Asthma Express: Bridging the Emergency to Primary Care in Underserved Children
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Express Intervention
Standard Asthma Education Control Group
Sponsored by

About this trial
This is an interventional health services research trial for Asthma focused on measuring Pediatric, Emergency department visit
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Hospital Pediatric Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Asthma Express Intervention
Standard Asthma Education Control group
Arm Description
Clinic visit for asthma education + nurse home visits
Standard asthma education during nurse home visits
Outcomes
Primary Outcome Measures
Symptom Days
Symptom days for asthma during past 14 days
Secondary Outcome Measures
Emergency Department (ED) Visits for Asthma
Number of emergency department visits for asthma in the past 3 months
Full Information
NCT ID
NCT01981564
First Posted
October 30, 2013
Last Updated
March 4, 2019
Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01981564
Brief Title
Asthma Express: Bridging the Emergency to Primary Care in Underserved Children
Official Title
Asthma Express Intervention to Bridge Emergency to Primary Care for High Risk Children With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2013 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Pediatric, Emergency department visit
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asthma Express Intervention
Arm Type
Experimental
Arm Description
Clinic visit for asthma education + nurse home visits
Arm Title
Standard Asthma Education Control group
Arm Type
Active Comparator
Arm Description
Standard asthma education during nurse home visits
Intervention Type
Behavioral
Intervention Name(s)
Asthma Express Intervention
Other Intervention Name(s)
Asthma Express
Intervention Description
Asthma Express clinic visit for asthma education + nurse home visit
Intervention Type
Behavioral
Intervention Name(s)
Standard Asthma Education Control Group
Other Intervention Name(s)
Attention Control
Intervention Description
Asthma Express home nurse visits for asthma education
Primary Outcome Measure Information:
Title
Symptom Days
Description
Symptom days for asthma during past 14 days
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Emergency Department (ED) Visits for Asthma
Description
Number of emergency department visits for asthma in the past 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene M Butz, ScD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital Pediatric Emergency Department
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34783687
Citation
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.
Results Reference
derived
PubMed Identifier
34041705
Citation
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.
Results Reference
derived
PubMed Identifier
31253454
Citation
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.
Results Reference
derived
PubMed Identifier
30742915
Citation
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.
Results Reference
derived
PubMed Identifier
30307351
Citation
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.
Results Reference
derived
PubMed Identifier
29540280
Citation
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.
Results Reference
derived
PubMed Identifier
28958744
Citation
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.
Results Reference
derived
PubMed Identifier
28254203
Citation
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.
Results Reference
derived
PubMed Identifier
27955875
Citation
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.
Results Reference
derived
PubMed Identifier
27304455
Citation
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.
Results Reference
derived
PubMed Identifier
25840499
Citation
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.
Results Reference
derived
Learn more about this trial
Asthma Express: Bridging the Emergency to Primary Care in Underserved Children
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