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Completed

NCT Number: NCT00140439

Improving Asthma Outcomes in an Urban Pediatric Population

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emergency Department based asthma follow-up clinic

Behavioral

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

Primary outcomes

  1. Unscheduled visits for asthma

    Time frame: 6 months following enrollment

Secondary outcomes

  1. Hospitalizations for asthma

    Time frame: 6 months following enrollment

  2. Compliance

    Time frame: 6 months following enrollment

  3. Quality of Life

    Time frame: 6 months following enrollment

  4. Morbidity

    Time frame: 6 months following enrollment

Sponsors and collaborators

Lead sponsor

Stephen J. Teach, MD, MPH

Other

Collaborators

  • American Academy of Allergy, Asthma, and Immunology
  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Sep 1, 2005
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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