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

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT03962894
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
2,500
Enrollment
7
Locations
2
Arms
45.6
Anticipated Duration (Months)
357.1
Patients Per Site
7.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 both Lee County EMS and Nassau County Fire Rescue Department, we will enroll between 300-500 patients over a three-year period o 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2500 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a stepped wedge designThis is a stepped wedge design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial
Actual Study Start Date :
Nov 13, 2019
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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 Lee County EMS, certain ambulance stations who are randomized to early adoption of an upcoming protocol change will administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival. Ambulance randomized to later protocol adoption will continue usual care, until the end of the study when all ambulance stations adopt the new protocol with early administration of prednisolone
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

Outcome Measures

Primary Outcome Measures

  1. Hospital Admission [Day 1 (ED stay)]

    Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation

Secondary Outcome Measures

  1. Emergency Department length-of-stay [Day 1 (from EMS arrival to ED discharge)]

    Length of time in emergency department for patients who are discharged home

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Walton County EMS DeFuniak Springs Florida United States 32433
2 Lee County Public Safety & Emergency Services Fort Myers Florida United States 33905
3 Sarasota County EMS Sarasota Florida United States 34236
4 Leon County EMS Tallahassee Florida United States 32301
5 Nassau County Fire Rescue Department Yulee Florida United States 32097
6 Cincinnati Children's Hospital Cincinnati Ohio United States 45229
7 Texas Children's Hospital / UT Houston Houston Texas United States 77030

Sponsors and Collaborators

  • University of Florida
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Jennifer Fishe, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT03962894
Other Study ID Numbers:
  • IRB201901351
  • 1K23HL149991-01
First Posted:
May 24, 2019
Last Update Posted:
Dec 8, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Prednisolone

Study Results

No Results Posted as of Dec 8, 2021