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Objective: Describe and analyze reasoning patterns of clinicians responding to drug-drug interaction alerts in order to understand the role of patient-specific information in the decision-making process about the risks and benefits of medication therapy. Insights could be used to inform the design of decision-support interventions., Methods: Thirty-two clinicians working with five EHRs in two countries completed sets of six medication orders each and responded to high- and low-severity drug-drug interaction alerts while verbalizing their thoughts in a standard think-aloud protocol. Tasks were recorded and analyzed to describe reasoning patterns about patient-risk assessment and strategies to avoid or mitigate it., Results: We observed a total of 171 prescribing decisions. Clinicians actively sought to reduce risk when responding to high-severity alerts, mostly by monitoring patients and making dose adjustments (52 alerts, 40%). In contrast, they routinely left prescriptions unchanged after low-severity alerts when they felt confident that patients would tolerate the drug combination and that treatment benefits outweighed the risks (30 alerts, 71%). Clinicians used similar reasoning patterns regardless of the EHR used and differences in alert design., Discussion: Clinicians conceptualized risk as a complex set of interdependent tradeoffs specific to individual patients and had a tendency not to follow advice they considered of low clinical value. Omission of patient-specific data, which was not shown in alerts or included in trigger logic, may have contributed to the constancy of reasoning and to similarities in risk-control strategies we observed despite significant differences in interface design and system function., Conclusion: Declining an alert suggestion was preceded by sometimes brief but often complex reasoning, prioritizing different aspects of care quality and safety, especially when the perceived risk was higher. Clinicians believed that the risk indicated in drug-drug interaction alerts needs to be interpreted as one factor in the broader context of care, specific to a patient., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Objective: To collect and critically review patient safety initiatives for health information technology (HIT)., Method: Publicly promulgated set of advisories, recommendations, guidelines, or standards potentially addressing safe system design, build, implementation or use were identified by searching the websites of regional and national agencies and programmes in a non-exhaustive set of exemplar countries including England, Denmark, the Netherlands, the USA, Canada and Australia. Initiatives were categorised by type and software systems covered., Results: We found 27 patient safety initiatives for HIT predominantly dealing with software systems for health professionals. Three initiatives addressed consumer systems. Seven of the initiatives specifically dealt with software for diagnosis and treatment, which are regulated as medical devices in England, Denmark and Canada. Four initiatives dealt with blood bank and image management software which is regulated in the USA. Of the 16 initiatives directed at unregulated software, 11 were aimed at increasing standardisation using guidelines and standards for safe system design, build, implementation and use. Three initiatives for unregulated software were aimed at certification in the USA, Canada and Australia. Safety is addressed alongside interoperability in the Australian certification programme but it is not explicitly addressed in the US and Canadian programmes, though conformance with specific functionality, interoperability, security and privacy requirements may lead to safer systems. England appears to have the most comprehensive safety management programme for unregulated software, incorporating safety assurance at a local healthcare organisation level based on standards for risk management and user interface design, with national incident monitoring and a response function., Conclusions: There are significant gaps in the safety initiatives for HIT systems. Current initiatives are largely focussed on software. With the exception of diagnostic, prognostic, monitoring and treatment software, which are subject to medical device regulations in some countries, the safety of the most common types of HIT systems such as EHRs and CPOE without decision support is not being explicitly addressed in most nations. Appropriate mechanisms for safety assurance are required for the full range of HIT systems for health professionals and consumers including all software and hardware throughout the system lifecycle. In addition to greater standardisation and oversight to ensure safe system design and build, appropriate implementation and use of HIT is critical to ensure patient safety., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Objective: To evaluate the problems experienced after implementing a computerized physician order entry (CPOE) system, their possible root causes, and the responses of providers in order to incorporate the system into daily workflow., Methods: A qualitative study in the medication-use process after implementation of a CPOE system in an academic hospital in The Netherlands. Data included 21 interviews with clinical end-users, paper-based and system-generated documents used daily in the process, and educational materials used to train users., Findings: The problems in the medication-use process included cognitive overload on physicians and nurses, unmet information needs, miscommunication of orders and ideas, problematic coordination of interrelated tasks between co-working professionals, a potentially faulty administration phase, and suboptimal monitoring of the medication plans. These problems were mainly rooted in the lack of mobile computer devices, the uneasy integration of coexisting electronic and paper-based systems, suboptimal usability of the system, and certain organizational factors with regard to procuring drugs affecting the technology use. Various types of workarounds were used to address the difficulties, including phone calls, taking multiple paper notes, issuing paper-based and verbal orders, double-checking, using other patients' procured drugs or another department's drug supply, and modifying and annotating the printed orders., Conclusion: This study shows how providers are actively involved in working around the interruptions in workflow by bypassing the technology or adapting the work processes. Although certain workarounds help to maintain smooth workflow and/or to ensure patient safety, others may burden providers by necessitating extra time and effort and/or endangering patient safety. It is important that workarounds having a negative nature are recognized and discussed in order to find solutions to mitigate their effects., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Purpose: To study correctness of drug safety alert handling and error type in a computerized physician order entry (CPOE) system in a simulated work environment., Methods: Disguised observation study of 18 physicians (12 from internal medicine and 6 from surgery) entering 35 orders of predefined patient cases with 13 different drug safety alerts in a CPOE. Structured interviews about how the generated drug safety alerts were handled in the simulation test and resemblance of the test to the normal work environment. Handling and reasons for this were scored for correctness and error type., Results: Thirty percent of alerts were handled incorrectly, because the action itself and/or the reason for the handling were incorrect. Sixty-three percent of the errors were categorized as rule based and residents in surgery used incorrect justifications twice as often as residents in internal medicine. They often referred to monitoring of incorrect substances or parameters. One alert presented as a second alert in one screen was unconsciously overridden several times. One quarter of residents showed signs of alert fatigue., Conclusion: Although alerts were mainly handled correctly, underlying rules and reasoning were often incorrect, thereby threatening patient safety. This study gave an insight into the factors playing a role in incorrect drug safety alert handling that should be studied in more detail. The results suggest that better training, improved concise alert texts, and increased specificity might help. Furthermore, the safety of the predefined override reason 'will monitor' and double alert presentation in one screen is questioned., (Copyright 2010 Elsevier Ireland Ltd. All rights reserved.)

Purpose: To evaluate the functionality of drug safety alerting in hospital computerized physician order entry (CPOE) systems by a newly developed comprehensive test., Methods: Comparative evaluation of drug safety alerting quality in 6 different CPOEs used in Dutch hospitals, by means of 29 test items for sensitivity and 19 for specificity in offices of CPOE system vendors. Sensitivity and specificity were calculated for the complete test, and for the categories "within-order checks", "patient-specific checks", and "checks related to laboratory data and new patient conditions". Qualitative interviews with 16 hospital pharmacists evaluating missing functionality and corresponding pharmacy checks., Results: Sensitivity ranged from 0.38 to 0.79 and specificity from 0.11 to 0.84. The systems achieved the same ranking for sensitivity as for specificity. Within-order checks and patient-specific checks were present in all systems; alert generation or suppression due to laboratory data and new patient conditions was largely absent. Hospital pharmacists unanimously rated checks on contra-indications (absent in 2 CPOEs) and dose regimens less than once a day (absent in 4 CPOEs) as important. Pharmacists' opinions were more divergent for other test items. A variety of pharmacy checks were used, and clinical rules developed, to address missing functionality., Conclusions: Our test revealed widely varying functionality and appeared to be highly discriminative. Basic clinical decision support was partly absent in two CPOEs. Hospital pharmacists did not rate all test items as important and tried to accommodate the lacking functionality by performing additional checks and developing clinical rules., ((c) 2010 Elsevier Ireland Ltd. All rights reserved.)

Objective: To investigate the human, social and organizational issues surrounding a Computerized Physician Order Entry system for Laboratory ordering (CPOE-L) implementation process and to analyze their interrelated effects on the system implementation failure in an academic medical setting. Second, to provide lessons learned and recommendations on to how to manage challenges of human, social and organizational nature surrounding CPOE-L implementations., Methods: The themes surrounding CPOE introduction were identified by a heuristic analysis of literature on CPOE implementations. The resulting set of themes was applied as a reference model for 20 semi-structured interviews conducted during the CPOE-L implementation process with 11 persons involved in the CPOE-L project and in reviewing all CPOE-L related project documentation. Data was additionally gathered by user questionnaires, by user discussion rounds and through an ethnographical study performed at the involved clinical and laboratory departments. In analyzing the interview transcripts, project documentation and data from user questionnaires and discussion rounds a grounded theory approach was applied by the evaluation team to identify problem areas or issues deserving further analysis., Results: Outlined central problem areas concerning the CPOE-L implementation and their mutual relations were depicted in a conceptual interpretative model. Understanding of clinical workflow was identified as a key theme pressured by organizational, human and social issues ultimately influencing the entire implementation process in a negative way. Vast delays in CPOE introduction, system immaturity and under-functionality could all be directly attributed to a superficial understanding of workflow. Consequently, final CPOE integration into clinical and laboratory workflows was inhibited by both end-users as well as department managers and withdrawal of the CPOE-L system became inevitable., Conclusion: This case study demonstrates which human, social and organizational issues relevant to CPOE implementation cumulatively led to a failure outcome of the CPOE-L pilot introduction. The experiences and considerations described in this paper show important issues for CPOE systems to be successfully introduced and to be taken into account in future CPOE implementations. Understanding and consideration of (clinical) workflow aspects by project managers and the involved clinical organization is of extreme importance from the very start of a CPOE implementation process., ((c) 2009 Elsevier Ireland Ltd. All rights reserved.)

Objective: To compare how nurses in two different paper-based systems perceive the impact of a computerized physician order entry (CPOE) system on their medication-related activities., Setting: 13 non-surgical, adult inpatient wards in a Dutch academic hospital., Methods: Questionnaire survey of 295 nurses before and 304 nurses after the implementation of a CPOE system. These nurses worked with two different paper-based medication systems before the implementation: 'Kardex-system' and 'TIMED-system'. In the Kardex-system, the structure of the nursing medication work was similar to that of after the CPOE implementation, while in the TIMED-system, it was different. 'Adaptive Structuration Theory' (AST) was used to interpret the results., Results: The response rates were 52.2% (154/295) before and 44.7% (136/304) after the implementation. Kardex-nurses reported more positive effects than TIMED-nurses. TIMED-nurses reported that the computerized system was more inflexible, more difficult to work with, and slower than the TIMED-system. In the TIMED group, the overall mean score of the computerized process was not significantly different from that of the paper-based process. Moreover, nurses in both groups were more satisfied with the post-implementation process than with the pre-implementation process. Nevertheless, none of groups reported a better workflow support in the computerized system when compared to that of the paper-based systems., Conclusions: Our findings suggest that not only the technology but also large differences between pre- and post-implementation work structure influence the perceptions of users, and probably make the transition more difficult. This study also suggests that greater satisfaction with a system may not necessarily be a reflection of better workflow support.

Objective: To describe the perceived effect of computerized physician order entry (CPOE) on professional collaboration, workflow and quality of care., Design: Semi-structured interviews with experts involved in the design, implementation and evaluation of computerized physician order systems in the United States., Measurements: The interview transcripts were analyzed using six key concepts that identify context, professional collaboration, workflow and quality of care., Results: The interviews reveal the complexity of CPOE. Although providers enter the orders, others collaborate in the decision-making process. There is a profound impact on workflow beyond that of the provider. While quality of care is the main impetus for implementation, it remains terribly difficult to measure the impact on quality., Conclusions: A proper understanding of CPOE as a collaborative effort and the transformation of the health care activities into integrated care programs requires an understanding of how orders are created and processed, how CPOE as part of an integrated system can support the workflow, and how risks affecting patient care can be identified and reduced, especially during hand-offs in the workflow.

In this paper, we present a model that describes the stages of the implementation of an information system in a health care organization. The model offers no explanation of the implementation process but rather describes in a cyclic order the domains that are relevant when implementing a system. The model offers thus an opportunity to identify gaps in our knowledge and understanding of implementation processes and provides also the conceptual basis for a higher education course of health informatics that is focusing on organizational change and the pivotal role of information and communication technology.