The usability of electronic health records (EHRs) continues to be a point of dissatisfaction for providers, despite certification requirements from the Office of the National Coordinator that require EHR vendors to employ a user-centered design (UCD) process. To better understand factors that contribute to poor usability, a research team visited 11 different EHR vendors in order to analyze their UCD processes and discover the specific challenges that vendors faced as they sought to integrate UCD with their EHR development. Our analysis demonstrates a diverse range of vendors’ UCD practices that fall into 3 categories: well-developed UCD, basic UCD, and misconceptions of UCD. Specific challenges to practicing UCD include conducting contextually rich studies of clinical workflow, recruiting participants for usability studies, and having support from leadership within the vendor organization. The results of the study provide novel insights for how to improve usability practices of EHR vendors.
INTRODUCTION
As the adoption of electronic health records (EHRs) by hospitals and ambulatory health care facilities continues to increase rapidly, dissatisfaction with EHRs also continues to increase, primarily driven by usability and safety challenges.1–3 A survey of clinicians, conducted by the American College of Physicians, suggests that dissatisfaction with the EHR’s ease of use increased from 23% in 2010 to 37% in 2012.4 EHRs are often perceived by providers as difficult to use, and usability analysts have cited issues with difficult-to-read interfaces, confusing displays, and iconography that lacks consistency and intuitive meaning.5,6 In addition, providers often feel that there are missed opportunities; the systems do not fully support their cognitive workflow or information needs and often display data in ways that inhibit clinicians from easily drawing insights.7,8 Poor usability not only results in an increased level of clinician frustration, it can lead to errors, posing serious threats to patient safety.9–11
Realizing that usability will encourage adoption, enhance safety, and is a critical element in the design and development of EHRs, the Office of the National Coordinator of Health Information Technology (ONC) has included “Safety Enhanced Design” certification requirements in the 2014 Standards and Certification Criteria, which stipulate both usability process requirements and testing requirements.12 A vendor that seeks to develop a certified EHR must attest to employing a user-centered design (UCD) process and must conduct and report the results of summative usability testing on 8 specified EHR functions. UCD is a process in which the needs of the user are taken into consideration during each stage of design and development (see International Organization for Standardization 9241 for a more extensive description). This definition of UCD is used by the ONC and the National Institute of Standards and Technologies for EHRs.12,13
Few studies have focused on EHR vendors’ UCD processes; rather, the majority of research on EHR usability has focused on describing the impact of the EHR on clinician work processes and optimal EHR design principles.5,14,15 Since the quality of the UCD process is thought to be a major factor in determining the usability of the EHR, our research goal was to better understand the current range of UCD processes being employed by vendors and the specific challenges that vendors face as they practice UCD.13,16 Our research is unique in that it is a vendor-centric project that was conducted within ONC’s larger strategic health information technology (IT) advanced research projects—SHARPC—program that focuses on efforts to improve the usability of health IT systems.
METHODS
To gain a better understanding of vendors’ UCD processes, a team composed of a human factors scientist, a clinician/human factors expert, a clinician/informatics expert, and an industrial engineer traveled to a diverse set of EHR vendors to conduct onsite interviews with vendors’ staff. Because no previous studies have sought to understand current UCD processes in the EHR vendor community, qualitative methods were determined to be the most appropriate approach.
The research team defined UCD as any approach to design that integrates extensive information about the people who will use the product (end users) into each stage of the design process, including information about the cognitive needs, abilities, and limitations of the end users, and about the factors and constraints introduced by the work environment and tasks.17
Following the ONC certification requirements, vendors could develop their own UCD process or follow published processes such as the International Organization for Standardization guidelines or guidance from the National Institute of Standards and Technology.13,18
Vendor Selection
Given the diversity of EHR vendors in terms of company size and product types, a representative sample was sought. A purposive sampling method was used to recruit vendor participants. This qualitative research recruitment method facilitated the selection of vendors based on their position in the marketplace and the type of knowledge that might be elicited. Eleven different vendors were recruited for the interviews that varied in total revenue, total number of employees, and size of the usability staff (if present), as shown in table 1. The vendors were not compensated for their participation and were ensured anonymity.
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