Electronic ordering and the management of treatment interdependencies: a qualitative study of paediatric chemotherapy.

BACKGROUND: There are serious safety risks associated with chemotherapy, often associated with interdependencies in regimens administered over months or years. Various strategies are used to manage these risks. Computerized provider order entry (CPOE) systems are also implemented to improve medication safety. Little is known regarding the effect of CPOE on how clinicians manage chemotherapy interdependencies and their associated safety strategies. METHODS: We conducted a multi-method qualitative study in a paediatric hospital. We analysed 827 oncology incidents reported following CPOE implementation and carried out semi-structured interviews with doctors (n = 10), nurses (n = 6), a pharmacist, and oncology CPOE team members (n = 2). Results were interpreted according to safety models (ultra-safe, high-reliability organisations [HROs], or ultra-adaptive). RESULTS: Incident reports highlighted two interrelated types of interdependencies: those within organisation of clinical activities and those inherent in chemotherapy regimens. Clinicians reported strategies to address chemotherapy risks and interdependencies. These included rigid rules and 'no go' contexts for treatment to proceed, typical of the ultra-safe model; use of time (e.g. planning only so far ahead) and sensitivity to operations, typical of HROs. We identified three different time horizons in CPOE use in relation to patients' treatments: life-long, the whole regimen, and the 'here and now'. CPOE supported ultra-safe strategies through automation and access to rules/standardisation, but also created difficulties and contributed to incidents. It supported the 'here and now' better than a life-long or whole regimen view of a patient treatment. Sensitivity to operations was essential to anticipate and resolve uncertainties, hazards, CPOE limitations, and mismatches between CPOE processes and workflow in practice. CONCLUSIONS: Within oncology, CPOE appears to move the 'mix' of risk strategies towards ultra-safe models of safety and protocol-mandated care. However, in order to operate ultra-safe strategies embedded in CPOE and stay on protocol it is essential for clinicians to be thoughtful and show sensitivity to operations in CPOE use. CPOE design can be advanced by better consideration of mechanisms to support interdependencies.

Medication safety incidents in paediatric oncology after electronic medication management system implementation.

OBJECTIVE: To explore medication safety issues related to use of an electronic medication management system (EMM) in paediatric oncology practice, through the analysis of patient safety incident reports. METHODS: We analysed 827 voluntarily reported incidents relating to oncology patients that occurred over an 18-month period immediately following implementation of an EMM in a paediatric hospital in Australia. We identified medication-related and EMM-related incidents and carried out a content analysis to identify patterns. RESULTS: We found ~79% (n = 651) of incidents were medication-related and, of these, ~45% (n = 294) were EMM-related. Medication-related incidents included issues with: prescribing; dispensing; administration; patient transfers; missing chemotherapy protocols and information on current stage of patient treatment; coordination of chemotherapy administration; handling or storing medications; children or families handling medications. EMM-related incidents were classified into four groups: technical issues, issues with the user experience, unanticipated problems in EMM workflow, and missing safety features. CONCLUSIONS: Incidents reflected difficulties with managing therapies rich in interdependencies. EMM, and especially its 'automaticity', contributed to these incidents. As EMM impacts on safety in such high-risk settings, it is essential that users are aware of and attend to EMM automatic behaviours and are equipped to troubleshoot them.

The assessment and management of pain in patients with dementia in hospital settings: a multi-case exploratory study from a decision making perspective.

BACKGROUND: Pain is often poorly managed in people who have a dementia. Little is known about how this patient population is managed in hospital, with research to date focused mainly on care homes. This study aimed to investigate how pain is recognised, assessed and managed in patients with dementia in a range of acute hospital wards, to inform the development of a decision support tool to improve pain management for this group. METHODS: A qualitative, multi-site exploratory case study. Data were collected in four hospitals in England and Scotland. Methods included non-participant observations, audits of patient records, semi-structured interviews with staff and carers, and analysis of hospital ward documents. Thematic analysis was performed through the lens of decision making theory. RESULTS: Staff generally relied on patients' self-report of pain. For patients with dementia, however, communication difficulties experienced because of their condition, the organisational context, and time frames of staff interactions, hindered patients' ability to provide staff with information about their pain experience. This potentially undermined the trials of medications used to provide pain relief to each patient and assessments of their responses to these treatments. Furthermore, given the multidisciplinary environment, a patient's communication about their pain involved several members of staff, each having to make sense of the patient's pain as in an 'overall picture'. Information about patients' pain, elicited in different ways, at different times and by different health care staff, was fragmented in paper-based documentation. Re-assembling the pieces to form a 'patient specific picture of the pain' required collective staff memory, 'mental computation' and time. CONCLUSIONS: There is a need for an efficient method of eliciting and centralizing all pain-related information for patients with dementia, which is distributed in time and between personnel. Such a method should give an overall picture of a patient's pain which is rapidly accessible to all involved in their care. This would provide a much-needed basis for making decisions to support the effective management of the pain of older people with dementia in hospital.

The relative meaning of absolute numbers: the case of pain intensity scores as decision support systems for pain management of patients with dementia.

BACKGROUND: Assessment and management of pain in patients with dementia is known to be challenging, due to patients' cognitive and/or communication difficulties. In the UK, pain in hospital is managed through regular assessments, with the use of pain intensity scores as triggers for action. The aim of this study was to understand current pain assessment practices, in order to later inform the development of a decision support tool designed to improve the management of pain for people with dementia in hospital. METHODS: An exploratory study was conducted in four hospitals in the UK (11 wards), with observations of patients with dementia (n = 31), interviews of staff (n = 52) and patients' family members (n = 4) and documentary analysis. A thematic analysis was carried out, structured along dimensions of decision making. This paper focuses on the emergent themes related to the use of assessment tools and pain intensity scores. RESULTS: A variety of tools were used to record pain intensity, usually with numerical scales. None of the tools in actual use had been specifically designed for patients with cognitive impairment. With patients with more severe dementia, the patient's body language and other cues were studied to infer pain intensity and then a score entered on behalf of the patient. Information regarding the temporality of pain and changes in pain experience (rather than a score at a single point in time) seemed to be most useful to the assessment of pain. CONCLUSIONS: Given the inherent uncertainty of the meaning of pain scores for patients with dementia, numerical scales were used with caution. Numerical scores triggered action but their meaning was relative - to the patient, to the clinician, to the time of recording and to the purpose of documenting. There are implications for use of data and computerized decision support systems design. Decision support interventions should include personalized alerting cut-off scores for individual patients, display pain scores over time and integrate professional narratives, mitigating uncertainties around single pain scores for patients with dementia.

Pain assessment for people with dementia: a systematic review of systematic reviews of pain assessment tools.

BACKGROUND: There is evidence of under-detection and poor management of pain in patients with dementia, in both long-term and acute care. Accurate assessment of pain in people with dementia is challenging and pain assessment tools have received considerable attention over the years, with an increasing number of tools made available. Systematic reviews on the evidence of their validity and utility mostly compare different sets of tools. This review of systematic reviews analyses and summarises evidence concerning the psychometric properties and clinical utility of pain assessment tools in adults with dementia or cognitive impairment. METHODS: We searched for systematic reviews of pain assessment tools providing evidence of reliability, validity and clinical utility. Two reviewers independently assessed each review and extracted data from them, with a third reviewer mediating when consensus was not reached. Analysis of the data was carried out collaboratively. The reviews were synthesised using a narrative synthesis approach. RESULTS: We retrieved 441 potentially eligible reviews, 23 met the criteria for inclusion and 8 provided data for extraction. Each review evaluated between 8 and 13 tools, in aggregate providing evidence on a total of 28 tools. The quality of the reviews varied and the reporting often lacked sufficient methodological detail for quality assessment. The 28 tools appear to have been studied in a variety of settings and with varied types of patients. The reviews identified several methodological limitations across the original studies. The lack of a 'gold standard' significantly hinders the evaluation of tools' validity. Most importantly, the samples were small providing limited evidence for use of any of the tools across settings or populations. CONCLUSIONS: There are a considerable number of pain assessment tools available for use with the elderly cognitive impaired population. However there is limited evidence about their reliability, validity and clinical utility. On the basis of this review no one tool can be recommended given the existing evidence.

Systems for Identification and Location of Items at Scale: Study of Scan4Safety in Leeds Hospitals.

Hospitals improve safety and workflow efficiency by implementing systems for identification of items and patients. Little is known about the implementation of these systems across entire hospitals. The aim of this study is to identify challenges and enablers of adoption of such systems at scale, within a hospital organisation and across the English NHS. The focus is on the experience of the Scan4Safety project at Leeds Teaching Hospital NHS Trust (UK). Study methods are qualitative and include interviews with staff and review of documents. This poster paper presents preliminary findings of research in progress.

Automatic dispensing cabinets and governance of controlled drugs: an exploratory study in an intensive care unit.

BACKGROUND: Governance of controlled drugs (CDs) in hospitals is resource intensive but important for patient safety and policy compliance. OBJECTIVES: To explore whether and how storing CDs in an automated dispensing cabinet (ADC) in a children's hospital intensive care unit (ICU) contributes to the effectiveness and efficiency of CD governance. METHODS: We conducted a mixed-methods exploratory study, comprising observations, interviews and audits, 3 months after ADC implementation. We observed 54 hours of medications activities in the ICU medication room (with 42 hours of timed data); interviewed nurses (n=19), management (n=1) and pharmacy staff (n=3); reviewed 6 months of ICU incident reports pertaining to CD governance; audited 6 months of CD register data and extracted logs of all ADC transactions for the 3 months following implementation. Data analysis focused on four main CD governance activities: safekeeping/controlling access, documenting use, monitoring, and reporting/investigating. RESULTS: Nurses and pharmacists perceived spending less time on CD governance tasks with the ADC. The ADC supported CD governance through automated documentation of CD transactions; 'blind counts'; automated count discrepancy checks; electronic alerts and reporting functionalities. It changed quality and distribution of governance tasks, such as removing the requirement for 'nurses with keys' to access CDs, and allowing pharmacists to generate reports remotely, rather than reviewing registers on the ward. For CDs in the ADC, auditing and monitoring appeared to be ongoing rather than periodic. Such changes appeared to create positive reinforcing loops. However, the ADC also created challenges for CD governance. Most importantly, it was not suitable for all CDs, leading to workarounds and parallel use of a safe plus paper registers. CONCLUSIONS: ADCs can significantly alter CDs governance in clinical areas. Effects of an ADC on efficiency and effectiveness of governance tasks appear to be complex, going beyond simple time savings or more stringent controls.

Mindful Workarounds in Bar Code Medication Administration.

Bar-Coded Medication Administration systems (BCMA) are often used with workarounds. These workarounds are usually judged against standard operating procedures or the use of the technology as 'designers' intended'. However, some workarounds may be reasonable and justified to prevent safety errors. In this conceptual paper, we clarify BCMA safety mechanisms and provide a framework to identify workarounds with BCMA that nullify the error prevention mechanisms inherent in the technology design and process. We also highlight the importance of understanding the purpose behind a nurse's workaround in BCMA, focusing on the notion of mindful (thoughtful) workarounds that have the potential to improve patient safety.

Overcoming Challenges to Inclusive User-based Testing of Health Information Technology with Vulnerable Older Adults: Recommendations from a Human Factors Engineering Expert Inquiry.

OBJECTIVES: Involving representative users in usability testing of health information technology (HIT) is central to user-centered design. However, (vulnerable) older adults as representative users have unique requirements. Aging processes may affect physical capabilities and cognitive skills, which can hamper testing with this demographic and may require special attention and revised protocols. This study was performed to provide expert-based recommendations for HIT user-testing with (vulnerable) older adults to support inclusive HIT design and evaluation. METHODS: First, we conducted a structured workshop with ten experts in HIT implementation and research, recruited through purposeful sampling, to generate insights into how characteristics of older adults may influence user-testing. Next, five Human Factor researchers experienced in HIT user-testing with (vulnerable) older adults validated the results and provided additional textual insights to gain consensus on the most important recommendations. A thematic analysis was performed on the resulting inquiries. Applied codes were based on the User-Centered Design framework. RESULTS: The analysis resulted in nine recommendations for user-testing of HIT with older adults, divided into three main themes: (1) empathetic approach and trust-building, (2) new requirements for testing and study design, and (3) adjustments to usability evaluation methods. For each theme a checklist of relevant items to follow-up on the recommendation is provided. CONCLUSIONS: The recommendations generated through expert inquiry contribute to more effective usability testing of HIT with older adults. This provides an important step towards improved accessibility of HIT amongst older adults through inclusive user-centered design.

Challenges of Digital Commons: A Qualitative Study of an Automated Dispensing Cabinet in a Paediatric Intensive Care Unit.

Missed medication doses can affect patient safety in hospitals. The use of automated dispensing cabinets (ADC) in clinical areas may reduce the occurrence of medications being unavailable at the time of need by alerting pharmacy to replenish stock. However, workarounds in ADC use can affect this capability. We studied nurses' use of an ADC in a paediatric intensive care unit with  54 hours of observation, semi-structure interviews (19 nurses; 4 pharmacy/management staff) and review of reported incidents. We found running out of medication a recurrent problem despite the ADC. Contributing factors affecting data entry in the ADC, and therefore replenishment alerts to pharmacy, included: the organisation of medication activities in the ward, nurses' information needs, patients' medication needs, and ADC design. Running out of medications was a 'tragedy of the commons'. Effective solutions may require going beyond user training and directives for accurate data entry, to work process redesign.

Evaluation of an Automated Dispensing Cabinet in Paediatric Intensive Care - Focus on Controlled Medications.

Evidence is limited of automated dispensing cabinets (ADCs) impact on effectiveness and efficiency of controlled drugs' (CDs) governance processes. We carried out a mixed-methods study of an ADC in an intensive care unit. We found ADC improved effectiveness and efficiency of governance of CDs through secure storage, alerts and automated recording of transactions. Limitations were associated with ADC design and 'fit' between ADC and some types of CDs.

The impact of introducing automated dispensing cabinets, barcode medication administration, and closed-loop electronic medication management systems on work processes and safety of controlled medications in hospitals: A systematic review.

BACKGROUND: Technology in the form of Automated Dispensing Cabinets (ADCs), Barcode Medication Administration (BCMA), and closed-loop Electronic Medication Management Systems (EMMS) are implemented in hospitals to assist with the supply, use and monitoring of medications. Although there is evidence to suggest that these technologies can reduce errors and improve monitoring of medications in general, little is known about their impact on controlled medications such as opioids. OBJECTIVES: This review aimed to fill this knowledge gap by synthesising literature to determine the impact of ADCs, BCMA and closed-loop EMMS on clinical work processes, medication safety, and drug diversion associated with controlled medications in the inpatient setting. METHODS: Eight databases (Medline, Pubmed, Embase, Scopus, Web of Science, PsycINFO, CINAHL, and ScienceDirect) were searched for relevant papers published between January 2000 and May 2019. Qualitative, quantitative, and mixed-methods empirical studies published in English that reported findings on the impact of ADCs, BCMA and/or closed-loop EMMS on controlled medications in the inpatient setting were included. RESULTS: In total, 16 papers met the inclusion criteria. Eleven studies reported on ADCs, four on BCMA, and only one on closed-loop EMMS. Only four studies focused on controlled medications, with the remainder reporting only incidental findings. Studies reported the elimination of manual end-of-shift counts of controlled medications after ADC implementation but cases of drug diversion were reported despite introducing ADCs. Three quantitative studies reported reductions in medication errors after implementing BCMA, but medications labelled with wrong barcodes and unreadable barcodes led to confusion and administration errors. CONCLUSIONS: More quality, targeted research is needed to provide evidence on the benefits and also risks of implementing technology to safeguard against inappropriate use of controlled medications in the inpatient setting. Processes need to be in place to supplement technological capabilities, and resources should be made available for post-implementation evaluations and interventions.

Associations between double-checking and medication administration errors: a direct observational study of paediatric inpatients.

BACKGROUND: Double-checking the administration of medications has been standard practice in paediatric hospitals around the world for decades. While the practice is widespread, evidence of its effectiveness in reducing errors or harm is scarce. OBJECTIVES: To measure the association between double-checking, and the occurrence and potential severity of medication administration errors (MAEs); check duration; and factors associated with double-checking adherence. METHODS: Direct observational study of 298 nurses, administering 5140 medication doses to 1523 patients, across nine wards, in a paediatric hospital. Independent observers recorded details of administrations and double-checking (independent; primed-one nurse shares information which may influence the checking nurse; incomplete; or none) in real time during weekdays and weekends between 07:00 and 22:00. Observational medication data were compared with patients' medical records by a reviewer (blinded to checking-status), to identify MAEs. MAEs were rated for potential severity. Observations included administrations where double-checking was mandated, or optional. Multivariable regression examined the association between double-checking, MAEs and potential severity; and factors associated with policy adherence. RESULTS: For 3563 administrations double-checking was mandated. Of these, 36 (1·0%) received independent double-checks, 3296 (92·5%) primed and 231 (6·5%) no/incomplete double-checks. For 1577 administrations double-checking was not mandatory, but in 26·3% (n=416) nurses chose to double-check. Where double-checking was mandated there was no significant association between double-checking and MAEs (OR 0·89 (0·65-1·21); p=0·44), or potential MAE severity (OR 0·86 (0·65-1·15); p=0·31). Where double-checking was not mandated, but performed, MAEs were less likely to occur (OR 0·71 (0·54-0·95); p=0·02) and had lower potential severity (OR 0·75 (0·57-0·99); p=0·04). Each double-check took an average of 6·4 min (107 hours/1000 administrations). CONCLUSIONS: Compliance with mandated double-checking was very high, but rarely independent. Primed double-checking was highly prevalent but compared with single-checking conferred no benefit in terms of reduced errors or severity. Our findings raise questions about if, when and how double-checking policies deliver safety benefits and warrant the considerable resource investments required in modern clinical settings.

The 'Back Office' of a Dispensing Cabinet: Technology and Work Contributing to Medication Safety.

Automated dispensing cabinets in clinical wards may contribute to improving safety by reducing the likelihood of medications not being available when needed. However, achieving this safety benefit is dependent on a 'back office' sociotechnical infrastructure that combines semi-automated processes with mindful, resilient work practices.

Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology: a Synthesis of Testimonies.

OBJECTIVE: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. METHODS: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. RESULTS: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. CONCLUSION: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.

Collective Mindfulness and Processes of Sensemaking in Health IT Implementation.

High reliability organisations operate safely in situations of high risk by organising for collective mindfulness. They do so through five ongoing processes geared towards anticipating, containing, and making sense of the unexpected. The five processes are: preoccupation with failure, reluctance to simplify interpretations, sensitivity to operations, commitment to resilience, and deference to expertise. The theory of collective mindfulness builds on Hutchins's theory of distributed cognition (the 'collective mind' of ship navigation teams) and on Langer's theory of mindfulness about individuals' interpreting information in context. However, in the theory of collective mindfulness, attention is paid not to individual cognition or decision making, but to collective processes of sensemaking emerging from individuals' interactions in dealing with an equivocal environment. In health informatics, the theory of collective mindfulness can be used to explain health information technology (IT) development and implementation, across its life cycle, and inform guidance towards mindful management of IT projects. For example, applied to a case of electronic health record implementation in a hospital context, the theory explains how mindful management of the sense-making challenges of post-roll out adaptation processes contributes to a 'successful' IT project. Further, the theory challenges a static and linear understanding of success (or failure) of health IT initiatives, supporting instead an argument for outcomes - be it reliability and safety, or IT project success - as collective, complex and dynamic achievements of mindful organising practices.

Researching Collective Mindfulness and Health IT: A Framework and Translation to Context-Specific Questions.

To improve patient safety, hospital organisations are encouraged to run their operations in line with high reliability organisations' collective mindfulness principles and practices. For the same safety goals, they also implement health information technology (IT). However, little is known about whether, or how, health IT can impact organisational mindfulness, and thereby safety. We propose that research in this area can be approached through a simple framework of overarching, umbrella questions, then carefully translated into nuanced context-specific questions and study designs. The framework and approach we propose provides a structure for comparing results from studies of collective mindfulness and health IT, across different clinical contexts and IT applications.

The challenging nature of patient identifiers: an ethnographic study of patient identification at a London walk-in centre.

The correct identification of a patient's health record is the foundation of any safe patient record system. There is no building of a ;patient history', no sharing or integration of a patient's data without the retrieval and matching of existing records. Yet there can often be errors in this process and these may remain invisible until a safety incident occurs. This article presents the findings of an ethnographic study of patient identification at a walk-in centre in the UK. We offer a view of patient identifiers as used in practice and show how seemingly simple data, such as a person's name or date of birth, are more complex than they may at first appear and how they potentially pose problems for the use of integrated health records. We further report and discuss a dichotomy between the identifiers needed to access health records and the identifiers used by practitioners in their everyday work.

Pharmacy Interweaving Safety Within Hospital Health Information Technology.

Research on the impact of hospital technology on medication safety usually focuses on prescribing and administration. Less is known about the pharmacy-related processes of reviewing, ordering and dispensing medications and how technology supports this work. We carried out a qualitative exploratory study of a hospital in England (UK) with the aim of gaining insight into processes of digitalisation. We found that hospital pharmacy staff perform safety work with technology aiming to prevent harm, such as 'scaffolding' people's thinking processes, or linking-up unintegrated systems. Their work seems to 'interweave' safety in between others' medication activities, but they do so sometimes struggling with technological deficiencies.