With the enactment of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, hospitals and physician practices across the country converted from a system of paper recordkeeping to fully integrated electronic health records (EHR).1,2 With financial incentives in hand, there was a rush to market to acquire and implement these systems. Fast-forward 10 years, and it is apparent that the EHR space has significantly evolved in technology, processes, and policies.3 These changes should make organizations examine their EHR and organizational models and consider if they are using the best EHR to meet their organizational needs for the next 20 years.
The National Institutes of Health (NIH) Clinical Center (CC) implemented its EHR in 2004 and, recognizing all of the new participants, technologies, and the advancement of clinical research needs since then, made the decision to embark on a comprehensive business case analysis to evaluate the best solution to meet the CC’s and NIH’s needs over the next 20 years. The goal was to answer this question: “Given the evolution of the EHR market, is the CC on the best platform to meet its needs now and in the future?”
Keywords: electronic health record, EHR, business case
The NIH CC is a biomedical research hospital and the delivery setting for NIH intramural clinical research protocols. The hospital contains 200 inpatient beds, 93 day hospital stations, 15 outpatient care clinics, and more than 1,600 research laboratories. Patients are admitted to the NIH CC for the sole purpose of clinical research as prescribed in a clinical research protocol. The CC supports approximately 1,500 active protocols. The CC admits patients from all over the world for clinical trials and natural history studies.
To support patient care and research, the NIH relies on the Clinical Research Information System (CRIS), first deployed in 2004. It is based on the EHR solution Allscripts’ Sunrise Clinical Manager, previously owned by Eclipsys. Of note, the CC is the only federal organization that has been certified Stage 7 using the Healthcare Information and Management Systems Society’s (HIMSS) Adoption Model for Analytics Maturity (AMAM). This certification is for both inpatient (as of 2015) and outpatient (as of 2018) environments, a designation achieved by only approximately 6.4 percent of hospitals nationwide as of fourth quarter 2017.4 As an EHR system, CRIS meets the core requirements to support patient care, but it has also been highly customized over the years to link patient medical information to clinical research protocols and meet several other NIH research-specific requirements. These customizations are a result of the different patient care and clinical research workflow requirements associated with the diverse needs of the NIH Institutes and Centers (ICs) and IC investigators. Much has changed since CRIS’s implementation. The EHR market has changed substantially in terms of interoperability, expectations for safety, and technology, including artificial intelligence and machine learning, data and predictive analytics, virtual health, and connected applications. Given CRIS’s age, uniqueness, end-user challenges, and advancements in the EHR market, the CC conducted this business case analysis.
How to Approach Such an Analysis?
The CC took a very deliberate approach to conduct its business case analysis, which included three major components: market research, best practice reviews of other federal facilities and academic medical centers (AMCs), and identification of current functionality and gaps. The information obtained from these activities was used to arrive at recommendations for the optimal path forward.
A thorough evaluation should be conducted of both emerging technology and currently available EHR systems. Research shows that clinical information system and EHR vendors are beginning to develop capabilities to prepare and capitalize on future market trends. Disruptive trends such as intelligence, Internet of Medical Things (IoMT), and data analytics are reshaping the healthcare industry.5,6 These technologies support increased clinical decision support, pharmacogenomics, precision medicine, and quality care and patient safety, as well as patient engagement, telehealth, and telemedicine. All of these market trends mentioned are focused on improving the experience for both patients and providers. The EHR of the future will serve not only as a repository of healthcare data but also as a hub for healthcare data management, exchange, advanced analysis, care coordination, patient and provider communication, and data for healthcare and population health research.7
For a clinical research hospital such as the CC, a major movement toward virtual care and remote patient monitoring provides capabilities that could be especially transformative, since study participants live all over the world. Cloud-based technology will also be increasingly important as the NIH Intramural Research Program (IRP) scales up with genomics data, artificial intelligence (AI), and voice recognition.
The market research conducted was structured to provide an overview of viable commercial off-the-shelf (COTS) EHR products in the marketplace that could meet the CC’s unique needs and provide the best support for the clinical research mission over the next 10 years. The market research process is shown below:
- Conduct a market scan to identify all viable COTS EHR products.
- Utilize industry reports such as KLAS, Gartner, financial statements, recent news, and publications to summarize EHR features, market share, financial conditions, and clients.
- Leveraged internal materials from leading AMC’s EHR selection and implementation engagements, and conducted hours of internal interviews with SMEs to identify pros and cons of each product.
- Develop a summary report of each EHR’s functionality, market share, financial condition, and top 10 clients, which includes an analysis of pros or cons for each EHR vendor reviewed.
The market research narrowed the field to three systems capable of meeting the needs of a complex hospital environment. Each of the three presented differing areas of focus: AMCs; the EHR solution for federal facilities (US Department of Defense (DoD) and the US Department of Veterans Affairs (VA)); and one oriented more toward private practice, international markets, and acute care.
Healthcare organizations should regularly evaluate and compare their five to 10 year roadmaps to ensure that their selected vendor appropriately addresses emerging and future health IT trends.
Currently, each of the three EHR platform vendors are differentiated by factors illustrated in Figure 1. Vendor A is the market leader within both the acute care and ambulatory markets. Vendors A and B have comparable market shares. However, Vendor A is the leading vendor among AMCs, with several surveyed AMCs highlighting its innovative partnership approach and on-time delivery. Vendor A relies on its fully integrated, homegrown platform, offering an integrated look and feel, while Vendors B and C rely on partnerships and acquisitions to provide and support a full suite of EHR platform functionality. According to reaction data from 2018,8 Vendor A is the leader in EHR physician satisfaction (overall satisfaction for each vendor is 45 percent for Vendor A, 22 percent for Vendor B, and 16 percent for Vendor C).
To develop an initial understanding of each platform’s roadmap, the NIH CC held meetings with all three platform vendors at the annual HIMSS conference on February 12, 2019. Dedicated time for these candid conversations was invaluable for gaining insights into each platform’s current core functionality, future planned capabilities, and ability to support clinical research, including near- and long-term roadmaps. Discussions indicated that all EHR vendors provide the basic functionality required, with some unique differentiators, such as the ability to support genomics and precision medicine, degree of data aggregation and analytical tools, and visions of the future of healthcare as it relates to health information technology.
Learning From Others
When conducting research, there is no substitute for reaching out to similar institutions to learn from their EHR journeys.9 The NIH CC conducted site visits with multiple AMCs and federal facilities. For each of the selected sites, the CC brought a small team that included those working in the fields of informatics and health information management, as well as nurses, physicians, pharmacists, and consultants with EHR expertise.
Each site visit was structured as follows:
- An overview of the NIH CC (for context).
- A demonstration of the site’s EHR.
- The site’s EHR journey that led to the system utilized.
- Specifics regarding clinical research functionality (as applicable).
During these visits, inputs were obtained for benefits and challenges of existing EHR systems, lessons learned implementing their system, best practices employed for process flows, customizations developed (both scope of customizations required for a functionality void and unique requirements of the site), research functionality and applications in use, change management models, and the rationale and criteria used in selecting EHR vendors. Each site had prioritized needs that guided their selection. Some of the primary drivers and insights gained are included in Table 1: Site Visit Key Insights.
In sum, the decision criteria to rank EHR vendors varies for each organization. Among consistently considered criteria are the alignments for: vendors, function, innovation, and support; the ability to support research (either now or in the future); revenue management; and, finally, the vendor’s ability to serve as a partner. Surprisingly, cost was not a major driver. While each site viewed their EHR selection as a critical capital investment, their priority was choosing mission-based support to serve as a backbone in providing high quality and safe patient care.
Knowing What You Need—Now and Then
Research is key to any success. It is also essential when determining the need for a new EHR.10 Two crucial research tasks already discussed are market research and site visits. The third leg of the stool is an internal assessment: What functionality is currently available, and what will be of critical importance in the future? Conducting this internal assessment at the NIH CC required three audiences for critical input: the Department of Clinical Research Informatics (DCRI, the overarching CC IT department), NIH stakeholders, and NIH leadership.
The DCRI is led by the CC chief information officer and is responsible for clinical informatics, infrastructure and technical operations, user support, IT security, privacy, and project and portfolio management. The DCRI is also responsible for the EHR. They are the subject matter experts for all development, configuration, testing, change management, training, etc. Boards overseeing the DCRI include the Architecture Review Board, Technical Review Board, and Change Management Review Board. These boards supervise any changes made to the system, including patches and upgrades. As such, this was the group critical to identifying the current system environment (all modules and/or interfaces), core system functionality provided, and maintenance required. The DCRI compiled a minimum mandatory capabilities matrix that clearly delineated critical capabilities (such as documentation, order entry, patient management, etc.) and their associated mandatory requirements. The matrix was used to align with current EHR systems identified in market research to validate DCRI’s ability to meet the minimum mandatory requirements. Over the last decade, the DCRI has employed a CRIS users group, nursing leadership forum, medical executive committee, and clinical staff surveys to keep abreast of the evolving needs and future technologies desired by the NIH. The user group was also utilized in the analysis of future state needs.
An EHR transition is not confined to technical teams. A transition takes networks of clinical subject matter experts to assess and endorse the clinical content that will live within the EHR.11 Any healthcare organization has many different stakeholders with varying requirements, needs, and expectations of the EHR, its functionality, and data.12 The NIH stakeholders include: the CC Clinical Department staff; NIH Institute Licensed Independent Practitioners (LIPs) and clinical personnel (research teams, fellows, and informaticists); and IT and customer support. These staff were interviewed in six focus group sessions. In these sessions, several questions were posed, including: What do you like about CRIS? What do you not like about CRIS? What would you like to have incorporated into an EHR in the future? The answers to these and additional questions were documented, consolidated, and grouped into themes.
The NIH leadership included the CC executive team (CEO, COO, CFO, CMO, CNO, and CIO), NIH Institute clinical directors, and key senior level physicians that are prominent CRIS users. The NIH leadership participated in individual interviews with two senior leaders of the project team. They engaged in candid discussions designed to elicit essential EHR needs, now and in the future.
These stakeholder feedback sessions with CC and IC staff led to some valuable insights about CRIS, the current EHR:
- CRIS is a great option for a clinically focused research medical center, and it meets the majority of CC functional needs, but there is room for improvement.
- The lack of a cross-organizational governance structure for clinical processes across protocols impairs knowledge exchange between the CC and the ICs. The existing framework should be optimized to reduce inefficiencies and safety concerns.
- Clinicians recognize that harmonization of clinical workflows is needed to improve business processes and that a training enforcement mechanism is needed to ensure proper levels of knowledge.
Further, the information gathered from all three of these stakeholder groups informed the development of a comprehensive needs and gaps assessment. The market research for each of the identified vendors was then appended to this assessment to evaluate the fit and/or gap for each component. A formal report was produced from the above information, as well as information gleaned from the meetings with each of the vendors at the HIMSS conference, which included system demonstrations, strategic five- to 10-year vendor priorities, and research support.
Arriving at an Answer
The culmination of the analysis conducted was documented in the abovementioned formal report. The report included an executive summary, detailed analysis of the components discussed above (background, market research, best practices reviews, current state, needs/gaps assessment) and recommendations.
- Maintain and upgrade the current CRIS platform and improve key processes to ensure full system functionality and deploy important new functions.
- Develop a strategic plan that aligns with the overall CC strategic plan.
- Implement system governance for CRIS and other relevant NIH systems that need to be reformed, including the elimination of duplicate systems to improve accountability, clinical documentation, and patient safety.
- Implement a revised training model to ensure that people know how to use basic and future functionality associated with CRIS.
- Start the procurement process now for a new EHR platform or undertake a significant modernization effort within three to six years. The procurement process would likely take two years, and implementation another two to four years.
The analysis and recommendations for improving the existing CRIS platform and implementing a new EHR system in the future was socialized across the major governing bodies within the NIH: the Medical Executive Committee, Clinical Center Governing Board, and the CC Research Hospital Board. All of these groups embraced the results and concurred with the recommendations.
The NIH CC is now actively working on both recommendations. The DCRI continues to provide new functionality in CRIS to improve patient safety and patient care with enhancements in telehealth, plans of care, and medication reconciliation. This also includes a major Allscripts upgrade. Additionally, the DCRI will soon embark on an updated strategic plan and enhanced data governance, starting first with a data cataloging tool.
The NIH CC has also started work on the development of a procurement strategy and associated procurement documents, with the goal of issuing a solicitation in the next 12 months.
This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing Interests Statement
The authors have no competing interests to declare.
All authors wrote and reviewed the final manuscript.
As used in this document, “Deloitte” means Deloitte Consulting LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries.
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