A randomized, embedded, pragmatic, Bayesian clinical trial examining clinical decision support for high flow nasal cannula management in children with bronchiolitis: design and statistical analysis plan.

BACKGROUND: High flow nasal cannula (HFNC) has been increasingly adopted in the past 2 decades as a mode of respiratory support for children hospitalized with bronchiolitis. The growing use of HFNC despite a paucity of high-quality data regarding the therapy's efficacy has led to concerns about overutilization. We developed an electronic health record (EHR) embedded, quality improvement (QI) oriented clinical trial to determine whether standardized management of HFNC weaning guided by clinical decision support (CDS) results in a reduction in the duration of HFNC compared to usual care for children with bronchiolitis. METHODS: The design and summary of the statistical analysis plan for the REspiratory SupporT for Efficient and cost-Effective Care (REST EEC; "rest easy") trial are presented. The investigators hypothesize that CDS-coupled, standardized HFNC weaning will reduce the duration of HFNC, the trial's primary endpoint, for children with bronchiolitis compared to usual care. Data supporting trial design and eventual analyses are collected from the EHR and other real world data sources using existing informatics infrastructure and QI data sources. The trial workflow, including randomization and deployment of the intervention, is embedded within the EHR of a large children's hospital using existing vendor features. Trial simulations indicate that by assuming a true hazard ratio effect size of 1.27, equivalent to a 6-h reduction in the median duration of HFNC, and enrolling a maximum of 350 children, there will be a > 0.75 probability of declaring superiority (interim analysis posterior probability of intervention effect > 0.99 or final analysis posterior probability of intervention effect > 0.9) and a > 0.85 probability of declaring superiority or the CDS intervention showing promise (final analysis posterior probability of intervention effect > 0.8). Iterative plan-do-study-act cycles are used to monitor the trial and provide targeted education to the workforce. DISCUSSION: Through incorporation of the trial into usual care workflows, relying on QI tools and resources to support trial conduct, and relying on Bayesian inference to determine whether the intervention is superior to usual care, REST EEC is a learning health system intervention that blends health system operations with active evidence generation to optimize the use of HFNC and associated patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05909566. Registered on June 18, 2023.

Primary Care Enhanced Access Services and the Association With Nonurgent Pediatric Emergency Department Utilization and Child Opportunity Index.

OBJECTIVES: This study aims to examine the association between primary care practice characteristics (enhanced access services) and practice-level rates of nonurgent emergency department (ED) visits using ED and practice-level data. Survey data suggest that enhanced access services within a child's primary care practice may be associated with reduced nonurgent ED visits. METHODS: We performed a cross-sectional analysis of nonurgent ED visits to a tertiary pediatric hospital in Western Pennsylvania with nearly 85,000 annual ED visits. We obtained patient encounter data of all nonurgent pediatric ED (PED) visits between January 2018 and December 2019. We identified the primary care provider at the time of the study period. For each of the 42 included offices, we determined the number of unique children in the office with a nonurgent PED visit, allowing us to determine the percentage of children in the practice with such a visit during the study period. We then stratified the 42 offices into low, intermediate, and high tertiles of nonurgent PED use. Using Kruskal-Wallis tests, logistic regression, and Pearson χ2 tests, we compared practice characteristics, enhanced access services, practice location Child Opportunity Index 2.0, and PED visit diagnoses across tertiles. RESULTS: We examined 52,459 nonurgent PED encounters by 33,209 unique patients across 42 outpatient offices. Primary care practices in the lowest ED visit tertile were more likely to have 4 or more evenings with office hours (36% vs 14%, P = 0.04), 4 or more evenings of weekday extended hours (43% vs 14%, P = 0.05), and at least 1 day of any weekend hours (86% vs 29%, P = 0.01), compared with practices in other tertiles. High PED use tertile offices were also associated with lower Child Opportunity Index scores. CONCLUSIONS: Primary care offices with higher nonurgent PED utilization had fewer enhanced access services and were located in neighborhood with fewer child-focused resources.

Odds of COVID-19-associated asthma exacerbations in children higher during Omicron wave.

BACKGROUND: We aimed to determine the association of COVID-19 variant wave with asthma exacerbations in children with asthma. METHODS: We conducted a retrospective cross-sectional study of children in the Western Pennsylvania COVID-19 Registry (WPACR). We extracted data for all children in the WPACR with asthma and compared their acute clinical presentation and outcomes during the Pre-Delta (7/1/20-6/30/21), Delta (8/1/21-12/14/21), and Omicron (12/15/21-8/30/22) waves. We conducted multivariable logistic regression analyses of SARS-CoV-2-associated asthma exacerbations, adjusting for characteristics that have been associated with COVID-19 outcomes in prior studies. RESULTS: Among 573 children with asthma in the WPACR during the study period, the proportion of children with COVID-19 who had an asthma exacerbation was higher during the Omicron wave than during the prior two variant waves (40.2% vs. 22.6% vs. 26.2%, p = 0.002; unadjusted OR = 2.12 [95% confidence interval (CI) = 1.39-3.22], p < 0.001). In our multivariable regression models, the odds of an asthma exacerbation were 2.8 times higher during the Omicron wave than during prior waves (adjusted OR = 2.80 [95% CI = 1.70-4.61]). Results were similar after additionally adjusting for asthma severity but were no longer significant after additionally adjusting for poor asthma control. CONCLUSION: The proportion of children with asthma experiencing an asthma exacerbation during SARS-CoV-2 infection was higher during Omicron than prior variant waves, adding to the body of evidence that COVID-19-associated respiratory symptoms vary by variant. These findings provide additional support for vaccination and prevention.

The Impact of SARS-CoV-2 Infection on Symptom Control and Lung Function in Children with Asthma.

Rationale: Little is known about the long-term impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on children with asthma. Objectives: To determine whether SARS-CoV-2 infection affects symptom control and lung function in children with asthma. Methods: Using data from clinical registries and the electronic health record, we conducted a prospective case-control study of children with asthma aged 6-21 years who had (cases) or did not have (control subjects) SARS-CoV-2 infection, comparing baseline and follow-up asthma symptom control and spirometry within an ∼18-month time frame and, for cases, within 18 months of acute coronavirus disease (COVID-19). Results: A total of 171 cases had baseline and follow-up asthma symptom data, and 114 cases had baseline and follow-up spirometry measurements. There were no significant differences in asthma symptom control (P = 0.50), forced expiratory volume in 1 second (P = 0.47), forced vital capacity (P = 0.43), forced expiratory volume in 1 second/forced vital capacity (P = 0.43), or forced expiratory flow, midexpiratory phase (P = 0.62), after SARS-CoV-2 infection. Compared with control subjects (113 with symptom data and 237 with spirometry data), there were no significant differences in follow-up asthma symptom control or lung function. A similar proportion of cases and control subjects had poorer asthma symptom control (17.5% vs. 9.7%; P = 0.07) or worse lung function (29.0% vs. 32.5%; P = 0.50) at follow-up. Patients whose asthma control worsened after COVID-19 had a shorter time to follow-up (3.5 [1.5-7.5] vs. 6.1 [3.1-9.8] mo; P = 0.007) and were more likely to have presented with an asthma exacerbation during COVID-19 (46% vs. 26%; P = 0.04) than those without worse control. Conclusions: We found no significant differences in asthma symptom control or lung function in youth with asthma up to 18 months after acute COVID-19, suggesting that COVID-19 does not affect long-term asthma severity or control in the pediatric population.

Reduction in Antibiotic Delivery Time Following Improving Pediatric Sepsis Outcomes Quality Improvement Initiative at a Major Children's Hospital.

OBJECTIVE: Sepsis causes morbidity and mortality in pediatric patients, but timely antibiotic administration can improve sepsis outcomes. The pharmacy department can affect the time from order to delivery of antibiotics. By evaluating the pharmacy process, this study aimed to decrease the time from antibiotic order to delivery to within 45 minutes. METHODS: All antibiotic orders placed following a positive sepsis screen for acute care patients at a freestanding children's hospital from April 1, 2019, to December 31, 2019, were reviewed. Lean Six Sigma methodology including process mapping was used to identify and implement improvements, including educational interventions for providers. Outcome measures included time from antibiotic order placement to delivery and to administration. Additional assessment of process measures included evaluation of order priority, PowerPlan (an internally created order set) use, and delivery method. RESULTS: Ninety-eight antibiotic orders for 85 patients were evaluated. In an individual chart of antibiotic delivery time, a trend towards faster delivery time was observed after interventions. Stat orders (40.5 minutes [IQR, 19.5-48]) were delivered more quickly than routine orders (51 minutes [IQR, 45-65]; p < 0.001). Orders using the PowerPlan (20.5 minutes [IQR, 18.5-38]) were delivered more quickly than those that did not (47 minutes [IQR, 34-64]; p < 0.01). Shorter time to administration was observed with pneumatic tube delivery (41 minutes [IQR, 20-50]) than with direct delivery to a health care provider (51 minutes [IQR, 31-83]; p < 0.05) or to the automated dispensing cabinet's refrigerator (47 minutes [IQR, 41-62]; p < 0.0001). CONCLUSIONS: Multifactorial coordinated interventions within the pharmacy department improve medication delivery time for pediatric sepsis antibiotic orders.

Replacing Computed Tomography with "Rapid" Magnetic Resonance Imaging for Ventricular Shunt Imaging.

INTRODUCTION: Children with ventricular shunts undergo frequent neuroimaging, and therefore, radiation exposures, to evaluate shunt malfunctions. The objective of this study was to safely reduce radiation exposure in this population by reducing computed tomography (CT) and increasing "rapid" magnetic resonance imaging (rMRI-shunt) among patients warranting neuroimaging for possible shunt malfunction. METHODS: This was a single-center quality improvement study in a tertiary care pediatric emergency department (ED). We implemented a multidisciplinary guideline for ED shunt evaluation, which promoted the use of rMRI-shunt over CT. We included patients younger than 18 years undergoing an ED shunt evaluation during 11 months of the preintervention and 25 months of the intervention study periods. The primary outcome was the CT rate, and we evaluated the relevant process and balancing measures. RESULTS: There were 266 encounters preintervention and 488 during the intervention periods with similar neuroimaging rates (80.7% versus 81.5%, P = 0.8.) CT decreased from 90.1% to 34.8% (difference -55.3%, 95% confidence interval [CI]: -71.1, -25.8), and rMRI-shunt increased from 9.9% to 65.2% (difference 55.3%, 95% CI: 25.8, 71.1) during the preintervention and intervention periods, respectively. There were increases in the mean time to neuroimaging (53.1 min; [95% CI: 41.6, 64.6]) and ED length of stay (LOS) (52.3 min; [95% CI: 36.8, 67.6]), without changes in total neuroimaging, 72-hour revisits, or follow-up neuroimaging. CONCLUSIONS: Multidisciplinary implementation of a standardized guideline reduced CT and increased rMRI-shunt use in a pediatric ED setting. Clinicians should balance the reduction in radiation exposure with ED rMRI-shunt for patients with ventricular shunts against the increased time of obtaining imaging and LOS.

Making Residents Part of the Safety Culture: Improving Error Reporting and Reducing Harms.

OBJECTIVES: Reporting medical errors is a focus of the patient safety movement. As frontline physicians, residents are optimally positioned to recognize errors and flaws in systems of care. Previous work highlights the difficulty of engaging residents in identification and/or reduction of medical errors and in integrating these trainees into their institutions' cultures of safety. METHODS: The authors describe the implementation of a longitudinal, discipline-based, multifaceted curriculum to enhance the reporting of errors by pediatric residents at Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center. The key elements of this curriculum included providing the necessary education to identify medical errors with an emphasis on systems-based causes, modeling of error reporting by faculty, and integrating error reporting and discussion into the residents' daily activities. The authors tracked monthly error reporting rates by residents and other health care professionals, in addition to serious harm event rates at the institution. RESULTS: The interventions resulted in significant increases in error reports filed by residents, from 3.6 to 37.8 per month over 4 years (P < 0.0001). This increase in resident error reporting correlated with a decline in serious harm events, from 15.0 to 8.1 per month over 4 years (P = 0.01). CONCLUSIONS: Integrating patient safety into the everyday resident responsibilities encourages frequent reporting and discussion of medical errors and leads to improvements in patient care. Multiple simultaneous interventions are essential to making residents part of the safety culture of their training hospitals.

An Evidence-Based Care Protocol Improves Outcomes and Decreases Cost in Pediatric Appendicitis.

BACKGROUND: Appendicitis is a common indication for urgent abdominal surgery in the pediatric population. The postoperative management varies significantly in time to discharge and cost of care. The objective of this study was to investigate whether implementation of an evidence-based protocol after an appendectomy would lead to decreased length of stay and cost of care. METHODS: In 2014 at the Children's Hospital of Pittsburgh, an initiative to develop an evidenced-based protocol to treat appendicitis was undertaken. A work group was formed of pediatric surgeons and other important personnel to determine best practices. Treatment pathways were created. Pathways differed with recommendation on postoperative antibiotic choice and duration, diet initiation, and discharge criteria. Data were prospectively gathered from all patients (ages 0-18 y) with acute appendicitis from January 2015 to December 2016. Primary outcomes were length of stay and cost of care. Secondary outcomes were surgical site infection, readmission rate, and duration of postoperative antibiotics. RESULTS: Among the 1289 patients, 481 patients were in the preprotocol cohort and 808 patients were in the postprotocol cohort. 27% of patients had an intraoperative diagnosis of complicated appendicitis. There was a significantly shorter length of stay in the postprotocol cohort (P < 0.001). Median costs for the whole cohort decreased 0.6% and 24.6% for patients with complicated appendicitis after protocol initiation (P < 0.01). CONCLUSIONS: This study has demonstrated that introduction of an evidence-based clinical care protocol for pediatric patients with appendicitis leads to shorter hospital stay and decreased hospital costs.

ERAS protocol for pediatric laparoscopic cholecystectomy promotes safe and early discharge.

PURPOSE: Elective laparoscopic cholecystectomy (LC) pediatric patients in our institution have historically been admitted for an overnight hospital stay (OHS). The purpose of this study was to implement an ERAS protocol for elective LC in pediatric patients to promote same-day discharge (SDD) while maintaining excellent outcomes. METHODS: An ERAS protocol for elective LC was implemented encompassing pre-, peri-, and postoperative management. A retrospective review of prospectively collected data from patients before (BI) and after implementation (AI) of the protocol was performed. RESULTS: A total of 250 patients (BI 105, AI 145) were included in the study. The AI group had significantly higher rate of SDD compared to BI (77.2% vs. 1.9%, p < <0.01) and significantly decreased opioid use (morphine equivalents mg/kg AI 0.36 vs. BI 0.46, p < <0.001). There were also no significant differences in the rate of total 30-day emergency department visits (BI 11.4% vs. AI 9.7%, p = 0.52) or surgery-related 30-day emergency department visits (BI 7.6% vs. AI 8.3%, p = 0.53). Factors that predisposed patients to an OHS after LC included higher ASA, later surgery start times, and longer operative times. CONCLUSIONS: The ERAS protocol significantly increased the rate of SDD after elective LC in pediatric patients without an associated increase in emergency department visits or readmissions. LEVEL OF EVIDENCE: III.

Clinical Pathways: Driving High-Reliability and High-Value Care.

Health care in the United States is plagued by errors, inconsistencies, and inefficiencies. It is also extremely costly. Clinical pathways can drive high-value care and high reliability within a health care organization. Clinical pathways are much more than just guidelines or order sets as a part of a protocol of care, however; they must incorporate multiple elements that are critical to their successful implementation and sustainability. Additionally, clinical pathways can be utilized to accomplish strategic goals of the organization while fulfilling the quality, safety, and clinical aspects of the organization's mission.

Pediatric Quality and Safety: A Nursing Perspective.

Patient safety and quality are 2 of many competing priorities facing health care providers. As safety and quality rise on the agenda of executives, payers, and consumers, competing priorities, such as financial sustainability, patient engagement, regulatory standards, and governmental demands, remain organizational priorities. Nursing represents the largest health care profession in the United States and has the ability to influence the culture of patient safety and quality. It is essential for hospital leadership to provide a culture whereby nurses and staff are actively engaged and feel comfortable speaking up. Transparency is critical in the strategy and implementation of improving quality and safety.