User-Centered Design and Implementation of an Interoperable FHIR Application for Pediatric Pneumonia Prognostication in a Randomized Trial.

OBJECTIVE: To support a pragmatic, electronic health record (EHR)-based randomized controlled trial, we applied user-centered design (UCD) principles, evidence-based risk communication strategies, and interoperable software architecture to design, test, and deploy a prognostic tool for children in emergency departments (EDs) with pneumonia. METHODS: Risk for severe in-hospital outcomes was estimated using a validated ordinal logistic regression model to classify pneumonia severity. To render the results usable for ED clinicians, we created an integrated SMART on FHIR web application built for interoperable use in two pediatric EDs using different EHR vendors: Epic and Cerner. We followed a UCD framework, including problem analysis and user research, conceptual design and early prototyping, user interface development, formative evaluation, and post-deployment summative evaluation. RESULTS: Problem analysis and user research from 39 clinicians and nurses revealed user preferences for risk aversion, accessibility, and timing of risk communication. Early prototyping and iterative design incorporated evidence-based design principles, including numeracy, risk framing, and best-practice visualization techniques. After rigorous unit and end-to-end testing, the application was successfully deployed in both EDs, which facilitatd enrollment, randomization, model visualization, data capture, and reporting for trial purposes. CONCLUSIONS: The successful implementation of a custom application for pneumonia prognosis and clinical trial support in two health systems on different EHRs demonstrates the importance of UCD, adherence to modern clinical data standards, and rigorous testing. Key lessons included the need for understanding users' real-world needs, regular knowledge management, application maintenance, and the recognition that FHIR applications require careful configuration for interoperability.

Adapting Cognitive Task Analysis Methods for Use in a Large Sample Simulation Study of High-Risk Healthcare Events.

Cognitive task analysis (CTA) methods are traditionally used to conduct small-sample, in-depth studies. In this case study, CTA methods were adapted for a large multi-site study in which 102 anesthesiologists worked through four different high-fidelity simulated high-consequence incidents. Cognitive interviews were used to elicit decision processes following each simulated incident. In this paper, we highlight three practical challenges that arose: (1) standardizing the interview techniques for use across a large, distributed team of diverse backgrounds; (2) developing effective training; and (3) developing a strategy to analyze the resulting large amount of qualitative data. We reflect on how we addressed these challenges by increasing standardization, developing focused training, overcoming social norms that hindered interview effectiveness, and conducting a staged analysis. We share findings from a preliminary analysis that provides early validation of the strategy employed. Analysis of a subset of 64 interview transcripts using a decompositional analysis approach suggests that interviewers successfully elicited descriptions of decision processes that varied due to the different challenges presented by the four simulated incidents. A holistic analysis of the same 64 transcripts revealed individual differences in how anesthesiologists interpreted and managed the same case.

Decision-Making During High-Risk Events: A Systematic Literature Review.

Effective decision-making in crisis events is challenging due to time pressure, uncertainty, and dynamic decisional environments. We conducted a systematic literature review in PubMed and PsycINFO, identifying 32 empiric research papers that examine how trained professionals make naturalistic decisions under pressure. We used structured qualitative analysis methods to extract key themes. The studies explored different aspects of decision-making across multiple domains. The majority (19) focused on healthcare; military, fire and rescue, oil installation, and aviation domains were also represented. We found appreciable variability in research focus, methodology, and decision-making descriptions. We identified five main themes: (1) decision-making strategy, (2) time pressure, (3) stress, (4) uncertainty, and (5) errors. Recognition-primed decision-making (RPD) strategies were reported in all studies that analyzed this aspect. Analytical strategies were also prominent, appearing more frequently in contexts with less time pressure and explicit training to generate multiple explanations. Practitioner experience, time pressure, stress, and uncertainty were major influencing factors. Professionals must adapt to the time available, types of uncertainty, and individual skills when making decisions in high-risk situations. Improved understanding of these decisional factors can inform evidence-based enhancements to training, technology, and process design.

Antibiotic clinical decision support for pneumonia in the ED: A randomized trial.

BACKGROUND: Electronic health record-based clinical decision support (CDS) is a promising antibiotic stewardship strategy. Few studies have evaluated the effectiveness of antibiotic CDS in the pediatric emergency department (ED). OBJECTIVE: To compare the effectiveness of antibiotic CDS vs. usual care for promoting guideline-concordant antibiotic prescribing for pneumonia in the pediatric ED. DESIGN: Pragmatic randomized clinical trial. SETTING AND PARTICIPANTS: Encounters for children (6 months-18 years) with pneumonia presenting to two tertiary care children s hospital EDs in the United States. INTERVENTION: CDS or usual care was randomly assigned during 4-week periods within each site. The CDS intervention provided antibiotic recommendations tailored to each encounter and in accordance with national guidelines. MAIN OUTCOME AND MEASURES: The primary outcome was exclusive guideline-concordant antibiotic prescribing within the first 24 h of care. Safety outcomes included time to first antibiotic order, encounter length of stay, delayed intensive care, and 3- and 7-day revisits. RESULTS: 1027 encounters were included, encompassing 478 randomized to usual care and 549 to CDS. Exclusive guideline-concordant prescribing did not differ at 24 h (CDS, 51.7% vs. usual care, 53.3%; odds ratio [OR] 0.94 [95% confidence interval [CI]: 0.73, 1.20]). In pre-specified stratified analyses, CDS was associated with guideline-concordant prescribing among encounters discharged from the ED (74.9% vs. 66.0%; OR 1.53 [95% CI: 1.01, 2.33]), but not among hospitalized encounters. Mean time to first antibiotic was shorter in the CDS group (3.0 vs 3.4 h; p = .024). There were no differences in safety outcomes. CONCLUSIONS: Effectiveness of ED-based antibiotic CDS was greatest among those discharged from the ED. Longitudinal interventions designed to target both ED and inpatient clinicians and to address common implementation challenges may enhance the effectiveness of CDS as a stewardship tool.

Understanding Patient and Clinician Reported Nonroutine Events in Ambulatory Surgery.

OBJECTIVE: Nonroutine events (NREs, i.e., deviations from optimal care) can identify care process deficiencies and safety risks. Nonroutine events reported by clinicians have been shown to identify systems failures, but this methodology fails to capture the patient perspective. The objective of this prospective observational study is to understand the incidence and nature of patient- and clinician-reported NREs in ambulatory surgery. METHODS: We interviewed patients about NREs that occurred during their perioperative care using a structured interview tool before discharge and in a 7-day follow-up call. Concurrently, we interviewed the clinicians caring for these patients immediately postoperatively to collect NREs. We trained 2 experienced clinicians and 2 patients to assess and code each reported NRE for type, theme, severity, and likelihood of reoccurrence (i.e., likelihood that the same event would occur for another patient). RESULTS: One hundred one of 145 ambulatory surgery cases (70%) contained at least one NRE. Overall, 214 NREs were reported-88 by patients and 126 by clinicians. Cases containing clinician-reported NREs were associated with increased patient body mass index ( P = 0.023) and lower postcase patient ratings of being treated with respect ( P = 0.032). Cases containing patient-reported NREs were associated with longer case duration ( P = 0.040), higher postcase clinician frustration ratings ( P < 0.001), higher ratings of patient stress ( P = 0.019), and lower patient ratings of their quality of life ( P = 0.010), of the quality of clinician teamwork ( P = 0.010), being treated with respect ( P = 0.003), and being listened to carefully ( P = 0.012). Trained patient raters evaluated NRE severity significantly higher than did clinician raters ( P < 0.001), while clinicians rated recurrence likelihood significantly higher than patients for both clinician ( P = 0.032) and patient-reported NREs ( P = 0.001). CONCLUSIONS: Both patients and clinicians readily report events during clinical care that they believe deviate from optimal care expectations. These 2 primary stakeholders in safe, high-quality surgical care have different experiences and perspectives regarding NREs. The combination of patient- and clinician-reported NREs seems to be a promising patient-centered method of identifying healthcare system deficiencies and opportunities for improvement.

Perioperative Care Structures and Non-Routine Events: Network Analysis.

Non-routine events (NREs) are any aspect of care perceived by clinicians as a deviation from optimal care. The reporting of NREs to peers (or care teams) may help healthcare organizations improve patient safety in high-risk work environments (e.g., surgery). While various factors, including care structure and organizational factors may influence a clinician's NRE reporting behavior, their role has not been systematically studied. We conducted a retrospective study relying on NREs and electronic health records to determine if perioperative interaction structures among clinicians are associated with the frequency of NRE reporting in a large academic medical center. The data covers November 1, 2016, to January 31, 2019 and includes 295 perioperative clinicians, 225 neonatal surgical cases, and 543 NREs. Using network analysis, we measured a clinician's status in interaction structures according to the sociometric factors of degree, betweenness, and eigenvector centrality. We applied a proportional odds model to measure the relationship between each sociometric factor and NRE reporting frequency. Our findings indicate that the centrality of clinicians is directly associated with the quantity of NREs per surgical case.

A pilot study to determine the incidence, type, and severity of non-routine events in neonates undergoing gastrostomy tube placement.

BACKGROUND: Non-routine events (NRE) are defined as any suboptimal occurrences in a process being measured in the opinion of the reporter and comes from the field of human factors engineering. These typically occur well up-stream of an adverse event and NRE measurement has not been applied to the complex context of neonatal surgery. We sought to apply this novel safety event measurement methodology to neonates in the NICU undergoing gastrostomy tube placement. METHODS: A prospective pilot study was conducted between November 2016 and August 2020 in the Level IV NICU and the pediatric operating rooms of an urban academic children's hospital to determine the incidence, severity, impact, and contributory factors of clinician-reported non-routine events (NREs, i.e., deviations from optimal care) and 30-day NSQIP occurrences in neonates receiving a G-tube. RESULTS: Clinicians reported at least one NRE in 32 of 36 (89%) G-tube cases, averaging 3.0 (Standard deviation: 2.5) NRE reports per case. NSQIP-P review identified 7 cases (19%) with NSQIP-P occurrences and each of these cases had multiple reported NREs. One case in which NREs were not reported was without NSQIP-P occurrences. The odds ratio of having a NSQIP-P occurrence with the presence of an NRE was 0.695 (95% CI 0.06-17.04). CONCLUSION: Despite being considered a "simple" operation, >80% of neonatal G-tube placement operations had at least one reported NRE by an operative team member. In this pilot study, NRE occurrence was not significantly associated with the subsequent reporting of an NSQIP-P occurrence. Understanding contributory factors of NREs that occur in neonatal surgery may promote surgical safety efforts and should be evaluated in larger and more diverse populations. LEVEL OF EVIDENCE: IV.

Measuring Collaboration Through Concurrent Electronic Health Record Usage: Network Analysis Study.

BACKGROUND: Collaboration is vital within health care institutions, and it allows for the effective use of collective health care worker (HCW) expertise. Human-computer interactions involving electronic health records (EHRs) have become pervasive and act as an avenue for quantifying these collaborations using statistical and network analysis methods. OBJECTIVE: We aimed to measure HCW collaboration and its characteristics by analyzing concurrent EHR usage. METHODS: By extracting concurrent EHR usage events from audit log data, we defined concurrent sessions. For each HCW, we established a metric called concurrent intensity, which was the proportion of EHR activities in concurrent sessions over all EHR activities. Statistical models were used to test the differences in the concurrent intensity between HCWs. For each patient visit, starting from admission to discharge, we measured concurrent EHR usage across all HCWs, which we called temporal patterns. Again, we applied statistical models to test the differences in temporal patterns of the admission, discharge, and intermediate days of hospital stay between weekdays and weekends. Network analysis was leveraged to measure collaborative relationships among HCWs. We surveyed experts to determine if they could distinguish collaborative relationships between high and low likelihood categories derived from concurrent EHR usage. Clustering was used to aggregate concurrent activities to describe concurrent sessions. We gathered 4 months of EHR audit log data from a large academic medical center's neonatal intensive care unit (NICU) to validate the effectiveness of our framework. RESULTS: There was a significant difference (P<.001) in the concurrent intensity (proportion of concurrent activities: ranging from mean 0.07, 95% CI 0.06-0.08, to mean 0.36, 95% CI 0.18-0.54; proportion of time spent on concurrent activities: ranging from mean 0.32, 95% CI 0.20-0.44, to mean 0.76, 95% CI 0.51-1.00) between the top 13 HCW specialties who had the largest amount of time spent in EHRs. Temporal patterns between weekday and weekend periods were significantly different on admission (number of concurrent intervals per hour: 11.60 vs 0.54; P<.001) and discharge days (4.72 vs 1.54; P<.001), but not during intermediate days of hospital stay. Neonatal nurses, fellows, frontline providers, neonatologists, consultants, respiratory therapists, and ancillary and support staff had collaborative relationships. NICU professionals could distinguish high likelihood collaborative relationships from low ones at significant rates (3.54, 95% CI 3.31-4.37 vs 2.64, 95% CI 2.46-3.29; P<.001). We identified 50 clusters of concurrent activities. Over 87% of concurrent sessions could be described by a single cluster, with the remaining 13% of sessions comprising multiple clusters. CONCLUSIONS: Leveraging concurrent EHR usage workflow through audit logs to analyze HCW collaboration may improve our understanding of collaborative patient care. HCW collaboration using EHRs could potentially influence the quality of patient care, discharge timeliness, and clinician workload, stress, or burnout.

Reliability of simulation-based assessment for practicing physicians: performance is context-specific.

INTRODUCTION: Even physicians who routinely work in complex, dynamic practices may be unprepared to optimally manage challenging critical events. High-fidelity simulation can realistically mimic critical clinically relevant events, however the reliability and validity of simulation-based assessment scores for practicing physicians has not been established. METHODS: Standardised complex simulation scenarios were developed and administered to board-certified, practicing anesthesiologists who volunteered to participate in an assessment study during formative maintenance of certification activities. A subset of the study population agreed to participate as the primary responder in a second scenario for this study. The physicians were assessed independently by trained raters on both teamwork/behavioural and technical performance measures. Analysis using Generalisability and Decision studies were completed for the two scenarios with two raters. RESULTS: The behavioural score was not more reliable than the technical score. With two raters > 20 scenarios would be required to achieve a reliability estimate of 0.7. Increasing the number of raters for a given scenario would have little effect on reliability. CONCLUSIONS: The performance of practicing physicians on simulated critical events may be highly context-specific. Realistic simulation-based assessment for practicing physicians is resource-intensive and may be best-suited for individualized formative feedback. More importantly, aggregate data from a population of participants may have an even higher impact if used to identify skill or knowledge gaps to be addressed by training programs and inform continuing education improvements across the profession.

Defining the Epidemiology of Safety Risks in Neonatal Intensive Care Unit Patients Requiring Surgery.

OBJECTIVE: The aim of the study was to determine the incidence, type, severity, preventability, and contributing factors of nonroutine events (NREs)-events perceived by care providers or skilled observers as a deviations from optimal care based on the clinical situation-in the perioperative (i.e., preoperative, operative, and postoperative) care of surgical neonates in the neonatal intensive care unit and operating room. METHODS: A prospective observational study of noncardiac surgical neonates, who received preoperative and postoperative neonatal intensive care unit care, was conducted at an urban academic children's hospital between November 1, 2016, and March 31, 2018. One hundred twenty-nine surgical cases in 109 neonates were observed. The incidence and description of NREs were collected via structured researcher-administered survey tool of involved clinicians. Primary measurements included clinicians' ratings of NRE severity and contributory factors and trained research assistants' ratings of preventability. RESULTS: One or more NREs were reported in 101 (78%) of 129 observed cases for 247 total NREs. Clinicians reported 2 (2) (median, interquartile range) NREs per NRE case with a maximum severity of 3 (1) (possible range = 1-5). Trained research assistants rated 47% of NREs as preventable and 11% as severe and preventable. The relative risks for National Surgical Quality Improvement Program - pediatric major morbidity and 30-day mortality were 1.17 (95% confidence interval = 0.92-1.48) and 1.04 (95% confidence interval = 1.00-1.08) in NRE cases versus non-NRE cases. CONCLUSIONS: The incidence of NREs in neonatal perioperative care at an academic children's hospital was high and of variable severity with a myriad of contributory factors.

Shared Decisions: A Qualitative Study on Clinician and Patient Perspectives on Statin Therapy and Statin-Associated Side Effects.

Background Despite guideline recommendations and clinical trial data suggesting benefit, statin therapy use in patients with atherosclerotic cardiovascular disease remains suboptimal. The aim of this study was to understand clinician and patient views on statin therapy, statin-associated side effects (SASEs), SASE management, and communication around statin risks and benefits. Methods and Results We conducted qualitative interviews of patients with atherosclerotic cardiovascular disease who had SASEs (n=17) and clinicians who regularly prescribe statins (n=20). We used directed content analysis, facilitated by Atlas.ti software, to develop and revise codebooks for clinician and patient interviews. The most relevant codes were "pile sorted" into 5 main topic domains: (1) SASEs vary in severity, duration, and time of onset; (2) communication practices by clinicians around statins and SASEs are variable and impacted by clinician time limitations and patient preconceived notions of SASEs; (3) although a "trial and error" approach to managing SASEs may be effective in allowing clinicians to keep patients with atherosclerotic cardiovascular disease on a statin, it can be frustrating for patients; (4) outside sources, such as the media, internet, social networks, and social circles, influence patients' perceptions and often impact the risk benefit discussion; and (5) a decision aid would be beneficial in facilitating clinician decision-making around SASEs and discussion of SASEs with the patients. Conclusions Statin use among patients with atherosclerotic cardiovascular disease remains suboptimal because of various patient- and clinician-related factors. The development of a decision aid to facilitate discussion of SASEs, clinician decision-making, and SASE management may improve statin use in this high-risk population.

Incidence and Classification of Nonroutine Events during Anesthesia Care.

BACKGROUND: A nonroutine event is any aspect of clinical care perceived by clinicians or trained observers as a deviation from optimal care based on the context of the clinical situation. The authors sought to delineate the incidence and nature of intraoperative nonroutine events during anesthesia care. METHODS: The authors prospectively collected audio, video, and relevant clinical information on 556 cases at three academic hospitals from 1998 to 2004. In addition to direct observation, anesthesia providers were surveyed for nonroutine event occurrence and details at the end of each study case. For the 511 cases with reviewable video, 400 cases had no reported nonroutine events and 111 cases had at least one nonroutine event reported. Each nonroutine event was analyzed by trained anesthesiologists. Rater reliability assessment, comparisons (nonroutine event vs. no event) of patient and case variables were performed. RESULTS: Of 511 cases, 111 (21.7%) contained 173 nonroutine events; 35.1% of event-containing cases had more than one nonroutine event. Of the 173 events, 69.4% were rated as having patient impact and 12.7% involved patient injury. Longer case duration (25th vs. 75th percentile; odds ratio, 1.83; 95% CI, 1.15 to 2.93; P = 0.032) and presence of a comorbid diagnosis (odds ratio, 2.14; 95% CI, 1.35 to 3.40; P = 0.001) were associated with nonroutine events. Common contributory factors were related to the patient (63.6% [110 of 173]) and anesthesia provider (59.0% [102 of 173]) categories. The most common patient impact events involved the cardiovascular system (37.4% [64 of 171]), airway (33.3% [57 of 171]), and human factors, drugs, or equipment (31.0% [53 of 171]). CONCLUSIONS: This study describes characteristics of intraoperative nonroutine events in a cohort of cases at three academic hospitals. Nonroutine event-containing cases were commonly associated with patient impact and injury. Thus, nonroutine event monitoring in conjunction with traditional error reporting may enhance our understanding of potential intraoperative failure modes to guide prospective safety interventions.

CYP2D6 Genotype-guided Metoprolol Therapy in Cardiac Surgery Patients: Rationale and Design of the Pharmacogenetic-guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery (PREEMPTIVE) Pilot Study.

OBJECTIVES: The Preemptive Pharmacogenetic-guided Metoprolol Management for Atrial Fibrillation in Cardiac Surgery (PREEMPTIVE) pilot trial aims to use existing institutional resources to develop a process for integrating CYP2D6 pharmacogenetic test results into the patient electronic health record, to develop an evidence-based clinical decision support tool to facilitate CYP2D6 genotype-guided metoprolol administration in the cardiac surgery setting, and to determine the impact of implementing this CYP2D6 genotype-guided integrated approach on the incidence of postoperative atrial fibrillation (AF), provider, and cost outcomes. DESIGN: One-arm Bayesian adaptive design clinical trial. SETTING: Single center, university hospital. PARTICIPANTS: The authors will screen (including CYP2D6 genotype) up to 600 (264 ± 144 expected under the adaptive design) cardiac surgery patients, and enroll up to 200 (88 ± 48 expected) poor, intermediate, and ultrarapid CYP2D6 metabolizers over a period of 2 years at a tertiary academic center. INTERVENTIONS: All consented and enrolled patients will receive the intervention of CYP2D6 genotype-guided metoprolol management based on CYP2D6 phenotype classified as a poor, intermediate, extensive (normal), or ultrarapid metabolizer. MEASUREMENTS AND MAIN RESULTS: The primary outcome will be the incidence of postoperative AF. Secondary outcomes relating to rates of CYP2D6 genotype-guided prescription changes, costs, lengths of stay, and implementation metrics also will be investigated. CONCLUSIONS: The PREEMPTIVE pilot study is the first perioperative pilot trial to provide essential information for the design of a future, large-scale trial comparing CYP2D6 genotype-guided metoprolol management with a nontailored strategy in terms of managing AF. In addition, secondary outcomes regarding implementation, clinical benefit, safety, and cost-effectiveness in patients undergoing cardiac surgery will be examined.

Towards a Maturity Model for Clinical Decision Support Operations.

Clinical decision support (CDS) systems delivered through the electronic health record are an important element of quality and safety initiatives within a health care system. However, managing a large CDS knowledge base can be an overwhelming task for informatics teams. Additionally, it can be difficult for these informatics teams to communicate their goals with external operational stakeholders and define concrete steps for improvement. We aimed to develop a maturity model that describes a roadmap toward organizational functions and processes that help health care systems use CDS more effectively to drive better outcomes. We developed a maturity model for CDS operations through discussions with health care leaders at 80 organizations, iterative model development by four clinical informaticists, and subsequent review with 19 health care organizations. We ceased iterations when feedback from three organizations did not result in any changes to the model. The proposed CDS maturity model includes three main "pillars": "Content Creation," "Analytics and Reporting," and "Governance and Management." Each pillar contains five levels-advancing along each pillar provides CDS teams a deeper understanding of the processes CDS systems are intended to improve. A "roof" represents the CDS functions that become attainable after advancing along each of the pillars. Organizations are not required to advance in order and can develop in one pillar separately from another. However, we hypothesize that optimal deployment of preceding levels and advancing in tandem along the pillars increase the value of organizational investment in higher levels of CDS maturity. In addition to describing the maturity model and its development, we also provide three case studies of health care organizations using the model for self-assessment and determine next steps in CDS development.

The use of structured data elements to identify ASCVD patients with statin-associated side effects: Insights from the Department of Veterans Affairs.

BACKGROUND: Accurate identification of patients with statin-associated side effects (SASEs) is critical for health care systems to institute strategies to improve guideline-concordant statin use. OBJECTIVE: The objective of this study was to determine whether adverse drug reaction (ADR) entry by clinicians in the electronic medical record can accurately identify SASEs. METHODS: We identified 1,248,214 atherosclerotic cardiovascular disease (ASCVD) patients seeking care in the Department of Veterans Affairs. Using an ADR data repository, we identified SASEs in 15 major symptom categories. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were assessed using a chart review of 256 ASCVD patients with identified SASEs, who were not on high-intensity statin therapy. RESULTS: We identified 171,189 patients (13.71%) with documented SASEs over a 15-year period (9.9%, 2.7%, and 1.1% to 1, 2, or >2 statins, respectively). Statin use, high-intensity statin use, low-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol levels were 72%, 28.1%, 99 mg/dL, and 129 mg/dL among those with vs 81%, 31.1%, 84 mg/dL, and 111 mg/dL among those without SASEs. Progressively lower statin and high-intensity statin use, and higher low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol levels were noted among those with SASEs to 1, 2, or >2 statins. Two-thirds of SASEs were related to muscle symptoms. Sensitivity, specificity, PPV, NPV compared with manual chart review were 63.4%, 100%, 100%, and 85.3%, respectively. CONCLUSION: A strategy of using ADR entry in the electronic medical record is feasible to identify SASEs with modest sensitivity and NPV but high specificity and PPV. Health care systems can use this strategy to identify ASCVD patients with SASEs and operationalize efforts to improve guideline-concordant lipid-lowering therapy use in such patients. The sensitivity of this approach can be further enhanced by the use of unstructured text data.

Descriptive Usability Study of CirrODS: Clinical Decision and Workflow Support Tool for Management of Patients With Cirrhosis.

BACKGROUND: There are gaps in delivering evidence-based care for patients with chronic liver disease and cirrhosis. OBJECTIVE: Our objective was to use interactive user-centered design methods to develop the Cirrhosis Order Set and Clinical Decision Support (CirrODS) tool in order to improve clinical decision-making and workflow. METHODS: Two work groups were convened with clinicians, user experience designers, human factors and health services researchers, and information technologists to create user interface designs. CirrODS prototypes underwent several rounds of formative design. Physicians (n=20) at three hospitals were provided with clinical scenarios of patients with cirrhosis, and the admission orders made with and without the CirrODS tool were compared. The physicians rated their experience using CirrODS and provided comments, which we coded into categories and themes. We assessed the safety, usability, and quality of CirrODS using qualitative and quantitative methods. RESULTS: We created an interactive CirrODS prototype that displays an alert when existing electronic data indicate a patient is at risk for cirrhosis. The tool consists of two primary frames, presenting relevant patient data and allowing recommended evidence-based tests and treatments to be ordered and categorized. Physicians viewed the tool positively and suggested that it would be most useful at the time of admission. When using the tool, the clinicians placed fewer orders than they placed when not using the tool, but more of the orders placed were considered to be high priority when the tool was used than when it was not used. The physicians' ratings of CirrODS indicated above average usability. CONCLUSIONS: We developed a novel Web-based combined clinical decision-making and workflow support tool to alert and assist clinicians caring for patients with cirrhosis. Further studies are underway to assess the impact on quality of care for patients with cirrhosis in actual practice.

Use of a Portable Functional Near-Infrared Spectroscopy (fNIRS) System to Examine Team Experience During Crisis Event Management in Clinical Simulations.

Objective: The aim of this study was to investigate the utilization of a portable functional near-infrared spectroscopy (fNIRS) system, the fNIRS PioneerTM, to examine team experience in high-fidelity simulation-based crisis event management (CEM) training for anesthesiologists in operating rooms. Background: Effective evaluation of team performance and experience in CEM simulations is essential for healthcare training and research. Neurophysiological measures with wearable devices can provide useful indicators of team experience to compliment traditional self-report, observer ratings, and behavioral performance measures. fNIRS measured brain blood oxygenation levels and neural synchrony can be used as indicators of workload and team engagement, which is vital for optimal team performance. Methods: Thirty-three anesthesiologists, who were attending CEM training in two-person teams, participated in this study. The participants varied in their expertise level and the simulation scenarios varied in difficulty level. The oxygenated and de-oxygenated hemoglobin (HbO and HbR) levels in the participants' prefrontal cortex were derived from data recorded by a portable one-channel fNIRS system worn by all participants throughout CEM training. Team neural synchrony was measured by HbO/HbR wavelet transformation coherence (WTC). Observer-rated workload and self-reported workload and mood were also collected. Results: At the individual level, the pattern of HbR level corresponded to changes of workload for the individuals in different roles during different phases of a scenario; but this was not the case for HbO level. Thus, HbR level may be a better indicator for individual workload in the studied setting. However, HbR level was insensitive to differences in scenario difficulty and did not correlate with observer-rated or self-reported workload. At the team level, high levels of HbO and HbR WTC were observed during active teamwork. Furthermore, HbO WTC was sensitive to levels of scenario difficulty. Conclusion: This study showed that it was feasible to use a portable fNIRS system to study workload and team engagement in high-fidelity clinical simulations. However, more work is needed to establish the sensitivity, reliability, and validity of fNIRS measures as indicators of team experience.

Application of contextual design methods to inform targeted clinical decision support interventions in sub-specialty care environments.

BACKGROUND & OBJECTIVES: In healthcare, the routine use of evidence-based specialty care management plans is mixed. Targeted computerized clinical decision support (CCDS) interventions can improve physician adherence, but adoption depends on CCDS' 'fit' within clinical work. We analyzed clinical work in outpatient and inpatient settings as a basis for developing guidelines for optimizing CCDS design. METHODS: The contextual design approach guided data collection, collation and analysis. Forty (40) consenting physicians were observed and interviewed in general internal medicine inpatient units and gastroenterology (GI) outpatient clinics at two academic medical centers. Data were collated using interpretive debriefing, and consolidated using thematic analysis and three work modeling approaches (communication flow, sequence and artifact models). RESULTS: Twenty-six consenting physicians were observed at Site A and 14 at Site B. Observations included attending (33%) and resident physicians. During research team debriefings, 220 of 341 unique topics were categorized into 5 CCDS-relevant themes. Resident physicians relied on patient assessment & planning processes to support their roles as communication and coordination hubs within the medical team. Artifact analysis further elucidated the evolution of assessment and planning over work shifts. CONCLUSIONS: The usefulness of CCDS tools may be enhanced in clinical care if the design: 1) accounts for clinical work that is distributed across people, space, and time; 2) targets communication and coordination hubs (specific roles) that can amplify the usefulness of CCDS interventions; 3) integrates CCDS with early clinical assessment & planning processes; and 4) provides CCDS in both electronic & hardcopy formats. These requirements provide a research agenda for future research in clinician-CCDS integration.

Prevalence of Potentially Distracting Noncare Activities and Their Effects on Vigilance, Workload, and Nonroutine Events during Anesthesia Care.

BACKGROUND: When workload is low, anesthesia providers may perform non-patient care activities of a clinical, educational, or personal nature. Data are limited on the incidence or impact of distractions on actual care. We examined the prevalence of self-initiated nonclinical distractions and their effects on anesthesia workload, vigilance, and the occurrence of nonroutine events. METHODS: In 319 qualifying cases in an academic medical center using a Web-based electronic medical chart, a trained observer recorded video and performed behavioral task analysis. Participant workload and response to a vigilance (alarm) light were randomly measured. Postoperatively, participants were interviewed to elicit possible nonroutine events. Two anesthesiologists reviewed each event to evaluate their association with distractions. RESULTS: At least one self-initiated distraction was observed in 171 cases (54%), largely during maintenance. Distractions accounted for 2% of case time and lasted 2.3 s (median). The most common distraction was personal internet use. Distractions were more common in longer cases but were not affected by case type or American Society of Anesthesiologists physical status. Workload ratings were significantly lower during distraction-containing case periods and vigilance latencies were significantly longer in cases without any distractions. Three distractions were temporally associated with, but did not cause, events. CONCLUSIONS: Both nurse anesthetists and residents performed potentially distracting tasks of a personal and/or educational nature in a majority of cases. Self-initiated distractions were rarely associated with events. This study suggests that anesthesia professionals using sound judgment can self-manage nonclinical activities. Future efforts should focus on eliminating more cognitively absorbing and less escapable distractions, as well as training in distraction management.