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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL149991-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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 design in multiple EMS agencies, we will enroll patients 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Prehospital Systemic Corticosteroids | Experimental | Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services |
|
| Usual Care | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Admission | Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation | Day 1 (ED stay) |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department Length-of-stay | Length of time in emergency department for patients from arrival to disposition (i.e., length of time for discharge, admission, or transfer to another hospital) | Day 1 (from EMS arrival to ED disposition) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Fishe, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walton County EMS | DeFuniak Springs | Florida | 32433 | United States | ||
| Lee County Public Safety & Emergency Services |
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EMS agencies who decided to incorporate oral systemic corticosteroids as part of clinical care were for this study. The study assigned the start date for EMS agencies to include oral systemic corticosteroids. For the purpose of analysis, we treated that as a stepped wedge protocol design. All agencies contributed one year of data for early prehospital systemic corticosteroids, and one year of data for no prehospital systemic corticosteroids.
There was no recruitment, as this was an observational study of patients who were receiving EMS treatment regardless of the study.
| ID | Title | Description |
|---|---|---|
| FG000 | Houston EMS Pre and Post-Protocol Change | Children with asthma attacks treated by Houston EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 10/1/2014. |
| FG001 | Cincinnati EMS Pre- and Post-Protocol Change | Children with asthma attacks treated by Cincinnati EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 1/1/2016. |
| FG002 | Nassau County FL EMS Pre- and Post- Protocol Change | Children with asthma attacks treated by Nassau County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 6/1/2019. |
| FG003 | Lee County FL EMS Pre- and Post- Protocol Change | Children with asthma attacks treated by Lee County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 11/1/2019. |
| FG004 | Walton County FL EMS Pre- and Post-Protocol Change | Children with asthma attacks treated by Walton County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 11/1/2020. |
| FG005 | Leon County FL EMS Pre- and Post-Protocol Change | Children with asthma attacks treated by Leon County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 2/1/2021. |
| FG006 | Sarasota County FL EMS Pre- and Post-Protocol Change | Children with asthma attacks treated by Sarasota County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 6/1/2021/ |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Prehospital Systemic Corticosteroids | Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Admission | Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation | Posted | Count of Participants | Participants | Day 1 (ED stay) |
|
2 years
There were no serious AEs, no mortality, and no other non serious AEs observed in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Prehospital Systemic Corticosteroids | Children with asthma attacks who receive systemic corticosteroids and bronchodilators in the prehospital environment by emergency medical services |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Fishe | University of Florida | 904-244-4046 | Jennifer.Fishe@jax.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2019 | Aug 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Fort Myers |
| Florida |
| 33905 |
| United States |
| Sarasota County EMS | Sarasota | Florida | 34236 | United States |
| Leon County EMS | Tallahassee | Florida | 32301 | United States |
| Nassau County Fire Rescue Department | Yulee | Florida | 32097 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Texas Children's Hospital / UT Houston | Houston | Texas | 77030 | United States |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Bronchodilator Administered | Bronchodilators included albuterol and xopenex, administered either via inhaler or nebulizer | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Emergency Department Length-of-stay | Length of time in emergency department for patients from arrival to disposition (i.e., length of time for discharge, admission, or transfer to another hospital) | Posted | Median | Inter-Quartile Range | minutes | Day 1 (from EMS arrival to ED disposition) |
|
|
|
| 0 |
| 175 |
| 0 |
| 175 |
| 0 |
| 175 |
| EG001 | No Early Prehospital Systemic Corticosteroids | Children with asthma attacks treated by emergency medical services who receive bronchodilators en route to emergency departments, where in the ED they then receive systemic corticosteroids | 0 | 659 | 0 | 659 | 0 | 659 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |