against expectations.

This information is vital not only to achieving effective patient management, but also to judging whether experiments with new delivery system models, payment incentives, or standards of care are having their intended effect on improving patient health and promoting efficiency. Measuring performance and disseminating innovations that work (and eliminating those that do not) constitute a systematic way of improving healthcare delivery. One presentation highlighted how this systematic approach to improvement allowed the speaker’s organization to enhance care by conducting comprehensive reviews of interventions for different conditions, adopting the best practices identified by that review, and measuring the performance of the revised standard of care.

Transparent: Information on the outcomes of care—both effectiveness and efficiency—should be readily accessible and understandable to patients­ and their families. Several speakers mentioned the frustration felt by patients regarding the lack of understandable information on the costs, quality, and outcomes of care, especially in light of reports about medical errors and the increasing personal burden of costs and inefficiencies of

care. It was noted that, when offered a choice, patients do not routinely choose more costly or more intensive interventions. However, choice and information about alternatives are rarely available. It is clear that action to improve value—better outcomes at lower cost—requires transparent information on the costs and outcomes of care.

Trustworthy: Patients should expect a strong and secure trust fabric on all dimensions—safety, quality, security, efficiency, accountability, and equity.

In few areas of human endeavor is trust on each of these dimensions more important. Yet one presenter noted that, even in the face of information that 50,000 to 90,000 deaths per year are caused by medical errors, health care lacks the basic trust elements of transparency and accountability needed to drive improvements in quality and safety. In a learning system that draws lessons from each care experience, public trust must be bolstered in all aspects of the healthcare enterprise: equitable access to reliable clinician knowledge and skills, safeguards on clinical processes, privacy and security of medical records, and validity and safety of clinical trials.

Learning: In a learning health system, the patient is an active contributor to, and supporter of, the learning process. Each patient experience offers the potential to deepen the knowledge base that drives care quality and outcomes—at the individual, practice, and societal levels. A focus of the workshop was the stake of the patient in fostering a digital health utility that provides needed information to patients and their clinicians, ensures synchronization among providers, and generates knowledge for progress— for example, for comparative effectiveness insights, public health activities, or postmarket monitoring of approved technologies and drugs. Reference was made, for example, to the need for a common core data set for EHR− based data that would allow reliable, platform-independent research across large patient populations. These are issues in which patients have a strong stake, and they must have confidence in the system’s functionality for the generation of timely and reliable new insights.

9. COST AND OUTCOMES

The Healthcare Imperative: Lowering Costs and Improving Outcomes

Challenges for health costs and outcomes

Health cost excesses with personal, institutional, and national consequences. In the past decade, U.S. health costs have increased by 92 percent, representing approximately four times the inflation rate for the economy as a whole. Out-of-pocket costs for individuals have increased by 40 percent.

Overall, Medicaid now takes almost 20 percent of state budgets, crowding out other state priorities such as education.

Health outcomes far short of expectations.

Despite health spending double the average for other developed nations, U.S. health outcomes rank below two to three dozen other countries on indices such as life expectancy, care for chronic disease, and persistent disparities in the access and outcomes of care.

Fragmented decision points, inconsistent principles, and political distortions. Barriers to appropriate care include poor care coordination, lack of consistent evidence-based

guidelines, payment systems that encourage volume over value, and political influences that sometimes overturn scientific determinations.

Domains of waste and inefficiency in healthcare spending

Unnecessary services: services reflecting choices or levels beyond those supported by evidence or benchmarks.

Inefficiently delivered services: inefficient labor use, time-flow discontinuities, duplicate services, medical errors.

Excess administrative costs: billing and insurance-related costs for payers and providers, inefficient reporting requirements.

Prices that are too high: for medical services, pharmaceuticals, products and devices, relative to benchmarks.

Missed prevention opportunities: for preventable obesity, diabetes, heart disease, stroke, pulmonary disease, cancers, infections.

Medical fraud: systemic over-billing, billing for undelivered services, use of unlicensed providers.

Drivers of the problems

Scientific uncertainty. Clinical evidence development is not keeping pace with new diagnostics, treatments, and insights into individual variation.