Effectiveness of subcutaneous monoclonal antibody treatment in emergency department outpatients with COVID-19.

Objectives: To evaluate whether subcutaneous neutralizing monoclonal antibody (mAb) treatment given in the emergency department (ED) setting was associated with reduced hospitalizations, mortality, and severity of disease when compared to nontreatment among mAb-eligible patients with coronavirus disease 2019 (COVID-19). Methods: This retrospective observational cohort study of ED patients utilized a propensity score-matched analysis to compare patients who received subcutaneous casirivimab and imdevimab mAb to nontreated COVID-19 control patients in November-December 2021. The primary outcome was all-cause hospitalization within 28 days, and secondary outcomes were 90-day hospitalization, 28- and 90-day mortality, and ED length of stay (LOS). Results: Of 1340 patients included in the analysis, 490 received subcutaneous casirivimab and imdevimab, and 850 did not received them. There was no difference observed for 28-day hospitalization (8.4% vs. 10.6%; adjusted odds ratio [aOR] 0.79, 95% confidence intervals [CI] 0.53-1.17) or 90-day hospitalization (11.6% vs. 12.5%; aOR 0.93, 95% CI 0.65-1.31). However, mortality at both the 28-day and 90-day timepoints was substantially lower in the treated group (28-day 0.6% vs. 3.1%; aOR 0.18, 95% CI 0.08-0.41; 90-day 0.6% vs. 3.9%; aOR 0.14, 95% CI 0.06-0.36). Among hospitalized patients, treated patients had shorter hospital LOS (5.7 vs. 11.4 days; adjusted rate ratio [aRR] 0.47, 95% CI 0.33-0.69), shorter intensive care unit LOS (3.8 vs. 10.2 days; aRR 0.22, 95% CI 0.14-0.35), and the severity of hospitalization was lower (aOR 0.45, 95% CI 0.21-0.97) compared to untreated. Conclusions: Among ED patients who presented for symptomatic COVID-19 during the Delta variant phase, ED subcutaneous casirivimab/imdevimab treatment was not associated with a decrease in hospitalizations. However, treatment was associated with lower mortality at 28 and 90 days, hospital LOS, and overall severity of illness.

Real-World Evidence of Neutralizing Monoclonal Antibodies for Preventing Hospitalization and Mortality in COVID-19 Outpatients.

BACKGROUND: Neutralizing monoclonal antibodies (mAbs) were authorized for the treatment of COVID-19 outpatients based on clinical trials completed early in the pandemic, which were underpowered for mortality and subgroup analyses. Real-world data studies are promising for further assessing rapidly deployed therapeutics. RESEARCH QUESTION: Did mAb treatment prevent progression to severe disease and death across pandemic phases and based on risk factors, including prior vaccination status? STUDY DESIGN AND METHODS: This observational cohort study included nonhospitalized adult patients with SARS-CoV-2 infection from November 2020 to October 2021 using electronic health records from a statewide health system plus state-level vaccine and mortality data. Using propensity matching, we selected approximately 2.5 patients not receiving mAbs for each patient who received mAb treatment under emergency use authorization. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and hospitalization severity. RESULTS: Of 36,077 patients with SARS-CoV-2 infection, 2,675 receiving mAbs were matched to 6,677 patients not receiving mAbs. Compared with mAb-untreated patients, mAb-treated patients had lower all-cause hospitalization (4.0% vs 7.7%; adjusted OR, 0.48; 95% CI, 0.38-0.60) and all-cause mortality (0.1% vs 0.9%; adjusted OR, 0.11; 95% CI, 0.03-0.29) to day 28; differences persisted to day 90. Among hospitalized patients, mAb-treated patients had shorter hospital length of stay (5.8 vs 8.5 days) and lower risk of mechanical ventilation (4.6% vs 16.6%). Results were similar for preventing hospitalizations during the Delta variant phase (adjusted OR, 0.35; 95% CI, 0.25-0.50) and across subgroups. Number-needed-to-treat (NNT) to prevent hospitalization was lower for subgroups with higher baseline risk of hospitalization; for example, multiple comorbidities (NNT = 17) and not fully vaccinated (NNT = 24) vs no comorbidities (NNT = 88) and fully vaccinated (NNT = 81). INTERPRETATION: Real-world data revealed a strong association between receipt of mAbs and reduced hospitalization and deaths among COVID-19 outpatients across pandemic phases. Real-world data studies should be used to guide practice and policy decisions, including allocation of scarce resources.

ED-based COVID-19 vaccination campaign finds higher vaccination rates for individuals from racial and ethnic minority groups compared with clinic setting.

BACKGROUND: Emergency department visits associated with Coronavirus Disease 2019 (COVID-19) continue to indicate racial and ethnic inequities. We describe the sociodemographic characteristics of individuals receiving COVID-19 vaccination in the emergency department and compare with an outpatient clinic population and emergency department (ED) patients who were eligible but not vaccinated. METHODS: We conducted a retrospective analysis of electronic health record data at an urban academic ED from May to July 2021. The primary aim was to characterize the ED-vaccinated population, compared with ED patients who were eligible but unvaccinated and the physically adjacent outpatient vaccination clinic population. RESULTS: A total of 627 COVID-19 vaccinations were administered in the ED. Overall, 49% of ED patients during that time had already received at least one vaccine dose prior to ED arrival. Hispanic, non-Hispanic Black patients, and patients on non-commercial insurance had higher odds of being vaccinated in the ED as compared with outpatient clinic setting. Among eligible ED patients, men and patients who were uninsured/self-pay were more likely to accept ED vaccination. CONCLUSIONS: This ED COVID-19 vaccination campaign demonstrated a higher likelihood to vaccinate individuals from racial/ethnic minority groups, those with high social vulnerability, and non-commercial insurance, when compared with a co-located outpatient vaccination clinic.

The Role of Academic Health Systems in Leading the "Third Wave" of Digital Health Innovation.

Investors, entrepreneurs, health care pundits, and venture capital firms all agree that the health care sector is awaiting a digital revolution. Steven Case, in 2016, predicted a "third wave" of innovation that would leverage big data, artificial intelligence, and machine learning to transform medicine and finally achieve reduced costs, improved efficiency, and better patient outcomes. Academic medical centers (AMCs) have the infrastructure and resources needed by digital health intrapreneurs and entrepreneurs to innovate, iterate, and optimize technology solutions for the major pain points of modern medicine. With large unique patient data sets, strong research programs, and subject matter experts, AMCs have the ability to assess, optimize, and integrate new digital health tools with feedback at the point of care and research-based clinical validation. As AMCs begin to explore digital health solutions, they must decide between forming internal teams to develop these innovations or collaborating with external companies. Although each has its drawbacks and benefits, AMCs can both benefit from and drive forward the digital health innovations that will result from this journey. This viewpoint will provide an explanation as to why AMCs are ideal incubators for digital health solutions and describe what these organizations will need to be successful in leading this "third wave" of innovation.

Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients.

BACKGROUND: It is not known whether sotrovimab, a neutralizing monoclonal antibody (mAb) treatment authorized for early symptomatic coronavirus disease 2019 (COVID-19) patients, is also effective in preventing the progression of severe disease and mortality following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta variant infection. METHODS: In an observational cohort study of nonhospitalized adult patients with SARS-CoV-2 infection, 1 October 2021-11 December 2021, using electronic health records from a statewide health system plus state-level vaccine and mortality data, we used propensity matching to select 3 patients not receiving mAbs for each patient who received outpatient sotrovimab treatment. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization. RESULTS: Of 10 036 patients with SARS-CoV-2 infection, 522 receiving sotrovimab were matched to 1563 not receiving mAbs. Compared to mAb-untreated patients, sotrovimab treatment was associated with a 63% decrease in the odds of all-cause hospitalization (raw rate 2.1% vs 5.7%; adjusted odds ratio [aOR], 0.37; 95% confidence interval [CI], .19-.66) and an 89% decrease in the odds of all-cause 28-day mortality (raw rate 0% vs 1.0%; aOR, 0.11; 95% CI, .0-.79), and may reduce respiratory disease severity among those hospitalized. CONCLUSIONS: Real-world evidence demonstrated sotrovimab effectiveness in reducing hospitalization and all-cause 28-day mortality among COVID-19 outpatients during the Delta variant phase.

Real World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients.

Background: It is not known whether sotrovimab, a neutralizing monoclonal antibody (mAb) treatment authorized for early symptomatic COVID-19 patients, is effective against the SARS-CoV-2 Delta variant to prevent progression to severe disease and mortality. Methods: Observational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from October 1 st 2021 - December 11 th 2021, using electronic health records from a statewide health system plus state-level vaccine and mortality data. We used propensity matching to select 3 patients not receiving mAbs for each patient who received outpatient sotrovimab treatment. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization. Results: Of 10,036 patients with SARS-CoV-2 infection, 522 receiving sotrovimab were matched to 1,563 not receiving mAbs. Compared to mAb-untreated patients, sotrovimab treatment was associated with a 63% decrease in the odds of all-cause hospitalization (raw rate 2.1% versus 5.7%; adjusted OR 0.37, 95% CI 0.19-0.66) and an 89% decrease in the odds of all-cause 28-day mortality (raw rate 0% versus 1.0%; adjusted OR 0.11, 95% CI 0.0-0.79), and may reduce respiratory disease severity among those hospitalized. Conclusion: Real-world evidence demonstrated sotrovimab effectiveness in reducing hospitalization and all-cause 28-day mortality among COVID-19 outpatients during the Delta variant phase.

COVID-19 Vaccine Clinic Real-Time Throughput Analysis: Development and Implementation of an Innovative Data Collection Tool.

BACKGROUND: The novel coronavirus disease 2019 (COVID-19) pandemic has presented the healthcare system with a plethora of challenges, including implementation of an efficient vaccination strategy. Mass vaccinations have been used during previous pandemics; however, the associated data have largely been limited to theoretical simulations and post hoc analysis. METHODS: An innovative data collection tool was created to deliver real-time data analysis during a drive-through mass vaccination. Patients were assigned unique identification numbers at the clinic entrance. Using these identification numbers, and the web-based spreadsheet, patients were tracked throughout the vaccination process. Static timestamps corresponding to the entry and exit at each checkpoint were recorded in real time. RESULTS: Data were collected on a total of 3,744 vehicles over five clinic days. Total time was collected, from entry to exit, on 2,860 vehicles. Registration and vaccination times were collected on 3,111 vehicles. Of the vehicles sampled, 1,588 (42%) had data points associated with all checkpoints. CONCLUSIONS: This open-source, innovative data collection tool was successfully implemented in our mass vaccination clinic for tracking patients in real time providing actionable data on overall throughput efficiency. This cost-effective tool can be used on a variety of healthcare-related projects to provide data-driven evaluation on the efficiency of care.

Real World Evidence of Neutralizing Monoclonal Antibodies for Preventing Hospitalization and Mortality in COVID-19 Outpatients.

BACKGROUND: Neutralizing monoclonal antibodies (mAbs) are authorized for early symptomatic COVID-19 patients. Whether mAbs are effective against the SARS-CoV-2 Delta variant, among vaccinated patients, or for prevention of mortality remains unknown. OBJECTIVE: To evaluate the effectiveness of mAb treatment in preventing progression to severe disease during the Delta phase of the pandemic and based on key baseline risk factors. DESIGN SETTING AND PATIENTS: Observational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from November 2020-October 2021, using electronic health records from a statewide health system plus state-level vaccine and mortality data. Using propensity matching, we selected approximately 2.5 patients not receiving mAbs for each patient who received mAbs. EXPOSURE: Neutralizing mAb treatment under emergency use authorization. MAIN OUTCOMES: The primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization. RESULTS: Of 36,077 patients with SARS-CoV-2 infection, 2,675 receiving mAbs were matched to 6,677 not receiving mAbs. Compared to mAb-untreated patients, mAb-treated patients had lower all-cause hospitalization (4.0% vs 7.7%; adjusted OR 0.48, 95%CI 0.38-0.60) and all-cause mortality (0.1% vs. 0.9%; adjusted OR 0.11, 95%CI 0.03-0.29) to day 28; differences persisted to day 90. Among hospitalized patients, mAb-treated patients had shorter hospital length of stay (5.8 vs. 8.5 days) and lower risk of mechanical ventilation (4.6% vs. 16.6%). Relative effectiveness was similar in preventing hospitalizations during the Delta variant phase (adjusted OR 0.35, 95%CI 0.25-0.50) and across subgroups. Lower number-needed-to-treat (NNT) to prevent hospitalization were observed for subgroups with higher baseline risk of hospitalization (e.g., multiple comorbidities (NNT=17) and not fully vaccinated (NNT=24) vs. no comorbidities (NNT=88) and fully vaccinated (NNT=81). CONCLUSION: Real-world evidence demonstrated mAb effectiveness in reducing hospitalization among COVID-19 outpatients, including during the Delta variant phase, and conferred an overall 89% reduction in 28-day mortality. Early outpatient treatment with mAbs should be prioritized, especially for individuals with highest risk for hospitalization.

Optimizing planning and design of COVID-19 drive-through mass vaccination clinics by simulation.

Drive-through clinics have previously been utilized in vaccination efforts and are now being more widely adopted for COVID-19 vaccination in different parts of the world by offering many advantages including utilizing existing infrastructure, large daily throughput and enforcing social distancing by default. Successful, effective, and efficient drive-through facilities require a suitable site and keen focus on layout and process design. To demonstrate the role that high fidelity computer simulation can play in planning and design of drive-through mass vaccination clinics, we used multiple integrated discrete event simulation (DES) and agent-based modelling methods. This method using AnyLogic simulation software to aid in planning, design, and implementation of one of the largest and most successful early COVID-19 mass vaccination clinics operated by UCHealth in Denver, Colorado. Simulations proved to be helpful in aiding the optimization of UCHealth drive through mass vaccination clinic design and operations by exposing potential bottlenecks, overflows, and queueing, and clarifying the necessary number of supporting staff. Simulation results informed the target number of vaccinations and necessary processing times for different drive through station set ups and clinic formats. We found that modern simulation tools with advanced visual and analytical capabilities to be very useful for effective planning, design, and operations management of mass vaccination facilities.

Surviving a Medical Malpractice Lawsuit.

Being named in a medical malpractice case is one of the most stressful events in a physician's career. This article reviews the legal system and the medical malpractice process. It details the steps a physician experiences during a medical malpractice case, from being served to the deposition and then to trial and appeals if the physician loses. This article also reviews necessary steps to take in order to proactively participate in one's own defense.

Virtual Reality-Based Resilience Programs: Feasibility and Implementation for Inpatient Oncology Nurses.

The high prevalence of compassion fatigue contributes to burnout among oncology nurses. Interventions are needed to support individuals across diverse roles and practice settings in oncology. Virtual reality (VR) is an emerging technology that has been applied in healthcare education and training and is being explored as an intervention to reduce stress and support wellness for healthcare providers. This article reviews recommendations from an implementation project about a VR intervention for oncology nurses.

How alternative payment models in emergency medicine can benefit physicians, payers, and patients.

While there has been considerable effort devoted to developing alternative payment models (APMs) for primary care physicians and for episodes of care beginning with inpatient admissions, there has been relatively little attention by payers to developing APMs for specialty ambulatory care, and no efforts to develop APMs that explicitly focus on emergency care. In order to ensure that emergency care is appropriately integrated and valued in future payment models, emergency physicians (EPs) must engage with the stakeholders within the broader health care system. In this article, we describe a framework for the development of APMs for emergency medicine and present four examples of APMs that may be applicable in emergency medicine. A better understanding of how APMs can work in emergency medicine will help EPs develop new APMs that improve the cost and quality of care, and leverage the value that emergency care brings to the system.

National study of health insurance type and reasons for emergency department use.

BACKGROUND: The rates of emergency department (ED) utilization vary substantially by type of health insurance, but the association between health insurance type and patient-reported reasons for seeking ED care is unknown. OBJECTIVE: We evaluated the association between health insurance type and self-perceived acuity or access issues among individuals discharged from the ED. DESIGN, PATIENTS: This was a cross-sectional analysis of the 2011 National Health Interview Survey. Adults whose last ED visit did not result in hospitalization (n = 4,606) were asked structured questions about reasons for seeking ED care. We classified responses as 1) perceived need for immediate evaluation (acuity issues), or 2) barriers to accessing outpatient services (access issues). MAIN MEASURES: We analyzed survey-weighted data using multivariable logistic regression models to test the association between health insurance type and reasons for ED visits, while adjusting for sociodemographic characteristics. KEY RESULTS: Overall, 65.0% (95% CI 63.0-66.9) of adults reported ≥ 1 acuity issue and 78.9% (95% CI 77.3-80.5) reported ≥ 1 access issue. Among those who reported no acuity issue leading to the most recent ED visit, 84.2% reported ≥ 1 access issue. Relative to those with private insurance, adults with Medicaid (OR 1.05; 95% CI 0.79-1.40) and those with Medicare (OR 0.98; 95% CI 0.66-1.47) were similarly likely to seek ED care due to an acuity issue. Adults with Medicaid (OR 1.50; 95% CI 1.06-2.13) and Medicaid + Medicare (dual eligible) (OR 1.94; 95% CI 1.18-3.19) were more likely than those with private insurance to seek ED care for access issues. CONCLUSION: Variability in reasons for seeking ED care among discharged patients by health insurance type may be driven more by lack of access to alternate care, rather than by differences in patient-perceived acuity. Policymakers should focus on increasing access to alternate sites of care, particularly for Medicaid beneficiaries, as well as strategies to increase care coordination that involve ED patients and providers.

The effect of an ambulance diversion ban on emergency department length of stay and ambulance turnaround time.

STUDY OBJECTIVE: Massachusetts became the first state in the nation to ban ambulance diversion in 2009. It was feared that the diversion ban would lead to increased emergency department (ED) crowding and ambulance turnaround time. We seek to characterize the effect of a statewide ambulance diversion ban on ED length of stay and ambulance turnaround time at Boston-area EDs. METHODS: We conducted a retrospective, pre-post observational analysis of 9 Boston-area hospital EDs before and after the ban. We used ED length of stay as a proxy for ED crowding. We compared hospitals individually and in aggregate to determine any changes in ED length of stay for admitted and discharged patients, ED volume, and turnaround time. RESULTS: No ED experienced an increase in ED length of stay for admitted or discharged patients or ambulance turnaround time despite an increase in volume for several EDs. There was an overall 3.6% increase in ED volume in our sample, a 10.4-minute decrease in length of stay for admitted patients, and a 2.2-minute decrease in turnaround time. When we compared high- and low-diverting EDs separately, neither saw an increase in length of stay, and both saw a decrease in turnaround time. CONCLUSION: After the first statewide ambulance diversion ban, there was no increase in ED length of stay or ambulance turnaround time at 9 Boston-area EDs. Several hospitals actually experienced improvements in these outcome measures. Our results suggest that the ban did not worsen ED crowding or ambulance availability at Boston-area hospitals.

Variation in use of head computed tomography by emergency physicians.

OBJECTIVE: Variation in emergency department head computed tomography (CT) use in patients with atraumatic headaches between hospitals is being measured nationwide. However, the magnitude of interphysician variation within a hospital is currently unknown. We hypothesized that there was significant variation in the rates of physician head CT use, both overall and for patients diagnosed with atraumatic headaches. METHODS: This cross-sectional study was conducted in the emergency department of a large urban academic hospital, and institutional review board approval was obtained. All emergency department visits from 2009 were analyzed, and the primary outcome measure was whether or not head CT was performed. Logistic regression was used to control for patient, physician, and visit characteristics potentially associated with head CT ordering. The degree of interphysician variability was tested, both before and after controlling for these variables. RESULTS: Of 55,286 emergency department patient encounters, 4919 (8.9%) involved head CT examinations. Unadjusted head CT ordering rates per physician ranged from 4.4% to 16.9% overall and from 15.2% to 61.7% in patients diagnosed with atraumatic headaches, with both rates varying significantly between physicians. Two-fold variation in head CT ordering overall (6.5%-13.5%) and approximately 3-fold variation in head CT ordering for atraumatic headaches (21.2%-60.1%) persisted even after controlling for pertinent variables. CONCLUSION: Emergency physicians vary significantly in their use of head CT both overall and in patients with atraumatic headaches. Further studies are needed to identify strategies to reduce interphysician variation in head CT use.

Effect of computerized clinical decision support on the use and yield of CT pulmonary angiography in the emergency department.

PURPOSE: To determine the effect of evidence-based clinical decision support (CDS) on the use and yield of computed tomographic (CT) pulmonary angiography for acute pulmonary embolism (PE) in the emergency department (ED). MATERIALS AND METHODS: Institutional review board approval was obtained for this HIPAA-compliant study, which was performed between October 1, 2003, and September 30, 2009, at a 793-bed quaternary care institution with 60,000 annual ED visits. Use (number of examinations per 1000 ED visits) and yield (percentage of examinations positive for acute PE) of CT pulmonary angiography were compared before and after CDS implementation in August 2007. The authors included all adult patients presenting to the ED and developed and validated a natural language processing tool to identify acute PE diagnoses. Linear trend analysis was used to assess for variation in CT pulmonary angiography use. Logistic regression was used to determine variation in yield after controlling for patient demographic and clinical characteristics. RESULTS: Of 338,230 patients presenting to the ED, 6838 (2.0%) underwent CT pulmonary angiography. Quarterly CT pulmonary angiography use increased 82.1% before CDS implementation, from 14.5 to 26.4 examinations per 1000 patients (P<.0001) between October 10, 2003, and July 31, 2007. After CDS implementation, quarterly use decreased 20.1%, from 26.4 to 21.1 examinations per 1000 patients between August 1, 2007, and September 30, 2009 (P=.0379). Overall, 686 (10.0%) of the CT pulmonary angiographic examinations performed during the 6-year period were positive for PE; subsequent to CDS implementation, yield by quarter increased 69.0%, from 5.8% to 9.8% (P=.0323). CONCLUSION: Implementation of evidence-based CDS in the ED was associated with a significant decrease in use, and increase in yield, of CT pulmonary angiography for the evaluation of acute PE.