Enhancing patient safety and quality of care by improving the usability of electronic health record systems: recommendations from AMIA

Blackford Middleton, Meryl Bloomrosen, Mark A Dente, Bill Hashmat, Ross Koppel, J Marc Overhage, Thomas H Payne, S Trent Rosenbloom, Charlotte Weaver, Jiajie Zhang, Enhancing patient safety and quality of care by improving the usability of electronic health record systems: recommendations from AMIA, Journal of the American Medical Informatics Association, Volume 20, Issue e1, June 2013, Pages e2–e8, https://doi.org/10.1136/amiajnl-2012-001458

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Abstract

In response to mounting evidence that use of electronic medical record systems may cause unintended consequences, and even patient harm, the AMIA Board of Directors convened a Task Force on Usability to examine evidence from the literature and make recommendations. This task force was composed of representatives from both academic settings and vendors of electronic health record (EHR) systems. After a careful review of the literature and of vendor experiences with EHR design and implementation, the task force developed 10 recommendations in four areas: (1) human factors health information technology (IT) research, (2) health IT policy, (3) industry recommendations, and (4) recommendations for the clinician end-user of EHR software. These AMIA recommendations are intended to stimulate informed debate, provide a plan to increase understanding of the impact of usability on the effective use of health IT, and lead to safer and higher quality care with the adoption of useful and usable EHR systems.

Introduction

US healthcare delivery is in the midst of a profound transformation which results, at least in part, from Federal public policy efforts to encourage the adoption and use of health information technology (health IT). For example, HITECH regulations 1 within the American Recovery and Reinvestment Act 2 incentivize health IT use, 3, 4 and are changing the practice of medicine and clinical care delivery in both beneficial 3, 5, 6 and untoward ways. 7 Increased adoption of electronic health record (EHR) systems has been accompanied by heightened recognition of issues related to ‘goodness of fit’ in the user-friendliness of EHR systems. 8 Some EHR users lament that health IT seems designed more for clinical transactions than for clinical care, and may not be easy to use in some care settings. 9, 10 In addition, many EHR systems require extensive training and lack standard user interfaces so that clinicians who work in multiple care settings using disparate technologies may struggle with the differences in interface design, with adverse impact on patient safety. 11 User interface design can influence provider productivity: well-designed interfaces speed work, while poorly designed interfaces steal minutes from busy schedules. The Institute of Medicine (IOM) report, Health IT and Patient Safety: Building Safer Systems for Better Care identified means by which health IT can lead to safer care, as well as introduce new safety risks. A critical component of safe and effective use of health IT is usability—‘the effectiveness, efficiency, and satisfaction with which the intended users can achieve their tasks in the intended context of product use.’ 12 The IOM recommended that ‘[t]he Secretary of HHS [Health and Human Services] should specify the quality and risk management process requirements that health IT vendors must adopt, with a particular focus on human factors, safety culture, and usability’ (recommendation 6, p 9 9).

Purpose of this AMIA statement

Given the anticipated adoption of health IT, and the potential for increased health IT-related harm or potential error, the AMIA Board of Directors convened a task force of members drawn from academia, clinical practice, and industry to produce a set of AMIA recommendations on enhancing patient safety and the quality of care with improved usability of EHR systems. These AMIA recommendations are intended to stimulate informed debate, form the basis of a plan to increase understanding of the impact of usability on the effective use of health IT, and lead to safer and higher quality care with the adoption of useful and usable EHR systems.

To address this issue, the task force convened for over a year. Subcommittees reviewed the literature on usability in health IT, current related activities underway at various US Federal agencies, lessons learned regarding usability and human factors in other industries, and current federally funded research activities. The key principles and recommendations described below are based on these reviews.

Relationship of usability to optimal healthcare practice

To frame this discussion, the AMIA Task Force on Usability considered the following issues related to health IT: (1) safe and effective use of EHR, (2) EHR usability, and (3) EHR usability-associated medical errors. Recent reports describe the safe and effective use of EHR as a property resulting from the careful integration of multiple factors in a broad socio-technical framework, 13 including coordination and consideration across requirements assessment, application design, usability and human factors engineering, implementation, training, monitoring, and feedback to application developers. 1, 14–16 Following best practices for EHR implementation is essential to safe and effective use. 2, 17 Analyses of facilitators and barriers to physicians' use of EHR systems suggest that usability is a major theme among system attributes, along with functionality, speed, support for hardware and software, required learning time, typing proficiency, understanding of the EHR system, motivation and personal initiative, and user-developed strategies and workarounds. 3, 4, 18 Further analysis suggests that understanding user behavioral models is important to achieving effective use. 3, 5, 6, 19, 20 Overcoming each of these issues is essential for improving the usability of EHR systems in clinical practice.

User error may result in untoward outcomes and unintended negative consequences. These may also occur as a result of poor usability, 7, 21–24 and may also be an emergent property only demonstrated after system implementation or widespread use. 8, 9 User errors may occur without adverse events, 9, 10, 24–26 and some may not even be apparent to the user, analyzed by hospital or clinic review boards, or reported to the vendor. 11 While not causing undue harm, these errors are still problematic as they represent a mismatch between the user's model of the task and expected outcome, 12, 25 and the application's functionality and the resulting action or event. 9, 13, 27 They may also represent a potential health IT-related error yet to happen. 13, 28 In some cases, clinicians use more than one commercial EHR system, with differences between the model of the task and the software functionality to execute the task, as well as differences in the terminologies used in the systems. 29, 30 Anecdotal reports suggest that these application differences result in an increased training burden for EHR users. Excessive alert fatigue can undermine the efficacy of clinical decision support in computer-based provider order entry (CPOE) 31, 32 and in other IT functions, 11, 33 and can result in very high override rates. 34–36 Some suggest that the expected gains sought with the adoption of EHR are not yet realized. 37–39

Actual adverse events or medical errors resulting from application design and usability, however, have also been described. 9, 10, 14, 15, 40–42 Walker et al define an EHR-related system flaw as ‘Any characteristic of an EHR or of its interactions with other healthcare systems that has the potential to worsen care quality or patient outcomes. Other healthcare systems include individuals, care teams, facilities, policies, care processes, and healthcare organizations. Flaws may be introduced during the specification, design, configuration, or continuous-improvement phases of the EHR lifecycle’ (p 273). 10 Sittig and Singh define EHR-related errors as occurring ‘anytime health IT is unavailable for use, malfunctions during use, is used incorrectly by someone, or when health IT interacts with another system component incorrectly, resulting in data being lost or incorrectly entered, displayed, or transmitted’ (p 1281). 43 The design of software applications requires both technical expertise and the ability to completely understand the user's goal, the user's workflow, and the socio-technical context of the intent. 5, 6, 13, 15, 16, 18, 44 The design of clinical information systems is evolving from transaction-oriented systems toward a design focusing on patient-centered care, and on the needs of patients and healthcare teams. 14, 15, 19, 20, 45 To achieve current US policy objectives, 1 transform our healthcare delivery system, 9 and create a learning healthcare system, 46–49 clinicians need to use usable, efficient health IT that enhances patient safety and the quality of care. Some experts suggest that improving the usability of EHR may be critical to the continued successful diffusion of the technology. 50 Taken together, these factors suggest a need for renewed attention and focus on improving the usability of health IT to enhance patient safety and the quality of care.

AMIA's guiding principles

Framing usability assessment in health IT

This work focuses on the usability of EHR, and leaves aside medical devices, mobile devices, personal health records, and other related health information technologies. In particular, this work focuses on usability as it pertains to EHR systems and EHR module components. 51 We touch upon usability principles, use cases, and interface guidelines 52 as essential building blocks for effective user-centered design (UCD) and system implementation. For this work, we reference the Healthcare Information Management and Systems Society (HIMSS) usability definition, which includes nine attributes: simplicity, naturalness, consistency, forgiveness and feedback, effective use of language, efficient interactions, effective information presentation, preservation of context, and minimization of cognitive load. 53 A more comprehensive and evidence-based perspective on usability is provided by Zhang and Walji, 54 where usability refers to how useful, usable, and satisfying a system is for the intended users to accomplish goals by performing certain sequences of tasks.

The research team at the National Center for Cognitive Informatics and Decision Making in Healthcare, based upon an evidence review, proposed 14 usability principles which may guide the design and implementation of EHR. 54 These principles are listed in table 1.

Fourteen usability principles for the design of electronic medical records