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Clinical Trials/NCT00140439
NCT00140439
Completed
Not Applicable

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

Stephen J. Teach, MD, MPH1 site in 1 country488 target enrollmentApril 2002
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Stephen J. Teach, MD, MPH
Enrollment
488
Locations
1
Primary Endpoint
Unscheduled visits for asthma
Status
Completed
Last Updated
10 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 2002
End Date
June 2005
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Stephen J. Teach, MD, MPH
Responsible Party
Sponsor Investigator
Principal Investigator

Stephen J. Teach, MD, MPH

MD

Children's National Research Institute

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Unscheduled visits for asthma

Time Frame: 6 months following enrollment

Secondary Outcomes

  • Hospitalizations for asthma(6 months following enrollment)
  • Quality of Life(6 months following enrollment)
  • Morbidity(6 months following enrollment)
  • Compliance(6 months following enrollment)

Study Sites (1)

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