The impact of clinical result acquisition and interpretation on task performance during a simulated pediatric cardiac arrest: a multicentre observational study.

PURPOSE: The acquisition and interpretation of clinical results during resuscitations is common; however, this can delay critical clinical tasks, resulting in increased morbidity and mortality. This study aims to determine the impact of clinical result acquisition and interpretation by the team leader on critical task completion during simulated pediatric cardiac arrest before and after team training. METHODS: This is a secondary data analysis of video-recorded simulated resuscitation scenarios conducted during Teams4Kids (T4K) study (June 2011-January 2015); scenarios included cardiac arrest before and after team training. The scenario included either a scripted paper or a phone call delivery of results concurrently with a clinical transition to pulseless ventricular tachycardia. Descriptive statistics and non-parametric tests were used to compare team performance before and after training. RESULTS: Performance from 40 teams was analyzed. Although the time taken to initiate CPR and defibrillation varied depending on the type of interruption and whether the scenario was before or after team training, these findings were not significantly associated with the leader's behaviour [Kruskal-Wallis test (p > 0.05)]. An exact McNemar's test determined no statistically significant difference in the proportion of leaders involved or not in interpreting results between and after the training (exact p value = 0.096). CONCLUSIONS: Team training was successful in reducing time to perform key clinical tasks. Although team training modified the way leaders behaved toward the results, this behaviour change did not impact the time taken to start CPR or defibrillate. Further understanding the elements that influence time to critical clinical tasks provides guidance in designing future simulated educational activities, subsequently improving clinical team performance and patient outcomes.

RéSUMé: BUT: L'acquisition et l'interprétation des résultats cliniques pendant les réanimations sont courantes; toutefois, cela peut retarder les tâches cliniques critiques, ce qui entraîne une augmentation de la morbidité et de la mortalité. Cette étude vise à déterminer l'impact de l'acquisition et de l'interprétation des résultats cliniques par le chef d'équipe sur la réalisation des tâches critiques lors d'un arrêt cardiaque pédiatrique simulé, avant et après la formation de l'équipe. MéTHODES: Il s'agit d'une analyse de données secondaires de scénarios de réanimation simulés enregistrés sur vidéo, réalisés au cours de l'étude Teams4Kids (T4K) (juin 2011-janvier 2015); les scénarios comprenaient un arrêt cardiaque avant et après la formation de l'équipe. Le scénario comprenait un document écrit ou un appel téléphonique donnant les résultats en même temps qu'une transition clinique vers la tachycardie ventriculaire sans pouls. Des statistiques descriptives et des tests non paramétriques ont été utilisés pour comparer le rendement de l'équipe avant et après la formation. RéSULTATS: Les performances de 40 équipes ont été analysées. Bien que le temps nécessaire au déclenchement de la RCP et de la défibrillation ait varié selon le type d'interruption et selon que le scénario se déroulait avant ou après la formation de l'équipe, ces résultats n'étaient pas significativement associés au comportement du leader [test de Kruskal-Wallis (p > 0,05)]. Un test exact de McNemar n'a déterminé aucune différence statistiquement significative dans la proportion de dirigeants impliqués ou non dans l'interprétation des résultats entre et après la formation (valeur p exacte = 0,096). CONCLUSIONS: La formation en équipe a permis de réduire le temps nécessaire pour effectuer les tâches cliniques clés. Bien que la formation de l'équipe ait modifié le comportement des dirigeants vis-à-vis des résultats, ce changement de comportement n'a pas eu d'incidence sur le temps nécessaire pour commencer la RCP ou la défibrillation. Une meilleure compréhension des éléments qui influencent le temps consacré aux tâches cliniques critiques fournit une orientation pour la conception des futures activités éducatives simulées, améliorant par la suite le rendement des équipes cliniques et les résultats pour les patients.

Adding a dose of empathy to healthcare: What can healthcare systems do?

RATIONALE, AIMS AND OBJECTIVES: Healthcare practitioners often note system-level barriers to empathy between patients and practitioners. These include burnout-inducing administrative workloads, unfriendly meeting times, burdensome protocols, lack of wellbeing spaces, and undervaluing empathy as a core part of an institution's mission. The need for empathy in healthcare has been magnified with the current SARS-COV-2 outbreak which has limited the expression of interpersonal empathy due to rigid isolation protocols and the use of personal protective equipment. METHOD: This study-the first of its kind that we are aware of-outlines the details of a facilitated workshop run with the leadership of a tertiary level pediatric center in Canada. The workshop used a modified nominal group technique to discuss and prioritize actions to enhance empathy into the hospital system. RESULTS: Inter-professional and inter-disciplinary group of healthcare leader participants agreed on several immediately actionable steps, including embedding patient satisfaction with care measures as standard, and streamlining booking appointments. A roadmap was created to implement the other priorities. CONCLUSION: A systematic approach to infusing empathy into the structure of our healthcare system is much needed. Furthermore, inter-professional and inter-disciplinary educational workshops was well-received as a way to facilitate discussion and drive change.

Death and Dying in Hospitalized Pediatric Patients: A Prospective Multicenter, Multinational Study.

Background: For hospitalized children admitted outside of a critical care unit, the location, mode of death, "do-not-resuscitate" order (DNR) use, and involvement of palliative care teams have not been described across high-income countries. Objective: To describe location of death, patient and terminal care plan characteristics of pediatric inpatient deaths inside and outside the pediatric intensive care unit (PICU). Design: Secondary analysis of inpatient deaths in the Evaluating Processes of Care and Outcomes of Children in Hospital (EPOCH) randomized controlled trial. Setting/Subjects: Twenty-one centers from Canada, Belgium, the United Kingdom, Ireland, Italy, the Netherlands, and New Zealand. Measurement: Descriptive statistics were used to compare patient and terminal care plan characteristics. A multivariable generalized estimating equation examined if palliative care consult during hospital admission was associated with location of death. Results: A total of 365 of 144,539 patients enrolled in EPOCH died; 219 (60%) died in PICU and 143 (40%) died on another inpatient unit. Compared with other inpatient wards, patients who died in PICU were less likely to be expected to die, have a DNR or palliative care consult. Hospital palliative care consultation was more common in older children and independently associated with a lower adjusted odds (95% confidence interval) of dying in PICU [0.59 (0.52-0.68)]. Conclusion: Most pediatric inpatient deaths occur in PICU where patients were less likely to have a DNR or palliative care consult. Palliative care consultation could be better integrated into end-of-life care for younger children and those dying in PICU.

Improving transparent team communication with the 'Glass Door' decal communication tool: a mixed methods analysis of family and staff perspectives.

OBJECTIVE: To determine the value and perspectives of intensive care unit (ICU) healthcare professionals (HCPs) and families about the Glass Door (GD) decal team communication tool. DESIGN: Quality improvement methodology was used to design, test and implement the GD. Uptake was measured through audit. Impact was assessed through mixed methodology (survey of ICU HCPs (n=96) and semi-structured interviews of HCPs (n=10) and families (n=7)). SETTING: Eighteen bed, closed, mixed medical-surgical-cardiac ICU in a tertiary care, university-affiliated, paediatric hospital. POPULATION: Interdisciplinary ICU HCPs and families of children admitted to the ICU. INTERVENTION: A transparent template (the GD) applied to the outside of ICU patients' doors with sections for HCPs names, physiological goals and planned tests and treatments for the day. Medical staff completed the GD in rounds (AM and PM) and any HCP caring for the patient updated it throughout the day. MEASUREMENTS AND MAIN RESULTS: After 3 months, 96% of 613 doors were employed of which 99% respected confidentiality. ICU HCPs reported improved understanding of the patient's plan (84% today vs 59% pre-GD, p<0.001) and sense that families were up-to-date (79% today vs 46% pre-GD, p<0.001). Based on semi-structured interviews, the GD promoted a shared understanding of the plan contributing to care continuity. The GD reassured families the team is working together and fostered family engagement in the care. Routine family experience surveys showed no change in families' sense of privacy during admission; families denied the GD's anticipated compromise of confidentiality. CONCLUSIONS: The GD decal communication tool, visible on the patient's door, improved ICU HCPs' perceived knowledge of their patient's plan. The GD improved the shared mental model, facilitated teaching and information transfer and fostered family engagement. Challenges included knowing the rules for use and consistent application. Concerns initially raised by HCPs about confidentiality were denied by families.

Kidney and blood pressure abnormalities 6 years after acute kidney injury in critically ill children: a prospective cohort study.

BACKGROUND: Acute kidney injury (AKI) in pediatric intensive care unit (PICU) children may be associated with long-term chronic kidney disease or hypertension. OBJECTIVES: To estimate (1) prevalence of kidney abnormalities (low estimated glomerular filtration rate (eGFR) or albuminuria) and blood pressure (BP) consistent with pre-hypertension or hypertension, 6 years after PICU admission; (2) if AKI is associated with these outcomes. METHODS: Longitudinal study of children admitted to two Canadian PICUs (January 2005-December 2011). Exposures (retrospective): AKI or stage 2/3 AKI (KDIGO creatinine-based definition) during PICU. Primary outcome (single visit 6 years after admission): presence of (a) low eGFR (<90 ml/min/1.73 m2) or albuminuria (albumin to creatinine ratio >30 mg/g) (termed "CKD signs") or (b) BP consistent with ≥pre-hypertension (≥90th percentile) or hypertension (≥95th percentile). RESULTS: Of 277 children, 25% had AKI. AKI and stage 2/3 AKI were associated with 2.2- and 6.6-fold higher adjusted odds, respectively, for the 6-year outcomes. Applying new hypertension guidelines attenuated associations; stage 2/3 AKI was associated with 4.5-fold higher adjusted odds for 6-year CKD signs or ≥elevated BP. CONCLUSIONS: Kidney and BP abnormalities are common 6 years after PICU admission and associated with AKI. Other risk factors must be elucidated to develop follow-up recommendations and reduce cardiovascular risk.

Effect of a Pediatric Early Warning System on All-Cause Mortality in Hospitalized Pediatric Patients: The EPOCH Randomized Clinical Trial.

Importance: There is limited evidence that the use of severity of illness scores in pediatric patients can facilitate timely admission to the intensive care unit or improve patient outcomes. Objective: To determine the effect of the Bedside Paediatric Early Warning System (BedsidePEWS) on all-cause hospital mortality and late admission to the intensive care unit (ICU), cardiac arrest, and ICU resource use. Design, Setting, and Participants: A multicenter cluster randomized trial of 21 hospitals located in 7 countries (Belgium, Canada, England, Ireland, Italy, New Zealand, and the Netherlands) that provided inpatient pediatric care for infants (gestational age ≥37 weeks) to teenagers (aged ≤18 years). Participating hospitals had continuous physician staffing and subspecialized pediatric services. Patient enrollment began on February 28, 2011, and ended on June 21, 2015. Follow-up ended on July 19, 2015. Interventions: The BedsidePEWS intervention (10 hospitals) was compared with usual care (no severity of illness score; 11 hospitals). Main Outcomes and Measures: The primary outcome was all-cause hospital mortality. The secondary outcome was a significant clinical deterioration event, which was defined as a composite outcome reflecting late ICU admission. Regression analyses accounted for hospital-level clustering and baseline rates. Results: Among 144 539 patient discharges at 21 randomized hospitals, there were 559 443 patient-days and 144 539 patients (100%) completed the trial. All-cause hospital mortality was 1.93 per 1000 patient discharges at hospitals with BedsidePEWS and 1.56 per 1000 patient discharges at hospitals with usual care (adjusted between-group rate difference, 0.01 [95% CI, -0.80 to 0.81 per 1000 patient discharges]; adjusted odds ratio, 1.01 [95% CI, 0.61 to 1.69]; P = .96). Significant clinical deterioration events occurred during 0.50 per 1000 patient-days at hospitals with BedsidePEWS vs 0.84 per 1000 patient-days at hospitals with usual care (adjusted between-group rate difference, -0.34 [95% CI, -0.73 to 0.05 per 1000 patient-days]; adjusted rate ratio, 0.77 [95% CI, 0.61 to 0.97]; P = .03). Conclusions and Relevance: Implementation of the Bedside Paediatric Early Warning System compared with usual care did not significantly decrease all-cause mortality among hospitalized pediatric patients. These findings do not support the use of this system to reduce mortality. Trial Registration: clinicaltrials.gov Identifier: NCT01260831.

It Takes a Village to Move a Hospital: Simulation Improves Intensive Care Team Preparedness for a Move to a New Site.

OBJECTIVES: To evaluate in-situ simulation to prepare a PICU to move to a new, redesigned unit. METHODS: The study setting is an academic PICU. This is a cross-sectional study using in-situ simulations of common PICU admissions. Postsimulation, participants completed a survey comparing the perception of preparedness pre- and postsimulation (via a 10-point Likert scale). Participants were resurveyed 6 months postmove to assess whether effects persisted. Qualitative data were obtained via thematic review of the survey comment section and from postsimulation debriefing. RESULTS: Response rates were initially 100% and 67% at the 6-month follow-up. In the initial phase, all questions had statistically significant improvements in post- versus presimulation scores. Participants felt better prepared (presimulation: 6.20, postsimulation: 7.90, P < .001) and more confident about caring for real patients (presimulation: 5.49, postsimulation: 7.41, P < .001). They felt more comfortable working in the new unit (presimulation: 5.65, postsimulation: 7.50, P < .001) and better able to deliver safe care (presimulation: 5.85, postsimulation: 7.60, P < .001). Six months postmove, participants still believed that simulation was helpful (7.43, SD: 2.20) and still reported improved team confidence (7.36, SD: 2.11). Only 1 of 28 participants preferred less simulation. Exercises were described as helpful in identifying process and latent patient safety issues. CONCLUSIONS: Our pediatric intensive care team found simulations to be beneficial in preparation for providing care to critically ill children in a complex new setting. Simulations uncovered latent process, personnel, and patient-safety issues that were addressed before actual patient care.

Comparison of Consent Models in a Randomized Trial of Corticosteroids in Pediatric Septic Shock.

OBJECTIVES: To describe the use of deferred and prior informed consent models in the context of a low additional risk to standard of care, placebo-controlled randomized controlled trial of corticosteroids in pediatric septic shock. DESIGN: An observational substudy of consent processes in a randomized controlled trial of hydrocortisone versus placebo. SETTING: Seven tertiary level PICUs in Canada. PATIENTS: Children newborn to 17 years inclusive admitted to PICU with suspected septic shock between July 2014 and March 2016. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Information on the number of families approached, consent rates obtained, and spontaneously volunteered reasons for nonparticipation were collected for both deferred and informed consent. The research ethics board of five of seven centers approved a deferred consent model; however, implementation criteria for use of this model varied across sites. The consent rate using deferred versus prior informed consent was significantly higher (83%; 35/42 vs 58%; 15/26; p = 0.02). The mean times from meeting inclusion criteria to randomization (1.8 ± 1.8 vs 3.6 ± 2.1 hr; p = 0.007) and study drug administration (3.4 ± 2.7 hr vs 4.8 ± 2.1 hr; p = 0.05) were significantly shorter with the use of deferred consent versus prior informed consent. No family member or research ethics board expressed concern following use of deferred consent. CONCLUSIONS: Deferred consent was acceptable in time-sensitive critical care research to most research ethics boards, families, and healthcare providers and resulted in higher consent rates and more efficient recruitment. Larger studies on deferred consent and consistency interpreting jurisdictional guidelines are needed to advance pediatric acute care.

Workload of Team Leaders and Team Members During a Simulated Sepsis Scenario.

OBJECTIVES: Crisis resource management principles dictate appropriate distribution of mental and/or physical workload so as not to overwhelm any one team member. Workload during pediatric emergencies is not well studied. The National Aeronautics and Space Administration-Task Load Index is a multidimensional tool designed to assess workload validated in multiple settings. Low workload is defined as less than 40, moderate 40-60, and greater than 60 signify high workloads. Our hypothesis is that workload among both team leaders and team members is moderate to high during a simulated pediatric sepsis scenario and that team leaders would have a higher workload than team members. DESIGN: Multicenter observational study. SETTING: Nine pediatric simulation centers (five United States, three Canada, and one United Kingdom). PATIENTS: Team leaders and team members during a 12-minute pediatric sepsis scenario. INTERVENTIONS: National Aeronautics and Space Administration-Task Load Index. MEASUREMENTS AND MAIN RESULTS: One hundred twenty-seven teams were recruited from nine sites. One hundred twenty-seven team leaders and 253 team members completed the National Aeronautics and Space Administration-Task Load Index. Team leader had significantly higher overall workload than team member (51 ± 11 vs 44 ± 13; p < 0.01). Team leader had higher workloads in all subcategories except in performance where the values were equal and in physical demand where team members were higher than team leaders (29 ± 22 vs 18 ± 16; p < 0.01). The highest category for each group was mental 73 ± 13 for team leader and 60 ± 20 for team member. For team leader, two categories, mental (73 ± 17) and effort (66 ± 16), were high workload, most domains for team member were moderate workload levels. CONCLUSIONS: Team leader and team member are under moderate workloads during a pediatric sepsis scenario with team leader under high workloads (> 60) in the mental demand and effort subscales. Team leader average significantly higher workloads. Consideration of decreasing team leader responsibilities may improve team workload distribution.

Biomarkers for Early Acute Kidney Injury Diagnosis and Severity Prediction: A Pilot Multicenter Canadian Study of Children Admitted to the ICU.

OBJECTIVE: Acute kidney injury occurs early in PICU admission and increases risks for poor outcomes. We evaluated the feasibility of a multicenter acute kidney injury biomarker urine collection protocol and measured diagnostic characteristics of urine neutrophil gelatinase-associated lipocalin, interleukin-18, and liver fatty acid binding protein to predict acute kidney injury and prolonged acute kidney injury. DESIGN: Prospective observational pilot cohort study. SETTING: Four Canadian tertiary healthcare PICUs. PATIENTS: Eighty-one children 1 month to 18 years old. Exclusion criteria were as follows: cardiac surgery, baseline severe kidney disease, and inadequate urine or serum for PICU days 1-3. INTERVENTIONS: PICUs performed standardized urine collection protocol to obtain early PICU admission urine samples, with deferred consent. MEASUREMENTS AND MAIN RESULTS: Study barriers and facilitators were recorded. Acute kidney injury was defined based on Kidney Disease: Improving Global Outcomes serum creatinine criteria (acute kidney injuryserum creatinine) and by serum creatinine and urine output criteria (acute kidney injuryserum creatinine+urine output) Prolonged acute kidney injury was defined as acute kidney injury duration of 48 hours or more. PICU days 1-3 neutrophil gelatinase-associated lipocalin, interleukin-18, and liver fatty acid binding protein were evaluated for acute kidney injury prediction (area under the curve). Biomarkers on the first day of acute kidney injury attainment (day 1 acute kidney injury) were evaluated for predicting prolonged acute kidney injury. Eighty-two to 95% of subjects had urine collected from PICU days 1-3. Acute kidney injuryserum creatinine developed in 16 subjects (20%); acute kidney injuryserum creatinine+urine output developed in 38 (47%). On PICU day 1, interleukin-18 predicted acute kidney injuryserum creatinine with area under the curve=0.82, but neutrophil gelatinase-associated lipocalin and liver fatty acid binding protein predicted acute kidney injuryserum creatinine with area under the curve of less than or equal to 0.69; on PICU day 2, area under the curve was higher (not shown). Interleukin-18 and liver fatty acid binding protein on day 1 acute kidney injury predicted prolonged acute kidney injuryserum creatinine (area under the curve=0.74 and 0.83, respectively). When acute kidney injuryserum creatinine+urine output was used to define acute kidney injury, biomarker area under the curves were globally lower. CONCLUSIONS: Protocol urine collection to procure early admission samples is feasible. Individual biomarker acute kidney injury prediction performance is highly variable and modest. Larger studies should evaluate utility and cost effectiveness of using early acute kidney injury biomarkers.

A Randomized Controlled Trial of Corticosteroids in Pediatric Septic Shock: A Pilot Feasibility Study.

OBJECTIVE: To determine the feasibility of conducting a randomized controlled trial of corticosteroids in pediatric septic shock. DESIGN: Randomized, double-blind, placebo controlled trial. SETTING: Seven tertiary level PICUs in Canada. PATIENTS: Children newborn to 17 years old inclusive with suspected septic shock. INTERVENTION: Administration of IV hydrocortisone versus placebo until hemodynamic stability is achieved or for a maximum of 7 days. MEASUREMENTS AND MAIN RESULTS: One hundred seventy-four patients were potentially eligible of whom 101 patients met eligibility criteria. Fifty-seven patients were randomized, and 49 patients (23 and 26 patients in the hydrocortisone and placebo groups, respectively) were included in the final analysis. The mean time from screening to randomization was 2.4 ± 2.1 hours and from screening to first dose of study drug was 3.8 ± 2.6 hours. Forty-two percent of potentially eligible patients (73/174) received corticosteroids prior to randomization: 38.5% (67/174) were already on corticosteroids for shock at the time of screening, and in 3.4% (6/174), the treating physician wished to administer corticosteroids. Six of 49 randomized patients (12.2%) received open-label steroids, three in each of the hydrocortisone and placebo groups. Time on vasopressors, days on mechanical ventilation, PICU and hospital length of stay, and the rate of adverse events were not statistically different between the two groups. CONCLUSIONS: This study suggests that a large randomized controlled trial on early use of corticosteroids in pediatric septic shock is potentially feasible. However, the frequent use of empiric corticosteroids in otherwise eligible patients remains a significant challenge. Knowledge translation activities, targeted recruitment, and alternative study designs are possible strategies to mitigate this challenge.

Improved Clinical Performance and Teamwork of Pediatric Interprofessional Resuscitation Teams With a Simulation-Based Educational Intervention.

OBJECTIVES: To measure the effect of a 1-day team training course for pediatric interprofessional resuscitation team members on adherence to Pediatric Advanced Life Support guidelines, team efficiency, and teamwork in a simulated clinical environment. DESIGN: Multicenter prospective interventional study. SETTING: Four tertiary-care children's hospitals in Canada from June 2011 to January 2015. SUBJECTS: Interprofessional pediatric resuscitation teams including resident physicians, ICU nurse practitioners, registered nurses, and registered respiratory therapists (n = 300; 51 teams). INTERVENTIONS: A 1-day simulation-based team training course was delivered, involving an interactive lecture, group discussions, and four simulated resuscitation scenarios, each followed by a debriefing. The first scenario of the day (PRE) was conducted prior to any team training. The final scenario of the day (POST) was the same scenario, with a slightly modified patient history. All scenarios included standardized distractors designed to elicit and challenge specific teamwork behaviors. MEASUREMENTS AND MAIN RESULTS: Primary outcome measure was change (before and after training) in adherence to Pediatric Advanced Life Support guidelines, as measured by the Clinical Performance Tool. Secondary outcome measures were as follows: 1) change in times to initiation of chest compressions and defibrillation and 2) teamwork performance, as measured by the Clinical Teamwork Scale. Correlation between Clinical Performance Tool and Clinical Teamwork Scale scores was also analyzed. Teams significantly improved Clinical Performance Tool scores (67.3-79.6%; p < 0.0001), time to initiation of chest compressions (60.8-27.1 s; p < 0.0001), time to defibrillation (164.8-122.0 s; p < 0.0001), and Clinical Teamwork Scale scores (56.0-71.8%; p < 0.0001). A positive correlation was found between Clinical Performance Tool and Clinical Teamwork Scale (R = 0.281; p < 0.0001). CONCLUSIONS: Participation in a simulation-based team training educational intervention significantly improved surrogate measures of clinical performance, time to initiation of key clinical tasks, and teamwork during simulated pediatric resuscitation. A positive correlation between clinical and teamwork performance suggests that effective teamwork improves clinical performance of resuscitation teams.

The Development of a Critical Care Resident Research Curriculum: A Needs Assessment.

Background. Conducting research is expected from many clinicians' professional profile, yet many do not have advanced research degrees. Research training during residency is variable amongst institutions and research education needs of trainees are not well understood. Objective. To understand needs of critical care trainees regarding research education. Methods. Canadian critical care trainees, new critical care faculty, program directors, and research coordinators were surveyed regarding research training, research expectations, and support within their programs. Results. Critical care trainees and junior faculty members highlighted many gaps in research knowledge and skills. In contrast, critical care program directors felt that trainees were prepared to undertake research careers. Major differences in opinion amongst program directors and other respondent groups exist regarding preparation for designing a study, navigating research ethics board applications, and managing a research budget. Conclusion. We demonstrated that Canadian critical care trainees and junior faculty reported gaps in knowledge in all areas of research. There was disagreement amongst trainees, junior faculty, research coordinators, and program directors regarding learning needs. Results from this needs assessment will be used to help redesign the education program of the Canadian Critical Care Trials Group to complement local research training offered for critical care trainees.

An Approach to Confederate Training Within the Context of Simulation-Based Research.

STATEMENT: Simulation-based education often relies on confederates, who provide information or perform clinical tasks during simulation scenarios, to play roles. Although there is experience with confederates in their more routine performance within educational programs, there is little literature on the training of confederates in the context of simulation-based research. The CPR CARES multicenter research study design included 2 confederate roles, in which confederates' behavior was tightly scripted to avoid confounding primary outcome measures. In this report, we describe our training process, our method of adherence assessment, and suggest next steps regarding confederate training scholarship.

Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial.

BACKGROUND: Physicians often administer corticosteroids for the treatment of fluid and vasoactive infusion dependent pediatric shock. This use of corticosteroids is controversial, however, and has never been studied in a pediatric randomized controlled trial (RCT). This pilot trial will determine the feasibility of a larger RCT on the role of corticosteroids in pediatric shock. METHODS/DESIGN: Steroids in Fluid and/or Vasoactive Infusion Dependent Pediatric Shock (STRIPES) is a pragmatic, seven-center, double-blind, pilot RCT. We aim to randomize 72 pediatric patients with fluid and vasoactive infusion dependent shock to receive either hydrocortisone or a saline placebo for 7 days or until clinical stability, whichever occurs first. The primary outcome of this pilot trial is the feasibility of recruitment, defined as the number of patients enrolled over a 1-year period. Secondary outcomes include the frequency of, and reasons for, open-label steroid use, protocol adherence, incidence of mortality and corticosteroid-associated adverse events, time to discontinuation of inotropes, and feasibility of blood sampling. DISCUSSION: Corticosteroids are used for the treatment of pediatric shock without sufficient evidence to support this practice. While there is a scientific rationale and limited data supporting their use in this setting, there is also evidence from other populations suggesting potential harm. The STRIPES pilot study will assess the feasibility of a larger, much needed trial powered for clinically important outcomes. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02044159.

Variability in quality of chest compressions provided during simulated cardiac arrest across nine pediatric institutions.

AIM: The variability in quality of CPR provided during cardiac arrest across pediatric institutions is unknown. We aimed to describe the degree of variability in the quality of CPR across 9 pediatric institutions, and determine if variability across sites would be affected by Just-in-Time CPR training and/or visual feedback during simulated cardiac arrest. METHODS: We conducted secondary analyses of data collected from a prospective, multi-center trial. Participants were equally randomized to either: (1) No intervention; (2) Real-time CPR visual feedback during cardiac arrest or (3) Just-in-Time CPR training. We report the variability in median chest compression depth and rate across institutions, and the variability in the proportion of 30-s epochs of CPR meeting 2010 American Heart Association guidelines for depth and rate. RESULTS: We analyzed data from 528 epochs in the no intervention group, 552 epochs in the visual feedback group, and 525 epochs in the JIT training group. In the no intervention group, compression depth (median range 22.2-39.2mm) and rate (median range 116.0-147.6 min(-1)) demonstrated significant variability between study sites (p<0.001). The proportion of compressions with adequate depth (0-11.5%) and rate (0-60.5%) also varied significantly across sites (p<0.001). The variability in compression depth and rate persisted despite use of real-time visual feedback or JIT training (p<0.001). CONCLUSION: The quality of CPR across multiple pediatric institutions is variable. Variability in CPR quality across institutions persists even with the implementation of a Just-in-Time training session and visual feedback for CPR quality during simulated cardiac arrest.

Evaluating processes of care and outcomes of children in hospital (EPOCH): study protocol for a randomized controlled trial.

BACKGROUND: The prevention of near and actual cardiopulmonary arrest in hospitalized children is a patient safety imperative. Prevention is contingent upon the timely identification, referral and treatment of children who are deteriorating clinically. We designed and validated a documentation-based system of care to permit identification and referral as well as facilitate provision of timely treatment. We called it the Bedside Paediatric Early Warning System (BedsidePEWS). Here we describe the rationale for the design, intervention and outcomes of the study entitled Evaluating Processes and Outcomes of Children in Hospital (EPOCH). METHODS/DESIGN: EPOCH is a cluster-randomized trial of the BedsidePEWS. The unit of randomization is the participating hospital. Eligible hospitals have a Pediatric Intensive Care Unit (PICU), are anticipated to have organizational stability throughout the study, are not using a severity of illness score in hospital wards and are willing to be randomized. Patients are >37 weeks gestational age and <18 years and are hospitalized in inpatient ward areas during all or part of their hospital admission. Randomization is to either BedsidePEWS or control (no severity of illness score) in a 1:1 ratio within two strata (<200, ≥ 200 hospital beds). All-cause hospital mortality is the selected primary outcome. It is objective, independent of do-not-resuscitate status and can be reliably measured. The secondary outcomes include (1) clinical outcomes: clinical deterioration, severity of illness at and during ICU admission, and potentially preventable cardiac arrest; (2) processes of care outcomes: immediate calls for assistance, hospital and ICU readmission, and perceptions of healthcare professionals; and (3) resource utilization: ICU days and use of ICU therapies. DISCUSSION: Following funding by the Canadian Institutes of Health Research and local ethical approvals, site enrollment started in 2010 and was closed in February 2014. Patient enrollment is anticipated to be complete in July 2015. The results of EPOCH will strengthen the scientific basis for local, regional, provincial and national decision-making and for the recommendations of national and international bodies. If negative, the costs of hospital-wide implementation can be avoided. If positive, EPOCH will have provided a scientific justification for the major system-level changes required for implementation. TRIAL REGISTRATION: NCT01260831 ClinicalTrials.gov date: 14 December 2010.

Improving cardiopulmonary resuscitation with a CPR feedback device and refresher simulations (CPR CARES Study): a randomized clinical trial.

IMPORTANCE: The quality of cardiopulmonary resuscitation (CPR) affects hemodynamics, survival, and neurological outcomes following pediatric cardiopulmonary arrest (CPA). Most health care professionals fail to perform CPR within established American Heart Association guidelines. OBJECTIVE: To determine whether "just-in-time" (JIT) CPR training with visual feedback (VisF) before CPA or real-time VisF during CPA improves the quality of chest compressions (CCs) during simulated CPA. DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, 2 × 2 factorial-design trial with explicit methods (July 1, 2012, to April 15, 2014) at 10 International Network for Simulation-Based Pediatric Innovation, Research, & Education (INSPIRE) institutions running a standardized simulated CPA scenario, including 324 CPR-certified health care professionals assigned to 3-person resuscitation teams (108 teams). INTERVENTIONS: Each team was randomized to 1 of 4 permutations, including JIT training vs no JIT training before CPA and real-time VisF vs no real-time VisF during simulated CPA. MAIN OUTCOMES AND MEASURES: The proportion of CCs with depth exceeding 50 mm, the proportion of CPR time with a CC rate of 100 to 120 per minute, and CC fraction (percentage CPR time) during simulated CPA. RESULTS: The quality of CPR was poor in the control group, with 12.7% (95% CI, 5.2%-20.1%) mean depth compliance and 27.1% (95% CI, 14.2%-40.1%) mean rate compliance. JIT training compared with no JIT training improved depth compliance by 19.9% (95% CI, 11.1%-28.7%; P < .001) and rate compliance by 12.0% (95% CI, 0.8%-23.2%; P = .037). Visual feedback compared with no VisF improved depth compliance by 15.4% (95% CI, 6.6%-24.2%; P = .001) and rate compliance by 40.1% (95% CI, 28.8%-51.3%; P < .001). Neither intervention had a statistically significant effect on CC fraction, which was excellent (>89.0%) in all groups. Combining both interventions showed the highest compliance with American Heart Association guidelines but was not significantly better than either intervention in isolation. CONCLUSIONS AND RELEVANCE: The quality of CPR provided by health care professionals is poor. Using novel and practical technology, JIT training before CPA or real-time VisF during CPA, alone or in combination, improves compliance with American Heart Association guidelines for CPR that are associated with better outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02075450.

Cystatin C in acute kidney injury diagnosis: early biomarker or alternative to serum creatinine?

BACKGROUND: Early acute kidney injury (AKI) diagnosis is needed to pursue treatment trials. We evaluated cystatin C (CysC) as an early biomarker of serum creatinine (SCr)-AKI and an alternative to define AKI. METHODS: We studied 160 non-cardiac children in the intensive care unit (ICU). We measured daily CysC and SCr. AKI was staged by KDIGO (Kidney Disease: Improving Global Outcomes) guidelines using SCr and CysC (CysC-AKI). We calculated area under the curve (AUC) for (1) neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1) and urine CysC to diagnose SCr- and CysC-AKI; and (2) for CysC to diagnose SCr-AKI. We evaluated AKI associations with length of stay and ventilation duration. RESULTS: We found that 44 % of patients developed SCr-AKI; 32 % developed CysC-AKI. Early ICU NGAL was most diagnostic of CysC-AKI (AUC 0.69, 95% CI 0.54-0.84); IL-18 was most diagnostic for SCr-AKI (AUC 0.69 95% CI 0.55-0.82). Combining SCr and CysC-AKI definition led to higher biomarker diagnostic AUC's. CysC-AKI was not more strongly associated with clinical outcomes. Early ICU CysC predicted SCr-AKI development (AUC 0.70, 95 % CI 0.53-0.89). CONCLUSIONS: Our findings do not support replacing SCr by CysC to define AKI. Early ICU CysC predicts SCr-AKI development and combined SCr-CysC-AKI definition leads to stronger AKI biomarker associations.

Extent, risk factors, and outcome of fluid overload after pediatric heart surgery*.

OBJECTIVES: Fluid overload is associated with poor PICU outcomes in different populations. Little is known about fluid overload in children undergoing cardiac surgery. We described fluid overload after cardiac surgery, identified risk factors of worse fluid overload and also determined if fluid overload predicts longer length of PICU stay, prolonged mechanical ventilation (length of ventilation) and worse lung function as estimated by the oxygenation index. DESIGN: Retrospective cohort study. SETTING: Montreal Children's Hospital PICU, Montreal, Canada. PATIENTS: Patients 18 years or younger undergoing cardiac surgery (2005-2007). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Cumulative fluid overload % was calculated as [(total fluid in - out in L)/admission weight (kg) × 100] and expressed as PICU peak cumulative fluid overload % throughout admission and PICU day 2 cumulative fluid overload %. Primary outcomes were length of stay and length of ventilation. The secondary outcome was oxygenation index. Fluid overload risk factors were evaluated using stepwise linear regression. Fluid overload-outcome relations were evaluated using stepwise Cox regression (length of stay, length of ventilation) and generalized estimating equations (daily PICU cumulative fluid overload % and oxygenation index repeated measures). There were 193 eligible surgeries. Peak cumulative fluid overload % was 7.4% ± 11.2%. Fluid overload peaked on PICU day 2. Lack of past cardiac surgery (p = 0.04), cyanotic heart disease (p = 0.03), and early postoperative fluids (p = 0.0001) was independently associated with higher day 2 fluid overload %. Day 2 fluid overload % predicted longer length of stay (adjusted hazard ratio, 0.95; 95% CI, 0.92-0.99; p = 0.009) and length of ventilation (adjusted hazard ratio, 0.97; 95% CI, 0.94-0.99; p = 0.03). In patients without cyanotic heart disease, worse daily fluid overload % predicted worse daily oxygenation index. CONCLUSION: Fluid overload occurs early after cardiac surgery and is associated with prolonged PICU length of stay and ventilation. Future fluid overload avoidance trials may confirm or refute a true fluid overload-outcome causative association.