Clinical trial NCT00140439: Improving Asthma Outcomes in an Urban Pediatric Population
Official title: Improving Asthma Outcomes in a High Morbidity Urban Pediatric Population: an Emergency Department-based Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
emergency department
compliance
randomized clinical trial
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: American Academy of Allergy, Asthma, and Immunology
name: Robert Wood Johnson Foundation
First posted: 2005-09-01
Enrollment: 488
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Unscheduled visits for asthma
timeFrame: 6 months following enrollment
Secondary outcomes:
measure: Hospitalizations for asthma
timeFrame: 6 months following enrollment
measure: Compliance
timeFrame: 6 months following enrollment
measure: Quality of Life
timeFrame: 6 months following enrollment
measure: Morbidity
timeFrame: 6 months following enrollment
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Stephen J Teach, MD
role: PRINCIPAL_INVESTIGATOR
References: