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Improving Asthma Outcomes in an Urban Pediatric Population

Improving Asthma Outcomes in a High Morbidity Urban Pediatric Population: an Emergency Department-based Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00140439
Enrollment
488
Registered
2005-09-01
Start date
2002-04-30
Completion date
2005-06-30
Last updated
2015-08-25

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

Conditions

Asthma

Keywords

asthma, emergency department, compliance, randomized clinical trial

Brief summary

Little is known about how ED-based programs can help to reduce pediatric ED visits for asthma. The current study evaluated a novel intervention in which the ED itself became the site of highly individualized, comprehensive follow-up asthma care. It sought to determine if such an intervention could decrease subsequent unscheduled visits for asthma while improving asthma quality of life.

Detailed description

Prospective, randomized clinical trial of a single visit to a specialized emergency department-based asthma follow-up clinic occurring 2-15 days after emergency department care for an acute exacerbation. All patients were followed for 6 months. Analysis was by intention-to-treat with adjustment for baseline differences. Our primary hypothesis was that this intervention would decrease subsequent unscheduled visits (both to EDs and other sources of urgent care) for asthma over a six-month follow-up period. We further hypothesized that the intervention would decrease hospitalizations for asthma, improve compliance with an individualized medical plan and with trigger control, increase scheduled primary care practitioner (PCP) visits for routine asthma care, and decrease asthma symptoms while improving asthma quality of life (QOL).

Interventions

BEHAVIORALEmergency Department based asthma follow-up clinic

The clinical activities of the intervention followed a fully specified protocol and provided education and care in three domains: 1. Asthma self-monitoring and management: Educators first reviewed the basic physiology of asthma with emphasis on its chronicity. After evaluating asthma severity and treatment history, the physician completed an individualized medical action plan (MAP) and provided any necessary device teaching. 2. Environmental modification and trigger control: After evaluation of potential environmental triggers in the home, each family was educated on their control. Each child was provided hypoallergenic bed encasings. 3. Linkages and referrals to ongoing primary care: Clinic staff stressed the importance of longitudinal asthma care by a PCP. A full report of the clinic visit was mailed to each child's PCP. In addition, the asthma educator scheduled a follow-up appointment with the PCP within 4 weeks

Sponsors

American Academy of Allergy, Asthma, and Immunology
CollaboratorOTHER
Robert Wood Johnson Foundation
CollaboratorOTHER
Stephen J. Teach, MD, MPH
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Months to 17 Years
Healthy volunteers
No

Inclusion criteria

1. age between 12 months and 17 years, inclusive; 2. prior physician-diagnosed asthma; 3. ≥1 other unscheduled visit for asthma in the previous 6 months and/or ≥1 hospitalization for asthma in the prior 12 months; 4. a parent/guardian available for interview; 5. residence in Washington, DC or a contiguous Maryland county; and 6. requirement for ≥3 doses of nebulized albuterol in the ED at the time of enrollment.

Exclusion criteria

1. significant medical co-morbidities affecting the cardiorespiratory system; 2. a visit to an allergist or a pulmonologist in the prior 6 months; 3. ≥2 of the following: a current written asthma medical action plan, current use of \>1 controller medication, or a scheduled visit for asthma care with their PCP in the prior two weeks; 4. enrollment in another asthma research study; 5. unavailability for telephone follow-up; or 6. primary language other than English or Spanish.

Design outcomes

Primary

MeasureTime frame
Unscheduled visits for asthma6 months following enrollment

Secondary

MeasureTime frame
Hospitalizations for asthma6 months following enrollment
Compliance6 months following enrollment
Quality of Life6 months following enrollment
Morbidity6 months following enrollment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026