The decision aid is the easy part: workflow challenges of shared decision making in cancer care.

Delivering high-quality, patient-centered cancer care remains a challenge. Both the National Academy of Medicine and the American Society of Clinical Oncology recommend shared decision making to improve patient-centered care, but widespread adoption of shared decision making into clinical care has been limited. Shared decision making is a process in which a patient and the patient's health-care professional weigh the risks and benefits of different options and come to a joint decision on the best course of action for that patient on the basis of their values, preferences, and goals for care. Patients who engage in shared decision making report higher quality of care, whereas patients who are less involved in these decisions have statistically significantly higher decisional regret and are less satisfied. Decision aids can improve shared decision making-for example, by eliciting patient values and preferences that can then be shared with clinicians and by providing patients with information that may influence their decisions. However, integrating decision aids into the workflows of routine care is challenging. In this commentary, we explore 3 workflow-related barriers to shared decision making: the who, when, and how of decision aid implementation in clinical practice. We introduce readers to human factors engineering and demonstrate its potential value to decision aid design through a case study of breast cancer surgical treatment decision making. By better employing the methods and principles of human factors engineering, we can improve decision aid integration, shared decision making, and ultimately patient-centered cancer outcomes.

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.

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.

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.

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.

The influence of stress responses on surgical performance and outcomes: Literature review and the development of the surgical stress effects (SSE) framework.

BACKGROUND: Surgical adverse events persist despite several decades of system-based quality improvement efforts, suggesting the need for alternative strategies. Qualitative studies suggest stress-induced negative intraoperative interpersonal dynamics might contribute to performance errors and undesirable patient outcomes. Understanding the impact of intraoperative stressors may be critical to reducing adverse events and improving outcomes. DATA SOURCES: We searched MEDLINE, psycINFO, EMBASE, Business Source Premier, and CINAHL databases (1996-2016) to assess the relationship between negative (emotional and behavioral) responses to acute intraoperative stressors and provider performance or patient surgical outcomes. RESULTS/CONCLUSIONS: Drawing on theory and evidence from reviewed studies, we present the Surgical Stress Effects (SSE) framework. This illustrates how emotional and behavioral responses to stressors can influence individual surgical provider (e.g. surgeon, nurse) performance, team performance, and patient outcomes. It also demonstrates how uncompensated intraoperative threats and errors can lead to adverse events, highlighting evidence gaps for future research efforts.

Impact of electronic health record technology on the work and workflow of physicians in the intensive care unit.

OBJECTIVE: To assess the impact of EHR technology on the work and workflow of ICU physicians and compare time spent by ICU resident and attending physicians on various tasks before and after EHR implementation. DESIGN: EHR technology with electronic order management (CPOE, medication administration and pharmacy system) and physician documentation was implemented in October 2007. MEASUREMENT: We collected a total of 289 h of observation pre- and post-EHR implementation. We directly observed the work of residents in three ICUs (adult medical/surgical ICU, pediatric ICU and neonatal ICU) and attending physicians in one ICU (adult medical/surgical ICU). RESULTS: EHR implementation had an impact on the time distribution of tasks as well as the temporal patterns of tasks. After EHR implementation, both residents and attending physicians spent more of their time on clinical review and documentation (40% and 55% increases, respectively). EHR implementation also affected the frequency of switching between tasks, which increased for residents (from 117 to 154 tasks per hour) but decreased for attendings (from 138 to 106 tasks per hour), and the temporal flow of tasks, in particular around what tasks occurred before and after clinical review and documentation. No changes in the time spent in conversational tasks or the physical care of the patient were observed. CONCLUSIONS: The use of EHR technology has a major impact on ICU physician work (e.g., increased time spent on clinical review and documentation) and workflow (e.g., clinical review and documentation becoming the focal point of many other tasks). Further studies should evaluate the impact of changes in physician work on the quality of care provided.

Implementing goal-directed protocols reduces length of stay after cardiac surgery.

OBJECTIVE: To test the effect of a high reliability organization (HRO) intervention on patient lengths of stay in the CVICU and hospital. The authors proposed that (1) higher safety related evidence based protocol (SREBP) team compliance scores and (2) lower SREBP milestone scores are associated with shorter lengths of CVICU and hospital stay. DESIGN: A prospective, longitudinal observational evaluation was used to assess the effects of SREBP-focused rounding processes and a milestone-tracking tool. SETTING: United States, university academic medical center's 27-bed CVICU. PARTICIPANTS: Six hundred sixty-five adult cardiac surgery patients and the CVICU care team (100 registered nurses and 16 clinical providers) participated. MEASUREMENTS AND MAIN RESULTS: Team compliance was the proportion of SREBP-related team behaviors exhibited during daily rounds. Patients' milestone scores were the cumulative difference between actual and expected times for 4 SREBP milestones over 48 hours. Milestones achieved earlier than expected indicated reduced complication risk, and milestones achieved later than expected indicated increased risk. As team compliance increased, CVICU length of stay decreased 0.66 (95% CI: -0.04 to 1.28; p = 0.08) days; hospital stay decreased 0.89 times (95% CI: 0.77-1.03; p = 0.008). As the mean milestone scores increased from -7 to 12, length of ICU stay increased 2.63 (95% CI: 1.66-3.59; p<0.001) days; hospital length of stay increased 1.44 times (95% CI: 1.23-1.7; p = 0.05). CONCLUSIONS: A milestone-driven pathway supported by team rounding was associated with decreased lengths of CVICU and hospital stay. However, tracking patient trajectories by milestones suggests a more complex relationship than anticipated and presents new opportunities for SREBP implementation and research.

Operating room clinicians' ratings of workload: a vignette simulation study.

OBJECTIVES: Increased clinician workload is associated with medical errors and patient harm. The Quality and Workload Assessment Tool (QWAT) measures anticipated (pre-case) and perceived (post-case) clinical workload during actual surgical procedures using ratings of individual and team case difficulty from every operating room (OR) team member. The purpose of this study was to examine the QWAT ratings of OR clinicians who were not present in the OR but who read vignettes compiled from actual case documentation to assess interrater reliability and agreement with ratings made by clinicians involved in the actual cases. METHODS: Thirty-six OR clinicians (13 anesthesia providers, 11 surgeons, and 12 nurses) used the QWAT to rate 6 cases varying from easy to moderately difficult based on actual ratings made by clinicians involved with the cases. Cases were presented and rated in random order. Before rating anticipated individual and team difficulty, the raters read prepared clinical vignettes containing case synopses and much of the same written case information that was available to the actual clinicians before the onset of each case. Then, before rating perceived individual and team difficulty, they read part 2 of the vignette consisting of detailed role-specific intraoperative data regarding the anesthetic and surgical course, unusual events, and other relevant contextual factors. RESULTS: Surgeons had higher interrater reliability on the QWAT than did OR nurses or anesthesia providers. For the anticipated individual and team workload ratings, there were no statistically significant differences between the actual ratings and the ratings obtained from the vignettes. There were differences for the 3 provider types in perceived individual workload for the median difficulty cases and in the perceived team workload for the median and more difficult cases. CONCLUSIONS: The case difficulty items on the QWAT seem to be sufficiently reliable and valid to be used in other studies of anticipated and perceived clinical workload of surgeons. Perhaps because of the limitations of the clinical documentation shown to anesthesia providers and OR nurses in the current vignette study, more evidence needs to be gathered to demonstrate the criterion-related validity of the QWAT difficulty items for assessing the workload of nonsurgeon OR clinicians.

A real-time assessment of factors influencing medication events.

Reducing medical error is critical to improving the safety and quality of healthcare. Physician stress, fatigue, and excessive workload are performance-shaping factors (PSFs) that may influence medical events (actual administration errors and near misses), but direct relationships between these factors and patient safety have not been clearly defined. This study assessed the real-time influence of emotional stress, workload, and sleep deprivation on self-reported medication events by physicians in academic hospitals. During an 18-month study period, 185 physician participants working at four university-affiliated teaching hospitals reported medication events using a confidential reporting application on handheld computers. Emotional stress scores, perceived workload, patient case volume, clinical experience, total sleep, and demographic variables were also captured via the handheld computers. Medication event reports (n = 11) were then correlated with these demographic and PSFs. Medication events were associated with 36.1% higher perceived workload (p < .05), 38.6% higher inpatient caseloads (p < .01), and 55.9% higher emotional stress scores (p < .01). There was a trend for reported events to also be associated with less sleep (p = .10). These results confirm the effect of factors influencing medication events, and support attention to both provider and hospital environmental characteristics for improving patient safety.

Evaluation of an integrated graphical display to promote acute change detection in ICU patients.

OBJECTIVE: The purpose of this study was to evaluate ICU nurses' ability to detect patient change using an integrated graphical information display (IGID) versus a conventional tabular ICU patient information display (i.e. electronic chart). DESIGN: Using participants from two different sites, we conducted a repeated measures simulator-based experiment to assess ICU nurses' ability to detect abnormal patient variables using a novel IGID versus a conventional tabular information display. Patient scenarios and display presentations were fully counterbalanced. MEASUREMENTS: We measured percent correct detection of abnormal patient variables, nurses' perceived workload (NASA-TLX), and display usability ratings. RESULTS: 32 ICU nurses (87% female, median age of 29 years, and median ICU experience of 2.5 years) using the IGID detected more abnormal variables compared to the tabular display [F(1, 119)=13.0, p<0.05]. There was a significant main effect of site [F(1, 119)=14.2], with development site participants doing better. There were no significant differences in nurses' perceived workload. The IGID display was rated as more usable than the conventional display [F(1, 60)=31.7]. CONCLUSION: Overall, nurses reported more important physiological information with the novel IGID than tabular display. Moreover, the finding of site differences may reflect local influences in work practice and involvement in iterative display design methodology. Information displays developed using user-centered design should accommodate the full diversity of the intended user population across use sites.

Anesthesia for liver transplantation in US academic centers: institutional structure and perioperative care.

Investigators at a single institution have shown that the organization of the anesthesia team influences patient outcomes after liver transplant surgery. Little is known about how liver transplant anesthesiologists are organized to deliver care throughout the United States. Therefore, we collected quantitative survey data from adult liver transplant programs in good standing with national governing agencies so that we could describe team structure and duties. Information was collected from 2 surveys in a series of quantitative surveys conducted by the Liver Transplant Anesthesia Consortium. All data related to duties, criteria for team membership, interactions/communication with the multidisciplinary team, and service availability were collected and summarized. Thirty-four of 119 registered transplant centers were excluded (21 pediatric centers and 13 centers not certified by national governing agencies). Private practice sites (26) were later excluded because of a poor response rate. There were minimal changes in the compositions of the programs between the 2 surveys. All academic programs had distinct liver transplant anesthesia teams. Most had set criteria for membership and protocols outlining the preoperative evaluation, attended selection committees, and were always available for transplant surgery. Fewer were involved in postoperative care or were available for patients needing subsequent surgery. Most trends were associated with the center volume. In conclusion, some of the variance in team structure and responsibilities is probably related to resources available at the site of practice. However, similarities in specific duties across all teams suggest some degree of self-initiated specialization.

Operating room team members' views of workload, case difficulty, and nonroutine events.

Interventions such as mandatory "time-outs" have contributed to intraoperative safety but improvements are still necessary. We present data provided by 3 professions always present in the intraoperative setting that suggest next steps in the quest for improvements. We describe the differences and similarities in operating room (OR) nurses', anesthesia providers', and surgeons' beliefs about team function, case difficulty, nonroutine event (NRE), and error causation using a qualitative design at 3 Veterans' Administration hospitals. Intraoperative errors are costly in lives, suffering, and dollars. A quality improvement tenet states that workers are a rich information source regarding the context within which quality can be improved. Identifying and describing OR providers' beliefs are necessary steps in devising novel approaches to quality improvement. Intraoperative NRE and error prevention opportunities exist within and outside of the OR. There may be "cascade" and "perfect storm conditions" before and during operative procedures that increase the likelihood of NREs. Confirmation of these phenomena could improve prediction and prevention of NREs. Exploration of differences in team definition and team performance ratings by provider type may also identify avenues for improvement.

Blood product positive patient identification: comparative simulation-based usability test of two commercial products.

BACKGROUND: The blood product administration process has been subject to various quality improvement initiatives aimed at reducing errors, including blood product labels that are missing, inaccessible, unreadable, or mismatched to orders and/or patients. This article reports the results of a formal simulation-based usability test of two comparable technologies designed to reduce blood product administration errors. STUDY DESIGN AND METHODS: Nineteen nurses and three anesthesia providers evaluated one of the two products during simulated use in realistic scenarios during 90-minute test sessions. Both products required additional learning despite 15 minutes of dedicated vendor-provided pretest training. RESULTS: There were significant effectiveness differences between the two products, but use of both devices was less efficient than manual checking. Usability issues included poor access to subtasks, lack of process feedback, inadequate error messaging, and confusing device interactions. CONCLUSION: While clinicians' subjective ratings of both devices were similarly high, both products had significant usability issues likely to lead to clinician frustration and workarounds during actual use. This study suggests that usability testing is a valuable and more effective method than preference surveys of determining the ability of blood administration products to meet clinicians' needs in the complex world of patient care.

A facilitated survey instrument captures significantly more anesthesia events than does traditional voluntary event reporting.

BACKGROUND: This study sought to evaluate the effectiveness of an active survey method for detecting anesthesia nonroutine events (NREs). An NRE is any aspect of clinical care perceived by clinicians or observers as a deviation from optimal care based on the context of the clinical situation. METHODS: A Comprehensive Open-ended Nonroutine Event Survey (CONES) was developed to elicit NREs. CONES, which consisted of multiple brief open-ended questions, was administered to anesthesia providers in the postanesthesia care unit. CONES data were compared with those from the same hospital's anesthesia quality assurance (QA) process, which relied on self-reporting of predefined adverse events. RESULTS: CONES interviews were conducted after 183 cases of varying patient, anesthesia, and surgical complexity. Fifty-five cases had at least one NRE (30.4% incidence). During the same 30-month period, the QA process captured 159 cases with 96.8% containing at least one NRE among the 8,303 anesthetic procedures conducted (1.9% overall incidence). The CONES data were more representative of the overall surgical population. There were significant differences in NRE incidence (P < 0.001), patient impact (74.5% vs. 96.2%; P < 0.001), and injury (23.6% vs. 60.3%) between CONES and QA data. Outcomes were more severe in the QA group (P < 0.001). Extrapolation of the CONES data suggested a significantly higher overall incidence of anesthesia-related patient injury (7.7% vs. only 1.0% with the QA method). CONCLUSIONS: An active surveillance tool using the NRE construct identified a large number of clinical cases with potential patient safety concerns. This approach may be a useful complement to more traditional QA methods of self-reporting.

Modeling workflow and information flow in chronic disease care.

Informatics applications may facilitate improved chronic disease care, but designing for this environment may have unique requirements. Clinic specific and generalized models of workflow and information flow were developed based data from over 150 hours of direct observation in three chronic disease clinics. Semi-structured interviews were also conducted to gather additional data and to verify the models. These models can be used to design more effective informatics tools for chronic disease care.

Retrospective data collection and analytical techniques for patient safety studies.

To enhance patient safety, data about actual clinical events must be collected and scrutinized. This paper has two purposes. First, it provides an overview of some of the methods available to collect and analyze retrospective data about medical errors, near misses, and other relevant patient safety events. Second, it introduces a methodological approach that focuses on non-routine events (NRE), defined as all events that deviate from optimal clinical care. In intermittent in-person surveys of anesthesia providers, 75 of 277 (27%) recently completed anesthetic cases contained a non-routine event (98 total NRE). Forty-six of the cases (17%) had patient impact while only 20 (7%) led to patient injury. In contrast, in the same hospitals over a two-year period, we collected event data on 135 cases identified with traditional quality improvement processes (event incidence of 0.7-2.7%). In these quality improvement cases, 120 (89%) had patient impact and 74 (55%) led to patient injury. Preliminary analyses not only illustrate some of the analytical methods applicable to safety data but also provide insight into the potential value of the non-routine event approach for the early detection of risks to patient safety before serious patient harm occurs.

Quantifying expert vs. novice skill in vivo for development of a laryngoscopy simulator.

Many medical procedures require fine motor skills, and these skills are developed over years of practice and through performing hundreds to thousands of procedures. However medical training that is based upon gaining this expertise by performing procedures on patients results in unnecessary risk to the patient. In this project expert medical skill is quantified, so that advanced medical simulators can be created to provide a realistic training environment. This approach is applied to airway intubation with a rigid laryngoscope; a procedure that is performed prior to general anesthesia and during emergency situations. A laryngoscope has been instrumented with a 3 dimensional force/torque sensor, and magnetic position sensors have been placed on the laryngoscope and the patient. Measurements are made in the operating room of both experts and novices as they perform laryngoscopy on consenting patients undergoing general anesthesia. The skill of the laryngoscopist is represented by the motion and force trajectories applied to the laryngoscope during the procedure. Preliminary results show that novices often err in the placement of the tip of the laryngoscope blade. However, when two experts perform laryngoscopy on the same patient, both experts perform key elements of the task consistently. The measured consistency among experts indicates that it will be possible to apply algorithms developed for Human Skill Acquisition, and thereby define regions of expert motion relative to patient anatomy. This is the first step in developing advanced training simulators that will simulate the procedure accurately, provide guidance to the trainee, and can be used for assessment of medical skill.