Western Journal of Emergency Medicine: Integrating Emergency Care with Population Health

In April 2018, the Surviving Sepsis Campaign (SSC) released an updated sepsis bundle, which combines directives previously listed in the three-hour and six-hour bundles. The authors discussed the reasoning and evidence supporting these changes. However, there are data that suggest these recommendations may be contrary to the best available evidence. Our purpose here is to highlight the areas where evidence is only as strong as the methodological constructs of the research used. This article is a narrative review of the available, limited evidence on which the one-hour bundle was based.

Pertussis, commonly referred to as “whooping cough,” is a highly contagious acute respiratory infection that has exhibited cyclical outbreaks throughout the last century. Although vaccines have provided some immunity, many populations, including infants and pregnant women, remain at risk for serious illness. Through the use of the novel “Identify, Isolate, Inform” (3I) tool, emergency department (ED) providers can readily recognize key symptoms of the disease and risk factors for exposure, thus curbing its transmission through early initiation of antimicrobial therapy and post-exposure prophylaxis. The three classic stages of pertussis include an initial catarrhal stage, characterized by nonspecific upper respiratory infection symptoms, which may advance to the paroxysmal stage, revealing the distinctive “whooping cough.” This cough can persist for weeks to months leading into the convalescent stage. Household contacts of patients with suspected pertussis or other asymptomatic, high-risk populations (infants, pregnant women in their third trimester, and childcare workers) may benefit from post-exposure prophylactic therapy. The Pertussis 3I tool can also alert healthcare professionals to the proper respiratory droplet precautions during contact with a symptomatic patient, as well as isolation practices until antimicrobial treatment is in progress. ED personnel should then inform local public health departments of any suspected cases. All of these actions will ultimately aid public health in controlling the incidence of pertussis cases, thus ensuring the protection of the general public from this re-emerging respiratory illness.

As the consequences of liberal opioid prescribing have become apparent, efforts to address the role of the health care system in supporting more  balanced opioid use and the prevention and treatment of opioid use disorder have increased. Developing a unified and multidisciplinary approach can lead to an integrated care model that emphasizes primary prevention, harm reduction, and transition to life-sustaining treatment while also maintaining attentiveness to effective pain management. A model for this, which follows the nomenclature in proscribing antimicrobial use, is the development of an opioid stewardship program. Such programs allow for the integration of diverse perspectives and new mandates and uses a patient-centered approach with an iterative evaluation process. We describe a group of adoptable efforts that have been utilized successfully at our institutions and may be adapted and optimized to the needs and resources of other hospitals and health care systems.

Headache is one of the most common reasons for presentation to the emergency department (ED), seen in up to 2% of patients.1 Most are benign, but it is imperative to understand and discern the life-threatening causes of headache when they present. Headache caused by a subarachnoid hemorrhage (SAH) from a ruptured aneurysm is one of the most deadly, with a median case-fatality of 27-44%.2 Fortunately, it is also rare, comprising only 1% of all headaches presenting to the ED.3 On initial presentation, the one-year mortality of untreated SAH is up to 65%.4 With appropriate diagnosis and treatment, mortality can be reduced to 18%.5 The implications are profound: Our careful assessment leading to the detection of a SAH as the cause of headache can significantly decrease our patients’ mortality. If this were an easy task, the 12% reported rate of missed diagnosis would not exist.6 We have multiple tools and strategies to evaluate the patient with severe headache and must understand the strengths and limitations of each tool. Herein we will describe the available strategies, as well as the ED management of the patient with SAH.

Introduction: Prehospital acquisition of electrocardiograms (ECG) has been consistently associated with reduced door-to-balloon times in the treatment of ST-segment myocardial infarction (STEMI). There is little evidence establishing best hospital practices once the ECG has been received by the emergency department (ED). This study evaluates the use of a push notification system to reduce delays in cardiac catheterization lab (CCL) activation for prehospital STEMI.

Methods: In this prospective before-and-after study, we collected prehospital ECGs with computer interpretation of STEMI from May 2012 to October 2013. Push notifications were implemented June 1, 2013. During the study period, we collected timestamps of when the prehospital ECG was received (email timestamp of receiving account), CCL team activation (timestamp in paging system), and patient arrival (timestamp in ED tracking board). When prehospital ECGs were received in the ED, an audible alert was played via the Vocera WiFi communication system, notifying nursing staff that an ECG was available for physician interpretation. We compared the time from receiving the ECG to activation of the CCL before and after the audible notification was implemented. 

Results: Of the 56 cases received, we included 45 in our analysis (20 cases with pre-arrival CCL activation and 25 with post-arrival activation). For the pre-arrival group, the interval from ECG received to CCL activation prior to implementation was 9.1 minutes with a standard deviation (SD) of 5.7 minutes. After implementation, the interval was reduced to 3.33 minutes with a SD of 1.63 minutes. Delay was decreased by 5.8 minutes (p < 0.01). Post-implementation activation times were more consistent, demonstrated by a decrease in SD from 5.75 to 1.63 min (p < 0.01). For patients with CCL activation after arrival, there was no significant change in mean delay after implementation.

Conclusion: In this small, single-center observational study, we demonstrated that the use of push notifications to ED staff alerting that a prehospital STEMI ECG was received correlated with a small reduction in, and increased consistency of, ED CCL activation.

Health informatics is a vital technology that holds great promise in the healthcare setting. We describe two prominent health informatics tools relevant to emergency care, as well as the historical background and the current state of informatics. We also identify recent research findings and practice changes. The recent advances in machine learning and natural language processing (NLP) are a prominent development in health informatics overall and relevant in emergency medicine (EM). A basic comprehension of machine-learning algorithms is the key to understand the recent usage of artificial intelligence in healthcare. We are using NLP more in clinical use for documentation. NLP has started to be used in research to identify clinically important diseases and conditions. Health informatics has the potential to benefit both healthcare providers and patients. We cover two powerful tools from health informatics for EM clinicians and researchers by describing the previous successes and challenges and conclude with their implications to emergency care.

Video review for quality and education purposes has been a valued tool for decades. However, the use of this process dropped significantly after the development of the Health Insurance Portability and Accountability Act in the 1990s. Video review was recently reestablished at our institution. By working with our institutional legal counsel and risk management team, we have been able to create a video review process that complies with legal requirements. Literature on this subject has not described the process of obtaining video recordings. We aimed to review the process of obtaining high quality recordings in a secure manner. We hope that in the future, the data collected through our multidisciplinary review process will be helpful in improving quality of care for injured patients and providing coaching and feedback to learners, as well as improving our trauma education curriculum.

Introduction: Despite significant morbidity and mortality from stroke, patient delays to emergency department (ED) presentation following the onset of stroke symptoms are one of the main contraindications to treatment for acute ischemic stroke (AIS). Our objective was to identify patient and environmental factors associated with delayed presentations to the ED after onset of stroke symptoms. 

Methods: This was a pre-planned secondary analysis of data from a multicenter, retrospective observational study at three hospitals in Colorado. We included consecutive adult patients if they were admitted to the hospital from the ED, and the ED diagnosed or initiated treatment for AIS. Patients were excluded if they were transferred from another hospital. Primary outcome was delayed presentation to the ED (> 3.5 hours) following onset stroke symptoms.

Results: Among 351 patients, 63% presented to the ED more than 3.5 hours after onset of stroke symptoms. Adjusted results show that patients who presented in the evening hours (odds ratio [OR] [0.45], 95% confidence interval [CI] [0.3-0.8]), as compared to daytime, were significantly less likely to have a delayed presentation. Speaking a language other than English (Spanish [OR 3.3, 95% CI 1.2-8.9] and “other” [OR 9.1, 95% CI 1.2-71.0]), having known cerebrovascular risk factors (>2 risk factors [OR 2.4, 95% CI 1.05-5.4] and 1-2 risk factors [OR 2.3, 95% CI 1.03-5.1], compared to zero risk factors), and presenting to a rural hospital (OR 2.2, 95% CI 1.2-4.2), compared to urban, were significantly associated with delayed presentation.

Conclusion: Important patient and environmental factors are significantly associated with delayed ED presentations following the onset of stroke symptoms. Identifying how best to educate patients on stroke risk and recognition remains critically important.

Introduction: Computed tomography pulmonary angiography (CTPA) is the test of choice for diagnosis of pulmonary embolism (PE) in the emergency department (ED), but this test may be indeterminate for technical reasons such as inadequate contrast filling of the pulmonary arteries.  Many hospitals have requirements for intravenous (IV) catheter size or location for CTPAs to reduce the chances of inadequate filling, but there is a lack of clinical data to support these requirements. The objective of this study was to determine if a certain size or location of IV catheter used for contrast for CTPA is associated with an increased chance of an indeterminate CTPA.

Methods: This was a retrospective chart review of patients who underwent CTPA in the emergency department.  A CTPA was considered indeterminate if the radiology report indicated it was inadequate to exclude a pulmonary embolism.  The reason for the study being indeterminate, and the size and location of the IV catheter were abstracted. The rate of inadequate contrast filling of the pulmonary vasculature was calculated and compared for various IV catheter sizes and locations.  In particular, 20-gauge or larger IV catheters in the antecubital fossa or forearm were compared to all other sizes and locations.

Results: A total of 19.3% of the 1500 CTPA reports reviewed met our criteria as indeterminate, and 51.6% of those were due to inadequate filling.  Patients with a 20-gauge IV catheter or larger placed in the antecubital fossa or forearm had inadequate filling 9.2% of the time compared to 13.2% for patients who had smaller IVs or IVs in other locations (difference:  4.0% [95% CI -1.7% to 9.7%]).  There were also no statistically significant differences in the rates of inadequate filling when data were further stratified by IV catheter location and size.

Conclusion: We did not detect any statistically significant differences in the rate of inadequate contrast filling based on IV catheter locations or sizes.  While small differences not detected in this study may exist, it seems prudent to proceed with CTPA in patients with difficult IV access who need emergent imaging even if they have a small or distally located IV.

Introduction: In an age of increasing scrutiny of each hospital admission, emergency department (ED) observation has been identified as a low-cost alternative. Prior studies have shown admission rates for syncope in the United States to be as high as 70%. However, the safety and utility of substituting ED observation unit (EDOU) syncope management has not been well studied. The objective of this study was to evaluate the safety of EDOU for the management of patients presenting to the ED with syncope and its efficacy in reducing hospital admissions.Methods: This was a prospective before-and-after cohort study of consecutive patients presenting with syncope who were seen in an urban ED and were either admitted to the hospital, discharged, or placed in the EDOU. We first performed an observation study of syncope management and then implemented an ED observation-based management pathway. We identified critical interventions and 30-day outcomes. We compared proportions of admissions and adverse events rates with a chi- squared or Fisher’s exact test.Results: In the “before” phase, 570 patients were enrolled, with 334 (59%) admitted and 27 (5%) placed in the EDOU; 3% of patients discharged from the ED had critical interventions within 30 days and 10% returned. After the management pathway was introduced, 489 patients were enrolled; 34% (p<0.001) of pathway patients were admitted while 20% were placed in the EDOU; 3% (p=0.99) of discharged patients had critical interventions at 30 days and 3% returned (p=0.001). Conclusion: A focused syncope management pathway effectively reduces hospital admissions and adverse events following discharge and returns to the ED.

Introduction: Emergency department (ED) patients experience a variety of barriers to care that can lead to unnecessary or repeated visits. By identifying the patterns of barriers experienced by subsets of the ED patient population, future researchers might effectively design interventions to circumvent these barriers and improve care. This study sought to identify classes of individuals with regard to perceived barriers to care. Methods: Over a 10-week period, two medical students distributed surveys to eligible patients ≥18 years who presented to the ED. After consent, patients provided demographics data and rated their perceived access to care on nine specific items (scored 1-5). We used latent class analysis (LCA), a parametric clustering method, to determine patient groups. Demographic characteristics were then compared across classes.Results: We enrolled a total of 637 patients. Results of the LCA indicated that a six-class solution fit best: 1) low barriers (60%); 2) “work responsibility” barriers (13%); 3) economic-related barriers (10%); 4) “appointment difficulty” barriers (8%); 5) “illness and care responsibilities” barriers (6%); and 6) diverse barriers (2%). Patients in the low-barriers class were the oldest across classes (p<.001). Individuals in the low-barriers class were also more likely to be White (p=.015) and have private insurance (p<.001) than those in the “appointment difficulty,” “illness and care responsibilities,” and diverse barriers classes. Conclusion: LCA suggests there are six distinct classes of patients with regard to perceived access to care. These classes may be used as a potential starting point in designing targeted interventions for ED patients to improve continuity of care.

Introduction: The national burden of radial head subluxations in the United States (U.S.) population is poorly defined, and non-classical injury mechanisms have been increasingly reported in recent years. The purpose of this study is to report historical national estimates and demographic characteristics of patients presenting to U.S. emergency departments (ED) with subluxations of the radial head.

Methods: This cross-sectional, retrospective study analyzes the National Electronic Injury Surveillance System (NEISS) database (2001-2017) to identify patients ≤ 7 years of age presenting to U.S. EDs with subluxations of the radial head.

Results: Linear regression (R2 = 0.65; P < 0.01) demonstrated that the annual number of patients presenting to U.S. EDs with subluxations of the radial head increased significantly (P < 0.001) between 2001 (N=13,247; confidence interval [CI], 9,492-17,001) and 2010 (N=21,723; CI, 18,762-24,685), but did not change significantly between 2010 and 2017 (R2 < 0.01; P = 0.85). It also demonstrated that 51.0% (CI, 45.3%-56.6%) of injuries were either self-induced or spontaneous, whereas 36.8% (CI, 31.6%-42.0%) and 9.4% (CI, 8.0%-10.7%) were associated with parents/guardians or siblings, respectively. The majority of injuries occurred in patients who were the age of one (33.5%; CI, 32.1%-35.0%) and two (35.1%; CI, 33.7%-36.6%); females (57.8%; CI, 56.8%-58.9%) were more commonly injured than males.

Conclusion: Although the national burden of radial head subluxations may be less than previously reported, it still results in over 20,000 ED visits annually in the U.S. Given that over half of such injuries are actually self-induced or spontaneous, caretakers should be taught to recognize the clinical presentation of radial head subluxation, since the classically described history of a patient being lifted or pulled by the arm may simply have never occurred.

Introduction: Our aim was to examine potential risk factors and modifiable behaviors that could lead to pediatric poisonings. Our secondary objectives were to explore socioeconomic factors associated with caregiver (parent/guardian) safe medication storage and knowledge of poison control contact information. 

Methods: We conducted a prospective, cross-sectional survey of caregivers of patients 2-10 years old presenting to an inner city pediatric emergency department. Caregiver and patient demographic data, prescription and nonprescription medication type, storage and when and where taken, were recorded. We used multivariable regression to explore factors associated with secure prescription medication storage and knowledge of poison control center contact information.

Results: Of 1457 caregivers, 29% took daily prescription and 17% took daily non-prescription medications. Only 25% of caregivers stored their prescription medications in a secure place, and <3% stored medications in a locked drawer or safe. Of demographic and socioeconomic factors, only income ≥$80,000 was associated with storage of prescription medication in a secure place (odds ratio [OR], 2.47; 95% confidence interval [CI], 1.27-4.81). When asked how they would access poison control in case of an ingestion, the majority, 86%, had an appropriate plan. In multivariable regression, the only factor associated with knowledge of poison control center contact information was college education in the caregiver (OR 1.6; 95% CI, 1.10-2.32). 

Conclusion: A minority of caregivers store medications in a safe place and even fewer keep prescription medications under lock and key. The majority, however, were aware of how to contact a poison control center in case of ingestion.

Physician well-being is a complex and multifactorial issue. A large number of tools have been developed in an attempt to measure the nature, severity, and impact of both burnout and well-being in a range of clinical populations. This two-article series provides a review of relevant tools and offers guidance to clinical mentors and researchers in choosing the appropriate instrument to suit their needs, whether assessing mentees or testing interventions in the research setting. Part One begins with a discussion of burnout and focuses on assessment tools to measure burnout and other negative states. Part Two of the series examines the assessment of well-being, coping skills, and other positive states.

Part One of this two-article series reviews assessment tools to measure burnout and other negative states. Physician well-being goes beyond merely the absence of burnout. Transient episodes of burnout are to be expected. Measuring burnout alone is shortsighted. Well-being includes being challenged, thriving, and achieving success in various aspects of personal and professional life. In this second part of the series, we identify and describe assessment tools related to wellness, quality of life, resilience, coping skills, and other positive states.

Introduction: Traumatic intracranial hemorrhage (TIH), brain injury with radiographic hemorrhage, is a common emergency department (ED) presentation, and encompasses a wide range of clinical syndromes. Patients with moderate and severe neurotrauma (Glasgow Coma Scale [GCS] < 13) with intracranial hemorrhage require care at a trauma center with neurosurgical capabilities. However, many patients with mild traumatic intracranial hemorrhage (mTIH), defined as radiographic bleeding and GCS ≥ 13, do not require operative intervention or intensive care unit monitoring, but are still routinely transferred to tertiary care centers. We hypothesized that a significant proportion of patients are managed non-operatively and are discharged within 24 hours of admission.

Methods: This was a retrospective, observational study of consecutive patients age ≥ 16 years, GCS ≥ 13 who were transferred to an urban, medical school-affiliated, 100,000 annual visit ED over a seven-year period with blunt isolated mTIH. The primary outcome was discharge within 24 hours of admission. We measured rates of neurosurgical intervention, computed tomography hemorrhage progression, and neurologic deterioration as well as other demographic and clinical variables.

Results: There were 1079 transferred patients with isolated mTIH. Of these, 92.4% were treated non-operatively and 35.8% were discharged within 24 hours of presentation to the tertiary ED. Patient characteristics associated with rapid discharge after transfer include a GCS of 15 (odds ratio [OR] 2.9, 95% confidence interval [CI], 1.9 – 4.4), subdural hematoma ≤ 6mm (OR 3.1, 95% CI, 2.2 – 4.5) or the presence of an isolated subarachnoid hemorrhage (OR 1.7, 95% CI, 1.3 – 2.4). Of patients with length of stay < 24 hours, 79.8% were discharged directly from the ED or ED observation unit. 

Conclusion: Patients transferred to tertiary care centers are frequently discharged after brief observation without intervention. Risk can be predicted by clinical and radiographic data. Further prospective research is required to determine a safe cohort of patients who could be managed at community sites.

Oncologic emergencies may be seen in any emergency department and will become more frequent as our population ages and more patients receive chemotherapy. Life-saving interventions are available for certain oncologic emergencies if the diagnosis is made in a timely fashion. In this article we will cover neutropenic fever, tumor lysis syndrome, hypercalcemia of malignancy, and hyperviscosity syndrome. After reading this article the reader should be much more confident in the diagnosis, evaluation, and management of these oncologic emergencies.

Emergency physicians (EP) frequently resuscitate and manage critically ill patients. Resuscitation of the crashing obese patient presents a unique challenge for even the most skilled physician. Changes in anatomy, metabolic demand, cardiopulmonary reserve, ventilation, circulation, and pharmacokinetics require special consideration. This article focuses on critical components in the resuscitation of the crashing obese patient in the emergency department, namely intubation, mechanical ventilation, circulatory resuscitation, and pharmacotherapy. To minimize morbidity and mortality, it is imperative that the EP be familiar with the pearls and pitfalls discussed within this article.

Septic arthritis is a dangerous medical condition associated with significant morbidity and mortality. However, the differential diagnosis can be broad with conditions that mimic this disease and require different evaluation and treatment. This narrative review presents the emergency medicine evaluation and management, as well as important medical conditions that may mimic this disease. Septic arthritis commonly presents with monoarticular joint pain with erythema, warmth, swelling, and pain on palpation and movement. Fever is present in many patients, though most are low grade. Blood testing and imaging may assist with the diagnosis, but the gold standard is joint aspiration. Management includes intravenous antibiotics and orthopedic surgery consult for operative management vs. serial aspirations. Clinicians should consider mimics, such as abscess, avascular necrosis, cellulitis, crystal-induced arthropathies, Lyme disease, malignancy, osteomyelitis, reactive arthritis, rheumatoid arthritis, and transient synovitis. While monoarticular arthritis can be due to septic arthritis, other medical and surgical conditions present similarly and require different management. It is essential for the emergency clinician to be aware how to diagnose and treat these mimics.

Introduction: Early recognition and pre-notification by emergency medical services (EMS) improves the timeliness of emergency department (ED) stroke care; however, little is known regarding the effects on care should EMS providers fail to pre-notify. We sought to determine if potential stroke patients transported by EMS, but for whom EMS did not provide pre-notification, suffer delays in ED door-to-stroke-team activation (DTA) as compared to the other available cohort of patients for whom the ED is not pre-notified–those arriving by private vehicle.Methods: We queried our prospective stroke registry to identify consecutive stroke team activation patients over 12 months and retrospectively reviewed the electronic health record for each patient to validate registry data and abstract other clinical and operational data. We compared patients arriving by private vehicle to those arriving by EMS without pre-notification, and we employed a multivariable, penalized regression model to assess the probability of meeting the national DTA goal of ≤15 minutes, controlling for a variety of clinical factors.Results: Our inclusion criteria were met by 200 patients. Overall performance of the regression model was excellent (area under the curve 0.929). Arrival via EMS without pre-notification, compared to arrival by private vehicle, was associated with an adjusted risk ratio of 0.55 (95% confidence interval, 0.27-0.96) for achieving DTA ≤ 15 minutes. Conclusion: Our single-center data demonstrate that potential stroke patients arriving via EMS without pre-notification are less likely to meet the national DTA goal than patients arriving via other means. These data suggest a negative, unintended consequence of otherwise highly successful EMS efforts to improve stroke care, the root of which may be ED staff over-reliance on EMS for stroke recognition.

Introduction: Recruiting and retaining residents who will complete their emergency medicine (EM) training is vital, not only because residency positions are a limited and costly resource, but also to prevent the significant disruptions, increased workload, and low morale that may arise when a resident prematurely leaves a program. We investigated national rates of EM resident attrition and examined the reasons and factors associated with their attrition. 

Methods: In this retrospective, observational study we used national data from the American Medical Association National Graduate Medical Education Census for all residents who entered Accreditation Council for Graduate Medical Education-accredited EM programs between academic years 2006-2007 and 2015-2016. Our main outcome was the annual national rate of EM resident attrition. Secondary outcomes included the main reason for attrition as well as resident factors associated with attrition. 

Results: Compared to the other 10 largest specialties, EM had the lowest rate of attrition (0.8%, 95% confidence interval [CI] [0.7-0.9]), or approximately 51.6 (95% CI [44.7-58.5]) residents per year. In the attrition population, 44.2% of the residents were women, a significantly higher proportion when compared to the proportion of female EM residents overall (38.8%, p=0.011). A greater proportion of Hispanic/Latino (1.8%) residents also left their programs when compared to their White (0.9%) counterparts (p<0.001). In examining reasons for attrition as reported by the program director, female residents were significantly more likely than male residents to leave due to “health/family reasons” (21.5% vs 9.6%, p=0.019). 

Conclusion: While the overall rate of attrition among EM residents is low, women and some under-represented minorities in medicine had a higher than expected rate of attrition. Future studies that qualitatively investigate the factors contributing to greater attrition among female and some ethnic minority residents are necessary to inform efforts promoting inclusion and diversity within the specialty.

Introduction: The use of competency-based milestones for emergency medicine (EM) was mandated by the Accreditation Council for Graduate Medical Education in 2013. However, clinical competency committees (CCC) may lack diverse, objective data to assess these new competencies. To remedy the lack of objective data when assessing the pharmacotherapy sub-competency (PC5) we introduced a unique approach that actively involves departmental clinical pharmacists in determining the milestone level achieved by the resident.

Methods: Our pharmacists assess the pharmacotherapy knowledge of the residents through multiple methods: direct observation of orders, communication with the residents while performing patient care within the emergency department (ED), and real-time chart review. This observation occurs informally on a daily basis in the ED and is incorporated into the routine work of the pharmacist. The pharmacists use the PC5 sub-competency as their standard evaluation tool in this setting to keep all assessments consistent.

Results: Since our residency program introduced pharmacist assessment of resident pharmacotherapy knowledge, the CCC has conducted seven biannual meetings. Of the 120 separate PC5 sub-competency assessments made during those meetings  there was 100% agreement between the pharmacist’s assessment and the CCC’s final assessment of the trainee. A survey of the CCC members concluded that the pharmacists’ assessments were useful and aided in accurate resident evaluation.

Conclusion: The use of ED pharmacists in assessing the pharmacotherapy sub-competency provides important information used in resident assessment of the PC5 milestone.

Over the last several years, there has been increasing interest in transitioning a portion of residency education from traditional, lecture-based format to more learner-centered asynchronous opportunities. These asynchronous learning activities were renamed in 2012 by the Accreditation Council for Graduate Medical Education (ACGME) as individualized interactive instruction (III). The effectiveness and applicability of III in residency education has been proven by multiple studies, and its routine use has been made officially acceptable as per the ACGME. This article provides a review of the current literature on the implementation and utilization of III in emergency medicine residency education. It provides examples of currently implemented and studied III curricula, identifies those III learning modalities that can be considered best practice, and provides suggestions for program directors to consider when choosing how to incorporate III into their residency teaching.

Introduction: In the context of the upcoming single accreditation system for graduate medical education resulting from an agreement between the Accreditation Council for Graduate Medical Education (ACGME), American Osteopathic Association and American Association of Colleges of Osteopathic Medicine, we saw the opportunity for charting a new course for emergency medicine (EM) scholarly activity (SA). Our goal was to engage relevant stakeholders to produce a consensus document. 

Methods: Consensus building focused on the goals, definition, and endpoints of SA. Representatives from stakeholder organizations were asked to help develop a survey regarding the SA requirement. The survey was then distributed to those with vested interests. We used the preliminary data to find areas of concordance and discordance and presented them at a consensus-building session. Outcomes were then re-ranked. 

Results: By consensus, the primary role(s) of SA should be the following: 1) instruct residents in the process of scientific inquiry; 2) expose them to the mechanics of research; 3) teach them lifelong skills, including search strategies and critical appraisal; and 4) teach them how to formulate a question, search for the answer, and evaluate its strength. To meet these goals, the activity should have the general elements of hypothesis generation, data collection and analytical thinking, and interpretation of results. We also determined consensus on the endpoints, and acceptable documentation of the outcome.

Conclusion: This consensus document may serve as a best-practices guideline for EM residency programs by delineating the goals, definitions, and endpoints for EM residents’ SA. However, each residency program must evaluate its available scholarly activity resources and individually implement requirements by balancing the ACGME Review Committee for Emergency Medicine requirements with their own circumstances.

Introduction: Despite the ever-increasing numbers of mental health patients presenting to United States emergency departments, there are large gaps in knowledge about acute care of the behavioral health patient. To address this important problem, the Coalition on Psychiatric Emergencies convened a research consensus conference in December 2016 consisting of clinical researchers, clinicians from emergency medicine, psychiatry and psychology, and representatives from governmental agencies and patient advocacy groups.

Methods: Participants used a standardized methodology to select and rank research questions in the order of importance to both researchers and patients.

Introduction: Patients with substance use disorders (SUDs) frequently seek emergency care, and the emergency department (ED) may be their only point of contact with the healthcare system. While the ED visit has been increasingly recognized as providing opportunity for interventions around substance use, many questions remain. 

Methods: In December 2016 the Coalition on Psychiatric Emergencies (CPE) convened the first Research Consensus Conference on Acute Mental Illness, which consisted of clinical researchers, clinicians from emergency medicine, emergency psychiatry, emergency psychology, representatives from governmental agencies and patient advocacy groups. Background literature review was conducted prior to the meeting, and questions were iteratively focused, revised, voted on and ranked by perceived importance using nominal group method. 

Results: The main goal of the SUD workgroup was to identify research priorities and develop a research agenda to improve the early identification of and management of emergency department (ED) patients with SUDs with the goal of improving outcomes. This article is the product of a breakout session on “Special Populations: Substance Use Disorder.” The workgroup identified with high consensus six research priorities for their importance related to the care of ED patients with SUDs in these overall domains: screening; ED interventions; the role of peer navigators; initiation of SUD management in the ED; specific patient populations that may impact the effectiveness of interventions including sociogenerational and cultural factors; and the management of the acutely intoxicated patient.

Conclusion: Emergency providers are increasingly recognizing the important role of the ED in reducing adverse outcomes associated with untreated SUDs. Additional research is required to close identified knowledge gaps and improve care of ED patients with SUD.

Introduction: Agitation, mental illness, and delirium are common reasons for older adults to seek care in the emergency department (ED). There are significant knowledge gaps in understanding how to best screen older adults for these conditions and how to manage them. In addition, in areas where research has been performed, implementation has been slow. A working group convened to develop a set of high-priority research questions that would advance the understanding of optimal management of older adults with acute behavioral changes in the ED. This manuscript is the product of a breakout session on “Special Populations: Agitation in the Elderly” from the 2016 Coalition on Psychiatric Emergencies’ first Research Consensus Conference on Acute Mental Illness.

Methods: Participants were identified with expertise in emergency medicine (EM), geriatric EM, and psychiatry. Background literature reviews were performed prior to the in-person meeting in four key areas: delirium; dementia; substance abuse or withdrawal; and mental illness in older adults. Input was solicited from all participants during the meeting, and questions were iteratively focused and revised, voted on, and ranked by importance.

Results: Fourteen questions were identified by the group with high consensus for their importance related to the care of older adults with agitation in the ED. The questions were grouped into three topic areas: screening and identification; management strategies; and the approach to delirium. 

Conclusion: It is important for emergency physicians to recognize the spectrum of underlying causes of behavioral changes, have the tools to screen older adults for those causes, and employ methods to treat the underlying causes and ameliorate their symptoms. Answers to the identified research questions have great potential to improve the care of older adults presenting with behavioral changes.

Introduction: Emergency departments (ED) manage a wide variety of critical medical presentations. Traumatic, neurologic, and cardiac crises are among the most prevalent types of emergencies treated in an ED setting. The high volume of presentations has led to collaborative partnerships in research and process development between experts in emergency medicine (EM) and other disciplines. While psychosis is a medical emergency frequently treated in the ED, there remains a paucity of evidence-based literature highlighting best practices for management of psychotic presentations in the ED. In the absence of collaborative research, development of best practice guidelines cannot begin. A working group convened to develop a set of high-priority research questions to address the knowledge gaps in the care of psychotic patients in the ED. This article is the product of a subgroup considering “Special Populations: Psychotic Spectrum Disorders,” from the 2016 Coalition on Psychiatric Emergencies first Research Consensus Conference on Acute Mental Illness.

Methods: Participants were identified with expertise in psychosis from EM, emergency psychiatry, emergency psychology, clinical research, governmental agencies, and patient advocacy groups. Background literature reviews were performed prior to the in-person meeting. A nominal group technique was employed to develop group consensus on the highest priority research gaps. Following the nominal group technique, input was solicited from all participants during the meeting, questions were iteratively focused and revised, voted on, and then ranked by importance.

Results: The group developed 28 separate questions. After clarification and voting, the group identified six high-priority research areas. These questions signify the perceived gaps in psychosis research in emergency settings. Questions were further grouped into two topic areas: screening and identification; and intervention and management strategies.

Conclusion: While psychosis has become a more common presentation in the ED, standardized screening, intervention, and outcome measurement for psychosis has not moved beyond attention to agitation management. As improved outpatient-intervention protocols are developed for treatment of psychosis, it is imperative that parallel protocols are developed for delivery in the ED setting.

Introduction: Agitation in children and adolescents in the emergency department (ED) can be dangerous and distressing for patients, family and staff. We present consensus guidelines for management of agitation among pediatric patients in the ED, including non-pharmacologic methods and the use of immediate and as-needed medications.

Methods: Using the Delphi method of consensus, a workgroup comprised of 17 experts in emergency child and adolescent psychiatry and psychopharmacology from the the American Association for Emergency Psychiatry and the American Academy of Child and Adolescent Psychiatry Emergency Child Psychiatry Committee sought to create consensus guidelines for the management of acute agitation in children and adolescents in the ED.

Results: Consensus found that there should be a multimodal approach to managing agitation in the ED, and that etiology of agitation should drive choice of treatment. We describe general and specific recommendations for medication use.

Conclusion: These guidelines describing child and adolescent psychiatry expert consensus for the management of agitation in the ED may be of use to pediatricians and emergency physicians who are without immediate access to psychiatry consultation.

Introduction: Emergency department (ED) visits for mental health and substance use disorders have been on the rise, with substance use disorders frequently coexisting with mental health disorders. This study evaluated substances commonly used/abused by patients presenting to the ED of a rural, regional medical center with subsequent admission for mental health treatment in Robeson County, North Carolina. 

Methods: This retrospective, single-center study was approved by the Southeastern Health Institutional Review Board. We reviewed medical records of psychiatric patients presenting to the ED with ultimate admission to the inpatient psychiatric unit between January 1, 2016, and June 30, 2016. Frequencies of controlled substances testing positive on urine drug and alcohol screenings in admitted patients were obtained and analyzed. We also made ethnic and gender comparisons.

Results: A total of 477 patients met inclusion criteria. The percentage of patients testing positive were as follows: tetrahydrocannabinol (THC) (40%); cocaine (28.7%); alcohol (15.1%); benzodiazepines (13%); opiates (9.6%); amphetamines (2.9%); barbiturates (2.3%); and methadone (0.8%). A relatively higher proportion of patients tested positive for THC than any other substance (p≤.0002). We found statistically significant differences for gender (p=.0004) and ethnicity (p<.0001) compositions regarding substance use/abuse.  

Conclusion: The majority of admitted psychiatric patients in this study tested positive for at least one controlled substance. The two substances that most often returned positive on the urine drug screen test in our sample were THC (marijuana) and cocaine. These findings may provide insight into concomitant substance abuse and psychiatric disorders, which could instigate public policy development of preventative health initiatives that explore the relationship between controlled substance use/abuse and mental health disorders in rural counties like Robeson County.

Introduction: Feedback provides valuable input for improving physician performance. Conventionally, feedback is obtained from attending physicians; however, residents work in close contact with other members of the care team, especially nurses. Nurses may have more opportunity to directly observe trainees. In addition, they may value different behaviors and provide unique feedback. The objective of this study was to examine the nurse’s perspective of resident performance in the emergency department.

Methods: This was a retrospective, mixed-methods study of nursing assessments of residents using a  five-point scale from 1 (unsatisfactory) to 5 (outstanding) and providing comments. Analysis included descriptive statistics of the quantitative assessments and content analysis of the nursing comments by a group of attendings, residents, and nurses. 

Results: Nurses assessed residents as above expectation or outstanding, especially for the categories of “How would you rate this resident’s attitude?” (65%) and “Is this resident a team player?” (64%). Content analysis of the comments yielded nine themes including being kind, communication with nurses, being a team player, work ethic and efficiency, and respect for other team members. Of the comments made, 50% provided positive feedback, and the majority of comments (80%) were determined to be actionable.

Conclusion: Our data indicate that nurses provide feedback on residents’ kindness, efficiency and communication. These two aspects of interacting in the healthcare setting may not be highlighted in conventional, attending provider feedback, yet they are clearly noted by the nurse’s voice.

Introduction: Agitation in pediatric acute care settings is common and disruptive. We begin with a case example of an agitated patient on a pediatric medical unit. Using data from a survey of 38 North American children’s hospitals we will outline the prevalence, screening methods, clinical guidelines, and physician training in the management of agitation. We will describe hospital practice in the comprehensive evaluation and management of pediatric agitation and aggression at one institution, followed by a summary of the literature on medications for agitation. We conclude with the National Consensus Pediatric BETA Guidelines for the management of pediatric agitation and aggression in emergent settings.

Methods: A case presentation will be followed by data from a national survey of pediatric hospitalists and consultation/liaison psychiatrists.  A clinical pathway for management of agitation will be described. Using a Medline and PsycINFO search from 01/01/1996-01/01/2017, we will summarize the literature on psychopharmacological management of agitation in pediatric patients. Using the Delphi method for consensus guideline development, a team of emergency department-based child and adolescent psychiatrists from across the United States created the Consensus Guidelines.

Results: Results of the survey of 38 North American academic children’s hospitals revealed 85.5% of the respondents encountered agitation in pediatric patients at least once a month. Most viewed agitation in pediatric patients as highly important, yet 55.1% do not screen for risk factors of agitation, 65.3% reported no clinical guidelines for agitation, and 57.1% indicated no physician training in pediatric agitation. A multidisciplinary clinical pathway for agitation in pediatric patients will be outlined. Evidence for the following medication classes will be described: antihistamines, benzodiazepines, typical antipsychotics, atypical antipsychotics, mood stabilizers, anti-depressants, and stimulants. The Consensus Guidelines outline standardized recommendations for medications.

Conclusion: Agitation in pediatrics patients is a concern continent-wide, but there is little training or standardization of care. Clinical pathways exist and can ensure identification and early management. Data about psychopharmacological management of agitation exists and updated Consensus Guidelines provide standardized guidelines for the management of agitation.

Introduction: Somatic symptom and related disorders (SSRDs) are a group of diagnoses characterized by the presentation of one or more physical symptoms that are either inconsistent with physical disease based on a thorough medical evaluation or vastly disproportionate to findings on a thorough medical evaluation, and result in significant impairment. These symptoms are often significantly influenced by psychological factors including acute or chronic distress, as well as visceral hypersensitivity and habituation of maladaptive responses to somatic sensations. These conditions are common in pediatric medicine, accounting for up to 50% of primary care visits for abdominal pain, headache, and fatigue. There is a lack of a coordinated approach to SSRD care, often resulting in excessive and unnecessary healthcare utilization, miscommunications, missed opportunities to intervene, and considerable frustration from patients, families and providers.

Methods: There is limited information in the literature for how to provide SSRD care in practice and no current consensus guidelines for SSRD care in youth. At our institution, we convened a multidisciplinary group of providers, used LEAN methodology to assess problematic areas, including areas of inefficiency or disruption in work flow, gathered data from primary care providers statewide to inform understanding, and developed an evidence-based, institutional clinical practice guideline for management of SSRD care within the emergency department (ED) and inpatient setting. In addition, we have integrated education on SSRDs into our pediatric and psychiatric trainee curriculum.

Results: We will present the consensus-building process and multidisciplinary group formation used at our institution to develop standardized tools, resources, a clinical protocol and a clinical practice guideline. This includes a review of our value stream map as part of incorporating LEAN methodology in our process. We will review current evidence in SSRD practice, including data gathered from a statewide survey on practice. We will share our clinical protocol that outlines a detailed approach to suspect and confirm diagnoses of SSRD starting in the ED setting, as well as principles and contents from an interdisciplinary, hospital-wide clinical practice guideline with several associated clinical resources for practical application of the practice guideline and protocol.

Conclusion: Our institutional and statewide data align closely with existing evidence that indicates SSRDs are common, that providers, both medical and psychiatric, have little training or education on these conditions, that these conditions often present in emergent settings, and that patients and families often seek an overly physical conceptualization to their symptoms that is devoid of mental health involvement, which often leads to unnecessary and significant healthcare utilization. Initial results from our institutional approach, resulting in consensus-based practice guidelines, protocol and resources, suggest a model that can be used in ED and inpatient settings to address the needs of this pediatric population.

Introduction: Children and adolescents evaluated in the emergency department (ED) represent a vulnerable population, especially when presenting for psychiatric symptoms. For these patients the ED environment may be stressful and lacking in needed resources. Data describing children seen within the ED are currently limited; this study aims to describe the pediatric patient population treated for mental health concerns within one ED, which may promote better-tailored treatment and support resources in the future.

Methods: The study describes 339 visits generated over two months in 2017 at LAC+USC Medical Center. We reviewed charts to determine each child’s stated age and gender, as well as whether the patient belonged to one or more vulnerable subpopulations. The factors of interest included involvement with the social services and legal systems, history of psychological trauma, diagnoses of post-traumatic stress disorder (PTSD) or autism spectrum disorder (ASD), and whether the patient required a “behavioral code” during his or her visit.

Results: The study determined that 76.1% of the charts included at least one risk factor assessed during our review. Males were more likely than females to present by the age of 11, while the opposite was true for patients age 12-17. We also determined that 38% of patients had been involved with child protective services, or a regional center (system for individuals with developmental disabilities), or the juvenile justice system, and that 5.6% were involved with multiple systems. Two hundred twenty-five patients had experienced psychological trauma, with 30 patients carrying an official diagnosis of PTSD. Of behavior codes called, 23% were for ASD patients, with these patients being far more likely to display dangerous behaviors in the ED compared with neurotypical children.

Conclusion: This study demonstrates that a majority of children evaluated in our ED for psychiatric concerns also belonged to at least one vulnerable subpopulation. Especially striking was that behavioral codes were far more likely to be called for ASD patients than neurotypical patients, implying that EDs that work with this population may benefit from extra training in preventing and managing agitated behavior in children with ASD.

Introduction: As the population of New Orleans continues to increase, psychiatric services at its main safety-net hospital, the relatively new University Medical Center New Orleans (UMCNO), have had to increase with it. At UMCNO, psychiatric patients in the emergency department (ED) are ideally managed in the behavioral health emergency room (BHER) until either admission, transfer, or discharge. The BHER holds 26 beds, but staffing limitations prevent all 26 from being open continuously. Historically, there are fewer discharges from inpatient psychiatric units citywide on weekends, which then causes overflow of the BHER into the main ED and slows throughput throughout the hospital. Because of this, elasticity in the system and effective reassessments by the emergency psychiatry consult service are key to minimizing lengths of stay and saturation events.

Methods: In April 2018, efforts were undertaken to create more elasticity in the BHER as well as more effective handoffs to easily identify what is needed for each patient to ensure a safe discharge. Changes included the following: actively anticipating the need to expand to 26 beds starting Sunday evening; creating a mindset of “continuously seeking an inpatient bed” during peak times; and using the electronic health record (EHR) for handoffs between providers. Lengths of stay (LOS) for patients in the BHER as well as hours on psychiatric saturation were tracked monthly before and after the changes were made, as were the total number of emergency psychiatry consults, discharge rates, and transfer rates.

Results: The number of consults per day has been increasing by about 13.8% a month over the last few years and is now around 16-17 a day. The service discharges about 45% of the patients consulted to us; and of those requiring admission, about 35% are transferred to other psychiatric unit, with the rest being admitted to UMCNO’s 60-bed inpatient psychiatric unit. Looking at the seven months before and after the changes were made, the average LOS has decreased from 15.98 hours to 13.78 hours (a 17% decrease), and the number of hours on saturation decreased from 42.3 hours a month to 19.2 hours (a 55% decrease).

Discussion: While our goal of zero hours on saturation was not met, the data show that by planning for the increase in volume during the weekend with more staff starting Sunday evening to open all 26 beds, we were able to lower saturation hours, which helps throughput in the main ED and throughout the hospital. Furthermore, by increasing the hours of clerks on weekends (who are responsible for transferring patients when our inpatient unit is full), we were able to transfer more patients throughout the weekend than previously. And finally, by integrating our handoff within our EHR, we were able to quickly identify those patients who could potentially be discharged safely and what was needed to ensure that safe discharge. Combined, these efforts lowered the average of LOS in the BHER.

Objective: Over 40% of the 2.4 million emergency department (ED) visits to Veterans Health Administration (VHA) hospitals are from veterans who live in rural areas, a population at increased risk of interfacility transfer. Veterans may undergo interfacility transfer to obtain emergent or urgent access to specialized health services, particularly mental health care. However, such transfers raise questions regarding appropriate use of resources, travel burdens for patients and families, and logistical challenges for ED staff and providers that may delay timely care. We sought to describe ED-based, interfacility transfer rates within the VHA and to estimate the proportion of potentially avoidable transfers (PAT) of patients with mental health conditions relative to other diseases. Methods: This observational cohort included all patients who were transferred from a VHA ED to another VHA hospital between 2012 and 2014. We extracted data from Clinical Data Warehouse administrative data. PAT was defined as discharge from the receiving ED without a procedure, or hospital length of stay at the receiving hospital ≤ 1 day without having a procedure performed. We conducted facility-level and diagnosis-level analysis to identify conditions for which an alternative to transfer, such as telehealth access to specialty care, could be developed and implemented in low-volume or rural EDs. Results: Of 6,131,734 ED visits during the three-year study period, 18,875 (0.3%) were transferred from one VHA ED to another VHA facility. Rural residents were transferred three times as often as urban residents (0.6% vs. 0.2%, p<0.001), and 23.6% of all VHA-to-VHA transfers met the PAT definition. Mental health conditions were the most common reason for interfacility transfer (34% of all interfacility transfers), followed by heart disease (12%). Of transfers that met PAT criteria, 11% were for mental health diagnoses whereas 21% were for heart disease. Geographic analysis suggested that overall PAT proportion ranged across regions from 8-53% with mental health PATs between 2-42%. Conclusion: VHA interfacility transfer is commonly performed for mental health diagnoses, and there is substantial regional variation in potentially avoidable transfers in a national sample of transfers. A significant proportion of these transfers may be potentially avoidable. Future work should focus on improving capabilities to provide specialty evaluation locally for these conditions, possibly using telehealth solutions. Additional work should also focus on measuring the timeliness of these transfers.

Introduction: In the past 20 years there has been a significant decline in the number of inpatient psychiatric beds in the United States, while the number of patients seeking psychiatric treatment in the emergency department (ED) has increased over the same time period. Given the increase in demand for psychiatric services and decrease in availability of inpatient treatment the ED is becoming the de facto place of treatment for the majority of psychiatric crises. Psychiatric patients experience longer lengths of stay (LOS) when compared to non-psychiatric patients, especially when transfer to another facility is required. Therefore, improvements in the efficiency of evaluation, treatment and disposition of psychiatric patients benefit both patients and the EDs that care for them.

Methods: To improve throughput and reduce wait times in the ED at our Level I trauma center located in the Upstate region of South Carolina, we implemented several improvements. We then tracked pre- and post-intervention metrics, including LOS and the time from ED consultation order to the completion of psychiatric consultant documentation. The intervention consisted of several protocols with various checkpoints for required documentation necessary for progression through overall mental health evaluation and treatment. In addition, structured psychiatrist and social worker evaluation-note templates were standardized to improve documentation accuracy, consistency, efficiency and overall patient safety. A separate tracking system is monitored by a dedicated psychiatric advanced practice provider to ensure compliance on note completion and order set utilization. The time from ED consult order to completion of psychiatric consultant documentation and mean LOS (in hours +/-standard deviation [SD]) were measured for six months before (10/2016 to 03/2017) and eight months after (4/2017 to 11/2017) institution of these protocols. We then compared pre- and post-intervention measures using Student’s t-test (p<0.05).

Results: The number of ED patients seen by a psychiatrist were 3,331 and 4,482 in the pre- and post-intervention time frames, respectively. Overall mean LOS significantly decreased from 38.2 (SD+57.5) to 24.9 (SD+37.6) hours after institution of these new protocols. In addition, mean LOS for patients discharged to home or to a psychiatric facility also significantly decreased from 36.9 (SD+53.7) to 21.8 (SD+30.7) and 42.8 (SD+66.5) to 31.8 (SD+49.1) hours, respectively. Time from consult order to completion of ED psychiatrist documentation significantly decreased from 11.3 (SD+9.8) to 6.2 (SD+6.9) hours.  All four comparisons were significantly different with p-values ≤ 0.01.

Conclusion: The implementation of these protocols showed a rapid, sustained improvement in overall efficiency of evaluation and disposition of psychiatric patients in our ED. The decrease in time to evaluation for patients discharged home, as well as a decreased time to transfer to inpatient level of care for those requiring hospitalization made for greater throughput and decreased demand on ED resources. Of note, this improvement in efficiency was observed despite an increase in the volume of psychiatric patients seen by the ED over the course of the study. Our institution continues to track outcomes and has implemented further changes including hiring several dedicated ED psychiatrists, with a goal of providing 24/7 availability of in-house psychiatrists embedded in the ED in an effort to further decrease LOS and improve patient care.

Given the shortage of psychiatrists and declining numbers of psychiatric hospital beds, until an alternative solution for this difficulty of access to psychiatric services is implemented the demand for psychiatric services in the ED will remain high. While more study is needed to determine the generalizability of our findings, we believe that implementation of similar interventions would likely benefit other EDs struggling with delays in psychiatric evaluation and disposition.

Introduction: A 2008 survey of emergency department staff (ED) found that 65% had witnessed physical attacks, 32% reported at least one verbal threat per day, and 18% had been assaulted at least once with a weapon. While many of the attacks were due to acute agitation, only 6% of the surveyed EDs had a protocol for medication selection and 40% provided training for staff. During acute agitation episodes – up to seven million/year in U.S. hospitals and EDs –  olanzapine (OLZ) intramuscular (IM) is favoured due to a shorter T_max over oral tablets or oral disintegrating tablets (ODT); however, IM administration requires cooperation, is invasive and can be painful. Uncooperative patients require restraint for the administration of OLZ IM that may be viewed as an assault, thereby reducing trust in medical personnel and increasing the likelihood of staff injuries. When possible, non-injectable forms are preferred during agitation; however, currently approved oral products have slower onset of effect, often requiring labour-intensive observation of the medicated patient until resolved.

INP105 is a drug-device combination product consisting of a powder form of OLZ delivered by a precision olfactory delivery (POD®) device to the vascular-rich, upper nasal space for rapid control of agitation in a cooperative or uncooperative patient (with a potentially caregiver‑administered dose). For this study a near-final formulation of OLZ was administered by the research embodiment of the POD (I231) device. For subsequent studies, INP105 will use the final commercial formulation adjustments and the commercial POD device. INP105 should provide faster onset of relief compared to oral therapy and be a more accessible dosage form compared to IM therapy without a needle. INP105 may also be suitable for early use by the patient who has insight into his or her condition and can recognize early symptoms of agitation before escalating, uncontrolled agitation leads to violence and injury to the patient, the caregiver and/or healthcare workers. The objectives of this SNAP 101 study were the following: 1) Establish safety and tolerability of three single, ascending doses of INP105; 2) compare pharmacokinetic (PK) data for OLZ)from three INP105 doses with OLZ IM (5 and 10 milligrams [mg]) and orally disintegrating tablets (OLZ-ODT) 10 mg; 3) establish and compare pharmacodynamic (PD) effects of INP105 to OLZ IM and OLZ-ODT; and 4) explore PK/PD and dose-response relationships for INP105.

Methods: SNAP 101 was a randomized, double-blind, placebo- and active comparator-controlled, ascending-dose, 2-way, 2‑period, incomplete block, crossover Phase 1 trial to compare the safety, tolerability, PK and PD of three doses of INP105 (5 mg, 10 mg and 20 mg) with two doses of OLZ IM (5 mg and 10 mg) and one dose of OLZ-ODT (10 mg).

Period 1 was open label; Period 2 was double-blind with at least 14 days between dosing in the two periods. Dose escalation was staggered across cohorts to allow a monitoring committee to assess safety and tolerability of INP105 between doses.

Following all dosings in both periods, PD assessments were made by frequent and regular vital signs recordings as well as visual analogue scale for subjective assessment of sedation, the Agitation/Calmness Evaluation Scale, an objective assessment by the investigator, and the timed Digit Symbol Substitution Test. Blood was drawn at frequent timepoints over the 120 hours post dosing for PK evaluation.

All subjects were observed as inpatients for at least 72 hours post-dosing of reference therapy and IP. Follow-up occurred four, five and 14 days after dosing for each study period. The first two subjects receiving 10 mg OLZ IM had clinically significant hypotensive events following administration, and thus the study design was immediately changed with the remaining 36 subjects (12 per cohort) being randomized to OLZ 5 mg IM or OLZ ODT 10 mg. After each block of 12 subjects completed period 1 dosing, five days of observation and nine days of washout, they returned for period 2 dosing when they received INP105 (n=9) or placebo. After a further five days of observations and nine days of washout, a safety monitoring committee (SMC) reviewed the safety data before allowing dose to be escalated to the next level, ie, SMC 1 approved proceeding from INP105 5 mg to INP105 10 mg; but at SMC 2, the decision was made to reduce the dose for cohort 3 from INP105 20 mg (four capsules) to 15 mg (three capsules) due to the frequent but not substantial drops in blood pressure noted after cohort 2, period 2 dosing.

Conclusion: This SNAP 101 study (completed in 2018 with results expected in December), which administered OLZ to the vascular-rich, upper nasal space with the novel POD® device, should guide further clinical development for a needle-free, easy self- or caregiver-administered, rapidly effective OLZ treatment to abort episodes of acute agitation in low-intensity community or ED settings. Safety signals (blood pressure drops) suggestive of appreciable pharmacodynamic effects of OLZ were noted with OLZ IM 5 mg and with cohort 2 and 3, period 2 dosings (INP105 at 10 and 15 mg doses or placebo) at the SMCs. Their formal analysis, along with other PD measures and PK data, is anticipated.

Introduction: Agitation is a cluster of behaviors observed in multiple psychiatric diseases, which can increase the likelihood of violent behavior. Atypical antipsychotics, including oral and intramuscular (IM) olanzapine (OLZ), have been approved for chronic and acute agitation treatment, respectively, for schizophrenia and bipolar I disorder in the U.S. for over 20 years. During acute agitation episodes, IM OLZ is preferred over oral treatments due to a shorter T_max. However, IM OLZ is invasive, predominantly administered in a hospital setting, and may require restraint if the patient is uncooperative, potentially reducing trust between patient and medical personnel and increasing the likelihood of injuries. When possible, non-injectable routes of administration are preferred during agitation events; however, slower-onset oral products often require labor-intensive observation of the medicated patient until adequate symptom resolution.

Impel NeuroPharma is developing INP105, a drug-device combination product consisting of a novel OLZ powder formulation for upper nasal cavity administration using precision olfactory delivery (POD®) technology. This rescue therapy is designed to provide non-invasive, rapid relief of acute agitation comparable to IM injection, without excessively sedating the patient, in a reasonably safe and tolerable manner. POD technology is designed to deliver drug to the upper nasal mucosa with minimal effort or coordination for self or caregiver administration.

Methods: OLZ formulations were designed and manufactured to optimize powder characteristics and device compatibility. Formulations were characterized by analytical methods to assess chemical and physical state as well as device compatibility. Lead formulations were evaluated in rat and non-human primate (NHP) pharmacokinetic (PK) studies, where dose was administered by species-specific POD devices, and plasma samples for PK analysis were analyzed by liquid chromatography mass spectrometry. Formulation selection for further evaluation was based on analytical and PK properties, and a single formulation was identified for inclusion in the INP105-101 proof-of-concept, clinical study.

Results: Approximately 30 formulations designed for nasal delivery by POD technology were manufactured and then assessed using analytical chemistry techniques and device-compatibility testing. Twenty of the formulations were evaluated in rat and NHP PK models. Short-term stability tests and device compatibility testing were used to further narrow down formulations for additional PK studies. The lead formulation was tested to five months of stability with >99% assay, <1% total impurities, and positive device compatibility over the storage period. All formulations tested in NHP PK studies resulted in a T_max of less than 53 minutes and a C_max greater than 26 nanograms per milliliter (ng/mL). The lead formulation, selected for clinical development in the INP105-101 study, exhibited a T_max of 17 minutes, similar to that reported for IM OLZ, and a C_max of 71 ng/mL, approximately threefold higher than the reported C_max in patients receiving 10 milligrams (mg) IM OLZ.

Conclusion: Impel NeuroPharma is developing a drug-device combination product that will administer powder OLZ to the vascular-rich, upper nasal space with a novel precision olfactory delivery (POD®) device. It is needle-free, easily administered by self or caregiver, and a potentially rapidly effective OLZ treatment to abort episodes of acute agitation in the low-intensity community clinic or emergency department setting. This series of preclinical development studies has led to the identification of a lead formulation to be tested in the INP105-101 proof-of-concept clinical study for further development.

Introduction: Kratom, an herb that was traditionally used by Southeast Asians to boost energy, is increasingly being used in the United States. According to the American Kratom Association, an estimated two to three million chronic pain sufferers resort to kratom as a “safe,” natural alternative to prescription opioids. Some of the reported beneficial effects include analgesic effects, muscle relaxation, and anti-inflammatory properties. In the drug addiction world however, kratom is being propagated as a legal alternative to getting high that is undetectable on routine drug screen. Kratom, or mitragynine, is a major psychoactive alkaloid. Several studies have found that kratom has stimulant effects in small doses but sedative effects in large doses, binding to mu and kappa receptors (Yusoff et al. 2014). Kratom causes cravings and an array of opioid-like withdrawal symptoms when users attempt to decrease usage. Withdrawal symptoms include restlessness, severe bone pain, muscle aches, tearing or runny nose, gastrointestinal (GI) symptoms, blurred vision, depression, irritability, and changes in mood. This case report documents one patient who used kratom as an alternative to heroin use. We also describe its subsequent addictive potential and the successful management of his withdrawal symptoms with an opioid detoxification protocol.

Case Presentation: Our patient was an adult Caucasian male with a past psychiatric history of depression and severe opioid use disorder identified by appropriate history- taking. The patient recounted that he had been using kratom for the prior two and a half years as a “legal alternative” to heroin, motivated by his partner. At the time of encounter, he reported “strong cravings” and withdrawal symptoms when he attempted to abstain from kratom. Urine drug screen was negative. A quick Clinical Opioid Withdrawal Scale (COWS) evaluation was noted to be 30, and inpatient detoxification was deemed appropriate. He admitted to using initially four capsules per day, which increased up to 30 capsules a day over the 30-month time period. He reported having spent a lot of money to feed his habit and noted weight loss and decreased appetite. He reported, “I felt high,” and maintained that he had abstained from illicit heroine use. The patient admitted that he had not known kratom had addictive properties and reported that the withdrawal symptoms were more protracted – as long as two months post his last use when compared to that of heroin after being “hard stopped” during a brief incarceration. We used a COWS assessment and scoring to determine management of his withdrawal symptoms at initial presentation and over a short period of time. We measured vital signs, hepatic function, and management of withdrawal symptoms daily two hours after the delivery of daily buprenorphine and naloxone (using tapering protocol) for five days. We also administered clonidine at a dose of 0.1 milligrams (mg) by mouth every six hours (PO q6h), baclofen 10 mg PO for muscle spasms, chlorproamazine/diphenhydramine 50mg as needed (PRN) for agitation, and ibuprofen 600mg PO q6h PRN for generalized joint pain. We monitored his symptomology by patient evaluation, daily vital signs, and a physician-guided questionnaire.

Results: Electrolytes, renal function and liver studies were found to be within normal limits; however, his heart rate was elevated at 100 beats per minute on day of admission. Blood pressure was 122/75 millimeters of mercury and temperature was 97.5° Fahrenheit with a body mass index of 21.5. Urine toxicology was negative for all drugs of abuse including methadone and opiates. The patient’s pupils were constricted and there was profuse diaphoresis visible over his forehead. He also reported joint pain throughout his body, and he was unable to sit still. His eyes were tearing, he had uncontrollable yawning, and complained of “skin crawl.” The patient denied having any GI symptoms such as diarrhea or nausea, and he also denied having tremors. No tremors were observed, although muscle twitching of his forearm and biceps was noted. His COWS score was noted to be 30 on day one, and considered moderately severe. HIS COWS score reduced to five by day four. Of note, the COWs scale increased to 10 by day seven on 0mg of buprenorphine and naloxone.

Conclusion: Kratom possesses properties that can be successfully used as an alternative to heroin use. Nonetheless, there is a potential for abuse, which results in severe opioid- like withdrawal symptoms when the user attempts abstinence. Patients require increasing amounts of kratom as they develop tolerance. Kratom withdrawal symptoms can be successfully managed with opioid detox protocol or buprenorphine/naloxone protocol over a period of five days, although symptoms noticeably last longer. Pharmaceutical companies should explore safe, physician-guided administration of kratom to reduce heroin use and add to our repertoire of methadone or buprenorphine in managing opioid use disorders.

Introduction: Emotionalism post stroke, when inadequately addressed, can cause distress to patients including embarrassment, confusion, possible caregiver complaints, and an overall decrease in health-related quality of life (Badhan, et al, 2014). Also known as pathological laughing and crying (PLC), emotionalism post stroke refers to the involuntary and neurologic pseudo-bulbar affect (PBA). It often leads to uncontrolled and exaggerated expressions of inappropriate, emotionally charged outbursts such as laughing and/or crying (Parvizi, et al, 2001).  This “emotional lability” is usually seen in patients with neurological disorders, in particular stroke, and was first described in the literature in 1872. While the exact mechanism can be debated, studies suggest a lesion in the upper brainstem leading to involuntary triggering of the facio-respiratory patterns associated with laughter and crying that involve the motor cortices (Parvizi, et al. 2001) or the cerebellum (Sak, Wilson, 1924). However, with recent studies reporting the prevalence of depression as high as 29% post stroke (Ayerbe, et al, 2013), identifying differences between post-stroke depression and PBA in the emergency setting is crucial for appropriate treatment and disposition. A critical component of patient history with regard to PLC is the lack of inciting stimulus in reports of numerous episodes of pathological crying. This study aims to outline a systematic approach to evaluate and manage patients with PLC in the emergency department (ED).

Case Presentation: The patient was a 74-year-old Caucasian male with no formal PPH and PMH of T2D, HLD, HTN, who was brought by his wife to the ED with complaints of excessive crying and a reported verbalization of suicidal ideation. Upon interview, patient stated that he had been having "crying spells" in excess of emotional stimulus for the prior three months, increasing in severity. He denied neuro-vegetative symptoms of depression. Patient also denied recent stressors. He admitted to a transient ischemic attack five months prior to his presentation. He stated there were no neurological deficits at the time of encounter except for a noted decreased sense of taste. The patient admitted to having suicidal ideations (SI) but without intent, plan, or means. He determined that he had intermittent SI in the context of observing, "Doesn't everyone think about that sometimes?" He did not report details of his SI as he determined they were passive and vague thoughts of what it would be like to be dead. He denied past or recent suicide attempts or self-injurious behavior. The patient reported he had met with his primary care physician who advised him to go to the ED for further evaluation. The patient and his wife, also in her 70s, reported they thought the ED could prescribe medications and were not seeking hospitalization.  His wife stated that the patient had been “crying at the drop of a hat.” She noted that this was not usual for him and denied any recent stressors, or past episodes. She further stated, “I was at my wit’s end and I feel like something is wrong with him.” Patient stated the breaking point was his inability to attend an important engagement due to a dis-inhibited “crying spell” that lasted > 10 minutes. He and his wife reported frustration. The patient also reported, “I can’t take it. Please help me.” Patient affect was depressed, with intermittent “episodes of crying.” We placed him on hold and re-evaluate status.

Method: Patient consent for this study was obtained. A literature search was performed in PubMed and JAMA Psychiatry for articles published on pathological laughing and crying since 1900, using multiple combinations of the search terms, which included the following: post stroke crying syndrome, emotionalism post stroke, involuntary emotional expression, and post stroke neurological disorders. The development of evidence approach and drafting of systemic approach.

Results: On observation, the patient had depressed affect and intermittent episodes of crying without provocation. He repeatedly denied being depressed and denied neuro-vegetative symptoms of depression despite his affect. Psychological review of systems was negative. Vital signs, complete blood count, and electrolytes were within normal limits. Collateral information was obtained and old chart review revealed mild to moderate small-vessel ischemic changes, including a semi-ovale infarct five months prior to presentation. His wife stated she wanted help for his presumed depression. Clinical pathway for the evaluation of emotionalism post stroke in the crisis unit includes performing the following: patient intake and triaging à medical clearance and laboratory work à patient history, and collateral information à If patient psychiatrically stable by negative psychological review of systems, consider past medical history for risk factors significant for stroke à consider ancillary tests to rule out differential diagnoses à Patient education and reassurance à Discharge with follow up as a key to diagnosis. Criteria for discharge can include lack of PPH, patient denial of neuro-vegetative depressive symptoms, access to immediate follow-up, social support, lack of social concerns, collateral comfortable with discharge plan and understanding of next steps regarding treatment and follow-up. Citalopram prescribed to patient resulted in decrease in incidence of crying spells. Studies show Citalopram, paroxetine, and sertraline provide >90% efficacy and reduction in depressive affect and pathological crying in patients (Schiffer et al, 2005).

Conclusion: Post-stroke, neuro-psychiatric pathological crying syndrome is a disorder that results from lesions affecting the pseudo-bulbar aspects of the brain and can go unrecognized. Due diligence on the part of the physician can allow for appropriate disposition, and time and cost-effective steps for proper management of the patient presenting with PLC in the ED. Definitive treatment includes outpatient management with a selective serotonin re-uptake inhibition, in particular Citalopram, paroxetine, and sertraline.

Acknowledgment: I would like to thank Dilys Ngu, MD, for her help in review of this report.