- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01981564
Asthma Express: Bridging the Emergency to Primary Care in Underserved Children
March 4, 2019 updated by: Johns Hopkins University
Asthma Express Intervention to Bridge Emergency to Primary Care for High Risk Children With Asthma
Asthma is the number one cause of pediatric emergency department (ED) visits in young minority children and is responsible for high healthcare costs.
The ED is often the point of contact for many inner city children and many families view the ED as the child's primary source of asthma care.
This study plans to test a new model of asthma care, Asthma Express (AEx), that includes a follow-up asthma visit in the ED for an asthma "check-up" , asthma education, a prescription for preventive asthma medications, an appointment for the child to see their pediatric provider and a home visit to assist families with environmental control methods to prevent asthma symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Asthma, the leading chronic disorder in childhood, is the number one cause of pediatric emergency department (ED) visits in young children and is responsible for a substantial impact on healthcare costs.
The ED is often the point of contact for low-income children and many families view the ED as their primary source of asthma care.
Poor and minority children have the highest asthma morbidity, are the least likely to receive adequate preventive therapy or specialty care and more frequently exposed to environmental triggers than non-poor children.
However, prior studies, including our pilot, indicate that children with frequent asthma ED visits will attend a one-time ED-based follow-up clinic for an asthma "check-up" and education.
The goal of this randomized controlled trial is to test the efficacy of a multifaceted, ED + primary care provider (PCP) and home-based intervention, Asthma Express (AEx), for children with > 2 asthma ED visits or 1 hospitalization/year that provides tailored guideline based asthma care.
Allergy and cotinine biomarkers, collected during the ED visit, are used to target the home environmental control component of the intervention.
The AEx intervention (n=132) will be compared to an attention control (CON) group (n=132) for the specific aims: (1) to reduce asthma morbidity (increase symptom free days and nights) and decrease ED visits and hospitalizations and increase asthma control and caregiver quality of life, (2) to improve the use of appropriate preventive anti-inflammatory medication based on child pharmacy refill records and (3) to compare the economic cost and effects of this intervention.
Children aged 3-12 years with > 2 asthma ED visits or 1 hospitalization within the past 12 months and a current ED visit for asthma will be recruited from the Johns Hopkins Pediatric-ED and followed for 12 months.
Symptom frequency, health care utilization, caregiver quality of life and cotinine measures will be collected at baseline, 6 and 12 months and pharmacy data collected at baseline and 12 months.
Data analysis includes initial cross tabulations of health outcomes by group (AEx vs. CON) and multivariate generalized linear regression models to study the effects of the AEx treatment on mean symptom free days/nights, repeat ED visits, hospitalizations and caregiver quality of life scores and anti-inflammatory medication refills.
Mean total costs of ED, PCP visits, hospital days and medication costs will be compared between groups (AEx and CON) for the economic analysis.
The AEx model is designed to be accessible, guideline-based, easily replicated and incorporated into ED care.
If successful, this study will fill critical gaps in the ED transition to preventive care asthma interventional research.
Study Type
Interventional
Enrollment (Actual)
222
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital Pediatric Emergency Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- asthma diagnosis,
- age 3 to 12 years,
- two or more ED visits or one hospitalization for asthma within past 12 months, -working phone
Exclusion Criteria:
-other respiratory chronic disease such as Cystic Fibrosis or Bronchopulmonary dysplasia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Asthma Express Intervention
Clinic visit for asthma education + nurse home visits
|
Asthma Express clinic visit for asthma education + nurse home visit
Other Names:
|
Active Comparator: Standard Asthma Education Control group
Standard asthma education during nurse home visits
|
Asthma Express home nurse visits for asthma education
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom Days
Time Frame: 3 months
|
Symptom days for asthma during past 14 days
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emergency Department (ED) Visits for Asthma
Time Frame: 3 months
|
Number of emergency department visits for asthma in the past 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Arlene M Butz, ScD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kub JE, DePriest KN, Bellin MH, Butz A, Lewis-Land C, Morphew T. Predictors of Depressive Symptoms in Caregivers of Children With Poorly Controlled Asthma: Is the Neighborhood Context Important? Fam Community Health. 2022 Jan-Mar 01;45(1):10-22. doi: 10.1097/FCH.0000000000000313.
- Margolis RHF, Dababnah S, Sacco P, Jones-Harden B, Bollinger ME, Butz A, Bellin MH. The Effects of Caregiver Social Support and Depressive Symptoms on Child Medication Adherence and Asthma Control. J Racial Ethn Health Disparities. 2022 Aug;9(4):1234-1242. doi: 10.1007/s40615-021-01065-w. Epub 2021 May 26.
- Margolis RHF, Bellin MH, Bookman JRM, Collins KS, Bollinger ME, Lewis-Land C, Butz AM. Fostering Effective Asthma Self-Management Transfer in High-Risk Children: Gaps and Opportunities for Family Engagement. J Pediatr Health Care. 2019 Nov-Dec;33(6):684-693. doi: 10.1016/j.pedhc.2019.05.004. Epub 2019 Jun 26.
- Bollinger ME, Butz A, Tsoukleris M, Lewis-Land C, Mudd S, Morphew T. Characteristics of inner-city children with life-threatening asthma. Ann Allergy Asthma Immunol. 2019 Apr;122(4):381-386. doi: 10.1016/j.anai.2019.02.002. Epub 2019 Feb 10.
- Butz AM, Tsoukleris M, Elizabeth Bollinger M, Jassal M, Bellin MH, Kub J, Mudd S, Ogborn CJ, Lewis-Land C, Thompson RE. Association between second hand smoke (SHS) exposure and caregiver stress in children with poorly controlled asthma. J Asthma. 2019 Sep;56(9):915-926. doi: 10.1080/02770903.2018.1509989. Epub 2018 Oct 11.
- Bellin MH, Newsome A, Lewis-Land C, Kub J, Mudd SS, Margolis R, Butz AM. Improving Care of Inner-City Children with Poorly Controlled Asthma: What Mothers Want You to Know. J Pediatr Health Care. 2018 Jul-Aug;32(4):387-398. doi: 10.1016/j.pedhc.2017.12.009. Epub 2018 Mar 12.
- Butz AM, Bellin M, Tsoukleris M, Mudd SS, Kub J, Ogborn J, Morphew T, Lewis-Land C, Bollinger ME. Very Poorly Controlled Asthma in Urban Minority Children: Lessons Learned. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):844-852. doi: 10.1016/j.jaip.2017.08.007. Epub 2017 Sep 22.
- Butz A, Morphew T, Lewis-Land C, Kub J, Bellin M, Ogborn J, Mudd SS, Bollinger ME, Tsoukleris M. Factors associated with poor controller medication use in children with high asthma emergency department use. Ann Allergy Asthma Immunol. 2017 Apr;118(4):419-426. doi: 10.1016/j.anai.2017.01.007. Epub 2017 Feb 21.
- Bellin MH, Newsome A, Land C, Kub J, Mudd SS, Bollinger ME, Butz AM. Asthma Home Management in the Inner-City: What can the Children Teach us? J Pediatr Health Care. 2017 May-Jun;31(3):362-371. doi: 10.1016/j.pedhc.2016.11.002. Epub 2016 Dec 9.
- Bellin MH, Land C, Newsome A, Kub J, Mudd SS, Bollinger ME, Butz AM. Caregiver perception of asthma management of children in the context of poverty. J Asthma. 2017 Mar;54(2):162-172. doi: 10.1080/02770903.2016.1198375. Epub 2016 Jun 15.
- Butz AM, Ogborn J, Mudd S, Ballreich J, Tsoukleris M, Kub J, Bellin M, Bollinger ME. Factors associated with high short-acting beta2-agonist use in urban children with asthma. Ann Allergy Asthma Immunol. 2015 May;114(5):385-92. doi: 10.1016/j.anai.2015.03.002. Epub 2015 Mar 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2013
Primary Completion (Actual)
February 28, 2018
Study Completion (Actual)
February 28, 2018
Study Registration Dates
First Submitted
October 30, 2013
First Submitted That Met QC Criteria
November 5, 2013
First Posted (Estimate)
November 11, 2013
Study Record Updates
Last Update Posted (Actual)
March 6, 2019
Last Update Submitted That Met QC Criteria
March 4, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA00078937
- R01NR013486 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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