OBJECTIVES: In the United States, pediatric emergency department (ED) visits for behavioral health (BH) are increasing. We sought to determine ED-level characteristics associated with having recommended BH-related policies. METHODS: We conducted a retrospective serial cross-sectional study of National Pediatric Readiness Project assessments administered to US EDs in 2013 and 2021. Changes in responses related to BH items over time were examined. Multivariable logistic regression models examined ED characteristics associated with the presence of specific BH-related policies in 2021. RESULTS: Of 3554 EDs that completed assessments in 2021, 73.0% had BH-related policies, 66.5% had transfer guidelines for children with BH issues, and 38.6% had access to BH resources in a disaster. Of 2570 EDs that completed assessments in both 2013 and 2021, presence of specific BH-related policies increased from 48.6% to 72.0% and presence of appropriate transfer guidelines increased from 56.2% to 64.9%. The adjusted odd ratios (aORs) of having specific BH-related policies were lower in rural (aOR 0.73; 95% confidence interval [CI] 0.57, 0.92) and remote EDs (aOR 0.65; 95% CI 0.48, 0.88) compared to urban EDs; lower among EDs with versus without trauma center designation (aOR 0.80; 95% CI 0.67, 0.95); and higher among EDs with a nurse and physician pediatric emergency care coordinator (PECC) (aOR 1.89; 95% CI 1.54, 2.33) versus those without a PECC. CONCLUSION: Although pediatric readiness for BH conditions increased from 2013 to 2021, gaps remain, particularly among rural EDs and designated trauma centers. Having nurse and physician PECCs is a modifiable strategy to increase ED pediatric readiness pertaining to BH.

Background

There is wide variability of transfusion practices for children with hemorrhagic injuries across trauma centers. We are planning a multicenter, randomized clinical trial evaluating tranexamic acid in children with hemorrhage. Standardization of transfusion practices across sites is important to minimize confounding. Therefore, we sought to generate consensus-based transfusion guidelines for the trial.

Methods

We used a modified Delphi process utilizing a multi-site, multi-disciplinary panel of experts to develop our transfusion guidelines. A survey of 23 clinical categories on various aspects of transfusion practices was developed and distributed via SurveyMonkey®. Statements were graded on a 5-point Likert scale ("Strongly agree" to "This intervention may be harmful"). Statements were accepted if ≥ 80% of the panelists rated the statement as "Strongly agree" or "Agree". After each round, the responses were calculated and the results included on subsequent rounds.

Results

35 panelists from four pediatric trauma centers participated in the study, including 11 (31%) pediatric EM physicians, 8 (23%) pediatric trauma surgeons, 5 (14%) transfusionists, 5 (14%) pediatric anesthesiologists, and 6 (17%) pediatric critical care physicians (range of 8 to 10 from each clinical site). Four survey iterations were performed. In total 176 statements were rated and 39 were accepted by criteria across all 23 categories. An rational algorithm for transfusion in trauma was then developed.

Conclusions

We successfully developed transfusion guidelines for various aspects of the management of children with hemorrhagic injuries using a modified Delphi process with broad interdisciplinary participation. We anticipate implementation of these guidelines will help minimize heterogeneity of transfusion practices across clinical sites for the upcoming clinical trial evaluating tranexamic acid in children with hemorrhage.

OBJECTIVE: Whether ambulance transport patterns are optimized to match children to high-readiness emergency departments (EDs) and the resulting effect on survival are unknown. We quantified the number of children transported by 9-1-1 emergency medical services (EMS) to high-readiness EDs, additional children within 30 minutes of a high-readiness ED, and the estimated effect on survival. METHODS: This was a cross-sectional study using data from the National EMS Information System for 5,461 EMS agencies in 28 states from 1/1/2012 through 12/31/2019, matched to the 2013 National Pediatric Readiness Project assessment of ED pediatric readiness. We performed a geospatial analysis of children 0 to 17 years requiring 9-1-1 EMS transport to acute care hospitals, including day-, time-, and traffic-adjusted estimates for driving times to all EDs within 30 minutes of the scene. We categorized receiving hospitals by quartile of ED pediatric readiness using the weighted Pediatric Readiness Score (wPRS, range 0-100) and defined a high-risk subgroup of children as a proxy for admission. We used published estimates for the survival benefit of high readiness EDs to estimate the number of lives saved. RESULTS: There were 808,536 children transported by EMS, of whom 253,541 (31.4%) were high-risk. Among the 2,261 receiving hospitals, the median wPRS was 70 (IQR 57-85, range 26-100) and the median number of receiving hospitals within 30 minutes was 4 per child (IQR 2-11, range 1 to 53). Among all children, 411,685 (50.9%) were taken to EDs in the highest quartile of pediatric readiness, and 180,547 (22.3%) children transported to lower readiness EDs were within 30 minutes of a high readiness ED. Findings were similar among high-risk children. Based on high-risk children, we estimated that 3,050 pediatric lives were saved by transport to high-readiness EDs and an additional 1,719 lives could have been saved by shifting transports to high readiness EDs within 30 minutes. CONCLUSIONS: Approximately half of children transported by EMS were taken to high-readiness EDs and an additional one quarter could have been transported to such an ED, with measurable effect on survival.

Background

There is wide variability of transfusion practices for children with hemorrhagic injuries across trauma centers. We are planning a multicenter, randomized clinical trial evaluating tranexamic acid in children with hemorrhage. Standardization of transfusion practices across sites is important to minimize confounding. Therefore, we sought to generate consensus-based transfusion guidelines for the trial.

Methods

We used a modified Delphi process utilizing a multi-site, multi-disciplinary panel of experts to develop our transfusion guidelines. A survey of 23 clinical categories on various aspects of transfusion practices was developed and distributed via SurveyMonkey®. Statements were graded on a 5-point Likert scale ("Strongly agree" to "This intervention may be harmful"). Statements were accepted if ≥ 80% of the panelists rated the statement as "Strongly agree" or "Agree". After each round, the responses were calculated and the results included on subsequent rounds.

Results

35 panelists from four pediatric trauma centers participated in the study, including 11 (31%) pediatric EM physicians, 8 (23%) pediatric trauma surgeons, 5 (14%) transfusionists, 5 (14%) pediatric anesthesiologists, and 6 (17%) pediatric critical care physicians (range of 8 to 10 from each clinical site). Four survey iterations were performed. In total 176 statements were rated and 39 were accepted by criteria across all 23 categories. An rational algorithm for transfusion in trauma was then developed.

Conclusions

We successfully developed transfusion guidelines for various aspects of the management of children with hemorrhagic injuries using a modified Delphi process with broad interdisciplinary participation. We anticipate implementation of these guidelines will help minimize heterogeneity of transfusion practices across clinical sites for the upcoming clinical trial evaluating tranexamic acid in children with hemorrhage.

Background

Federal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries.

Methods

We conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3 months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC.

Results

We enrolled one of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, seven (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12 months.

Conclusions

In a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.

OBJECTIVE: We estimate annual hospital expenditures to achieve high emergency department (ED) pediatric readiness (HPR), that is, weighted Pediatric Readiness Score (wPRS) ≥ 88 (0-100 scale) across EDs with different pediatric volumes of children, overall and after accounting for current levels of readiness. METHODS: We calculated the annual hospital costs of HPR based on two components: (1) ED pediatric equipment and supplies and (2) labor costs required for a Pediatric Emergency Care Coordinator (PECC) to perform pediatric readiness tasks. Data sources to generate labor cost estimates included: 2021 national salary information from U.S. Bureau of Labor Statistics, detailed patient and readiness data from 983 EDs in 11 states, the 2021 National Pediatric Readiness Project assessment; a national PECC survey; and a regional PECC survey. Data sources for equipment and supply costs included: purchasing costs from seven healthcare organizations and equipment usage per ED pediatric volume. We excluded costs of day-to-day ED operations (ie, direct clinical care and routine ED supplies). RESULTS: The total annual hospital costs for HPR ranged from $77,712 (95% CI 54,719-100,694) for low volume EDs to $279,134 (95% CI 196,487-362,179) for very high volume EDs; equipment costs accounted for 0.9-5.0% of expenses. The total annual cost-per-patient ranged from $3/child (95% CI 2-4/child) to $222/child (95% CI 156-288/child). After accounting for current readiness levels, the cost to reach HPR ranged from $23,775 among low volume EDs to $145,521 among high volume EDs, with costs per patient of $4/child to $48/child. CONCLUSIONS: Annual hospital costs for HPR are modest, particularly when considered per child.

BACKGROUND: Injured children initially treated at trauma centers with high emergency department (ED) pediatric readiness have improved survival. Centers with limited resources may not be able to address all pediatric readiness deficiencies, and there currently is no evidence-based guidance for prioritizing different components of readiness. The objective of this study was to identify individual components of ED pediatric readiness associated with better-than-expected survival in US trauma centers to aid in the allocation of resources targeted at improving pediatric readiness. METHODS: This cohort study of US trauma centers used the National Trauma Data Bank (2012-2017) matched to the 2013 National Pediatric Readiness Project assessment. Adult and pediatric centers treating at least 50 injured children (younger than 18 years) and recording at least one death during the 6-year study period were included. Using a standardized risk-adjustment model for trauma, we calculated the observed-to-expected mortality ratio for each trauma center. We used bivariate analyses and multivariable linear regression to assess for associations between individual components of ED pediatric readiness and better-than-expected survival. RESULTS: Among 555 trauma centers, the observed-to-expected mortality ratios ranged from 0.07 to 4.17 (interquartile range, 0.93-1.14). Unadjusted analyses of 23 components of ED pediatric readiness showed that trauma centers with better-than-expected survival were more likely to have a validated pediatric triage tool, comprehensive quality improvement processes, a pediatric-specific disaster plan, and critical airway and resuscitation equipment (all p < 0.03). The multivariable analysis demonstrated that trauma centers with both a physician and a nurse pediatric emergency care coordinator had better-than-expected survival, but this association weakened after accounting for trauma center level. Child maltreatment policies were associated with lower-than-expected survival, particularly in Levels III to V trauma centers. CONCLUSION: Specific components of ED pediatric readiness were associated with pediatric survival among US trauma centers. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

High emergency department (ED) pediatric readiness is associated with improved survival in children, but the cost is unknown. We evaluated the costs of emergency care for children across quartiles of ED pediatric readiness. This was a retrospective cohort study of children aged 0-17 years receiving emergency services in 747 EDs in 9 states from January 1, 2012, through December 31, 2017. We measured ED pediatric readiness using the weighted Pediatric Readiness Score (range: 0-100). The primary outcome was the total cost of acute care (ED and inpatient) in 2022 dollars, adjusted for ED case mix and hospital characteristics. A total of 15 138 599 children received emergency services, including 27.6% with injuries and 72.4% with acute medical illness. The average adjusted per-patient cost by quartile of ED pediatric readiness ranged from $991 (quartile 1) to $1064 (quartile 4) for injured children and $1104-$1217 for medical children. The resulting cost differences were $72 (95% CI: -$6 to $151) and $113 (95% CI: $20-$206), respectively. Receiving emergency care in high-readiness EDs was not associated with marked increases in the cost of delivering services.

Background

Trauma is the leading cause of morbidity and mortality in children in the United States. The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage, however, the drug has not been evaluated in a clinical trial in severely injured children. We designed the Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC) trial to evaluate the feasibility of conducting a confirmatory clinical trial that evaluates the effects of TXA in children with severe trauma and hemorrhagic injuries.

Methods

Children with severe trauma and evidence of hemorrhagic torso or brain injuries will be randomized to one of three arms: (1) TXA dose A (15 mg/kg bolus dose over 20 min, followed by 2 mg/kg/hr infusion over 8 h), (2) TXA dose B (30 mg/kg bolus dose over 20 min, followed by 4 mg/kg/hr infusion over 8 h), or (3) placebo. We will use permuted-block randomization by injury type: hemorrhagic brain injury, hemorrhagic torso injury, and combined hemorrhagic brain and torso injury. The trial will be conducted at four pediatric Level I trauma centers. We will collect the following outcome measures: global functioning as measured by the Pediatric Quality of Life (PedsQL) and Pediatric Glasgow Outcome Scale Extended (GOS-E Peds), working memory (digit span test), total amount of blood products transfused in the initial 48 h, intracranial hemorrhage progression at 24 h, coagulation biomarkers, and adverse events (specifically thromboembolic events and seizures).

Discussion

This multicenter trial will provide important preliminary data and assess the feasibility of conducting a confirmatory clinical trial that evaluates the benefits of TXA in children with severe trauma and hemorrhagic injuries to the torso and/or brain.

Trial registration

ClinicalTrials.gov registration number: NCT02840097 . Registered on 14 July 2016.

Background

The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We assessed the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries.

Methods

Severely injured children (0 up to 18th birthday) were randomized into a double-blind randomized trial of (1) TXA 15 mg/kg bolus dose, followed by 2 mg/kg/h infusion over 8 h, (2) TXA 30 mg/kg bolus dose, followed by 4 mg/kg/h infusion over 8 h, or (3) normal saline placebo bolus and infusion. The trial was conducted at four pediatric Level I trauma centers in the United States between June 2018 and March 2020. We enrolled patients under federal exception from informed consent (EFIC) procedures when parents were unable to provide informed consent. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The target enrollment rate was at least 1.25 patients per site per month.

Results

A total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 h (SD 0.6 h). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (nine patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified.

Conclusion

Based on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.