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

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Parshuram is one of the named inventors of the Bedside Paediatric Early Warning System and owns shares in a company involved in commercialization of the BedsidePEWS. No other disclosures were reported.

Figures

Figure 1.. Hospital Site and Patient Flow Through Study

aEnrollment began in 2011 for 8 hospitals, in 2012 for 10 hospitals, and in 2013 for 5 hospitals. Disclosure of randomization to the hospital occurred during the second week of the 26-week baseline period. bHospitals randomized to the BedsidePEWS intervention collected data during the 26-week baseline period as they prepared for implementation of the intervention. During the 5-week run-in phase, adherence to vital sign documentation was assessed and reported to the study executive steering committee. Implementing hospitals required a minimum of 80% adherence to documentation standards and the majority vote of the executive steering committee to move into the intervention period. cHospitals randomized to usual care collected data during the 26-week baseline period, did not collect data during the 5-week run-in phase, and then resumed data collection for the 52-week intervention period. dDid not include beds in the intensive care unit. eDischarges were all eligible patients discharged from the hospital and included the patients who died. Patients who were in the hospital at the end of the study period were regarded as discharged. fUnable to adhere to implementation timelines specified by the study and were excluded before implementation. These hospitals were regional pediatric centers. One hospital had a rapid response team and no extracorporeal membrane oxygenation and the other did not have a rapid response team but had extracorporeal membrane oxygenation. The numbers of patient-days and patient discharges reported reflect the amount of data received from each hospital before they withdrew from the study. gThe 5-week run-in phase included weekly assessment beginning during the second week of implementation.

Figure 2.. Mortality by Hospital

All-cause hospital mortality rates during the baseline and intervention periods are presented by hospital. Each circle represents a hospital. The circle center reflects the coordinates of the baseline and intervention mortality rates. The colored lines represent the linearized fitted relationships between mortality during the baseline and intervention periods for the BedsidePEWS intervention hospitals (dashed orange line) and usual care hospitals (solid blue line). The estimated difference in the slopes between the BedsidePEWS (slope = 0.57) and the usual care group (slope = 0.53) was not statistically significantly different from 0 (P = .94). In the analysis, the slopes were assumed to be equal. In Supplement 3, eFigure 1 provides linkage of these hospital-level mortality data to additional information about the individual hospitals contained in eTables 2 and 3. aThe circle size is proportional to the number of discharges during the intervention period of that hospital. Thus hospitals with larger circles are contributing more data and will have narrower 95% CIs for the true values of their mortality rates.