Early Administration of Steroids in the Ambulance Setting (EASI-AS-ODT)
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| ClinicalTrials.gov Identifier: NCT03962894 |
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Recruitment Status :
Recruiting
First Posted : May 24, 2019
Last Update Posted : December 8, 2021
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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 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 |
|---|---|---|
| Asthma in Children | Drug: Prednisolone | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 2500 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This 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 : | November 13, 2019 |
| Estimated Primary Completion Date : | September 2023 |
| Estimated Study Completion Date : | September 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Early Prehospital Systemic Corticosteroids
Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services
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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 |
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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
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- Hospital Admission [ Time Frame: Day 1 (ED stay) ]Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation
- Emergency Department length-of-stay [ Time Frame: Day 1 (from EMS arrival to ED discharge) ]Length of time in emergency department for patients who are discharged home
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| Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962894
| Contact: Jennifer Fishe, MD | 904-244-5812 | Jennifer.fishe@jax.ufl.edu | |
| Contact: Michelle Lott | Michelle.Lott@jax.ufl.edu |
| United States, Florida | |
| Walton County EMS | Recruiting |
| DeFuniak Springs, Florida, United States, 32433 | |
| Contact: Tim Turner 850-892-8111 turtim@waltonso.org | |
| Lee County Public Safety & Emergency Services | Recruiting |
| Fort Myers, Florida, United States, 33905 | |
| Contact: Benjamin Abes 239-533-3911 Benjamin.Abes@leegov.com | |
| Contact: Jennifer Fishe, MD 804-931-7567 Jennifer.Fishe@jax.ufl.edu | |
| Sarasota County EMS | Recruiting |
| Sarasota, Florida, United States, 34236 | |
| Contact: Marshall Frank, MD 941-861-5000 fmarshall@scgov.net | |
| Leon County EMS | Recruiting |
| Tallahassee, Florida, United States, 32301 | |
| Contact: Mac Kemp 850-606-2100 kempm@leoncountyfl.gov | |
| Contact: Kim Landry, MD 850-606-2100 landryk@leoncountyfl.gov | |
| Nassau County Fire Rescue Department | Recruiting |
| Yulee, Florida, United States, 32097 | |
| Contact: Jennifer Fishe, MD 804-931-7567 Jennifer.Fishe@jax.ufl.edu | |
| United States, Ohio | |
| Cincinnati Children's Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Lauren C Riney, DO Lauren.Riney@cchmc.org | |
| United States, Texas | |
| Texas Children's Hospital / UT Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Kathryn Kothari, MD Kathryn.Kothari@bcm.edu | |
| Principal Investigator: | Jennifer Fishe, MD | University of Florida |
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT03962894 |
| Other Study ID Numbers: |
IRB201901351 1K23HL149991-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 24, 2019 Key Record Dates |
| Last Update Posted: | December 8, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 |
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