Early Administration of Steroids in the Ambulance Setting (EASI-AS-ODT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Drug: Prednisolone

• Study Type: Interventional
• Enrollment (Actual): 1464
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • DeFuniak Springs, Florida, United States, 32433
      • Walton County EMS
    • Fort Myers, Florida, United States, 33905
      • Lee County Public Safety & Emergency Services
    • Sarasota, Florida, United States, 34236
      • Sarasota County EMS
    • Tallahassee, Florida, United States, 32301
      • Leon County EMS
    • Yulee, Florida, United States, 32097
      • Nassau County Fire Rescue Department
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital / UT Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Prehospital Systemic Corticosteroids; Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services	Drug: Prednisolone; 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.
No Intervention: Usual Care; 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?

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)

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Jennifer Fishe, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: IRB201901351 -N-A; 1K23HL149991-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No