Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platform.

BACKGROUND: Germ Defence ( www.germdefence.org ) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly. METHODS: With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n = 3292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n = 3287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics. RESULTS: Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0-10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p = 0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list. CONCLUSIONS: While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment. TRIAL REGISTRATION: This trial was registered in the ISRCTN registry (14602359) on 12 August 2020.

Impact of rapid near-patient STI testing on service delivery outcomes in an integrated sexual health service in the United Kingdom: a controlled interrupted time series study.

OBJECTIVES: To evaluate the impact of a new clinic-based rapid sexually transmitted infection testing, diagnosis and treatment service on healthcare delivery and resource needs in an integrated sexual health service. DESIGN: Controlled interrupted time series study. SETTING: Two integrated sexual health services (SHS) in UK: Unity Sexual Health in Bristol, UK (intervention site) and Croydon Sexual Health in London (control site). PARTICIPANTS: Electronic patient records for all 58 418 attendances during the period 1 year before and 1 year after the intervention. INTERVENTION: Introduction of an in-clinic rapid testing system for gonorrhoea and chlamydia in combination with revised treatment pathways. OUTCOME MEASURES: Time-to-test notification, staff capacity, cost per episode of care and overall service costs. We also assessed rates of gonorrhoea culture swabs, follow-up attendances and examinations. RESULTS: Time-to-notification and the rate of gonorrhoea swabs significantly decreased following implementation of the new system. There was no evidence of change in follow-up visits or examination rates for patients seen in clinic related to the new system. Staff capacity in clinics appeared to be maintained across the study period. Overall, the number of episodes per week was unchanged in the intervention site, and the mean cost per episode decreased by 7.5% (95% CI 5.7% to 9.3%). CONCLUSIONS: The clear improvement in time-to-notification, while maintaining activity at a lower overall cost, suggests that the implementation of clinic-based testing had the intended impact, which bolsters the case for more widespread rollout in sexual health services.

Emergency department physicians' distribution of time in the fast paced-workflow-a novel time-motion study of drug-related activities.

Background In the emergency department physicians are forced to distribute their time to ensure that all admitted patients receive appropriate emergency care. Previous studies have raised concerns about medication discrepancies in patient's drug lists at admission to the emergency department. Thus, it is important to study how emergency department physicians distribute their time, to highlight where workflow redesign can be needed.Aim to quantify how emergency department physicians distribute their time between various task categories, with particular focus on drug-related tasks.Method Direct observation, time-motion study of emergency department physicians at Diakonhjemmet Hospital, Oslo, Norway. Physicians' activities were categorized in discrete categories and data were collected with the validated method of Work Observation Method By Activity Timing between October 2018 to January 2019. Bootstrap analysis determined 95% confidence intervals for proportions and interruption rates.Results During the observation time of 91.4 h, 31 emergency department physicians were observed. In total, physicians spent majority of their time gathering information (36.5%), communicating (26.3%), and documenting (24.2%). Further, physicians spent 17.8% (95% CI 16.8%, 19.3%) of their time on drug-related tasks. On average, physicians spent 7.8 min (95% CI 7.2, 8.6) per hour to obtain and document patients' drug lists.Conclusion Emergency department physicians are required to conduct numerous essential tasks and distributes a minor proportion of their time on drug-related tasks. More efficient information flow regarding drugs should be facilitated at transitions of care. The presence of healthcare personnel dedicated to obtaining drug lists in the emergency department should be considered.

Time distribution for pharmacists conducting a randomized controlled trial-An observational time and motion study.

INTRODUCTION: An expected future increase in older adults will demand changes in health care delivery, making development, implementation and evaluation of new health care models essential. The rationale for political decision-making concerning the implementation and application of interventions in health care should include cost estimations, specifically those involving clinical interventions. To provide such data knowledge of time spent on the intervention is imperative. Time and motion methodology is suitable to quantify health care personnel's time distribution. AIM: To investigate the time distribution for pharmacists conducting a randomized controlled trial (RCT) implementing a clinical intervention. MATERIALS AND METHODS: The setting was an RCT with a 5-step pharmacist-intervention in collaboration with the interdisciplinary team in a geriatric ward. Two pharmacists were involved in the trial during the observation period. Pharmacist activities, classified as RCT-tasks (intervention or administrative), non-RCT tasks and social/breaks, were recorded applying the Work Observation Method By Activity Timing methodology, enabling recording of predefined work tasks as well as interruptions and multitasking. One observer collected data over eight weeks. RESULTS: In total, 109.1 hours were observed resulting in 110.2 hours total task time, including multitasking. RCT tasks comprised 85.4% of the total observed time, and nearly 60% of the RCT time was spent on intervention tasks. Medication reviews was the most time consuming task, accounting for 32% of the observed time. The clinical pharmacists spent 14% of the intervention time communicating verbally, mainly with patients and healthcare professionals. CONCLUSION: During the RCT, the clinical pharmacists spent about half their time performing the actual intervention. Consequently, costs for providing such a clinical pharmacist service should reflect actual time spent; otherwise, we may risk overestimating theoretical costs.

Inter-observer agreement and reliability assessment for observational studies of clinical work.

Inter-observer agreement (IOA) is a key aspect of data quality in time-and-motion studies of clinical work. To date, such studies have used simple and ad hoc approaches for IOA assessment, often with minimal reporting of methodological details. The main methodological issues are how to align time-stamped task intervals that rarely have agreeing start and end times, and how to assess IOA for multiple nominal variables. We present a combination of methods that simultaneously addresses both these issues and provides a more appropriate measure by which to assess IOA for time-and-motion studies. The issue of alignment is addressed by converting task-level data into small time windows then aligning data from different observers by time. A method applicable to multivariate nominal data, the iota score, is then applied to the time-aligned data. We illustrate our approach by comparing iota scores to the mean of univariate Cohen's kappa scores through application of these measures to existing data from an observational study of emergency department physicians. While the two scores generated very similar results under certain conditions, iota was more resilient to sparse data issues. Our results suggest that iota applied to time windows considerably improves on previous methods used for IOA assessment in time-and-motion studies, and that Cohen's kappa and other univariate measures should not be considered the gold standard. Rather, there is an urgent need for ongoing explicit discussion of methodological issues and solutions to improve the ways in which data quality is assessed in time-and-motion studies in order to ensure the conclusions drawn from such studies are robust.

Visualising clinical work in the emergency department: Understanding interleaved patient management.

We present a unique data visualisation approach, called workflow time charts, to illustrate the sequential and multi-dimensional nature of work in emergency departments. Using 40 h of data from direct observations of emergency physicians, we applied the charts to visualise patient-stratified physicians' work as a continuous temporal process, including distinguishing tasks of different types and representing external prompts (similar to interruptions) and multitasking performance. The charts showed frequent changes in the nature of observed activities, with interleaved multitasking a constant feature and external prompts often clustered in time. Evidence of seniority-related differences in work were apparent with consultants switching between more concurrent patients and receiving more frequent clinical prompts than junior physicians, illustrating their overseeing and advice-giving role. The ubiquity of interleaved multitasking suggests a need to focus on developing individual strategies to support frequent cognitive switching. Work that appears fragmented at physician level may form part of a flexible and robust system, rather than an error-prone set of isolated individual behaviours.

Detecting Adverse Drug Events: Accuracy and Generalizability.

The incidence and impacts of adverse drug events (ADE) have been extensively studied, but there is an emerging focus on real-time detection systems. These can play an important role, along with systems pharmacology and population-level epidemiology, in a multipronged approach to prevent ADEs and mitigate their harm. Tailoring ADE detection systems to a particular health care setting or ADE type can improve predictive accuracy, but the added complexity reduces its wider applicability. As this approach becomes increasingly used we can imagine detection algorithms of greater complexity but also a set of algorithms encompassing the full range of health care settings and ADE types, thus creating a system that is both accurate and widely applicable.

Medication Management in Municipality-Based Healthcare: A Time and Motion Study of Nurses.

The objective of this observational time and motion study was to increase our understanding of how nurses in home healthcare currently distribute their work time with a focus on the medication management process. The research was conducted in four municipalities in the southern part of Sweden. Participants were nurses working in home healthcare. The study measured proportion of time, comparison of proportions of time, proportion of time spent multitasking, and rate of interruptions per hour. Of total observed time, 20.4% was spent on medication management and of these tasks the highest proportion of time was spent on communications and dispensing medications. Nurses in nursing homes spent more time (23.0% vs. 17.4%, p = 0.001) on medication management than nurses in private homes. Nurses spent 47.9% of their time completing tasks with someone else, including patients, but had minimal interaction with prescribers. We observed a rate of 1.2 (95% CI 1.1-1.4) interruptions per hour on average and 30% of all interruptions occurred during medication management tasks. Nurses spent 3.7% of their time multitasking. Interruptions while performing medication-related tasks were common, as well as multitasking. Causes and consequences of the results need to be addressed in order to improve the safety of medication management for patients receiving municipality-based home care.

Task errors by emergency physicians are associated with interruptions, multitasking, fatigue and working memory capacity: a prospective, direct observation study.

BACKGROUND: Interruptions and multitasking have been demonstrated in experimental studies to reduce individuals' task performance. These behaviours are frequently used by clinicians in high-workload, dynamic clinical environments, yet their effects have rarely been studied. OBJECTIVE: To assess the relative contributions of interruptions and multitasking by emergency physicians to prescribing errors. METHODS: 36 emergency physicians were shadowed over 120 hours. All tasks, interruptions and instances of multitasking were recorded. Physicians' working memory capacity (WMC) and preference for multitasking were assessed using the Operation Span Task (OSPAN) and Inventory of Polychronic Values. Following observation, physicians were asked about their sleep in the previous 24 hours. Prescribing errors were used as a measure of task performance. We performed multivariate analysis of prescribing error rates to determine associations with interruptions and multitasking, also considering physician seniority, age, psychometric measures, workload and sleep. RESULTS: Physicians experienced 7.9 interruptions/hour. 28 clinicians were observed prescribing 239 medication orders which contained 208 prescribing errors. While prescribing, clinicians were interrupted 9.4 times/hour. Error rates increased significantly if physicians were interrupted (rate ratio (RR) 2.82; 95% CI 1.23 to 6.49) or multitasked (RR 1.86; 95% CI 1.35 to 2.56) while prescribing. Having below-average sleep showed a >15-fold increase in clinical error rate (RR 16.44; 95% CI 4.84 to 55.81). WMC was protective against errors; for every 10-point increase on the 75-point OSPAN, a 19% decrease in prescribing errors was observed. There was no effect of polychronicity, workload, physician gender or above-average sleep on error rates. CONCLUSION: Interruptions, multitasking and poor sleep were associated with significantly increased rates of prescribing errors among emergency physicians. WMC mitigated the negative influence of these factors to an extent. These results confirm experimental findings in other fields and raise questions about the acceptability of the high rates of multitasking and interruption in clinical environments.

What is the impact of an electronic test result acknowledgement system on Emergency Department physicians' work processes? A mixed-method pre-post observational study.

OBJECTIVE: To examine the impact of an electronic Results Acknowledgement (eRA) system on emergency physicians' test result management work processes and the time taken to acknowledge microbiology and radiology test results for patients discharged from an Emergency Department (ED). METHODS: The impact of the eRA system was assessed in an Australian ED using: a) semi-structured interviews with senior emergency physicians; and b) a time and motion direct observational study of senior emergency physicians completing test acknowledgment pre and post the implementation of the eRA system. RESULTS: The eRA system led to changes in the way results and actions were collated, stored, documented and communicated. Although there was a non-significant increase in the average time taken to acknowledge results in the post period, most types of acknowledgements (other than simple acknowledgements) took less time to complete. The number of acknowledgements where physicians sought additional information from the Electronic Medical Record (EMR) rose from 12% pre to 20% post implementation of eRA. CONCLUSIONS: Given that the type of results are unlikely to have changed significantly across the pre and post implementation periods, the increase in the time physicians spent accessing additional clinical information in the post period likely reflects the greater access to clinical information provided by the integrated electronic system. Easier access to clinical information may improve clinical decision making and enhance the quality of patient care. For instance, in situations where a senior clinician, not initially involved in the care process, is required to deal with the follow-up of non-normal results.

Improving our understanding of multi-tasking in healthcare: Drawing together the cognitive psychology and healthcare literature.

Multi-tasking is an important skill for clinical work which has received limited research attention. Its impacts on clinical work are poorly understood. In contrast, there is substantial multi-tasking research in cognitive psychology, driver distraction, and human-computer interaction. This review synthesises evidence of the extent and impacts of multi-tasking on efficiency and task performance from health and non-healthcare literature, to compare and contrast approaches, identify implications for clinical work, and to develop an evidence-informed framework for guiding the measurement of multi-tasking in future healthcare studies. The results showed healthcare studies using direct observation have focused on descriptive studies to quantify concurrent multi-tasking and its frequency in different contexts, with limited study of impact. In comparison, non-healthcare studies have applied predominantly experimental and simulation designs, focusing on interleaved and concurrent multi-tasking, and testing theories of the mechanisms by which multi-tasking impacts task efficiency and performance. We propose a framework to guide the measurement of multi-tasking in clinical settings that draws together lessons from these siloed research efforts.

Emergency doctors' strategies to manage competing workload demands in an interruptive environment: An observational workflow time study.

An observational workflow time study was conducted involving doctors in the emergency department (ED) of a large Australian hospital. During 121.7 h across 58 sessions, we observed interruptive events, conceptualised as prompts, and doctors' strategies to handle those prompts (task-switching, multitasking, acknowledgement, deferral and deflection) to assess the role of multiple work system factors influencing doctors' work in the ED. Prompt rates varied vastly between work scenarios, being highest during non-verbal solo tasks. The propensity to use certain strategies also differed with task type, prompt type and location within the department, although task-switching was by far the most frequent. Communicative prompts were important in patient treatment and workload management. Clinicians appear to adjust their communication strategies in response to contextual factors in order to deliver patient care. Risk due to the interruptive nature of ED communication is potentially outweighed by the positive effects of timely information transfer and advice provision.

The impact of serious adverse drug reactions: a population-based study of a decade of hospital admissions in New South Wales, Australia.

AIMS: Adverse drug reactions (ADRs) have major impacts on patients and the hospital system. Methods identifying ADRs from selected International Classification of Diseases-10th revision (ICD-10) diagnosis and external cause codes can be applied to population-level hospital admissions data, enabling the study of rare, yet serious ADRs. The present study aimed to use ICD10-based methods to identify four types of serious idiosyncratic ADRs in Australia, and to assess changes in incidence and their impact on length of stay (LOS), readmission and in-hospital mortality. METHODS: The study used a census of hospital admission data from New South Wales between July 2000 and June 2012. Changes in incidence rates over time relative to a control group were estimated using log-linear regression. To assess impacts on LOS, readmission and mortality, each ADR case was matched with five controls, and cases were compared with controls via generalized linear models appropriate to each outcome. RESULTS: The incidence of three ADR types showed a significant increase over time relative to controls, while the fourth type showed no evidence of change. All ADR types were significantly associated with an increase in LOS of between 22% and 328%. Significant increases in risk of readmission or death were only observed for some ADR types. CONCLUSIONS: Reducing the incidence of idiosyncratic ADRs is challenging. ICD10-based methods support population-level analyses that can provide important insights into the effects and changes in ADRs over time. This, combined with strategies related to both patient care and drug monitoring pre- and post-commercial release, provides ways forward.

Measuring the relationship between interruptions, multitasking and prescribing errors in an emergency department: a study protocol.

INTRODUCTION: Interruptions and multitasking are frequent in clinical settings, and have been shown in the cognitive psychology literature to affect performance, increasing the risk of error. However, comparatively less is known about their impact on errors in clinical work. This study will assess the relationship between prescribing errors, interruptions and multitasking in an emergency department (ED) using direct observations and chart review. METHODS AND ANALYSIS: The study will be conducted in an ED of a 440-bed teaching hospital in Sydney, Australia. Doctors will be shadowed at proximity by observers for 2 h time intervals while they are working on day shift (between 0800 and 1800). Time stamped data on tasks, interruptions and multitasking will be recorded on a handheld computer using the validated Work Observation Method by Activity Timing (WOMBAT) tool. The prompts leading to interruptions and multitasking will also be recorded. When doctors prescribe medication, type of chart and chart sections written on, along with the patient's medical record number (MRN) will be recorded. A clinical pharmacist will access patient records and assess the medication orders for prescribing errors. The prescribing error rate will be calculated per prescribing task and is defined as the number of errors divided by the number of medication orders written during the prescribing task. The association between prescribing error rates, and rates of prompts, interruptions and multitasking will be assessed using statistical modelling. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the hospital research ethics committee. Eligible doctors will be provided with written information sheets and written consent will be obtained if they agree to participate. Doctor details and MRNs will be kept separate from the data on prescribing errors, and will not appear in the final data set for analysis. Study results will be disseminated in publications and feedback to the ED.

Bringing cohort studies to the bedside: framework for a 'green button' to support clinical decision-making.

When providing care, clinicians are expected to take note of clinical practice guidelines, which offer recommendations based on the available evidence. However, guidelines may not apply to individual patients with comorbidities, as they are typically excluded from clinical trials. Guidelines also tend not to provide relevant evidence on risks, secondary effects and long-term outcomes. Querying the electronic health records of similar patients may for many provide an alternate source of evidence to inform decision-making. It is important to develop methods to support these personalized observational studies at the point-of-care, to understand when these methods may provide valid results, and to validate and integrate these findings with those from clinical trials.

Trends in mortality after diagnosis of hepatitis C virus infection: an international comparison and implications for monitoring the population impact of treatment.

BACKGROUND & AIMS: People living with hepatitis C virus (HCV) are at increased risk of all-cause and liver-related mortality, although successful treatment has been shown to reduce this risk. The aim of this study was to provide baseline data on trends in cause-specific mortality and to establish an international surveillance system for evaluating the population level impact of HCV treatments. METHODS: Population level HCV diagnosis databases from Scotland (1997-2010), Australia (New South Wales [NSW]) (1997-2006), and Canada (British Columbia [BC]) (1997-2003) were linked to corresponding death registries using record linkage. For each region, age-adjusted cause-specific mortality rates were calculated, and trends in annual age-adjusted liver-related mortality were plotted. RESULTS: Of 105,138 individuals diagnosed with HCV (21,810 in Scotland, 58,484 in NSW, and 24,844 in BC), there were 7275 deaths (2572 in Scotland, 2655 in NSW, and 2048 in BC). Liver-related deaths accounted for 26% of deaths in Scotland, 21% in NSW, and 22% in BC. Temporal trends in age-adjusted liver related mortality were stable in Scotland (males p=0.4; females p=0.2) and NSW (males p=0.9; females p=0.9), while there was an increase in BC (males p=0.002; females p=0.04). CONCLUSIONS: The risk of liver-related mortality after a diagnosis of HCV has remained stable or increased over time across three regions with well-established diagnosis databases, highlighting that HCV treatment programmes to-date have had minimal impact on population level HCV-related liver disease. With more effective therapies on the horizon, and greater uptake of treatment anticipated, the potential of future therapeutic strategies to reduce HCV-related mortality is considerable.

Managing competing demands through task-switching and multitasking: a multi-setting observational study of 200 clinicians over 1000 hours.

OBJECTIVE: To provide a detailed characterisation of clinicians' work management strategies. DESIGN: 1002.3 h of observational data were derived from three previous studies conducted in a teaching hospital in Sydney, Australia, among emergency department (ED) doctors (n=40), ward doctors (n=57) and ward nurses (n=104). The rates of task-switching (pausing a task to handle an incoming task) and multitasking (adding a task in parallel to an existing task) were compared in each group. Random intercepts logistic regression was used to determine factors significantly associated with clinicians' use of task-switching over multitasking and to quantify variation between individual clinicians. RESULTS: Task-switching rates were higher among ED doctors (6.0 per hour) than ward staff (2.2 and 1.8 per hour for doctors and nurses, respectively) and vice versa for multitasking rates (9.2 vs 17.3 and 14.1 per hour). Clinicians' strategy use was significantly related to the nature and complexity of work and to the person they were working with. In some settings, time of day, day of the week or previous chosen strategy affected a clinician's strategy. Independent of these factors, there was significant variation between individual clinicians in their use of strategies in a given situation (ED doctors p=0.04, ward staff p=0.03). CONCLUSIONS: Despite differences in factors associated with work management strategy use among ED doctors, ward doctors and ward nurses, clinicians in all settings appeared to prioritise certain types of tasks over others. Documentation was generally given low priority in all groups, while the arrival of direct care tasks tended to be treated with high priority. These findings suggest that considerations of safety may be implicit in task-switching and multitasking decisions. Although these strategies have been cast in a negative light, future research should consider their role in optimising competing quality and efficiency demands.

Do electronic discharge summaries contain more complete medication information? A retrospective analysis of paper versus electronic discharge summaries.

Complete, accurate and timely hospital discharge summaries are important for continuity of care. The aim of this study was to evaluate the effectiveness of an electronic discharge summary system in improving the medication information provided compared to the information in paper discharge summaries. We conducted a retrospective audit of 199 paper and 200 electronic discharge summaries from a 350-bed teaching hospital in Sydney, Australia. The completeness of medication information, and whether medication changes during the admission were explained, were assessed. Further, the likelihood of any incomplete information having an impact on continuity of care was assessed. There were 1352 and 1771 medication orders assessed in paper and electronic discharge summaries, respectively. Of these, 90.9% and 93.4% were complete in paper and electronic discharge summaries, respectively. The dose (OR 25.24, 95%CI: 3.41-186.9) and route (OR 8.65, 95%CI: 3.46-21.59) fields of medication orders, were more likely to be complete in electronic as compared with paper discharge summaries. There was no difference for drug frequency (OR 1.09, 95%CI: 0.77-1.55). There was no significant improvement in the proportion of incomplete medication orders rated as unclear and likely to impede continuity of care in paper compared with electronic discharge summaries (7.3% vs. 6.5%). Of changes to medication regimen, only medication additions were more likely to be explained in the electronic (n=253, 37.2%) compared to paper (n=104, 14.3%) discharge summaries (OR 3.14; 95%CI: 2.20-4.18). In summary, electronic discharge summaries offer some improvements over paper discharge summaries in terms of the quality of medication information documented. However, explanations of changes to medication regimens remained low, despite this being crucial information. Future efforts should focus on including the rationale for changes to medication regimens in discharge summaries.