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Clinical Decision Support. The Road to Broad Adoption PDF

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Clinical Decision Support Clinical Decision Support The Road to Broad Adoption Second Edition Edited by Robert A. Greenes AMSTERDAM • BOSTON • HEIDELBERG • LONDON NEW YORK • OXFORD • PARIS • SAN DIEGO SAN FRANCISCO • SINGAPORE • SYDNEY • TOKYO Academic Press is an imprint of Elsevier Academic Press is an imprint of Elsevier 32 Jamestown Road, London NW1 7BY, UK 225 Wyman Street, Waltham, MA 02451, USA 525 B Street, Suite 1800, San Diego, CA 92101-4495, USA Copyright © 2014, 2007 Elsevier Inc. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise without the prior written permission of the publisher Permissions may be sought directly from Elsevier’s Science & Technology Rights Department in Oxford, UK: phone (+44) (0) 1865 843830; fax (+44) (0) 1865 853333; email: [email protected]. Alternatively, visit the Science and Technology Books website at www.elsevierdirect.com/rights for further information Notice No responsibility is assumed by the publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made. British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress ISBN: 978-0-12-398476-0 For information on all Academic Press publications visit our website at elsevierdirect.com Typeset by MPS Limited, Chennai, India www.adi-mps.com Printed and bound in United States of America 13 14 15 16 17 10 9 8 7 6 5 4 3 2 1 Foreword The processes by which some work achieves exponential success while others fade into failure have long been the topic of analyses and essays in business schools, government offices and university classrooms. In his 2000 book The Tipping Point, Malcom Gladwell describes three factors that underpin virtually all successful mar- ket phenomena. The Law of the Few describes that there must be a few key champions for an idea before it can reach the tipping point. The Stickiness Factor is the quality that compels people to pay close, sustained attention to the idea. The Power of Context recognizes how changes in the environment will define the likelihood that a given idea “tips.” The champions are here, and as you will read in the pages that follow, they tell a very compelling story about stickiness (shifting payment objectives in the United States toward incentivizing quality of care rather than quantity of care) and con- text: the semantic context (never before have we had both a semantic foundation in Health IT that has been so consistent), the technical context (never before have we had such well defined, focused and adopted standards for CDS), and the cultural context (physicians, focused on quality outcomes are asking for help – they expect computers to be able to offer clinical decision support). Clinical decision support is how we distribute knowledge from where it is to where it needs to be. This is not unlike similar endeavors in other vertical markets (law and transportation come to mind) or more general markets such as news and weather information – stuff we all need to know. In all of these cases, a conflu- ence of evangelism, technical readiness and market needs converged toward rapid adoption of new models of knowledge syndication. The best such example is that of RSS, an XML format for knowledge distribution, which was largely responsible for the explosion of both professional and peer-to-peer knowledge distribution on the Internet, sometimes referred to as “news.” In 1999, the Internet was beginning to change how people communicated, conducted business, and share information. Two engineers working at Netscape, a small company working to create a business model around the Netscape Navigator web browser, developed a format initially called RDF Site Summary – or RSS. This format, which evolved through predictably emotion-laden iterations not unlike the standards evolution we have witnessed with Arden Syntax (and ArdenML), GEM, vMR, or Health eDecisions, stabilized in 2002 with the release of the RSS 2.0 standard (re-named Really Simple Syndication) and adoption by the New York Times as a method for publishing their content. This was the tipping point. Any software tool that was capable of consuming RSS 2.0 was capable of consuming the New York Times! Soon most browsers were capable of doing so, as well as Microsoft Outlook and many 3rd-part tools. Most recently, Flipboard, Zite and several other unique solutions, developed for portable computing devices such as tablets and smartphones have incorporated methods of consuming RSS feeds and xxv xxvi Foreword creating “mashups” of digital content for consumers that makes the experience both meaningful and pleasurable. Such tools anticipate the needs of the user, and make it effortless for the user to have the information they need – when they need it – deliv- ered in a manner that is easy and aligns with their workflow. This revolution in consumer knowledge sharing could not have happened with- out the vision of the engineers who knew that the content must be normalized, the semantics well defined, and the syntax predictable. It took over a decade to get from the definition of the standards to where the capabilities those standards enable are not just instantiated in the background of our lives – but expected to be there, helping us quietly and inconspicuously perform better. Where are we with clinical decision support? We’re at the tipping point, as the news industry was in 2002. This book represents an extraordinary synopsis of where we have been, why this “simple” problem is so complex, and what we will leverage as a foundation as we weave these capabilities into the tapestry of health care for our communities. These capabilities will not be an extra tool that we con- sider using (or not using) as we provide care to our patients. Rather, clinical deci- sion support (and the other CDS – consumer decision support) will become an ally that is expected to be there, helping us quietly and inconspicuously perform better. Milestones in human history: Gutenberg’s press in 1450, RSS in 2002, and clinical decision support in 2014. Yes – it really is that big a deal. Congratulations to Dr Greenes and the incredible team who have written such an extraordinary review of this important topic. Jacob Reider MD Chief Medical Officer, Office of The National Coordinator for Health Information Technology, United States Department of Health and Human Services Preface When we published our first edition of this book in 2007, the effort to incorporate computer-based clinical decision support (CDS) into health care had already been pursued for more than four decades. Most of the progress had occurred in aca- demic medical centers in the United States, and in other scattered locales world- wide. Some of the successes had been adapted and incorporated into a variety of proprietary electronic health record (EHR) systems, but by and large, this was only scratching the surface in terms of what of CDS could potentially achieve, to ensure the safety, quality, and cost-effectiveness of health care practice. It also had provoked some backlash, based on instances in which it was not done well, was not sufficiently patient-specific or useful, and caused interruptions of workflow or increased effort to deal with. Further, although standards existed for exchanging some forms of CDS or delivering CDS as a service, most implementations in EHRs were in proprietary formats, integrated into applications in proprietary ways, and virtually no sharing was occurring. As a result, larger health care organizations had to develop mechanisms for handling their own (a) knowledge generation and vali- dation, (b) knowledge management, curation, and update, and (c) adaptation and integration into applications and workflow settings – three time-consuming and dif- ficult life cycle processes. Smaller health care entities – community hospitals and practices, for example – basically had no resources to do any of this. As a result of the above situation, stakeholders were beginning to recognize the need for larger-scale collaborative or national initiatives to promote adoption, and to develop both shared knowledge and tools to make it easier to do so. In our first edition, we proposed that efforts along those lines be developed. What we did not foresee is that in the seven years since that preceding edition, there would be tremendous changes on a number other fronts – some of which were already occurring but the impact of which had not yet been felt – that would bring about the situation we have today: namely, that there are many new drivers for CDS adoption and many initiatives that are stimulating the process. Drivers include advances in genomics and precision medicine, increasingly fine-tuning the knowledge needed for the care of individuals; increased use of home monitors, sen- sors, fitness trackers, and personal health records by individuals to record their own health status; new standards and interoperability, as well as natural language pro- cessing and image feature extraction methods, enabling us to integrate data from multiple sources to create “big data” repositories, that can be used to provide new capabilities for population-based prediction and management of cohorts of patients; new understanding of cognitive processes and development of methods for visuali- zation and management of complex data; and an increasing “app culture” in which lightweight applications can be developed which pull data from various sources and provide new opportunities to integrate, organize, analyze, and display data on top of or in conjunction with existing EHR systems. Initiatives include national policies xxvii xxviii Preface in a number of countries fostering EHR adoption and convergence on features that enhance integration of data, measurement and reporting of quality, and use of CDS; and new health care finance models for reimbursing care based on pay-for-value rather than fee-for-service; and new care delivery models incentivizing increased levels of care coordination, patient engagement, and emphasis on wellness, disease prevention, and early detection of problems. As a result of all these changes, we have added a number of new chapters, and substantially revised other chapters to capture the multiple forces now aligning for increased CDS adoption. This includes looking at the technical, cultural, organiza- tional, policy, legal, and financial factors that are now at play, or beginning to come into play. We also identify some key requirements that are starting to take shape but don’t have organized effort behind them yet to take CDS to scale. Nonetheless, perhaps over the next seven years or so, we will see that many of these ideas also become reality. The book is intended to familiarize stakeholders having the various back- grounds and perspectives we just mentioned with the factors involved, and to equip them to be effective in this fast-moving field. We are very pleased to have expanded the contributed list of chapters and to have, overall, the participation of a fantastic set of authors that are truly experts in their respective areas. I am extraordinarily grateful to this wonderful group of colleagues for sharing their knowledge and passion for this important activity. Bob Greenes November, 2013 Preface to the first edition In looking for a way to introduce this book, I came across a speech by Admiral Hyman G. Rickover, delivered at Columbia University in 1982, in which he said, “Good ideas are not adopted automatically. They must be driven into practice with courageous impatience. Once implemented they can be easily overturned or subverted through apathy or lack of follow-up, so a continuous effort is required.” Several citations of this quote on the internet present a curious discrepancy, in that the word “impatience” is replaced with “patience”. I find this variation to be intriguing, as it seems to me that both courageous patience and courageous impatience must be manifest for the greatest progress to occur. If one has a good idea, one must not only be both steadfast and patient to stay the course and see it through, but also, at the same time, one must continue to push aggressively, even impatiently, lest the effort lose momentum and flag. My idea for this book was based on the observation that computer-based clinical decision support (CDS) has the potential to be truly transformative in health care but that, despite considerable creativity and experimentation by enthusiasts over more than four decades, and convincing demonstration of effectiveness in particu- lar settings, the adoption of CDS has proceeded at a snail’s pace. This slow pro- gress has not significantly accelerated even with major national and regional efforts in a number of nations to promote the use of the electronic health record (EHR), computer-based physician order entry (CPOE), electronic prescribing, and the personal health record (PHR), which are important substrates on which CDS can operate (and for which the prospect of CDS itself is a major driver). Some capa- bilities have made their way into commercial health information system products – examples include advice and warnings during CPOE, to ensure proper doses, avoid harmful interactions, or warn about allergies, the provision of alerts to providers when an abnormal laboratory result is found, and the use of order sets, or group- ings of orders, for specific clinical problems and settings, such as coronary care unit admission or post-operative care after a hip replacement. Nonetheless, CDS usage remains spotty at best, most prevalent but by no means ubiquitous at aca- demic medical centers, less so in community hospitals, and almost non-existent in office practice. Although the public frequently now turns to the internet for medical knowledge, automated decision support oriented to patients and consumers in terms of reminders, alerts, and patient-specific advice is similarly largely lacking. What’s wrong with this picture? Is CDS perhaps not really a good idea? Are the requirements for wide dissemination and use beyond reach? Or are there initia- tives that can be undertaken that can change the dynamic, and significantly boost adoption? This book is an effort to address this conundrum. Our goal is to exam- ine CDS in detail from many perspectives – its history, the motivations for it, the technologies, the psychology and human factors concerning deployment and use xxix xxx Preface to the first edition of CDS, the sociology and organizational and management considerations that can lead to successful deployment, the financial and economic drivers and constraints, the marketplace and business opportunities, and lastly, the role of communal and top-down initiatives such as standardization and creation of infrastructure and shar- able resources. The premise is that if CDS is truly a good idea, then the sluggish progress in adoption and use to date can only mean that we are in need of a new approach. But to develop a new approach to a complex, multifaceted problem, one that would have a better chance of success than current incremental, uncoordinated efforts, the effort will require the participation of many stakeholders representing a range of perspectives. It is much easier in such situations to preserve the status quo, or to introduce minor tweaks than to take concerted action – since tweakers can tinker with an existing system without needing to build a huge consensus, but concerted action requires a major effort to promote a shared vision. Only by finding a way for these participants to come together with a commonality of purpose can this good idea be driven forward with the duality of courageous patience and impatience that it requires. This book is thus an effort to develop a common ground for addressing this challenge. It should be of most interest to health care organization managers, pol- icy makers and other senior leadership, payers, government funding agencies and foundations focused on health care delivery, medical informatics researchers and students, information technology development managers, information systems and knowledge product and service vendors, and clinical investigators and health care providers more generally who have interest in the issues of health care quality, safety, and cost-effectiveness. Let’s look a bit more at the motivations for CDS and the challenge of aligning them. In this book we adopt a view of CDS as decision support aimed at individual patient-specific health care. It is advice and guidance offered by computers (more properly, information and communication technology) to aid the problem solving and decision making of health care providers, patients, and the public (i.e., includ- ing those not currently patients). CDS is in most views not only a good idea but an essential one. The most compelling reasons for CDS are to help practitioners avoid errors, optimize quality, and improve efficiency in health care. Many pressures fuel the need – the explosion of biomedical knowledge over the past several decades, the multiplicity of diagnostic and therapeutic choices available for patient care, the specialization and fragmentation of care, the time constraints on practitioners, regu- latory and compliance demands, malpractice concerns, the increasing prevalence of multi-system diseases as the population ages, the spiralling costs of health care, the growing activism and involvement of individuals in their own health care, and the emerging capabilities for “personalized medicine” through genomics, biomarkers, and increasingly structured clinical phenotype data. Although the descriptors used to characterize the above trends have a kind of desperate urgency to them which collectively suggest hyperbole, the fact is that they do reflect the reality of health care today. Because the trends and their Preface to the first edition xxxi consequences impact on different stakeholders in various ways, however, the com- bined extent of the need perhaps has not been appreciated to its full degree by indi- viduals, as a result of which there has been little impetus for a broad-based effort to address it. It is important to understand the differences in perspective of the various stake- holders, and to recognize their motivations and needs. For practitioners, despite the benefits offered, there are a number of reasons why CDS is not unequivocally endorsed. Providers often become quite expert in their own particular subject domains, keep up with the literature, and don’t feel a compelling need for comput- ers to make recommendations. Despite this, they do generally accept the value of CDS to monitor their actions especially where the aim is to help avoid acciden- tal errors; they welcome alerts for unexpected lab results – if false positives are kept to a minimum; they appreciate timely reminders for schedulable actions; and they take advantage of predefined order sets for frequent clinical situations they encounter. In general, and not surprisingly, the satisfaction with CDS by practition- ers seems mostly related to the degree to which it is supportive, patient-specific and relevant, and provided in a way that doesn’t interfere with care or require inordinate additional effort and time. In some circumstances, however, the use of CDS not only requires extra time and effort by the practitioner, but the benefits of its use aren’t seen as accruing to the practitioner or the patient. Examples are applications of CDS aimed at limit- ing orders for expensive tests and treatments. This purpose has been manifested in adoption of drug formularies, substitution of generic for brand name drugs, utili- zation review and utilization management, and requirements for preapproval/prior authorization from payers for imaging procedures, specialty referrals, or surgery as a function of clinical indication. These may be tolerated by practitioners as nec- essary evils but they are regarded primarily as interference with medical judg- ment and are hardly embraced. Patients also exhibit disdain for and distrust of such applications. So although a societal net benefit may be at play, it is difficult to align support of institutions, payers, providers, and patients in cost containment circumstances. Difficulties such as the above have been true of many information system inno- vations in health care. Given the frequently tenuous acceptance or tolerance of such technologies by those who must interact with them directly, instances in which their implementation has been poorly done have been quick to be seized on by unhappy users and critics as examples of why the adoption of such systems should be resisted. Before an information system innovation is introduced, careful thought and experience with testbeds and pilot implementations are needed. Planning, both locally and at an organizational or enterprise level, needs to be directed at issues of how to motivate the participants, and how to make the innovation function effec- tively, including considerations of process flow and work flow, responsibilities and prerogatives of the users, and ease of use and perception of benefit by them. With respect to the deployment and support of CDS, it also appears that a major barrier to progress is a lack of recognition of how hard the problem is. On the

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