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

Award Number: K23HL149991
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 04/01/2020
PERIOD OF PERFORMANCE END DATE: 03/31/2025

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Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial - Program Director/Principal Investigator (Last, First, Middle): Fishe, Jennifer, N K23 Abstract Project Summary Asthma is the most common chronic disease of childhood and a leading cause of emergency medical treatment. Yet there is a paucity of evidence and guidelines for emergency medical services (EMS) treatment of pediatric asthma prior to emergency department (ED) arrival. ED guidelines recommend early systemic corticosteroid (CS) administration within one hour of ED arrival, since studies have shown associated decreases in hospital admissions and ED length-of-stay (LOS). For patients treated by EMS, there exists an opportunity for even earlier administration of CS. The goal of this project is to determine whether EMS administration of CS improves patient outcomes. Our preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival. Given the time-sensitivity of CS' effects on patient outcomes in the ED, our hypothesis is that EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions. By performing a pilot cluster randomized controlled trial, this study will fill a significant prehospital knowledge gap in the continuum of emergent pediatric asthma care. This study analyzes cost and transport times, two factors relevant to EMS operations and future guideline implementation. Through our partnership with Nassau County, Alachua County and Lake County EMS agencies, we plan to enroll 330 patients over a three-year period to analyze clinical outcomes and costs of EMS CS administration, and how both vary with EMS transport time. During the five-year K23 career development award period, Dr. Jennifer Fishe will progress from a mentored investigator to an independent investigator positioned to achieve R01 funding. That transition will occur due to strong mentorship and a structured training plan which includes: 1) Development of knowledge and experience with clinical trials, including protection of human subjects, 2) Attaining a Master of Science in Biostatistics, and 3) Grantsmanship and Leadership training necessary to become an independent investigator. Dr. Fishe's mentor and scientific advisor team contains subject matter experts on clinical trials and pediatric asthma / emergency medical services, experience with R01 grants and clinical trials, as well as career development. PHS 398/2590 (Rev. 06/09) Page 1 Continuation Format Page


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$40 )
2025	2024	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Lung Diseases Research	000	5	5/28/2025	NON-COMPETING CONTINUATION	-$40
														Subtotal = -$40

Issue Date FY: 2024 ( Subtotal = $103,352 )
2024	2024	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Lung Diseases Research	000	5	3/1/2024	NON-COMPETING CONTINUATION	$103,352
														Subtotal = $103,352

Issue Date FY: 2023 ( Subtotal = $137,374 )
2023	2023	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Lung Diseases Research	001	4	8/30/2023	NON-COMPETING CONTINUATION	-$24,911
2023	2023	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Lung Diseases Research	000	4	3/24/2023	NON-COMPETING CONTINUATION	$162,285
														Subtotal = $137,374

Issue Date FY: 2022 ( Subtotal = $162,366 )
2022	2022	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Lung Diseases Research	000	3	3/23/2022	NON-COMPETING CONTINUATION	$162,366
														Subtotal = $162,366

Issue Date FY: 2021 ( Subtotal = $162,852 )
2021	2021	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Lung Diseases Research	000	2	3/15/2021	NON-COMPETING CONTINUATION	$162,852
														Subtotal = $162,852

Issue Date FY: 2020 ( Subtotal = $162,852 )
2020	2020	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Lung Diseases Research	000	1	3/24/2020	NEW	$162,852
														Subtotal = $162,852

Grand Total All Awards = $728,756

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

Award Number: K23HL149991

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 04/01/2020

PERIOD OF PERFORMANCE END DATE: 03/31/2025

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