Improving Asthma Outcomes in an Urban Pediatric Population

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT00140439
• Lead Sponsor: Stephen J. Teach, MD, MPH

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).

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Unscheduled visits for asthma	6 months following enrollment

Secondary Outcome Measures

Name	Time	Method
Hospitalizations for asthma	6 months following enrollment
Quality of Life	6 months following enrollment
Morbidity	6 months following enrollment
Compliance	6 months following enrollment

Trial Locations

Locations (1)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States