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CompletedNCT00140439Updated Aug 25, 2015

Improving Asthma Outcomes in an Urban Pediatric Population

An interventional study of Emergency Department based asthma follow-up clinic in Asthma, sponsored by Stephen J. Teach, MD, MPH. Completed at 1 site in United States. Open to participants aged 12 Months to 17 Years. Per ClinicalTrials.gov, last updated 2015-08-25.

Sponsored by Stephen J. Teach, MD, MPH · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
488
Allocation
Randomized
Ages
12 Months to 17 Years
Sex
All
01

Study 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.

Read the 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).

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Conditions studied

  • Asthma

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Keywords

  • asthma
  • emergency department
  • compliance
  • randomized clinical trial
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 488 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Stephen J. Teach, MD, MPH is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
488 participants (actual)

Interventions

  • BehavioralEmergency 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: 1. 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. 2. 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. 3. 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

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What researchers measure

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

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Study locations

1 site
  • Children's National Medical Center
    Washington, District of Columbia 20010, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00140439
Lead sponsor
Stephen J. Teach, MD, MPH
Collaborators
American Academy of Allergy, Asthma, and Immunology, Robert Wood Johnson Foundation
Responsible party
Stephen J. Teach, MD, MPH (MD, Children's National Research Institute) — Sponsor-investigator
First posted
Sep 1, 2005
Start date
Apr 2002
Primary completion
Jun 2005
Completion
Jun 2005
Last update
Aug 25, 2015

Study contacts

Stephen J Teach, MD
principal investigator · Children's National Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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