Evaluating Pediatric Sepsis Definitions Designed for Electronic Health Record Extraction and Multicenter Quality Improvement.

OBJECTIVES: To describe the Children's Hospital Association's Improving Pediatric Sepsis Outcomes sepsis definitions and the identified patients; evaluate the definition using a published framework for evaluating sepsis definitions. DESIGN: Observational cohort. SETTING: Multicenter quality improvement collaborative of 46 hospitals from January 2017 to December 2018, excluding neonatal ICUs. PATIENTS: Improving Pediatric Sepsis Outcomes Sepsis was defined by electronic health record evidence of suspected infection and sepsis treatment or organ dysfunction. A more severely ill subgroup, Improving Pediatric Sepsis Outcomes Critical Sepsis, was defined, approximating septic shock. INTERVENTIONS: Participating hospitals identified patients, extracted data, and transferred de-identified data to a central data warehouse. The definitions were evaluated across domains of reliability, content validity, construct validity, criterion validity, measurement burden, and timeliness. MEASUREMENTS AND MAIN RESULTS: Forty hospitals met data quality criteria across four electronic health record platforms. There were 23,976 cases of Improving Pediatric Sepsis Outcomes Sepsis, including 8,565 with Improving Pediatric Sepsis Outcomes Critical Sepsis. The median age was 5.9 years. There were 10,316 (43.0%) immunosuppressed or immunocompromised patients, 4,135 (20.3%) with central lines, and 2,352 (11.6%) chronically ventilated. Among Improving Pediatric Sepsis Outcomes Sepsis patients, 60.8% were admitted to intensive care, 26.4% had new positive-pressure ventilation, and 19.7% received vasopressors. Median hospital length of stay was 6.0 days (3.0-13.0 d). All-cause 30-day in-hospital mortality was 958 (4.0%) in Improving Pediatric Sepsis Outcomes Sepsis; 541 (6.3%) in Improving Pediatric Sepsis Outcomes Critical Sepsis. The Improving Pediatric Sepsis Outcomes Sepsis definitions demonstrated strengths in content validity, convergent construct validity, and criterion validity; weakness in reliability. Improving Pediatric Sepsis Outcomes Sepsis definitions had significant initial measurement burden (median time from case completion to submission: 15 mo [interquartile range, 13-18 mo]); timeliness improved once data capture was established (median, 26 d; interquartile range, 23-56 d). CONCLUSIONS: The Improving Pediatric Sepsis Outcomes Sepsis definitions demonstrated feasibility for large-scale data abstraction. The patients identified provide important information about children treated for sepsis. When operationalized, these definitions enabled multicenter identification and data aggregation, indicating practical utility for quality improvement.

Clinical Indices Can Standardize and Monitor Pediatric Care: A Novel Mechanism to Improve Quality and Safety.

OBJECTIVE: The Cancer Care Index (CCI), a single metric that sums the number of undesirable patient events in a given time frame (either preventable harm events or missed opportunities to provide optimal care), resulted in a 42% improvement in performance. Our objective was to test the index concept in other service lines to determine whether similar performance improvement occurred. STUDY DESIGN: Care indices were developed and introduced in 3 additional service lines: Nephrology (Chronic Kidney Disease Care Index; CKDCI), Pulmonology (Lung Transplantation Care Index; LTCI), and Otolaryngology (Tracheostomy Care Index; TCI). After reaching agreement on specific harms to be avoided and elements of optimal care that should be reliably delivered, these items were compiled into indices that were updated monthly. Reports included each element individually and the total for all elements. Baseline performance was calculated retrospectively for the previous year. RESULTS: Significant improvement in performance occurred in each program following implementation of the clinical indices. The CKDCI was decreased by 63.2% (P < .001), the LTCI was decreased by 89.5% (P < .001), and the TCI was decreased by 53.0% (P < .001). Surveyed staff indicated satisfaction with use of the metric. CONCLUSIONS: Clinical indices are useful for evaluating and managing the overall reliability of a program's ability to deliver optimal care, and are associated with improved clinical performance and satisfaction by service line staff when incorporated into a program's operation.

Pediatric Critical Care Medicine Training: 2004-2016.

OBJECTIVES: To describe growth trends in the number of programs, positions, and applicants in pediatric critical care medicine fellowship training as part of the Pediatric Critical Care Medicine Training Study. DESIGN: Descriptive study. SETTINGS: Available archived Match data through the National Resident Matching Program and training data from the Accreditation Council for Graduate Medical Education. PATIENTS: None. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We analyzed all data on programs, positions, and applicants through the National Resident Matching Program Specialties Matching Service during the study period of 2004 to 2016. We also analyzed available training data available through the Accreditation Council for Graduate Medical Education for the corresponding study period. During the 12-year study period, there was a statistically significant expansion in programs (38%), positions (82%), and applicants (151%). Correspondingly, the percentage of pediatric critical care medicine programs participating in the Match as a percentage of all Accreditation Council for Graduate Medical Education-accredited programs for that academic year increased 24%. As of 2015, 94% of total first year positions offered for pediatric critical care medicine were through the Match. CONCLUSIONS: For the period 2004 to 2016, there was a substantial increase in positions and applicants applying for training in pediatric critical care medicine. We document an increase in demand (i.e., applicants) that has been matched by an increase in supply (i.e., positions) for pediatric critical care medicine fellowship training. The nearly complete use of the National Resident Matching Program for placing applicants in training positions in pediatric critical care medicine suggests that these data can be used to inform workforce analysis in pediatric critical care medicine.

Critical Care Delivery: The Importance of Process of Care and ICU Structure to Improved Outcomes: An Update From the American College of Critical Care Medicine Task Force on Models of Critical Care.

In 2001, the Society of Critical Care Medicine published practice model guidelines that focused on the delivery of critical care and the roles of different ICU team members. An exhaustive review of the additional literature published since the last guideline has demonstrated that both the structure and process of care in the ICU are important for achieving optimal patient outcomes. Since the publication of the original guideline, several authorities have recognized that improvements in the processes of care, ICU structure, and the use of quality improvement science methodologies can beneficially impact patient outcomes and reduce costs. Herein, we summarize findings of the American College of Critical Care Medicine Task Force on Models of Critical Care: 1) An intensivist-led, high-performing, multidisciplinary team dedicated to the ICU is an integral part of effective care delivery; 2) Process improvement is the backbone of achieving high-quality ICU outcomes; 3) Standardized protocols including care bundles and order sets to facilitate measurable processes and outcomes should be used and further developed in the ICU setting; and 4) Institutional support for comprehensive quality improvement programs as well as tele-ICU programs should be provided.

An internal quality improvement collaborative significantly reduces hospital-wide medication error related adverse drug events.

OBJECTIVE: To reduce the rate of harmful adverse drug events (ADEs) of severity level D-I from a baseline peak of 0.24 ADE/1000 doses to 0.08 ADE/1000 doses. STUDY DESIGN: A hospital-wide, quasi-experimental time series quality improvement (QI) initiative to reduce ADEs was implemented. High-reliability concepts, microsystem-based multidisciplinary teams, and QI science methods were used. ADEs were detected through a combination of voluntary reporting, trigger tool analysis, reversal agent review, and pharmacy interventions. A multidisciplinary ADE Quality Collaborative focused on medication use processes, not on specific classes of medications. Effective interventions included huddles and an ADE prevention bundle. RESULTS: The rate of harmful ADEs initially increased by >65% because of increased error reporting, temporally associated with the implementation of a program focused on high reliability and an improved safety culture. The quarterly rate was 0.17 ADE/1000 dispensed doses in Q1 2010. By the end of Q2 2013, the rate had decreased by 76.5%, to 0.04 ADE/1000 dispensed doses (P < .001). CONCLUSION: Using an internal collaborative model and QI methodologies focused on medication use processes, harmful ADEs were reduced hospital-wide by 76.5%. The concurrent implementation of a high-reliability, safety-focused program was important as well.

A comprehensive patient safety program can significantly reduce preventable harm, associated costs, and hospital mortality.

OBJECTIVE: To evaluate the effectiveness of a hospital-wide initiative to improve patient safety by implementing high-reliability practices as part of a quality improvement (QI) program aimed at reducing all preventable harm. STUDY DESIGN: A hospital wide quasi-experimental time series QI initiative using high-reliability concepts, microsystem-based multidisciplinary teams, and QI science tools to reduce hospital acquired harm was implemented. Extensive error prevention training was provided for all employees. Change concepts were enacted using the Institute for Healthcare Improvement's Model for Improvement. Compliance with change packages was measured. RESULTS: Between 2010 and 2012, the serious safety event rate decreased from 1.15 events to 0.19 event per 10 000 adjusted hospital-days, an 83.3% reduction (P < .001). Preventable harm events decreased by 53%, from a quarterly peak of 150 in the first quarter of 2010 to 71 in the fourth quarter of 2012 (P < .01). Observed hospital mortality decreased from 1.0% to 0.75% (P < .001), although severity-adjusted expected mortality actually increased slightly, and estimated harm-related hospital costs decreased by 22.0%. Hospital-wide safety climate scores increased significantly. CONCLUSION: Substantial reductions in serious safety event rate, preventable harm, hospital mortality, and cost were seen after implementation of our multifaceted approach. Measurable improvements in the safety culture were noted as well.

Bundled Care to Reduce Sepsis Mortality: The Improving Pediatric Sepsis Outcomes (IPSO) Collaborative.

OBJECTIVES: We sought to improve utilization of a sepsis care bundle and decrease 3- and 30- day sepsis-attributable mortality, as well as determine which care elements of a sepsis bundle are associated with improved outcomes. METHODS: Children's Hospital Association formed a QI collaborative to Improve Pediatric Sepsis Outcomes (IPSO) (January 2017-March 2020 analyzed here). IPSO Suspected Sepsis (ISS) patients were those without organ dysfunction where the provider "intended to treat" sepsis. IPSO Critical Sepsis (ICS) patients approximated those with septic shock. Process (bundle adherence), outcome (mortality), and balancing measures were quantified over time using statistical process control. An original bundle (recognition method, fluid bolus < 20 min, antibiotics < 60 min) was retrospectively compared with varying bundle time-points, including a modified evidence-based care bundle, (recognition method, fluid bolus < 60 min, antibiotics < 180 min). We compared outcomes using Pearson χ-square and Kruskal Wallis tests and adjusted analysis. RESULTS: Reported are 24 518 ISS and 12 821 ICS cases from 40 children's hospitals (January 2017-March 2020). Modified bundle compliance demonstrated special cause variation (40.1% to 45.8% in ISS; 52.3% to 57.4% in ICS). The ISS cohort's 30-day, sepsis-attributable mortality dropped from 1.4% to 0.9%, a 35.7% relative reduction over time (P < .001). In the ICS cohort, compliance with the original bundle was not associated with a decrease in 30-day sepsis-attributable mortality, whereas compliance with the modified bundle decreased mortality from 4.75% to 2.4% (P < .01). CONCLUSIONS: Timely treatment of pediatric sepsis is associated with reduced mortality. A time-liberalized care bundle was associated with greater mortality reductions.

Association Between Hospital-Acquired Harm Outcomes and Membership in a National Patient Safety Collaborative.

Importance: Hospital engagement networks supported by the US Centers for Medicare & Medicaid Services Partnership for Patients program have reported significant reductions in hospital-acquired harm, but methodological limitations and lack of peer review have led to persistent questions about the effectiveness of this approach. Objective: To evaluate associations between membership in Children's Hospitals' Solutions for Patient Safety (SPS), a federally funded hospital engagement network, and hospital-acquired harm using standardized definitions and secular trend adjustment. Design, Setting, and Participants: This prospective hospital cohort study included 99 children's hospitals. Using interrupted time series analyses with staggered intervention introduction, immediate and postimplementation changes in hospital-acquired harm rates were analyzed, with adjustment for preexisting secular trends. Outcomes were further evaluated by early-adopting (n = 73) and late-adopting (n = 26) cohorts. Exposures: Hospitals implemented harm prevention bundles, reported outcomes and bundle compliance using standard definitions to the network monthly, participated in learning events, and implemented a broad safety culture program. Hospitals received regular reports on their comparative performance. Main Outcomes and Measures: Outcomes for 8 hospital-acquired conditions were evaluated over 1 year before and 3 years after intervention. Results: In total, 99 hospitals met the inclusion criteria and were included in the analysis. A total of 73 were considered part of the early-adopting cohort (joined between 2012-2013) and 26 were considered part of the late-adopting cohort (joined between 2014-2016). A total of 42 hospitals were freestanding children's hospitals, and 57 were children's hospitals within hospital or health systems. The implementation of SPS was associated with an improvement in hospital-acquired condition rates in 3 of the 8 conditions after accounting for secular trends. Membership in the SPS was associated with an immediate reduction in central catheter-associated bloodstream infections (coefficient = -0.152; 95% CI, -0.213 to -0.019) and falls of moderate or greater severity (coefficient = -0.331; 95% CI, -0.594 to -0.069). The implementation of the SPS was associated with a reduction in the monthly rate of adverse drug events (coefficient = -0.021; 95% CI, -0.034 to -0.008) in the post-SPS period. The study team observed larger decreases for the early-adopting cohort compared with the late-adopting cohort. Conclusions and Relevance: Through the application of rigorous methods (standard definitions and longitudinal time series analysis with adjustment for secular trends), this study provides a more thorough analysis of the association between the Partnership for Patients hospital engagement network model and reductions in hospital-acquired conditions. These findings strengthen previous claims of an association between this model and improvement. However, inconsistent observations across hospital-acquired conditions when adjusted for secular trends suggests that some caution regarding attributing all effects observed to this model is warranted.

Multicenter cohort study of out-of-hospital pediatric cardiac arrest.

OBJECTIVES: To describe a large cohort of children with out-of-hospital cardiac arrest with return of circulation and to identify factors in the early postarrest period associated with survival. These objectives were for planning an interventional trial of therapeutic hypothermia after pediatric cardiac arrest. METHODS: A retrospective cohort study was conducted at 15 Pediatric Emergency Care Applied Research Network clinical sites over an 18-month study period. All children from 1 day (24 hrs) to 18 yrs of age with out-of-hospital cardiac arrest and a history of at least 1 min of chest compressions with return of circulation for at least 20 mins were eligible. MEASUREMENTS AND MAIN RESULTS: One hundred thirty-eight cases met study entry criteria; the overall mortality was 62% (85 of 138 cases). The event characteristics associated with increased survival were as follows: weekend arrests, cardiopulmonary resuscitation not ongoing at hospital arrival, arrest rhythm not asystole, no atropine or NaHCO3, fewer epinephrine doses, shorter duration of cardiopulmonary resuscitation, and drowning or asphyxial arrest event. For the 0- to 12-hr postarrest return-of-circulation period, absence of any vasopressor or inotropic agent (dopamine, epinephrine) use, higher lowest temperature recorded, greater lowest pH, lower lactate, lower maximum glucose, and normal pupillary responses were all associated with survival. A multivariate logistic model of variables available at the time of arrest, which controlled for gender, age, race, and asystole or ventricular fibrillation/ventricular tachycardia anytime during the arrest, found the administration of atropine and epinephrine to be associated with mortality. A second model using additional information available up to 12 hrs after return of circulation found 1) preexisting lung or airway disease; 2) an etiology of arrest drowning or asphyxia; 3) higher pH, and 4) bilateral reactive pupils to be associated with lower mortality. Receiving more than three doses of epinephrine was associated with poor outcome in 96% (44 of 46) of cases. CONCLUSIONS: Multiple factors were identified as associated with survival after out-of-hospital pediatric cardiac arrest with the return of circulation. Additional information available within a few hours after the return of circulation may diminish outcome associations of factors available at earlier times in regression models. These factors should be considered in the design of future interventional trials aimed to improve outcome after pediatric cardiac arrest.