key: cord-0767639-5pe44plg authors: Fennelly, Orna; Cunningham, Caitriona; Grogan, Loretto; Cronin, Heather; O’Shea, Conor; Roche, Miriam; Lawlor, Fiona; O’Hare, Neil title: Successfully implementing a national electronic health record: a rapid umbrella review date: 2020-09-23 journal: Int J Med Inform DOI: 10.1016/j.ijmedinf.2020.104281 sha: 45737ceb152d534f7d7a3289b435cc8d730b083e doc_id: 767639 cord_uid: 5pe44plg AIM: To summarize the findings from literature reviews with a view to identifying and exploring the key factors which impact on the success of an EHR implementation across different healthcare contexts. INTRODUCTION: Despite the widely recognised benefits of electronic health records (EHRs), their full potential has not always been achieved, often as a consequence of the implementation process. As more countries launch national EHR programmes, it is critical that the most up-to-date and relevant international learnings are shared with key stakeholders. METHODS: A rapid umbrella review was undertaken in collaboration with a multidisciplinary panel of knowledge-users and experts from Ireland. A comprehensive literature review was completed (2019) across several search engines (PubMed, CINAHL, Scopus, Embase, Web of Science, IEEE Xplore, ACM Digital Library, ProQuest, Cochrane) and Gray literature. Identified studies (n = 5,040) were subject to eligibility criterion and identified barriers and facilitators were analysed, reviewed, discussed and interpreted by the expert panel. RESULTS: Twenty-seven literature reviews were identified which captured the key organizational, human and technological factors for a successful EHR implementation according to various stakeholders across different settings. Although the size, type and culture of the healthcare setting impacted on the organizational factors, each was deemed important for EHR success; Governance, leadership and culture, End-user involvement, Training, Support, Resourcing, and Workflows. As well as organizational differences, individual end-users also have varying Skills and characteristics, Perceived benefits and incentives, and Perceived changes to the health ecosystem which were also critical to success. Finally, the success of the EHR technology depended on Usability, Interoperability, Adaptability, Infrastructure, Regulation, standards and policies, and Testing. CONCLUSION: Fifteen inter-linked organizational, human and technological factors emerged as important for successful EHR implementations across primary, secondary and long-term care settings. In determining how to employ these factors, the local context, individual end-users and advancing technology must also be considered. Capturing and effectively using clinical information and knowledge to ensure a quality, safe and sustainable healthcare service is widely recognised 1,2 and data from electronic health records (EHRs) have been vital to decision-making on public health policies during the COVID-19 pandemic 3 . An EHR provides a longitudinal record of information regarding the health status of an individual in computer-processible form across practices and specialists, and enables authorised access to clinical records in real-time 4, 5 . As well as expanding the capacity to utilise clinical data for monitoring of patient outcomes and conducting audits and research 6, 7 , the EHR provides access to patient information in a timely manner, enabling healthcare professionals (HCPs) to spend more time with patients 8 , reducing duplication of tests and work, and improving the safety and quality of care provided 4, 7, [9] [10] [11] [12] [13] [14] . Additionally, integration of other functions and software, such as clinical decision support and bar code medication administration, further expand its potential benefits 15, 16 . Electronic patient records (EPRs) or electronic medical records (EMRs) also offer many of these benefits but solely contain the records from an individual organization. Whilst shared or summary care records and patient portals respectively store and facilitate access to specific patient information required by HCPs 17 and patients 18 . Despite the number of benefits which can be derived from these systems, challenges have been met in implementing a fully interoperable EHR between primary and secondary care 13, 19 , often attributed to the implementation process as opposed to the product supplied by the EHR vendor 20, 21 . Therefore, the implementation process is critical 22 and must be considered as an ongoing process beginning during procurement and continuing throughout each phase of design, development, testing, 'Go Live' and optimization. Whilst hospital information systems (HIS) in the USA have been in existence since the 1960s 23 , HIS are a more recent phenomenon in the Republic of Ireland where public healthcare is managed by the Health Service Executive (HSE) which co-exists with a private health system. The Office of the Chief Information Officer (CIO) has overall responsibility for embedding technology within the health infrastructure 24 and to date, EPRs have been implemented in some individual private and public hospitals and the majority of general practitioner (GP) offices (i.e., private primary care physicians often with HSE contracts), as well as for specific cohorts of patients (e.g., maternal and newborn and epilepsy) 25 . However, many other hospitals and HSE primary care (i.e., community) centres remain largely paper-based. With an EHR in the pipeline 24, 26 , three national projects have been planned by eHealth Ireland; Acute EHR, Community EHR and the Shared and Integrated Care Record. Therefore, this is an opportune time for policy-makers and other key stakeholders to review the learnings from the implementations of health information technology (HIT) both in Ireland and internationally. However, a vast amount of literature is published on topics such as EHRs which renders it difficult for policy-makers to remain up-to-date 27, 28 , perhaps amplifying the "know-do" gap. Additionally, healthcare is a complex and adaptive system which needs to be recognized and acknowledged when attempting to replicate successes in another context 29 . The EHR programme in Ireland is also already underway and therefore, it's critical that knowledge is generated to provide actionable and relevant key considerations in a timely manner aligned with the policy and decision-making cycles 30 . Therefore, the aim of this review is to identify and explore the key factors which promote a successful EHR implementation across healthcare settings, with active collaboration from key stakeholders in the Irish context. A rapid umbrella review was conducted and guided by the World Health Organisation (WHO) practical guide for Rapid Reviews to Strengthen Health Policy and Systems 31 . Unlike a systematic review, an umbrella review also known as a review of reviews, compiles evidence from several research syntheses across different healthcare contexts and stakeholder groups 32, 33 . Active collaboration with an expert panel of knowledge users facilitated the acceleration of the systematic review process 30 and to facilitate uptake and use of these findings by planners and decision-makers, the synthesized findings were also presented in a report format 34 . A multi-disciplinary panel of experts and knowledge users (n=10) were engaged and involved throughout the review process to inform its methodology, validate the generalizability and relevance of the review findings 35 , and ensure it reflects current thinking and is useful 27 . The panel was convened in January 2019 by the Office of Nursing and Midwifery Services Director (HSE) and comprised of those currently involved in large HIT implementation projects across primary and secondary care at local and national levels in Ireland, as well as clinicians, health service researchers and academic partners from healthcare and health informatic backgrounds (Table 1) . Five consultative in-person group meetings and several individual meetings and email exchanges within the group were conducted throughout the review process. An initial exploratory scope of the EHR literature in the PubMed database was reviewed by the expert panel and the final research question, methodology and search strategy were developed and agreed. A large number of search terms to describe "Electronic Health Record", "Implementation" and "Literature Review" were identified from previous systematic reviews 7,36-40 , additional literature 17 , medical subject heading and controlled vocabulary and via consultation with the expert panel and an experienced information technologist at the Health Sciences Library, UCD [Appendix]. The search string was tailored to the indexing language of each database and in March 2019, it was executed across PubMed, CINAHL, Scopus, Embase, Web of Science, IEEE Xplore, ACM Digital Library, ProQuest and Cochrane, with limitations of English language and published since 2010. Grey literature including reports and conference proceedings were also searched (international Health Informatics Societies, the World Health Organization (WHO), European e-health network, Kings Fund, Gartner and Lenus). Panellists also drew on their expertise to identify any additional relevant sources 35 . Identified articles were calibrated in the citation management software Endnote version x9.2 and titles and abstracts were screened by one researcher using the inclusion and exclusion criteria agreed with the expert panel (Table 2) . Full text articles were then accessed and screened by the same researcher, with any doubts regarding inclusion or exclusion discussed with the panel to overcome any risk of errors or inconsistencies associated with using one reviewer 31 . In line with our chosen rapid review methodology, a quality assessment of identified reviews was not conducted. A standardized data extraction form was developed and included authors, year of publication, study design, participants, healthcare setting, included studies and findings related to factors impacting on the implementation (i.e., themes and/or paragraphs as required). Following data extraction, a qualitative content analysis of the factors impacting on the EHR implementation was undertaken by the researcher 41 . Using an iterative process, a list of codes representing the identified factors from each of the literature reviews was formed 42 . The expert panel reviewed these codes via an adapted nominal group technique, which saw collated appraisals distributed amongst the panellists 43 to assess whether they were comprehensive of the literature and their J o u r n a l P r e -p r o o f own experiences, and to determine whether the findings could be transferred to Irish contexts and settings 42 . Having reached a final consensus regarding the factors for a successful EHR implementation, these factors were further categorized into a theoretical framework 10 and resulted in the generation of key considerations 42 . Of the 5,040 articles retrieved, 27 literature reviews were identified which captured factors deemed important for the successful implementation of EHRs, as well as other HIT implementations (Fig. 1 ). Fifteen were classified as systematic reviews, whilst the others were umbrella reviews (n=3), scoping reviews (n=2), interpretive review (n=1), literature review with a meta-narrative (n=1) and other non-systematic literature reviews (n=5). Overlap in included publications existed across the literature reviews with 974 unique studies, literature reviews, reports, books and guidelines identified. Perspectives of a variety of stakeholders were captured in these reviews including GPs (or primary care physicians), other doctors, nurses, health and social care professionals, patients, policymakers, vendors and IT consultants (Table 3) . Although many literature reviews encompassed studies from a variety of healthcare settings, others were specific to primary care (i.e., community) 13, 44, 45 , long term care 46 and mental health settings 47 or within specific countries or groups of countries 19,48-51 . J o u r n a l P r e -p r o o f J o u r n a l P r e -p r o o f Fifteen common factors were identified and classified as organizational, human and technological. Each of these factors are discussed in detail below as well as how they interact within different contexts. Factors relating to the processes by which the EHR was introduced and incorporated into routine care were categorized as organizational 54 . Whilst each of the six factors were important across all contexts, the size and type of organization impacted on how each triggered success during the EHR implementation 46, 53, 61 . The governance of the EHR implementation 13, 19, 37 , as well as leaders 7, 10, 36, 44, 48, [52] [53] [54] 62, 63 and organizational culture, were identified as paramount in ensuring a successful EHR system 7, 10, 13, 36, 45, [50] [51] [52] [53] 56, 59, 62 . Whilst top-down, middle-out and bottom-up governance structures have been utilised, ongoing political willingness, national policies and some independence at an individual organizational level regarding EHR procurement, development and design, were recommended to promote engagement, usability and interoperability 13, 48, 51, 62 . It was also important that executive leaders such as CIOs and project management teams establish good and trusting relationships with vendors and consulting firms 12, 44, 52, 56, 63 , and designed the implementation strategy with clear measurable objectives 10,50,52 , a fitting implementation process (e.g., big-bang or phased) 44, 46, 51, 58 , and clear roles and divisions of labour 10, 60 . A shift away from the dominance of top and middle management has also been recommended 10, 19, 36 , with the appointment of local leaders or champions, and supporting of internal and external communication and collaboration 10, 11, 19, 52, 59 , innovation and continual improvement 52 , and patient-centred care 19 . This helps create a favourable 10, 36, 44, 63 and flexible 52 culture. During each stage of the EHR implementation process, end-user involvement was highlighted as important 7, 10, 37, 47, 48, 52, 54, 56, 57, 60, 62, 63 , as it helps to ensure that the EHR meets end-users' needs and workflows, as well as promoting a sense of ownership 37 and acceptance amongst staff 10, 37, 63 . Engaging end-users from each stakeholder group was recommended 36 , and this has often been done in the form of appointing champions. These leaders should be respected amongst their colleagues as well as having the relevant knowledge to act as a bridge between the end-users and IT staff 60, 62, 63 . However, champions may sometimes need to be shared between organizations 10 . Basic computer and EHR-specific training were identified as key to a successful EHR implementation 7, 10, 12, 13, 19, 36, 37, 45, 46, 48, [50] [51] [52] [53] 56, 57, 60, 61, 63 . However, the effectiveness and resourceefficiency of training depended on the appropriateness of the appointed trainers, training content, timing of training (i.e., as close to Go Live as possible 36 ) and methods of training e.g., classroom based versus eLearning 57 . EHR training was also recommended on an ongoing basis for new staff, as well as existing staff to optimize their use of the system 37,53 . Expert, technical, executive and external support have been critical to successful EHR implementations 7, [10] [11] [12] [13] 19, 36, 37, 44, [50] [51] [52] [53] [56] [57] [58] [60] [61] [62] [63] . Expert or peer support, often referred to as super-users, reportedly helped end-users to optimize their use of the EHR 7, 11, 12, 36, 53 , whereas technical support staff helped solve IT issues 51, 62 . During Go Live (often first 3-4 weeks 37 ), technical and peer support should be available 24/7 seven days a week in hospitals 12, 36 . However, this may not be feasible or required in primary care centres but channels to obtain support during working hours remain important. Other crucial support comes from an executive or policy level 19, 50, 52, 53, 56, 57, 60, 63 and professional networks or external parties 19, 53 . Although maintenance support for servers and networks was not as evidenced in the identified literature 50 , the expert panel also deemed this as important. The availability of resources in terms of finance, skilled workforce and time was also important 7, 10, 12, 13, 36, 37, [44] [45] [46] 48, 49, [51] [52] [53] [54] 56, [59] [60] [61] [62] [63] . Financial resourcing was often highlighted as a barrier especially by primary care doctors 12, 13 and those in lower income countries 48 , and scope creep of the budget was a common occurrence for larger hospitals 10, 52, 54 . Therefore, a cost analysis which encompasses infrastructure, personnel, maintenance and ongoing optimization was critical 36, 62 . Having a skilled workforce in-house who understand the clinical workflows was also recommended 53,61 as it can reduce dependence on and cost of vendors 12, 36 . However, this may not be feasible for smaller organizations, and larger organizations also reportedly had issues with IT staff retention 10, 13, 36, 48, 51 . Adequate time for end-user involvement and habituation to the EHR was also vital 7,10,12 to ensure organizational readiness 7, 13, 51, 53 . Inability of the EHR system to meet the workflows of end-users and organizations was commonly cited as negatively impacting on success 7, [10] [11] [12] 36, 37, 51, 52, 54, 56, 62, 63 , including end-user efficiency, productivity, satisfaction and acceptance of the EHR 7,11,63 . Although replicating existing paper-based practices may minimize disruptions for end-users 7,13,19,62 , re-engineering of workflows during digitization to make them safer and more efficient was recommended 19, 62, 63 . Ability of healthcare organizations to successfully adopt an EHR system was largely determined by the individual end-users 10, 54 , and three overarching human factors were identified. IT skills as well as personal characteristics of individuals impacted on the success of an EHR implementation 10, 12, 50, 51, 53, 56, 58, 60, 62, 13, 19, 36, 37, 44, [47] [48] [49] . Assessing computer literacy of end-users enabled provision of basic computer training to those requiring it, prior to effective EHR training 36, 48 . Whilst the research assessing the impact of age, gender and clinical experience on acceptance of the EHR reported in the identified reviews was inconclusive, personal traits such as being open-to-change and a problem-solver appeared to contribute to success 56, 62 . However, resistance to the EHR could also be attributed to unusable technology 10, 51 . Where individual end-users perceived the EHR to positively impact on patient care and workload, this reportedly facilitated a successful implementation 10, 12, 50, 51, 56, 58, 60, 13, 19, 36, 37, 44, [47] [48] [49] . However, realistic benefits and timeframes specific to the organization should be communicated with end-users 44, 45, 62 . Monetary incentives or penalties have also been shown to be important, especially for privately-governed organizations 13, 45, 59 . Perceived changes to the healthcare ecosystem End-users' concerns with changes to data privacy and security, patient-clinician relationships and their roles and responsibilities, appeared to negatively impact on EHR implementations 7, 10, 51, 53, 56, 58, [60] [61] [62] 12, 13, 19, 36, 44, [47] [48] [49] . These concerns may differ depending on the specific setting and type of sensitive personal information being collected (e.g., mental health) 47 . Therefore, specific concerns and their causes of concerns should be identified and addressed as soon as possible to mitigate their impact on EHR implementations 19, 36 . Six factors relating to the technology aspect of the EHR implementation were identified as critical to its success and were intrinsically linked to the organizational and human factors. Usability EHR usability was deemed important across several reviews 7, 10, 11, 13, 36, 37, 44, 46, 47, 49, 51, 52, 54, 58, 60, 62 , as it impacted on end-user efficiency, patient-facing time 12, 13, 37, 53 , quality of care 12 , patientclinician relationships 52 and safety 37 . However, a simple and intuitive system in one setting may not be transferrable to another, and therefore, end-user involvement in development, design 10, 37, 62 and usability testing were recommended at each site 37 . Additionally, enabling personalization of the EHR interface 53 and access to legacy paper-based records 50,51 as well as consideration of data quality and accuracy 13, 44, 51 with use of health terminologies and classifications 56 was recommended. However, usability needs to be balanced with security 44 . To enable health information exchange both within and across healthcare organizations, interoperability was identified as critical 7, [10] [11] [12] [13] 19, 37, 44, 45, [49] [50] [51] [52] 54, 58, 60, 62 . Local contextual factors within countries such as two tier and fully private health systems, lack of employment of national standards 45, 53, 62 , inconsistent data capture in incompatible formats 12 , have rendered the creation of a fully interoperable EHR as difficult. Therefore, technical standards and communication between organizations were recommended to ensure interoperability was built in from the outset including for legacy and existing health IT systems 7 . Procurement or enhancement of infrastructure, including software (e.g., EHR, anti-viral), hardware (e.g., data-entry devices, Wi-Fi, power outlets) and furniture, accounted for a large proportion of the financial resourcing and were deemed critical for the success of the overall EHR implementation 10, 12, 56, 62, 63, 36, [47] [48] [49] [50] [51] [52] [53] . The existing and new hardware and software must be compatible with the specific EHR product 45 , reliable and functional 13, 36, 44, 53, 56 , and enable sufficient accessibility to the EHR for end-users 36, 45, 52, 56 . According to the expert panel and additional literature reviewed, selection of mobile and stationary data-entry devices also require consideration of vendor certification, healthcare setting (e.g., outpatients versus isolation rooms), required functions and workflows (e.g., checklists versus long narrative notes), and end-user preferences for usability. As stated earlier, national and international standards as well as regulation and policies were critical for interoperability and addressing privacy and security concerns 7, 13, 19, 45, 46, 51, 52, 56, 58, 60, 62, 63 . Therefore, messaging and language standards 45, 52, 56 , as well as robust privacy laws and policies 13, 44, 52, 56, 62 were recommended. Where healthcare organizations were permitted to procure their own EHR product, these standards would likely be especially important. Many of the literature reviews reported that adaptability of the software was important to facilitate customization of the EHR software to meet the needs of the end-users and organizations 10, 36, 37, 50, 51, 53, 54, 62 . This reportedly required the software vendors to be open to sharing code development data and willing to adapt their product 36, 37, 53 , and the organization to have access to a skilled workforce with the capabilities to adapt the EHR to clinical workflows 37 . Where interoperability standards exist, the need for adaptations to the software may be reduced 37 . Comprehensive testing of the system was critical to ensure usability and safety 7,10,37,54 , and was more commonly cited as important by IT staff and management than HCPs 7 . This rigorous, resource-intensive, multi-step testing process of each EHR function needed to be conducted within live environments with actual end-users 54 and should not be underestimated. This umbrella review distilled the large volume of evidence available regarding the successful implementation of a national EHR and these findings were corroborated by an expert panel as being relevant to the Irish healthcare context. Fifteen key organizational, human and technological factors were identified as critical and by synthesizing the findings from several different stakeholder groups and clinical settings, such as doctors in primary or secondary care 11, 13, 45, 53, 58, 61 and nurses in a mental health setting 47 , this review of reviews identified that each of these factors were also relevant and important to EHR implementations across different healthcare settings. However, between country differences including health service management, politics, economics, regulation and socio-culture impact on how the identified factors influence success. This was evident in the literature reviews which largely focused on studies conducted in the largely private health service in the USA where return on investment and productivity were important perceived benefits and incentives 50, 51, 56 . Additionally whilst the governance approach was identified as important, a successful approach in one country cannot necessarily be replicated in another, as occurred in the UK where the top-down approach successfully employed in the Netherlands resulted in disengaged healthcare organizations in the UK 22 . Therefore, these factors need to be employed with consideration of the national context and in the Republic of Ireland this will also require close collaboration and communication across the co-existing public and private health sectors 64, 65 , as well as with Northern Ireland (UK). Additionally, European Union (EU) citizens may avail of healthcare from any members state under the Cross-Border Healthcare Directive (2011/24/EU) and thus, efficient exchange of health data across borders is a major priority 66 and is a pillar of EU4Health 2021-2027 67 . Therefore, the EU interoperability policies and frameworks 14 as well as standards such as the International Patient Summary, the General Data Protection Regulation (GDPR) and standardised terminologies 4 to support these frameworks need to be employed. Despite the expansion in internationally-recognised standards (e.g., HL7 FHIR) and significant regulatory and financial incentives created by the HITECH Act and "Meaningful Use" requirements in the USA, factors such as Usability and Regulations, standards and policies continue to be highlighted as important for success as opposed to being assumed components of EHR products. Whilst the inclusion of older studies by these reviews is perhaps attributable, it is also likely that standards and requirements alone will not ensure an interoperable and usable EHR. In fact, it is the dynamic interaction between each of the identified factors which promote a successful EHR 68 . However, more emphasis placed on an individual factor can reduce the resources required for others, for example promoting Usability and Standards can respectively reduce the burden of training and support, and adaptability 37 . Additionally, this may be achieved by advances in evidence and technology such as artificial intelligence (AI) including automated testing 69 , eLearning modules 70, 71 , and personalization of the EHR interface 72 . Therefore, it is recommended that those involved in each aspect of the implementation process communicate throughout if and review the latest evidence regarding technology including peer-reviewed publications and white papers. At a more local or meso level, the size of the organization, infrastructure, organizational readiness and culture, capabilities and beliefs of the workforce, and available finance 36, 37 , were also identified as important when considering the application of the identified factors. Certain aspects of the internal context can be enhanced to improve the likelihood of EHR success such as employing change management to create a clear and realistic vision of the EHR 73 and providing basic computer training 36, 48 . However, the size of the organization and its workforce will likely remain more limited compared to their larger counterparts 10, 37 . Therefore, sharing of resources such as champions, support staff and trainers between larger and smaller hospitals or primary care settings has been recommended, with some countries creating networks or encouraging collaboration between existing regional groups of healthcare organizations 73, 74 . Undertaking a rapid qualitative evidence synthesis requires acceleration of many of the research processes, is dependent on the reporting in the original reviews 32 and could risk losing the context and complexity of the original research setting 32, 42, 75 . Additionally, five of the literature reviews were conducted by the same lead author which could lead to bias of individual study inclusion. However, the inclusion of literature reviews, consideration of the inclusion criteria of each literature review and ongoing collaboration with an expert panel 30 provided a degree of confidence regarding the coherence, relevance and adequacy of the findings and their generalisability across healthcare settings 76 . Additionally, actively involving knowledge-users who were undertaking HIT implementations led to the concurrent translation of this knowledge into practice 77 . The key organizational, human and technological factors identified in this review provide policy-makers and other key stakeholders with a foundation for making evidence-based decisions during the implementation of a fully interoperable EHR across primary, secondary and long-term care. However, critical to the application of these factors within an implementation process also requires consideration of the specific contextual influences. Additionally, the end-users, existing technological standards and policies, and advances in technology and research in the area, will impact on how these factors dynamically interact during EHR implementation and will influence success. What was already known on the topic: J o u r n a l P r e -p r o o f  Despite recognition of the huge potential for EHRs to improve the delivery of healthcare, no country has successfully implemented a fully interoperable EHR across acute and community care.  The implementation process of EHRs is critical to their success and needs to be carefully planned and considered across the complex and adapting healthcare landscape.  A vast amount of literature exists on EHRs which has been relevant to specific stakeholder groups and healthcare contexts.  A comprehensive and clear overview of factors influencing the success of an EHR implementation across primary, secondary and long-term care and different stakeholder groups is presented.  Validation of these factors for the Irish healthcare context via co-production and transfer of knowledge with key knowledge-users.  Generation of key considerations for each of these factors for policy-makers and other knowledgeusers. 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