Early Administration of Steroids in the Ambulance Setting

Study Overview
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Brief Summary
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Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-sensitive, decreases in hospital admissions and ED length-of-stay (LOS). For patients who are treated by 911 emergency medical services (EMS) first, there exists an opportunity for even earlier administration of CS, prior to ED arrival. Yet, preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival. Given the known time-sensitivity of CS' effects on patient outcomes, the investigators hypothesize that even earlier EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions for pediatric patients with an acute asthma exacerbation. Using a pragmatic observation stepped wedge design in multiple EMS agencies, we will enroll patients over a three-year period to analyze clinical outcomes and comparative costs of EMS CS administration, and how both are influenced by EMS transport time. That novel combination of analyses will help build evidence-based guidelines adaptable for diverse EMS agencies nationwide.

Official Title
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Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial

Conditions
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Asthma in Children

Intervention / Treatment
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* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary problem: Asthma exacerbation stable to take an oral medication transported by EMS to an ED Exclusion Criteria: unconscious, hemodynamically unstable, or critically ill -> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol) daily or every other day corticosteroid therapy allergy to prednisolone or another corticosteroid chronic lung disease besides asthma, airway anatomic abnormalities, tracheostomy, immunocompromised, traumatic injury, pregnancy, law enforcement custody, non-English speaking

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a stepped wedge design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Prehospital Systemic Corticosteroids<br>Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services | Drug: Prednisolone<br>* During a sequenced rollout protocol change for several EMS agencies, those agencies will adopt protocol change to administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival.<br>|
| No Intervention: Usual Care<br>Children with asthma attacks treated by emergency medical services who receive usual care en route to emergency departments, where in the ED they then receive systemic corticosteroids | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Admission | Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation | Day 1 (ED stay) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Department length-of-stay | Length of time in emergency department for patients who are discharged home | Day 1 (from EMS arrival to ED discharge) |