Clinical Full-Time Equivalent in PICUs: Survey of the U.S. Pediatric Critical Care Chiefs Network, 2020-2022.

OBJECTIVES: To inform workforce planning for pediatric critical care (PCC) physicians, it is important to understand current staffing models and the spectrum of clinical responsibilities of physicians. Our objective was to describe the expected workload associated with a clinical full-time equivalent (cFTE) in PICUs across the U.S. Pediatric Critical Care Chiefs Network (PC3N). DESIGN: Cross-sectional survey. SETTING: PICUs participating in the PC3N. SUBJECTS: PICU division chiefs or designees participating in the PC3N from 2020 to 2022. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A series of three surveys were used to capture unit characteristics and clinical responsibilities for an estimated 1.0 cFTE intensivist. Out of a total of 156 PICUs in the PC3N, the response rate was 46 (30%) to all three distributed surveys. Respondents used one of four models to describe the construction of a cFTE-total clinical hours, total clinical shifts, total weeks of service, or % full-time equivalent. Results were stratified by unit size. The model used for construction of a cFTE did not vary significantly by the total number of faculty nor the total number of beds. The median (interquartile range) of clinical responsibilities annually for a 1.0 cFTE were: total clinical hours 1750 (1483-1858), total clinical shifts 142 (129-177); total weeks of service 13.0 (11.3-16.0); and total night shifts 52 (36-60). When stratified by unit size, larger units had fewer nights or overnight hours, but covered more beds per shift. CONCLUSIONS: This survey of the PC3N (2020-2022) provides the most contemporary description of clinical responsibilities associated with a cFTE physician in PCC. A 1.0 cFTE varies depending on unit size. There is no correlation between the model used to construct a cFTE and the associated clinical responsibilities.

Society of Critical Care Medicine Guidelines on Glycemic Control for Critically Ill Children and Adults 2024.

RATIONALE: Maintaining glycemic control of critically ill patients may impact outcomes such as survival, infection, and neuromuscular recovery, but there is equipoise on the target blood levels, monitoring frequency, and methods. OBJECTIVES: The purpose was to update the 2012 Society of Critical Care Medicine and American College of Critical Care Medicine (ACCM) guidelines with a new systematic review of the literature and provide actionable guidance for clinicians. PANEL DESIGN: The total multiprofessional task force of 22, consisting of clinicians and patient/family advocates, and a methodologist applied the processes described in the ACCM guidelines standard operating procedure manual to develop evidence-based recommendations in alignment with the Grading of Recommendations Assessment, Development, and Evaluation Approach (GRADE) methodology. Conflict of interest policies were strictly followed in all phases of the guidelines, including panel selection and voting. METHODS: We conducted a systematic review for each Population, Intervention, Comparator, and Outcomes question related to glycemic management in critically ill children (≥ 42 wk old adjusted gestational age to 18 yr old) and adults, including triggers for initiation of insulin therapy, route of administration, monitoring frequency, role of an explicit decision support tool for protocol maintenance, and methodology for glucose testing. We identified the best available evidence, statistically summarized the evidence, and then assessed the quality of evidence using the GRADE approach. We used the evidence-to-decision framework to formulate recommendations as strong or weak or as a good practice statement. In addition, "In our practice" statements were included when the available evidence was insufficient to support a recommendation, but the panel felt that describing their practice patterns may be appropriate. Additional topics were identified for future research. RESULTS: This guideline is an update of the guidelines for the use of an insulin infusion for the management of hyperglycemia in critically ill patients. It is intended for adult and pediatric practitioners to reassess current practices and direct research into areas with inadequate literature. The panel issued seven statements related to glycemic control in unselected adults (two good practice statements, four conditional recommendations, one research statement) and seven statements for pediatric patients (two good practice statements, one strong recommendation, one conditional recommendation, two "In our practice" statements, and one research statement), with additional detail on specific subset populations where available. CONCLUSIONS: The guidelines panel achieved consensus for adults and children regarding a preference for an insulin infusion for the acute management of hyperglycemia with titration guided by an explicit clinical decision support tool and frequent (≤ 1 hr) monitoring intervals during glycemic instability to minimize hypoglycemia and against targeting intensive glucose levels. These recommendations are intended for consideration within the framework of the patient's existing clinical status. Further research is required to evaluate the role of individualized glycemic targets, continuous glucose monitoring systems, explicit decision support tools, and standardized glycemic control metrics.

Randomized Trial of Weight-Based Versus Fixed Limit High-Flow Nasal Cannula in Bronchiolitis.

BACKGROUND: High flow nasal cannula (HFNC) is increasingly used to treat bronchiolitis. Although lower HFNC rates (≤8 L per minute) are commonly employed, higher weight-based flows more effectively alleviate dyspnea. The impact of higher flows on the need for care escalation is unclear. METHODS: A randomized clinical trial was performed in a community hospital inpatient pediatric unit. Patients with bronchiolitis on HFNC were randomized to an existing "standard" HFNC protocol (max flow of 8 L per minute), or to a novel weight-based protocol (max flow of 2 L/kg per minute). Weaning of HFNC for the patients in the standard arm was left to provider discretion but was prescribed in the weight-based arm. The primary outcome was interhospital transfer to a PICU. The study was powered to detect a 35% difference in transfer rate. RESULTS: 51 patients were randomized to the weight-based or standard HFNC arms. The interhospital PICU transfer rate did not differ significantly between the standard (41.7%) and weight-based arms (51.9%) P = .47. Hospital length of stay was significantly shorter in the weight-based arm with protocolized weaning (45 h [interquartile range 42.1-63.3] versus 77.6 h [interquartile range 47.3-113.4]); P = .01. There were no significant adverse events in either group. CONCLUSIONS: Weight-based provision of HFNC did not significantly impact the number of patients with bronchiolitis requiring interhospital transfer from a community hospital to a PICU, though we were underpowered for this outcome. Patients who received weight-based flow with protocolized weaning had a shorter length of stay, which may reflect a clinical impact of weight-based flow or the efficacy of the aggressive weaning pathway.

A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings.

BACKGROUND: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. METHODS: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. RESULTS: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. CONCLUSION: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Utility of plasma beta-hydroxybutyrate to define resolution of diabetic ketoacidosis.

BACKGROUND: Diabetic ketoacidosis (DKA) is a common, life-threatening complication of type 1 diabetes (T1D) characterized by unregulated ketogenesis caused by relative or absolute insulin deficiency. DKA management requires frequent biochemical monitoring. Plasma ß-hydroxybutyrate (BOHB) has not been included in traditional definitions of DKA resolution. OBJECTIVE: The aim of this study was to determine a cut-point level of BOHB to define DKA resolution in patients with T1D treated with intravenous (IV) insulin. SUBJECTS: We identified patients with T1D receiving IV insulin for DKA treatment at a quaternary children's hospital from January 1, 2017 through December 31, 2020 who had plasma measurements of BOHB after DKA onset and whose DKA resolved by traditional laboratory criteria (venous pH (vpH) ≥ 7.3, serum bicarbonate (HCO3 ) ≥ 15 mmol/L, and/or anion gap (AG) ≤ 14 mmol/L). METHODS: Associations between plasma BOHB and vpH, HCO3 , and AG were evaluated via scatterplots. Receiver operating characteristic (ROC) curves and area under the curve (AUC) were used to evaluate BOHB cut-points to predict DKA resolution. RESULTS: We analyzed 403 patients with 471 unique encounters. Plasma BOHB showed the most robust relationship with AG. The ROC curve comparing plasma BOHB to the accepted definition of DKA resolution, AG ≤14 mmol/L, had an AUC of 0.92. A BOHB value of <1.5 mmol/L had a sensitivity of 83% and specificity of 87%; this cut-point correctly classified 86% of the observations. CONCLUSIONS: A plasma BOHB value of <1.5 mmol/L can be used to define resolution of DKA.

Impact of tight glycemic control and hypoglycemia after pediatric cardiac surgery on neurodevelopmental outcomes at three years of age: Findings from a randomized clinical trial.

BACKGROUND: Studies examining the impact of randomization As per standard instruction, city is required for affiliations; however, this information is missing in affiliation 6. Please check if the provided city is correct and amend if necessary. to tight glycemic control (TGC) and resultant hypoglycemia on later neurodevelopmental outcomes have produced mixed results. Our study examined this association in children undergoing cardiac surgery. METHODS: Participants who were enrolled in the Safe Pediatric Euglycemia after Cardiac Surgery (SPECS) trial returned for neurodevelopmental (ND) follow-up between 30 to 42.5 months of age. ND outcomes were assessed using the Bayley Scales of Infant and Toddler Development, Third Edition. ND scores were compared between the TGC and standard care treatment groups and between patients with moderate to severe and no to mild hypoglycemia. As a secondary analysis, to increase sample size and power, we combined the three-year-old assessments with previously collected assessments done at < 30 months of age to further examine differences between groups longitudinally. RESULTS: Among the 269 participants who completed neurodevelopmental evaluation (in-person testing or questionnaires) at three years of age (follow-up rate, 31%), there were no statistically significant differences in ND outcomes according to treatment group or hypoglycemia status. In the combined analysis of all evaluations (from 9 to 42.5 months of age), we found no treatment group differences. However, in these longitudinal analyses, children who experienced moderate to severe hypoglycemia had lower scores on the Bayley-III cognitive and motor domains compared to children with no to mild hypoglycemia. CONCLUSIONS: For infants undergoing cardiac surgery, there was no impact of tight glycemic control on neurodevelopmental outcomes. Moderate to severe hypoglycemia was associated with worse ND outcomes in longitudinal analyses. TRIAL REGISTRATION: ClinicalTrials.gov NCT00443599. Registered: November 2016.

Computer clinical decision support that automates personalized clinical care: a challenging but needed healthcare delivery strategy.

How to deliver best care in various clinical settings remains a vexing problem. All pertinent healthcare-related questions have not, cannot, and will not be addressable with costly time- and resource-consuming controlled clinical trials. At present, evidence-based guidelines can address only a small fraction of the types of care that clinicians deliver. Furthermore, underserved areas rarely can access state-of-the-art evidence-based guidelines in real-time, and often lack the wherewithal to implement advanced guidelines. Care providers in such settings frequently do not have sufficient training to undertake advanced guideline implementation. Nevertheless, in advanced modern healthcare delivery environments, use of eActions (validated clinical decision support systems) could help overcome the cognitive limitations of overburdened clinicians. Widespread use of eActions will require surmounting current healthcare technical and cultural barriers and installing clinical evidence/data curation systems. The authors expect that increased numbers of evidence-based guidelines will result from future comparative effectiveness clinical research carried out during routine healthcare delivery within learning healthcare systems.

Guidance for Structuring a Pediatric Intermediate Care Unit.

The purpose of this policy statement is to update the 2004 American Academy of Pediatrics clinical report and provide enhanced guidance for institutions, administrators, and providers in the development and operation of a pediatric intermediate care unit (IMCU). Since 2004, there have been significant advances in pediatric medical, surgical, and critical care that have resulted in an evolution in the acuity and complexity of children potentially requiring IMCU admission. A group of 9 clinical experts in pediatric critical care, hospital medicine, intermediate care, and surgery developed a consensus on priority topics requiring updates, reviewed the relevant evidence, and, through a series of virtual meetings, developed the document. The intended audience of this policy statement is broad and includes pediatric critical care professionals, pediatric hospitalists, pediatric surgeons, other pediatric medical and surgical subspecialists, general pediatricians, nurses, social workers, care coordinators, hospital administrators, health care funders, and policymakers, primarily in resource-rich settings. Key priority topics were delineation of core principles for an IMCU, clarification of target populations, staffing recommendations, and payment.

Endocrine Dysfunction Criteria in Critically Ill Children: The PODIUM Consensus Conference.

CONTEXT: Endocrine dysfunction is common in critically ill children and is manifested by abnormalities in glucose, thyroid hormone, and cortisol metabolism. OBJECTIVE: To develop consensus criteria for endocrine dysfunction in critically ill children by assessing the association of various biomarkers with clinical and functional outcomes. DATA SOURCES: PubMed and Embase were searched from January 1992 to January 2020. STUDY SELECTION: We included studies in which researchers evaluated critically ill children with abnormalities in glucose homeostasis, thyroid function and adrenal function, performance characteristics of assessment and/or scoring tools to screen for endocrine dysfunction, and outcomes related to mortality, organ-specific status, and patient-centered outcomes. Studies of adults, premature infants or animals, reviews and/or commentaries, case series with sample size ≤10, and non-English-language studies were excluded. DATA EXTRACTION: Data extraction and risk-of-bias assessment for each eligible study were performed by 2 independent reviewers. RESULTS: The systematic review supports the following criteria for abnormal glucose homeostasis (blood glucose [BG] concentrations >150 mg/dL [>8.3 mmol/L] and BG concentrations <50 mg/dL [<2.8 mmol/L]), abnormal thyroid function (serum total thyroxine [T4] <4.2 µg/dL [<54 nmol/L]), and abnormal adrenal function (peak serum cortisol concentration <18 µg/dL [500 nmol/L]) and/or an increment in serum cortisol concentration of <9 µg/dL (250 nmol/L) after adrenocorticotropic hormone stimulation. LIMITATIONS: These included variable sampling for BG measurements, limited reporting of free T4 levels, and inconsistent interpretation of adrenal axis testing. CONCLUSIONS: We present consensus criteria for endocrine dysfunction in critically ill children that include specific measures of BG, T4, and adrenal axis testing.

Novel Deployment of Pediatric Biocontainment Unit Nurses in Response to COVID-19.

ABSTRACT: Most existing biocontainment units (BCUs) in U.S. hospitals are designed to care for a limited number of patients infected with epidemiologically significant pathogens. The COVID-19 pandemic presented substantial challenges to hospital preparedness and operations because of its high incidence rate and the high risk of transmission to staff members. This article describes a novel practice innovation: a hospital-wide deployment of nurses on a trained BCU team to support hospital staff in safely caring for patients with COVID-19. Their responsibilities included assisting in the development of guidelines and providing training on safety protocols and the appropriate use of personal protective equipment. The authors show how this deployment contributed significantly to staff education and support during the pandemic.

Performance of an Electronic Decision Support System as a Therapeutic Intervention During a Multicenter PICU Clinical Trial: Heart and Lung Failure-Pediatric Insulin Titration Trial (HALF-PINT).

BACKGROUND: The use of electronic clinical decision support (CDS) systems for pediatric critical care trials is rare. We sought to describe in detail the use of a CDS tool (Children's Hospital Euglycemia for Kids Spreadsheet [CHECKS]), for the management of hyperglycemia during the 32 multicenter Heart And Lung Failure-Pediatric Insulin Titration trial. RESEARCH QUESTION: In critically ill pediatric patients who were treated with CHECKS, how was user compliance associated with outcomes; and what patient and clinician factors might account for the observed differences in CHECKS compliance? STUDY DESIGN AND METHODS: During an observational retrospective study of compliance with a CDS tool used during a prospective randomized controlled trial, we compared patients with high and low CHECKS compliance. We investigated the association between compliance and blood glucose metrics. We describe CHECKS and use a computer interface analysis framework (the user, function, representation, and task analysis framework) to categorize user interactions. We discuss implications for future randomized controlled trials. RESULTS: Over a 4.5-year period, 658 of 698 children were treated with the CHECKS protocol for ≥24 hours with a median of 119 recommendations per patient. Compliance per patient was high (median, 99.5%), with only 30 patients having low compliance (<90%). Patients with low compliance were from 16 of 32 sites, younger (P = .02), and less likely to be on inotropic support (P = .04). They were more likely to be have been assigned randomly to the lower blood glucose target (80% vs 48%; P < .001) and to have spent a shorter time (53% vs 75%; P < .001) at the blood glucose target. Overrides (classified by the user, function, representation, and task analysis framework), were largely (89%) due to the user with patient factors contributing 29% of the time. INTERPRETATION: The use of CHECKS for the Heart And Lung Failure-Pediatric Insulin Titration trial resulted in a highly reproducible and explicit method for the management of hyperglycemia in critically ill children across varied environments. CDS systems represent an important mechanism for conducting explicit complex pediatric critical care trials. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01565941, registered March 29 2012; https://clinicaltrials.gov/ct2/show/NCT01565941?term=HALF-PINT&draw=2&rank=1.

Enabling a learning healthcare system with automated computer protocols that produce replicable and personalized clinician actions.

Clinical decision-making is based on knowledge, expertise, and authority, with clinicians approving almost every intervention-the starting point for delivery of "All the right care, but only the right care," an unachieved healthcare quality improvement goal. Unaided clinicians suffer from human cognitive limitations and biases when decisions are based only on their training, expertise, and experience. Electronic health records (EHRs) could improve healthcare with robust decision-support tools that reduce unwarranted variation of clinician decisions and actions. Current EHRs, focused on results review, documentation, and accounting, are awkward, time-consuming, and contribute to clinician stress and burnout. Decision-support tools could reduce clinician burden and enable replicable clinician decisions and actions that personalize patient care. Most current clinical decision-support tools or aids lack detail and neither reduce burden nor enable replicable actions. Clinicians must provide subjective interpretation and missing logic, thus introducing personal biases and mindless, unwarranted, variation from evidence-based practice. Replicability occurs when different clinicians, with the same patient information and context, come to the same decision and action. We propose a feasible subset of therapeutic decision-support tools based on credible clinical outcome evidence: computer protocols leading to replicable clinician actions (eActions). eActions enable different clinicians to make consistent decisions and actions when faced with the same patient input data. eActions embrace good everyday decision-making informed by evidence, experience, EHR data, and individual patient status. eActions can reduce unwarranted variation, increase quality of clinical care and research, reduce EHR noise, and could enable a learning healthcare system.

Impact of a Clinical Documentation Integrity Program on Severity of Illness of Expired Patients.

BACKGROUND: As payment models continue to move toward value-driven care, the quality of documentation has become more important than ever. Clinical Documentation Integrity (CDI) programs can aid in the documentation of diagnoses that are specific and consistent throughout the medical record, which leads to accurate code assignment, better understanding of patient complexity, and improved facility reimbursement. METHODS: An interrupted time series analysis was conducted by using a segmented regression model to estimate the impact of our hospital's CDI program on perceived patient complexity using severity of illness stratification, observed to expected mortality ratio and case-mix index. Patients who died during the admission were chosen to limit our analysis to patients with the highest severity of illness. RESULTS: A total of 206 patients who had died while inpatient at our 400 bed children's hospital were included. There was a 15.7% increase in patients who were final coded with the highest level of severity of illness after our CDI program launched compared with those patients admitted before program inception. The hospital case-mix index for inpatient cases increased 25% from 2011 to 2017. There was a 44% decrease in the observed to expected mortality ratio. DISCUSSION: A CDI program can have a significant impact, as evidenced by our ability to show complexity gains on some of the sickest patients by supporting documentation of precise, accurate diagnoses. In turn, this may allow for better understanding of the complexity of our patient population and support appropriate reimbursement and payer contract negotiations.

Nurses' Perceptions of Workload Burden in Pediatric Critical Care.

BACKGROUND: Quantifying nurses' perceptions of workload burden when managing critically ill patients is essential for designing interventions to ease nurses' workday. OBJECTIVES: To explore pediatric intensive care unit (PICU) nurses' perceptions of their workload when caring for critically ill patients and managing protocolized therapies. METHODS: This study was embedded in a multicenter randomized clinical trial where participants were assigned to receive either lower-target or higher-target glucose control. Nurses from 35 participating PICUs completed a baseline survey containing questions about their perceptions of PICU workload in general. They completed an intervention survey after caring for a study patient. Two workload measurement instruments, the Subjective Workload Assessment Technique (SWAT) and the National Aeronautics and Space Administration-Task Load Index (NASA-TLX), were embedded in these surveys. RESULTS: Baseline surveys were completed by 1476 PICU nurses, predominantly female with a bachelor's degree and a median (interquartile range) of 6 (3-11) years of nursing experience and 4 (2-9) years of PICU experience. Most nurses (65%) rated time burden as the most important component of their workload, followed by cognitive (22%) or psychological stress (13%) burden. Work performance was selected most often as contributing to workload, followed by cognitive demand, time pressure, effort, and physical demand. Intervention surveys were completed by 73% of enrolled participants (505 of 693). Nurses managing the lower glucose target group reported higher levels of workload burden as measured by the SWAT (P = .002) and NASA-TLX (P < .001). CONCLUSIONS: This study describes the workload burden perceived by PICU nurses when managing critically ill patients in general and when managing protocolized therapies.

Life-Threatening Hemoptysis in a Pediatric Referral Center.

OBJECTIVES: Hemoptysis is uncommon in children, even among the critically ill, with a paucity of epidemiological data to inform clinical decision-making. We describe hemoptysis-associated ICU admissions, including those who were critically ill at hemoptysis onset or who became critically ill as a result of hemoptysis, and identify predictors of mortality. DESIGN: Retrospective cohort study. Demographics, hemoptysis location, and management were collected. Pediatric Logistic Organ Dysfunction-2 score within 24 hours of hemoptysis described illness severity. Primary outcome was inhospital mortality. SETTING: Quaternary pediatric referral center between July 1, 2010, and June 30, 2017. PATIENTS: Medical/surgical (PICU), cardiac ICU, and term neonatal ICU admissions with hemoptysis during or within 24 hours of ICU admission. INTERVENTIONS: No intervention. MEASUREMENTS AND MAIN RESULTS: There were 326 hemoptysis-associated ICU admissions in 300 patients. Most common diagnoses were cardiac (46%), infection (15%), bronchiectasis (10%), and neoplasm (7%). Demographics, interventions, and outcomes differed by diagnostic category. Overall, 79 patients (26%) died inhospital and 109 (36%) had died during follow-up (survivor mean 2.8 ± 1.9 yr). Neoplasm, bronchiectasis, renal dysfunction, inhospital hemoptysis onset, and higher Pediatric Logistic Organ Dysfunction-2 score were independent risk factors for inhospital mortality (p < 0.02). Pharmacotherapy (32%), blood products (29%), computerized tomography angiography (26%), bronchoscopy (44%), and cardiac catheterization (36%) were common. Targeted surgical interventions were rare. Of survivors, 15% were discharged with new respiratory support. Of the deaths, 93 (85%) occurred within 12 months of admission. For patients surviving 12 months, 5-year survival was 87% (95% CI, 78-92) and mortality risk remained only for those with neoplasm (log-rank p = 0.001). CONCLUSIONS: We observed high inhospital mortality from hemoptysis-associated ICU admissions. Mortality was independently associated with hemoptysis onset location, underlying diagnosis, and severity of critical illness at event. Additional mortality was observed in the 12-month posthospital discharge. Future directions include further characterization of this vulnerable population and management recommendations for life-threatening pediatric hemoptysis incorporating underlying disease pathophysiology.

Perspective of the Surviving Sepsis Campaign on the Management of Pediatric Sepsis in the Era of Coronavirus Disease 2019.

Severe acute respiratory syndrome coronavirus 2 is a novel cause of organ dysfunction in children, presenting as either coronavirus disease 2019 with sepsis and/or respiratory failure or a hyperinflammatory shock syndrome. Clinicians must now consider these diagnoses when evaluating children for septic shock and sepsis-associated organ dysfunction. The Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-associated Organ Dysfunction in Children provide an appropriate framework for the early recognition and initial resuscitation of children with sepsis or septic shock caused by all pathogens, including severe acute respiratory syndrome coronavirus 2. However, the potential benefits of select adjunctive therapies may differ from non-coronavirus disease 2019 sepsis.

A Novel Framework Using Remote Telesimulation With Standardized Parents to Improve Research Staff Preparedness for Informed Consent in Pediatric Critical Care Research.

OBJECTIVES: The Heart And Lung Failure-Pediatric INsulin Titration study was experiencing poor subject enrollment due to low rates of informed consent. Heart And Lung Failure-Pediatric INsulin Titration investigators collaborated with the Perelman School of Medicine Standardized Patient Program to explore the novel use of telesimulation with standardized parents to train research staff to approach parents of critically ill children for informed consent. We describe the feasibility, learner acceptance, and financial costs of this novel intervention and performed a post hoc analysis to determine if this intervention improved study consent rates. DESIGN: Observational, comparative effectiveness study. SETTING: Heart And Lung Failure-Pediatric INsulin Titration study enrolling sites. SUBJECTS: Research staff (at the remote site). INTERVENTIONS: Individual 90-minute Skype telesimulation sessions with standardized parent and simulation facilitator (at the training site). MEASUREMENTS AND MAIN RESULTS: Forty telesimulation sessions with 79 Heart And Lung Failure-Pediatric INsulin Titration research staff (participants) at 24 remote sites were conducted. Despite some technical delays, 40 out of 40 simulations (100%) were completed. Based on feedback surveys, 100% of respondents agreed (81% strongly agreed) that telesimulation sessions achieved intended learning objectives to prepare research staff to approach parents of eligible critically ill children to obtain informed consent. Additionally, 100% of respondents agreed (74% strongly agreed) that they would use lessons from the telesimulation when approaching parents to obtain informed consent for research. Telesimulation with standardized parents achieved lower financial costs (approximately $85 per session) compared with traditional in-person site visits for training research staff. There was no significant improvement in study consent rates with the intervention (pre: 46% vs post: 48%; p = 0.78). CONCLUSIONS: Remote telesimulation with standardized parents is feasible, acceptable, and associated with lower financial costs to prepare research staff to obtain informed consent from parents of critically ill children eligible for clinical research trials. Despite this novel approach, Heart And Lung Failure-Pediatric INsulin Titration study consent rates did not improve, suggesting that other factors influence parental consent and decision making in complex multicenter clinical research trials.