Improving Asthma Outcomes in an Urban Pediatric Population

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Emergency Department based asthma follow-up clinic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 12 months and 17 years, inclusive; prior physician-diagnosed asthma; ≥1 other unscheduled visit for asthma in the previous 6 months and/or ≥1 hospitalization for asthma in the prior 12 months; a parent/guardian available for interview; residence in Washington, DC or a contiguous Maryland county; and requirement for ≥3 doses of nebulized albuterol in the ED at the time of enrollment. Exclusion Criteria: significant medical co-morbidities affecting the cardiorespiratory system; a visit to an allergist or a pulmonologist in the prior 6 months; ≥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; enrollment in another asthma research study; unavailability for telephone follow-up; or primary language other than English or Spanish.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Emergency 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: 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. 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. 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unscheduled visits for asthma |  | 6 months following enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations for asthma |  | 6 months following enrollment | 
| Compliance |  | 6 months following enrollment | 
| Quality of Life |  | 6 months following enrollment | 
| Morbidity |  | 6 months following enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, emergency department, compliance, randomized clinical trial