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.

Metric Development for the Multicenter Improving Pediatric Sepsis Outcomes (IPSO) Collaborative.

BACKGROUND: A 56 US hospital collaborative, Improving Pediatric Sepsis Outcomes, has developed variables, metrics and a data analysis plan to track quality improvement (QI)-based patient outcomes over time. Improving Pediatric Sepsis Outcomes expands on previous pediatric sepsis QI efforts by improving electronic data capture and uniformity across sites. METHODS: An expert panel developed metrics and corresponding variables to assess improvements across the care delivery spectrum, including the emergency department, acute care units, hematology and oncology, and the ICU. Outcome, process, and balancing measures were represented. Variables and statistical process control charts were mapped to each metric, elucidating progress over time and informing plan-do-study-act cycles. Electronic health record (EHR) abstraction feasibility was prioritized. Time 0 was defined as time of earliest sepsis recognition (determined electronically), or as a clinically derived time 0 (manually abstracted), identifying earliest physiologic onset of sepsis. RESULTS: Twenty-four evidence-based metrics reflected timely and appropriate interventions for a uniformly defined sepsis cohort. Metrics mapped to statistical process control charts with 44 final variables; 40 could be abstracted automatically from multiple EHRs. Variables, including high-risk conditions and bedside huddle time, were challenging to abstract (reported in <80% of encounters). Size or type of hospital, method of data abstraction, and previous QI collaboration participation did not influence hospitals' abilities to contribute data. To date, 90% of data have been submitted, representing 200 007 sepsis episodes. CONCLUSIONS: A comprehensive data dictionary was developed for the largest pediatric sepsis QI collaborative, optimizing automation and ensuring sustainable reporting. These approaches can be used in other large-scale sepsis QI projects in which researchers seek to leverage EHR data abstraction.

Developing Tools to Enhance the Adaptive Capacity (Safety II) of Health Care Providers at a Children's Hospital.

Current safety efforts in health care use Safety I (find and fix), which has benefits and shortcomings. Safety leaders in multiple industries realize that complex adaptive systems require a new approach-Safety II (proactive safety). Our goal was to develop practical, usable tools to spread Safety II and resilience engineering competencies to clinical frontline staff. Using our prior research and Plan-Do-Study-Act cycles, we developed tools to enhance Safety II competencies that individuals with various backgrounds could understand. Tools address recognizing (Pause to Predict), responding (IDEA), and learning (Feed Forward). These are being taught organizationally in a unit-by-unit sequence. Use of these tools is expected to prompt a shift toward a more proactive mental model of safety that we want our frontline providers to adopt. Coordinating the expertise of bedside clinicians during unprecedented events can safely expand the boundaries of conditions under which we can provide high-quality care by increasing individuals' and subsequently our systems' adaptive capacity. We believe this is the first work describing attempts to operationalize Safety II concepts broadly in a health care organization.

Development of a Quality Improvement Learning Collaborative to Improve Pediatric Sepsis Outcomes.

Pediatric sepsis is a major public health problem. Published treatment guidelines and several initiatives have increased adherence with guideline recommendations and have improved patient outcomes, but the gains are modest, and persistent gaps remain. The Children's Hospital Association Improving Pediatric Sepsis Outcomes (IPSO) collaborative seeks to improve sepsis outcomes in pediatric emergency departments, ICUs, general care units, and hematology/oncology units. We developed a multicenter quality improvement learning collaborative of US children's hospitals. We reviewed treatment guidelines and literature through 2 in-person meetings and multiple conference calls. We defined and analyzed baseline sepsis-attributable mortality and hospital-onset sepsis and developed a key driver diagram (KDD) on the basis of treatment guidelines, available evidence, and expert opinion. Fifty-six hospital-based teams are participating in IPSO; 100% of teams are engaged in educational and information-sharing activities. A baseline, sepsis-attributable mortality of 3.1% was determined, and the incidence of hospital-onset sepsis was 1.3 cases per 1000 hospital admissions. A KDD was developed with the aim of reducing both the sepsis-attributable mortality and the incidence of hospital-onset sepsis in children by 25% from baseline by December 2020. To accomplish these aims, the KDD primary drivers focus on improving the following: treatment of infection; recognition, diagnosis, and treatment of sepsis; de-escalation of unnecessary care; engagement of patients and families; and methods to optimize performance. IPSO aims to improve sepsis outcomes through collaborative learning and reliable implementation of evidence-based interventions.

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.

The Vitals Risk Index-Retrospective Performance Analysis of an Automated and Objective Pediatric Early Warning System.

INTRODUCTION: Pediatric in-hospital cardiac arrests and emergent transfers to the pediatric intensive care unit (ICU) represent a serious patient safety concern with associated increased morbidity and mortality. Some institutions have turned to the electronic health record and predictive analytics in search of earlier and more accurate detection of patients at risk for decompensation. METHODS: Objective electronic health record data from 2011 to 2017 was utilized to develop an automated early warning system score aimed at identifying hospitalized children at risk of clinical deterioration. Five vital sign measurements and supplemental oxygen requirement data were used to build the Vitals Risk Index (VRI) model, using multivariate logistic regression. We compared the VRI to the hospital's existing early warning system, an adaptation of Monaghan's Pediatric Early Warning Score system (PEWS). The patient population included hospitalized children 18 years of age and younger while being cared for outside of the ICU. This dataset included 158 case hospitalizations (102 emergent transfers to the ICU and 56 "code blue" events) and 135,597 control hospitalizations. RESULTS: When identifying deteriorating patients 2 hours before an event, there was no significant difference between Pediatric Early Warning Score and VRI's areas under the receiver operating characteristic curve at false-positive rates ≤ 10% (pAUC10 of 0.065 and 0.064, respectively; P = 0.74), a threshold chosen to compare the 2 approaches under clinically tolerable false-positive rates. CONCLUSIONS: The VRI represents an objective, simple, and automated predictive analytics tool for identifying hospitalized pediatric patients at risk of deteriorating outside of the ICU setting.

Improved Safety Culture and Teamwork Climate Are Associated With Decreases in Patient Harm and Hospital Mortality Across a Hospital System.

OBJECTIVES: Improved safety and teamwork culture has been associated with decreased patient harm within specific units in hospitals or hospital groups. Most studies have focused on a specific harm type. This study's objective was to document such an association across an entire hospital system and across multiple harm types. METHODS: The Safety Attitudes Questionnaire (SAQ) was administered to all clinical personnel (including physicians) before, 2 years after, and 4 years after establishing a comprehensive patient safety/high-reliability program at a major children's hospital. Resultant data were analyzed hospital-wide as well as by individual units, medical sections, and professional groups. RESULTS: Safety attitude scores improved over the 3 surveys (P < 0.05) as did teamwork attitude scores (P = nonsignificant). These increases were accompanied by contemporaneous statistically significant decreases in all-hospital harm (P < 0.01), serious safety events (P < 0.001), and severity-adjusted hospital mortality (P < 0.001). Differences were noted between physicians' and nurses' views on specific safety and teamwork items within individual units, with nursing scores often lower. These discipline-specific differences decreased with time. CONCLUSIONS: Improved safety and teamwork climate as measured by SAQ are associated with decreased patient harm and severity-adjusted mortality. Discrepancies in SAQ scores exist between different professional groups but decreased over time.

The Cancer Care Index: A Novel Metric to Assess Overall Performance of a Pediatric Oncology Program.

OBJECTIVE: Childhood cancer metrics are currently primarily focused on survival rates and late effects of therapy. Our objectives were to design and test a metric that reflected overall quality and safety performance, across all cancer types, of an oncology-bone marrow transplant service line and to use the metric to drive improvement. METHOD: The Cancer Care Index (CCI) aggregates adverse safety events and missed opportunities for best practices into a composite score that reflects overall program performance without regard to cancer type or patient outcome. Fifteen domains were selected in 3 areas as follows: (1) treatment-related quality and safety, (2) provision of a harm-free environment, and (3) psychosocial support. The CCI is the aggregate number of adverse events or missed opportunities to provide quality care in a given time frame. A lower CCI reflects better care and improved overall system performance. Multidisciplinary microsystem-based teams addressed specific aims for each domain. The CCI was widely followed by all team members, particularly frontline providers. RESULTS: The CCI was easy to calculate and deploy and well accepted by the staff. The annual CCI progressively decreased from 278 in 2012 to 160 in 2014, a 42% reduction. Improvements in care were realized across most index domains. Multiple new initiatives were successfully implemented. CONCLUSIONS: The CCI is a useful metric to document performance improvement across a broad range of domains, regardless of cancer type. By the use of quality improvement science, progressive reduction in CCI has occurred over a 3-year period.

Writing Group Increases Quality Improvement Writing Competency.

Quality improvement (QI) is critically important in current medical practice. Although many QI courses teach improvement science and methods, formal education in writing QI manuscripts for academic journal publication is lacking. The authors developed a QI Writing program, consisting of educational sessions with both coach and peer mentors, to improve comfort and productivity in preparing QI manuscripts for publication. Program participants conducted pre- and post-course QI writing skills self-evaluations in 4 competency domains: SQUIRE guidelines, writing for peer-reviewed journals, QI publication submission steps, and critically examining QI results. Course success was measured by the number of manuscripts submitted for publication. QI writing competencies doubled in 3 of 4 domains and increased 70% in the fourth. Fifteen of 17 (88%) course participants submitted manuscripts to a peer-reviewed journal, and 12 have been accepted to date. A formal writing group with didactic content and committed mentors increases QI writing competencies and manuscript submissions to peer-reviewed journals.

A National Approach to Pediatric Sepsis Surveillance.

Pediatric sepsis is a major public health concern, and robust surveillance tools are needed to characterize its incidence, outcomes, and trends. The increasing use of electronic health records (EHRs) in the United States creates an opportunity to conduct reliable, pragmatic, and generalizable population-level surveillance using routinely collected clinical data rather than administrative claims or resource-intensive chart review. In 2015, the US Centers for Disease Control and Prevention recruited sepsis investigators and representatives of key professional societies to develop an approach to adult sepsis surveillance using clinical data recorded in EHRs. This led to the creation of the adult sepsis event definition, which was used to estimate the national burden of sepsis in adults and has been adapted into a tool kit to facilitate widespread implementation by hospitals. In July 2018, the Centers for Disease Control and Prevention convened a new multidisciplinary pediatric working group to tailor an EHR-based national sepsis surveillance approach to infants and children. Here, we describe the challenges specific to pediatric sepsis surveillance, including evolving clinical definitions of sepsis, accommodation of age-dependent physiologic differences, identifying appropriate EHR markers of infection and organ dysfunction among infants and children, and the need to account for children with medical complexity and the growing regionalization of pediatric care. We propose a preliminary pediatric sepsis event surveillance definition and outline next steps for refining and validating these criteria so that they may be used to estimate the national burden of pediatric sepsis and support site-specific surveillance to complement ongoing initiatives to improve sepsis prevention, recognition, and treatment.

Fostering Quality Improvement Capacity in a Network of Primary Care Practices Affiliated With a Pediatric Accountable Care Organization.

OBJECTIVES: Quality improvement (QI) methodologies are not widely implemented in primary care practices. As an accountable care organization serving pediatric Medicaid recipients in Ohio, Partners For Kids (PFK) sought to build QI capacity in affiliated primary care practices to improve organizational performance on key quality measures. METHODS: A team of QI specialists developed a comprehensive training program focused on pediatric QI initiatives. From 2014 to 2017, community-based, primary care practices affiliated with PFK were recruited to participate in QI. The primary outcome, assessed yearly, was the proportion of eligible PFK patients accessing care at a practice with ≥1 active QI project. The proportion of QI projects that demonstrated moderate improvement, defined as the implementation of ≥1 intervention and observed improvement in process measures, within 12 months of initiation was also calculated for 2017. RESULTS: Over the study period, the PFK QI team supported 72 projects in 33 primary care practices throughout central and southeast Ohio. In 2017, 26 practices were engaged in ≥1 active QI project, reaching 26% of all eligible PFK patients. Of the 21 projects active as of January 2017, 11 (52%) showed moderate improvement within 12 months. CONCLUSIONS: The PFK QI team successfully supported QI capacity building in primary care practices throughout Ohio using a systematic approach to recruitment, training, and QI resource support. New, multilevel interventions are needed to promote the uptake of preventive services among patients.

Quality Improvement-Driven Reduction in Countywide Medicaid Acute Asthma Health Care Utilization.

OBJECTIVE: This study evaluates the impact of a coordinated effort by an urban pediatric hospital and its associated accountable care organization to reduce asthma-related emergency department (ED) and inpatient utilization by a large, countywide Medicaid patient population. METHODS: Multiple evidence-based interventions targeting general pediatric asthma care and high health care utilizers were implemented using standardized quality improvement methodologies. Annual asthma ED and inpatient utilization rates by 2- to 18-year-old members of an accountable care organization living in the surrounding county (>140,000 eligible members in 2016), adjusted per 1000 children from 2008 through 2016, were analyzed using Poisson regression. We compared these ED utilization rates to national rates from 2006 to 2014. RESULTS: Asthma ED utilization fell from 18.1 to 12.9 visits/1000 children from 2008 to 2016, representing a 28.7% reduction, with an average annual decrease of 3.9% (P < .001), during a time when national utilization was increasing. Asthma inpatient utilization did not change significantly during the study period. CONCLUSIONS: Asthma-related ED utilization was significantly reduced in a large population of primarily urban, minority, Medicaid-insured children by implementing a multimodal asthma quality improvement program. With adequate support, a similar approach could be successful in other communities.

Clinical Indices to Drive Quality Improvement in Otolaryngology.

A Pediatric Tracheostomy Care Index (PTCI) was developed by the authors to standardize care and drive quality improvement efforts at their institution. The PTCI comprises 9 elements deemed essential for safe care of children with a tracheostomy tube. Based on the PTCI scores, the number of missed opportunities per patient was tracked, and interventions through a "Plan-Do-Study-Act" approach were performed. The establishment of the PTCI has been successful at standardizing, quantifying, and monitoring the consistency and documentation of care provided at the authors' institution.

Accelerating Improvement in Children's Healthcare Through Quality Improvement Collaboratives: A Synthesis of Recent Efforts.

PURPOSE OF REVIEW: Quality improvement collaboratives can accelerate quality improvement and patient safety efforts. We reviewed major pediatric quality improvement collaboratives that have published results in the past five years and discussed common success factors and barriers encountered by these collaboratives. RECENT FINDINGS: Many pediatric quality improvement collaboratives are active in neonatal, cystic fibrosis, congenital heart disease, hematology/oncoogy, chronic kidney disease, rheumatology, critical care, and general pediatric care. SUMMARY: Factors important to the success of these pediatric quality improvement collaboratives include data sharing and communication, trust among institutions, financial support, support from national organizations, use of a theoretical framework to guide collaboration, patient and family involvement, and incentives for participation at both the individual and institutional levels. Common barriers encountered by these collaboratives include insufficient funding or resources, legal concerns, difficulty coming to consensus on best practices and outcome measures, and overcoming cultural barriers to change. Learning from the successes and challenges encountered by these collaboratives will enable the pediatric healthcare quality improvement community to continue to evolve this approach to maximize benefits to children.