Beliefs and perceptions of patient safety event reporting in a Canadian Emergency Department: a qualitative study.

OBJECTIVES: Patient safety events (PSEs) are unwanted or unexpected events that occur during medical care. High cognitive loads and frequent interruptions make emergency departments (EDs) uniquely error prone environments. Yet, frontline clinicians rarely report PSEs using incident reporting systems. The incidence, severity, and preventability of PSEs thus remain poorly understood, and contributing factors are understudied. We sought to understand ED staff beliefs and perceptions about their PSE reporting system and what features they believe are important in such a system. METHODS: We conducted a qualitative study among healthcare providers working in the ED and departmental leadership. We recruited participants via email and held a series of interviews, focus groups, and participatory workshops. We iteratively analyzed the data using the constant comparative method and used thematic analysis to establish themes. RESULTS: 50 participants attended at least one focus group, interview, or workshop. Participants perceived that PSE reporting through formal channels in the ED was challenging. Clinicians had an inherent desire to report PSEs and do so through numerous informal channels, yet underreported in formal reporting systems. The current PSE reporting system did not meet frontline staff needs and was viewed as ineffective in improving care quality and safety. We identified three key features for an improved PSE reporting system: (1) clear definitions; (2) transparency; and (3) simplicity. CONCLUSIONS: In this study, we have identified ideal features for PSE reporting processes to meet the needs of both frontline staff and departmental leadership based on perceptions of current PSE reporting practices. Improved PSE reporting processes have the potential to increase PSE reporting in the ED overall, increasing the availability of information about PSEs to support quality improvement and improve patient safety.

RéSUMé: OBJECTIFS: Les événements liés à la sécurité des patients (ESP) sont des événements non désirés ou inattendus qui se produisent pendant les soins médicaux. La charge cognitive élevée et les interruptions fréquentes font des services d'urgence des environnements particulièrement propices aux erreurs. Pourtant, les cliniciens de première ligne signalent rarement les ESP à l'aide des systèmes de déclaration des incidents. L'incidence, la gravité et le caractère évitable des ESP restent donc mal compris, et les facteurs contributifs sont peu étudiés. Nous avons cherché à comprendre les croyances et les perceptions du personnel des services d'urgence à l'égard de leur système de déclaration des ESP et les caractéristiques qu'ils jugent importantes dans un tel système. MéTHODES: Nous avons mené une étude qualitative auprès des prestataires de soins de santé travaillant aux urgences et de la direction du service. Nous avons recruté des participants par courrier électronique et organisé une série d'entretiens, de groupes de discussion et d'ateliers participatifs. Nous avons analysé les données de manière itérative en utilisant la méthode comparative constante et avons utilisé l'analyse thématique pour établir des thèmes. RéSULTATS: 50 participants ont assisté à au moins un groupe de discussion, une entrevue ou un atelier. Les participants estiment qu'il est difficile de rendre compte de l'ESP par les voies officielles au sein de l'urgence. Les cliniciens avaient un désir inhérent de signaler les ESP et le faisaient par de nombreuses voies informelles, mais ils étaient sous-déclarés dans les systèmes de déclaration officiels. Le système actuel de déclaration des ESP ne répondait pas aux besoins du personnel de première ligne et était considéré comme inefficace pour améliorer la qualité et la sécurité des soins. Nous avons identifié trois caractéristiques clés pour un système amélioré de rapports sur les ESP : (1) des définitions claires ; (2) la transparence ; et (3) la simplicité. CONCLUSIONS: Dans cette étude, nous avons identifié les caractéristiques idéales des processus de déclaration des ESP afin de répondre aux besoins du personnel de première ligne et de la direction du département, en fonction des perceptions des pratiques actuelles de déclaration des ESP. L'amélioration des processus de déclaration des ESP a le potentiel d'accroître la déclaration des ESP dans les urgences en général, augmentant ainsi la disponibilité des informations sur les ESP pour soutenir l'amélioration de la qualité et améliorer la sécurité des patients.

The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study.

BACKGROUND: Existing systems to document adverse drug events often use free text data entry, which produces nonstandardized and unstructured data that are prone to misinterpretation. Standardized terminology may improve data quality; however, it is unclear which data standard is most appropriate for documenting adverse drug event symptoms and diagnoses. OBJECTIVE: This study aims to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses. METHODS: We performed a mixed methods substudy of a multicenter retrospective chart review. We reviewed the research records of prospectively diagnosed adverse drug events at 5 Canadian hospitals. A total of 2 pharmacy research assistants independently entered the symptoms and diagnoses for the adverse drug events using four standards: Medical Dictionary for Regulatory Activities (MedDRA), Systematized Nomenclature of Medicine (SNOMED) Clinical Terms, SNOMED Adverse Reaction (SNOMED ADR), and International Classification of Diseases (ICD) 11th Revision. Disagreements between research assistants regarding the case-specific utility of data standards were discussed until a consensus was reached. We used consensus ratings to determine the proportion of adverse drug events covered by a data standard and coded and analyzed field notes from the consensus sessions. RESULTS: We reviewed 573 adverse drug events and found that MedDRA and ICD-11 had excellent coverage of adverse drug event symptoms and diagnoses. MedDRA had the highest number of matches between the research assistants, whereas ICD-11 had the fewest. SNOMED ADR had the lowest proportion of adverse drug event coverage. The research assistants were most likely to encounter terminological challenges with SNOMED ADR and usability challenges with ICD-11, whereas least likely to encounter challenges with MedDRA. CONCLUSIONS: Usability, comprehensiveness, and accuracy are important features of data standards for documenting adverse drug event symptoms and diagnoses. On the basis of our results, we recommend the use of MedDRA.

Patient Perspectives on Health Data Privacy and Implications for Adverse Drug Event Documentation and Communication: Qualitative Study.

BACKGROUND: Adverse drug events are unintended and harmful effects of medication use. Using existing information and communication technologies (ICTs) to increase information sharing about adverse drug events may improve patient care but can introduce concerns about data privacy. OBJECTIVE: This study aims to examine the views of patients and their caregivers about data protection when using ICTs to communicate adverse drug event information to improve patient safety. METHODS: We conducted an exploratory qualitative study. A total of 4 focus groups were held among patients who had experienced or were at risk of experiencing an adverse drug event, their family members, and their caregivers. We recruited participants through multiple avenues and iteratively analyzed the data using situational analysis. RESULTS: Of the 47 participants recruited, 28 attended our focus groups. We identified 3 primary themes. First, participants felt that improved information sharing about adverse drug events within their circle of care would likely improve care. Second, participants were concerned about data handling and inappropriate access but believed that the benefits of information sharing outweighed the risks of privacy breaches. Finally, participants were more concerned about data privacy in the context of stigmatized health conditions. CONCLUSIONS: Current conditions for maintaining health data privacy are consistent with participants' preferences, despite the fact that health data are susceptible to breaches and mismanagement. Information sharing that increases patient safety may justify potential privacy risks. Greater attention to patient concerns and the effect of social and contextual concerns in the design and implementation of health information technologies may increase patient confidence in the privacy of their information.

Organizational implications of implementing a new adverse drug event reporting system for care providers and integrating it with provincial health information systems.

Cross-sector collaborations between academia, government, and private industry, known as Triple Helix configurations, are increasingly common. In the health Information Technology (IT) sector, such configurations often also include health delivery organizations where technology is implemented and used. The complexity of collaborating within and between multiple organizations can present hurdles for innovators that are seldom discussed in the literature. We outline challenges we encountered in cross-sector collaboration and offer some guiding principles for decision-makers, academics, industry partners, and health delivery organizations to successfully negotiate divergent approaches to innovation and implementation. We discuss an innovative project that aims to implement a researcher-designed adverse drug event reporting system into clinical care and integrate it with provincial and health authority IT systems. Based on our experience, implementing an interoperable health IT system must extend beyond technical integration to encompass meaningful stakeholder engagement to ensure utility for end-users and beneficial impact for participating organizations.

Exploring How Evidence is Used in Care Through an Organizational Ethnography of Two Teaching Hospitals.

BACKGROUND: Numerous published articles show that clinicians do not follow clinical practice guidelines (CPGs). However, a few studies explore what clinicians consider evidence and how they use different forms of evidence in their care decisions. Many of these existing studies occurred before the advent of smartphones and advanced Web-based information retrieval technologies. It is important to understand how these new technologies influence the ways clinicians use evidence in their clinical practice. Mindlines are a concept that explores how clinicians draw on different sources of information (including context, experience, medical training, and evidence) to develop collectively reinforced, internalized tacit guidelines. OBJECTIVE: The aim of this paper was to explore how evidence is integrated into mindline development and the everyday use of mindlines and evidence in care. METHODS: We draw on ethnographic data collected by shadowing internal medicine teams at 2 teaching hospitals. Fieldnotes were tagged by evidence category, teaching and care, and role of the person referencing evidence. Counts of these tags were integrated with fieldnote vignettes and memos. The findings were verified with an advisory council and through member checks. RESULTS: CPGs represent just one of several sources of evidence used when making care decisions. Some forms of evidence were predominately invoked from mindlines, whereas other forms were read to supplement mindlines. The majority of scientific evidence was accessed on the Web, often through smartphones. How evidence was used varied by role. As team members gained experience, they increasingly incorporated evidence into their mindlines. Evidence was often blended together to arrive at shared understandings and approaches to patient care that included ways to filter evidence. CONCLUSIONS: This paper outlines one way through which the ethos of evidence-based medicine has been incorporated into the daily work of care. Here, multiple Web-based forms of evidence were mixed with other information. This is different from the way that is often articulated by health administrators and policy makers whereby clinical practice guideline adherence is equated with practicing evidence-based medicine.

Balancing quality improvement and unintended effects: The impact of implementing admission order sets for chronic obstructive pulmonary disease and heart failure at two teaching hospitals.

RATIONALE, AIMS, AND OBJECTIVES: Local health administrators implemented chronic obstructive pulmonary disease and heart failure admission order sets to increase guideline adherence. We explored the impact of these order sets on workflows and guideline adherence in the internal medicine specialty in two Canadian teaching hospitals. METHODS: A mixed methods study combined shadowing care providers (250 h), meeting observation and interviews (11 h), and patient medical chart audits for heart failure (n = 120) and chronic obstructive pulmonary disease (n = 120) patients. The chart audits analysed details of the admission process and 14 guideline elements associated with heart failure (nine) and chronic obstructive pulmonary disease (five). RESULTS: A subset (10/14) of the evaluated guideline elements were included in the heart failure or chronic obstructive pulmonary disease order sets. Order set use significantly increased adherence to some (4/10) of these elements. However, our qualitative work uncovered a perception that use of these two order sets increased order duplication. Our chart audits supported this perception. Order set use increased order duplication for heart failure (92% vs 43%) and chronic obstructive pulmonary disease (75% vs 43%). CONCLUSION: It is unclear whether, for these two hospitals, the gains brought by implementation of chronic obstructive pulmonary disease and heart failure admission order sets were worth their associated organisational shortcomings. Problems with order set implementation appeared to stem from poor integration with pre-existing complex organisational systems. Health administrators and clinicians interested in implementing order sets within their own hospitals need to remain cognizant of how these tools will fit into existing systems and practices.

Methods for evaluating adverse drug event preventability in emergency department patients.

BACKGROUND: There is a high degree of variability in assessing the preventability of adverse drug events, limiting the ability to compare rates of preventable adverse drug events across different studies. We compared three methods for determining preventability of adverse drug events in emergency department patients and explored their strengths and weaknesses. METHODS: This mixed-methods study enrolled emergency department patients diagnosed with at least one adverse drug event from three prior prospective studies. A clinical pharmacist and physician reviewed the medical and research records of all patients, and independently rated each event's preventability using a "best practice-based" approach, an "error-based" approach, and an "algorithm-based" approach. Raters discussed discordant ratings until reaching consensus. We assessed the inter-rater agreement between clinicians using the same assessment method, and between different assessment methods using Cohen's kappa with 95% confidence intervals (95% CI). Qualitative researchers observed discussions, took field notes, and reviewed free text comments made by clinicians in a "comment" box in the data collection form. We developed a coding structure and iteratively analyzed qualitative data for emerging themes regarding the application of each preventability assessment method using NVivo. RESULTS: Among 1356 adverse drug events, a best practice-based approach rated 64.1% (95% CI: 61.5-66.6%) of events as preventable, an error-based approach rated 64.3% (95% CI: 61.8-66.9%) of events as preventable, and an algorithm-based approach rated 68.8% (95% CI: 66.1-71.1%) of events as preventable. When applying the same method, the inter-rater agreement between clinicians was 0.53 (95% CI: 0.48-0.59), 0.55 (95%CI: 0.50-0.60) and 0.55 (95% CI: 0.49-0.55) for the best practice-, error-, and algorithm-based approaches, respectively. The inter-rater agreement between different assessment methods using consensus ratings for each ranged between 0.88 (95% CI 0.85-0.91) and 0.99 (95% CI 0.98-1.00). Compared to a best practice-based assessment, clinicians believed the algorithm-based assessment was too rigid. It did not account for the complexities of and variations in clinical practice, and frequently was too definitive when assigning preventability ratings. CONCLUSION: There was good agreement between all three methods of determining the preventability of adverse drug events. However, clinicians found the algorithmic approach constraining, and preferred a best practice-based assessment method.

Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset.

BACKGROUND: Patients commonly transition between health care settings, requiring care providers to transfer medication utilization information. Yet, information sharing about adverse drug events (ADEs) remains nonstandardized. OBJECTIVE: The objective of our study was to describe a minimum required dataset for clinicians to document and communicate ADEs to support clinical decision making and improve patient safety. METHODS: We used mixed-methods analysis to design a minimum required dataset for ADE documentation and communication. First, we completed a systematic review of the existing ADE reporting systems. After synthesizing reporting concepts and data fields, we conducted fieldwork to inform the design of a preliminary reporting form. We presented this information to clinician end-user groups to establish a recommended dataset. Finally, we pilot-tested and refined the dataset in a paper-based format. RESULTS: We evaluated a total of 1782 unique data fields identified in our systematic review that describe the reporter, patient, ADE, and suspect and concomitant drugs. Of these, clinicians requested that 26 data fields be integrated into the dataset. Avoiding the need to report information already available electronically, reliance on prospective rather than retrospective causality assessments, and omitting fields deemed irrelevant to clinical care were key considerations. CONCLUSIONS: By attending to the information needs of clinicians, we developed a standardized dataset for adverse drug event reporting. This dataset can be used to support communication between care providers and integrated into electronic systems to improve patient safety. If anonymized, these standardized data may be used for enhanced pharmacovigilance and research activities.

Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

BACKGROUND: Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. OBJECTIVE: Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. METHODS: This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. RESULTS: We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. CONCLUSIONS: Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care.

Patient Perceptions About Data Sharing & Privacy: Insights from ActionADE.

Information communication technologies (ICTs) may improve health delivery by enhancing informational continuity of care and enabling secondary use of health data including public health surveillance and research. ICTs also introduce concerns related to privacy. In this paper, we examine and address this tension in the context of the development and implementation of a novel platform that will enable the documentation and communication of patient-specific ADE information, titled ActionADE. We explored privacy concerns qualitatively from the perspective of patients. Our findings will inform a series of recommendations for system design that seek to balance the need to both share and protect personal health information.

Designing Novel Health ICTs to Support Work, Not Generate It: Five Principles.

In this paper, we offer five principles to inform how health ICT designers and healthcare organizations address and mitigate issues relating to clinician documentation burden. We draw on our experience and empirical work designing an ICT intervention, ActionADE, to illustrate how our team developed and will use these principles to ease documentation burden for clinician-users.

Pilot-testing an adverse drug event reporting form prior to its implementation in an electronic health record.

BACKGROUND: Adverse drug events (ADEs), harmful unintended consequences of medication use, are a leading cause of hospital admissions, yet are rarely documented in a structured format between care providers. We describe pilot-testing structured ADE documentation fields prior to integration into an electronic medical record (EMR). METHODS: We completed a qualitative study at two Canadian hospitals. Using data derived from a systematic review of the literature, we developed screen mock-ups for an ADE reporting platform, iteratively revised in participatory workshops with diverse end-user groups. We designed a paper-based form reflecting the data elements contained in the mock-ups. We distributed them to a convenience sample of clinical pharmacists, and completed ethnographic workplace observations while the forms were used. We reviewed completed forms, collected feedback from pharmacists using semi-structured interviews, and coded the data in NVivo for themes related to the ADE form. RESULTS: We completed 25 h of clinical observations, and 24 ADEs were documented. Pharmacists perceived the form as simple and clear, with sufficient detail to capture ADEs. They identified fields for omission, and others requiring more detail. Pharmacists encountered barriers to documenting ADEs including uncertainty about what constituted a reportable ADE, inability to complete patient follow-up, the need for inter-professional communication to rule out alternative diagnoses, and concern about creating a permanent record. CONCLUSION: Paper-based pilot-testing allowed planning for important modifications in an ADE documentation form prior to implementation in an EMR. While paper-based piloting is rarely reported prior to EMR implementations, it can inform design and enhance functionality. Piloting with other groups of care providers and in different healthcare settings will likely lead to further revisions prior to broader implementations.

Designing an Adverse Drug Event Reporting System to Prevent Unintentional Reexposures to Harmful Drugs: Study Protocol for a Multiple Methods Design.

BACKGROUND: Adverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within six months because culprit drugs are unintentionally represcribed and redispensed. Improving the electronic communication of ADE information between care providers, and across care settings, has the potential to reduce recurrent ADEs. OBJECTIVE: We aim to describe the methods used to design Action ADE, a novel electronic ADE reporting system that can be leveraged to prevent unintentional reexposures to harmful drugs in British Columbia, Canada. METHODS: To develop the new system, our team will use action research and participatory design, approaches that employ social scientific research methods and practitioner participation to generate insights into work settings and problem resolution. We will develop a systematic search strategy to review existing ADE reporting systems identified in academic and grey literature, and analyze the content of these systems to identify core data fields used to communicate ADE information. We will observe care providers in the emergency departments and on the wards of two urban tertiary hospitals and one urban community hospital, in one rural ambulatory care center, and in three community pharmacies in British Columbia, Canada. We will also conduct participatory workshops with providers to understand their needs and priorities related to communicating ADEs and preventing erroneous represcribing or redispensing of culprit medications. These methods will inform the iterative development of a preliminary paper-based reporting form, which we will then pilot test with providers in a real-world setting. RESULTS: This is an ongoing project with results being published as analyses are completed. The systematic review has been completed; field observations, focus groups, and pilot testing of a preliminary paper-based design are ongoing. Results will inform the development of software that will enable clinically useful user-friendly documentation and communication of ADEs. CONCLUSIONS: We take this approach with the recognition that information technology-based solutions in health care often fall short of expectations as a result of designers' failure to account for organizational and work practice considerations, and the needs of end-users. We describe how integrating qualitative methods into an iterative participatory design process (planned in partnership with end-users) will allow us to address specific clinical needs, conceptualize linkages between systems, integrate the reporting system into clinicians' workflow, and design the system to optimize its uptake into practice.

Adverse drug event reporting systems: a systematic review.

AIM: Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. METHODS: We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. RESULTS: We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). CONCLUSION: We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance.

Co-Creation With TickiT: Designing and Evaluating a Clinical eHealth Platform for Youth.

BACKGROUND: All youth are susceptible to mental health issues and engaging in risky behavior, and for youth with chronic health conditions, the consequences can be more significant than in their healthy peers. Standardized paper-based questionnaires are recommended by the American Academy of Pediatrics in community practice to screen for health risks. In hospitals, psychosocial screening is traditionally undertaken using the Home Education, Eating, Activities, Drugs, Depression, Sex, Safety (HEEADDSS) interview. However, time constraints and patient/provider discomfort reduce implementation. We report findings from an eHealth initiative undertaken to improve uptake of psychosocial screening among youth. OBJECTIVE: Youth are sophisticated "technology natives." Our objective was to leverage youth's comfort with technology, creating a youth-friendly interactive mobile eHealth psychosocial screening tool, TickiT. Patients enter data into the mobile application prior to a clinician visit. Response data is recorded in a report, which generates alerts for clinicians, shifting the clinical focus from collecting information to focused management. Design goals included improving the patient experience, improving efficiency through electronic patient based data entry, and supporting the collection of aggregated data for research. METHODS: This paper describes the iterative design and evaluation processes undertaken to develop TickiT including co-creation processes, and a pilot study utilizing mixed qualitative and quantitative methods. A collaborative industry/academic partnership engaged stakeholders (youth, health care providers, and administrators) in the co-creation development process. An independent descriptive study conducted in 2 Canadian pediatric teaching hospitals evaluated the feasibility of the platform in both inpatient and ambulatory clinical settings, evaluating both providers and patient responses to the platform. RESULTS: The independent pilot feasibility study included 80 adolescents, 12-18 years, and 38 medical staff-residents, inpatient and outpatient pediatricians, and surgeons. Youth uptake was 99% (79/80), and survey completion 99% (78/79; 90 questions). Youth found it easy to understand (92%, 72/78), easy to use (92%, 72/78), and efficient (80%, 63/79 with completion rate < 10 minutes). Residents were most positive about the application and surgeons were least positive. All inpatient providers obtained new patient information. CONCLUSIONS: Co-creative design methodology with stakeholders was effective for informing design and development processes to leverage effective eHealth opportunities. Continuing stakeholder engagement has further fostered platform development. The platform has the potential to meet IHI Triple Aim goals. Clinical adaptation requires planning, training, and support for health care providers to adjust their practices.

Socio-technical issues and challenges in implementing safe patient handovers: insights from ethnographic case studies.

PURPOSE: Ineffective handovers in patient care, including those where information loss occurs between care providers, have been identified as a risk to patient safety. Computerization of health information is often offered as a solution to improve the quality of care handovers and decrease adverse events related to patient safety. The purpose of this paper is to broaden our understanding of clinical handover as a patient safety issue, and to identify socio-technical issues which may come to bear on the success of computer based handover tools. METHODS: Three in depth ethnographic case studies were undertaken. Field notes were transcribed and analyzed with the aid of qualitative data analysis software. Within case analysis was performed on each case, and subsequently, cross case analyses were performed. RESULTS: We identified five types of socio-technical issues which must be addressed if electronic handover tools are to succeed. The inter-dependencies of these issues are addressed in relation to arenas in which health care work takes place. CONCLUSIONS: We suggest that the contextual nature of information, ethical and medico-legal issues arising in relation to information handover, and issues related to data standards and system interoperability must be addressed if computerized health information systems are to achieve improvements in patient safety related to handovers in care.

Caring for individual patients and beyond: enhancing care through secondary use of data in a general practice setting.

UNLABELLED: It is argued that with the introduction of electronic medical record (EMR) systems into the primary care sector, data collected can be used for secondary purposes which extend beyond individual patient care (e.g., for chronic disease management, prevention and clinical performance evaluation). However, EMR systems are primarily designed to support clinical tasks, and data entry practices of clinicians focus on the treatment of individual patients. Hence data collected through EMRs is not always useful in meeting these ends. PURPOSE: In this paper we follow a community health centre (CHC), and document the changes in work practices of the personnel that were necessary in order to make EMR data useful for secondary purposes. METHODS: This project followed an action research approach, in which ethnographic data were collected mainly by participant observations, by a researcher who also acted as an IT support person for the clinic's secondary usage of EMR data. Additionally, interviews were carried out with the clinical and administrative personnel of the CHC. RESULTS: The case study demonstrates that meaningful use of secondary data occurs only after a long process, aimed at creating the pre-conditions for meaningful use of secondary data, has taken place. PRECONDITIONS: Specific areas of focus have to be chosen for secondary data use, and initiatives have to be continuously evaluated and adapted to the workflow through a team approach. Collaboration between IT support and physicians is necessary to tailor the software to allow for the collection of clinically relevant data. Data entry procedures may have to be changed to encourage the usage of an agreed-upon coding scheme, required for meaningful use of secondary data. And finally resources in terms of additional personnel or dedicated time are necessary to keep up with data collection and other tasks required as a pre-condition to secondary use of data, communication of the results to the clinic, and eventual re-evaluation. CONSEQUENCES: Changes in the work practices observed in this case which were required to support secondary data use from the EMR included completion of additional tasks by clinical and administrative personnel related to the organization of follow-up tasks. Among physicians increased awareness of specific initiatives and guideline compliance in terms of chronic disease management and prevention was noticed. Finally, the clinic was able to evaluate their own practice and present the results to varied stakeholders. CONCLUSIONS: The case describes the secondary usage of data by a clinic aimed at improving management of the clinic's patients. It illustrates that creating the pre-conditions for secondary use of data from EMRs is a complex process which can be seen as a shift in paradigms from a focus on individual patient care to chronic disease management and performance measurement. More research is needed about how to best support clinics in the process of change management necessitated by emerging clinical management goals.

Everyday ethical dilemmas arising with electronic record use in primary care.

The introduction of electronic medical record systems (EMRs) into primary care settings alters work practices, introduces new challenges, and new roles. In the process of integrating an EMR into a primary care setting, clinic staff faced ethical challenges in their everyday work practices resulting from workarounds undertaken to compensate for a poor fit between system design and work practices, issues related to system access, and governance gaps. Examples of these issues are presented, and implications for system design are discussed.

Beyond individual patient care: enhanced use of EMR data in a primary care setting.

With the introduction of electronic medical record (EMR) systems into the primary care sector the collected data become available for purposes beyond individual patient care, i.e. chronic disease management, prevention and clinical performance evaluation. However EMR systems are primarily designed to support clinical tasks, and physicians focus on the treatment of individual patients. In this paper we follow the path of a community health centre (CHC), tracking the changes that came about with the secondary usage of EMR data, and presenting some of the lessons learned.