Blunt head trauma is a leading cause of mortality and morbidity in children. However, greater than 95% of the more than 450,000 children who present to US emergency departments annually with blunt head trauma have minor head trauma. Although important traumatic brain injuries (TBI) are infrequent, clinicians obtain cranial computed tomography (CT) in up to 50% of children with minor blunt head trauma, exposing them to radiation with its potential to induce malignancies. Given the substantial burden of blunt head trauma to families and society, as well as the importance of minimizing radiation exposure, this study will investigate whether implementation of the recently validated Pediatric Emergency Care Applied Research Network (PECARN) TBI prediction rules using computerized clinical decision support can decrease unnecessary use of CT in children with minor blunt head trauma. The overall goal of this study is to promote the appropriate use of CT for children with blunt head trauma by creating a generalizable model to translate evidence into clinical practice.
The study objectives are:
- To rigorously develop an integrated electronic health record blunt head trauma data collection template and computer-based clinical decision support system to implement the PECARN TBI prediction rules for children; and,
- To assess whether implementing the prediction rules via computerized clinical decision support decreases the number of (unnecessary) cranial CTs in children with minor blunt head trauma at very low risk of traumatic brain injuries.
In order to meet study objective one, we will conduct focus groups of clinicians and perform emergency department workflow evaluations; develop an electronic health record blunt head trauma template that captures patient encounter data; and develop computerized clinical decision support to provide CT recommendations. Subsequently (in order to meet objective two), we will conduct a seven–center prospective, interrupted time series trial with concurrent controls that assesses CT use prior to and after the implementation of the electronic health record-clinical decision support (EHR-CDS) intervention system. We hypothesize that the EHR-CDS intervention system will safely decrease the use of CT compared to passive diffusion. This project is funded by the American Recovery and Reinvestment Act—Office of the Secretary (ARRA OS): Grant #S02MC19289-01-00.
Preliminary data strongly support the concept that diabetic ketoacidosis (DKA) related cerebral injury and subsequent edema may occur as a spectrum of severity. Although only a minority of children develop clinically-overt DKA-related cerebral injury of sufficient severity for obvious, profound neurological dysfunction, a much larger percentage may have subtle cerebral injury. The impact of variation in DKA treatment protocols on this cerebral injury is unknown and arguments for either slower or faster fluid treatment protocols can be made.
This study is a factorial-design, randomized controlled trial comparing four fluid treatment protocols for pediatric DKA. Two rates of rehydration will be compared; a more rapid rate, designed to promote faster reperfusion of brain tissue and a slower rate, geared toward more gradual reperfusion. Within each of these two basic rehydration schemes, we will vary the type of rehydration fluid used (0.9% saline or 0.45% saline). We will compare treatment arms using a comprehensive set of assessments for neurological injury including measurements of subtle neurological dysfunction during DKA treatment (in addition to recording the frequency of acute, clinically-overt cerebral edema) and measures of long-term neurocognitive function. These studies will not only allow us to determine whether variations in fluid treatment protocols affect acute neurological outcomes of DKA, but also will provide important additional data regarding the impact of DKA and DKA treatment on long-term neurocognitive function in children. In this way, we hope to identify a more ideal fluid management strategy for children with DKA. The anticipated enrollment period is from Fall 2010-2015. This project is co-funded by NICHD.
This study assesses the effectiveness and safety of the administration of oral dexamethasone for acute moderate to severe bronchiolitis in children seen in the ED, both with regard to the need for hospitalization (primary outcome), and severity and duration of disease (secondary outcomes). The study hypothesized that dexamethasone would be more effective than placebo in preventing hospital admission of infants with bronchiolitis.
This study was was conducted at selected sites within PECARN for a three-year period (during Bronchiolitis seasons). The study was co-funded by the Health Resources and Services Administration’s (HRSA) Maternal and Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) Program and the Research Program. Data collection began in January, 2004. The study concluded in Spring, 2006. We successfully enrolled 600 patients in this study, and we determined that there was no reduction in hospitalizations or improvement in respiratory scores associated with the administration of oral dexamethasone. Findings were published in the New England Journal of Medicine on July 26th, 2007. The public use data set can be requested here.
The ED-STARS study will develop and test a brief, personalized, computer-based suicide risk screening tool for teenagers. During the first study, over 6,000 youth were screened, and researchers followed up on a subsample of 12-17 year-olds who scored high on suicide risk factors – as well as those who scored low. Their experiences over a 6-month period were used to develop a computerized adaptive screen (CAS) for predicting suicide attempts that adjusts its line of questioning depending on responses to previous questions. The researchers will then compare the sensitivity, specificity, and predictive value of the CAS with the Ask Suicide-Screening Questions (ASQ), a standardized ED youth suicide prevention screening tool. Study Two began the summer of 2017 and will validate the CAS and associated risk stratification algorithm, determining the measure’s ability to predict suicide attempts in a new sample of 4,000 youth. The potential benefit of including a behavioral test of suicidal thoughts, the Implicit Association Test (IAT), as part of the screening process will also be evaluated. This study is funded by the National Institute for Mental Health (NIMH).
The objective of this protocol was to study pediatric emergency medical services (EMS) within the PECARN network and establish the network’s capability to collect pre-hospital data. This descriptive study initiated data collection from EMS agencies. The project aimed to demonstrate that data transmission from EMS agencies to the data center is feasible. This study established research relationships between PECARN sites and respective EMS agencies and gather data to understand the demographics and disease/injury patterns of the sample that is available to the PECARN network. The data collected will be invaluable in the future for generating hypotheses for pediatric EMS studies and providing preliminary data for grant applications. Data collection and analyses are complete. The main manuscript, Characteristics of the Pediatric Patients Treated by the Pediatric Emergency Care Applied Research Network’s Affiliated EMS Agencies,was published in Pediatric Emergency Care, October 2013.
This was a prospective study of children with minor-to-moderate blunt head trauma with a goal of identifying high-risk and low-risk indicators of traumatic brain injury (TBI). The goal was to derive the evidence on which to base appropriate use of head computerized tomography (CT) in children with acute head injury, which will hopefully reduce the number of unnecessary CT scans for children at very low risk for TBI. This will minimize the exposure of these children to the significant drawbacks related to CT (ionizing radiation, transport of children away from the direct observation of the emergency department, pharmacological sedation, and additional health care costs).
The study was co-funded by the Health Resources and Services Administration’s (HRSA) Maternal and Child Health Bureau (MCHB) Emergency Medical Services for Children (EMSC) Program and the Research Program. Data collection began in June, 2004 at all PECARN sites, and concluded in September, 2006. The network successfully enrolled 34,000 patients for the derivation of two clinical decision rules (one for children < 2 years and one for children > 2 years), and an additional 9,000 patients to validate the decision rules. Multiple abstracts from this study have been presented at national emergency medicine and pediatric meetings to date. Several manuscripts have been published including the main prediction rule manuscript which was published in Lancet (October 3, 2009). The public use data set can be requested here.
This was a prospective study of children with blunt torso trauma with a goal of identifying high-risk and low-risk indicators of intra-abdominal injury (IAI). The long term objective of the study is to derive, validate, disseminate and implement decision support tools to optimize the evaluation of children with blunt torso trauma, which will lead to reduced morbidity and mortality. The overall objective of this particular study is to develop a clinical decision rule for appropriate use of abdominal computerized tomography (CT) scanning in children with blunt torso trauma. We will create a decision rule that identifies those children in need of emergent CT scan and treatment, while reducing the use of abdominal CT scans in those children with minimal risk of IAI. The study was funded by the Centers for Disease Control and Prevention. Patient enrollment began in May, 2007 and concluded in January 2010. The main paper, Identifying Children at Very Low Risk of Clinically Important Blunt Abdominal Injuries, was published in Annals of Emergency Medicine, in Feb 2013. The public use data set can be requested here.
ASSESS (Age Specific Screen for Ethanol and Substance Status) aims to validate the newly developed National Institute for Alcohol Abuse and Alcoholism (NIAAA) two-question screen for early detection of alcohol use and problems in 12-17 year olds in 16 PECARN pediatric emergency departments. Approximately 5000 youths presenting to participating PECARN pediatric emergency departments (PED) were enrolled over a 3 year period. Subjects completed the two-question screen along with an alcohol and other drug and behavior assessment battery. The advantage of the PED setting is the ability to capture high risk populations such as school dropouts and those without primary care or insurance, who often use PEDs for their medical care and are missed in other study settings. This study is funded by the National Institute for Alcohol Abuse and Alcoholism (NIAAA).
The Arginine Feasibility project was funded as part of an R34 clinical trials planning grant that will establish a protocol steering committee with expertise in Sickle Cell Disease (SCD) clinical trials, create a clinical network of sites with a strong track record of successful participation in multi-center trials, create an ED-based pain protocol, develop a data coordinating plan, identify safety and clinical endpoints and a completed protocol for a phase III clinical trial of L-arginine for the treatment of vaso-occlusive pain in children with SCD to be submitted for NIH funding. Specifically this study is creating a standardized ED-based pain therapy protocol based on NIH guidelines that will be utilized in the future phase III trial, collecting feasibility data on volume, time of visit and admission rates from high-volume PECARN and non-PECARN sites on all potentially eligible patients with SCD and collecting demographic and clinical data through a 20 patient chart review at each participating site. This study is funded through the NHLBI.
The ultimate goal of this project is to incorporate a RNA-based diagnostic technology (called transcriptional signatures) to distinguish between bacterial and non-bacterial infections in otherwise well-appearing febrile infants who present to the EDs. The project aims to create a PECARN wide infrastructure for conducting translational genomic research and demonstrate feasibility of screening, consenting, collecting, and processing of small volumes of blood samples to abstract high quality RNA from febrile infants. After initially defining bacterial and non-bacterial biosignatures, we will conduct a limited validation of these diagnostic biosignatures on an independent group of febrile infants. Patient enrollment began in 2008 and continued through May 2013. Analysis is in progress. This project is co-funded by NICHD.
