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Asthma Express: Bridging the Emergency to Primary Care in Underserved Children

Asthma Express Intervention to Bridge Emergency to Primary Care for High Risk Children With Asthma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01981564
Enrollment
222
Registered
2013-11-11
Start date
2013-04-15
Completion date
2018-02-28
Last updated
2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Pediatric, Emergency department visit

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.

Interventions

BEHAVIORALAsthma Express Intervention

Asthma Express clinic visit for asthma education + nurse home visit

BEHAVIORALStandard Asthma Education Control Group

Asthma Express home nurse visits for asthma education

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Symptom Days3 monthsSymptom days for asthma during past 14 days

Secondary

MeasureTime frameDescription
Emergency Department (ED) Visits for Asthma3 monthsNumber of emergency department visits for asthma in the past 3 months

Countries

United States

Participant flow

Participants by arm

ArmCount
Asthma Express Intervention
Clinic visit for asthma education + nurse home visits Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit Asthma Express Control Arm: Asthma Express home nurse visits for asthma education
107
Standard ASthma Education Control Group
STandard asthma education delivered in home by nurse Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit Asthma Express Control Arm: Asthma Express home nurse visits for asthma education
115
Total222

Baseline characteristics

CharacteristicAsthma Express InterventionStandard ASthma Education Control GroupTotal
Age, Categorical
<=18 years
107 Participants115 Participants222 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous6.2 years
STANDARD_DEVIATION 2.7
6.5 years
STANDARD_DEVIATION 2.6
6.3 years
STANDARD_DEVIATION 2.7
Emergency Department visits over past 3 months1.02 Number of ED visits over past 3 months
STANDARD_DEVIATION 1.1
1.48 Number of ED visits over past 3 months
STANDARD_DEVIATION 1.6
1.26 Number of ED visits over past 3 months
STANDARD_DEVIATION 1.4
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants3 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
103 Participants112 Participants215 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
101 Participants107 Participants208 Participants
Race (NIH/OMB)
More than one race
2 Participants5 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
4 Participants3 Participants7 Participants
Region of Enrollment
United States
107 participants115 participants222 participants
Sex: Female, Male
Female
45 Participants35 Participants80 Participants
Sex: Female, Male
Male
62 Participants80 Participants142 Participants
Symptoms days past 14 days5.55 symptom days
STANDARD_DEVIATION 4.6
6.17 symptom days
STANDARD_DEVIATION 4.9
5.88 symptom days
STANDARD_DEVIATION 4.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 980 / 106
other
Total, other adverse events
0 / 980 / 106
serious
Total, serious adverse events
0 / 980 / 106

Outcome results

Primary

Symptom Days

Symptom days for asthma during past 14 days

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Asthma Express InterventionSymptom Days6.24 symptom days over past 14 daysStandard Deviation 5.7
Standard ASthma Education Control GroupSymptom Days4.82 symptom days over past 14 daysStandard Deviation 5.1
Comparison: ANOVA F=3.55, df=1, p=0.06p-value: 0.06ANOVA
Secondary

Emergency Department (ED) Visits for Asthma

Number of emergency department visits for asthma in the past 3 months

Time frame: 3 months

Population: No data for one participant in the control group for this outcome

ArmMeasureValue (MEAN)Dispersion
Asthma Express InterventionEmergency Department (ED) Visits for Asthma0.64 visitsStandard Deviation 2.26
Standard ASthma Education Control GroupEmergency Department (ED) Visits for Asthma0.62 visitsStandard Deviation 1.02

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026