Improving Asthma Outcomes in an Urban Pediatric Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00140439
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : August 25, 2015
American Academy of Allergy, Asthma, and Immunology
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Stephen J. Teach, MD, MPH, Children's Research Institute

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Emergency Department based asthma follow-up clinic Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Asthma Outcomes in a High Morbidity Urban Pediatric Population: an Emergency Department-based Randomized Clinical Trial
Study Start Date : April 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Intervention Details:
    Behavioral: Emergency 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

Primary Outcome Measures :
  1. Unscheduled visits for asthma [ Time Frame: 6 months following enrollment ]

Secondary Outcome Measures :
  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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Ages Eligible for Study:   12 Months to 17 Years   (Child)
Sexes Eligible for Study:   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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00140439

United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Stephen J. Teach, MD, MPH
American Academy of Allergy, Asthma, and Immunology
Robert Wood Johnson Foundation
Principal Investigator: Stephen J Teach, MD Children's Research Institute

Additional Information:
Responsible Party: Stephen J. Teach, MD, MPH, MD, Children's Research Institute Identifier: NCT00140439     History of Changes
Other Study ID Numbers: RWJ EDDP
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015

Keywords provided by Stephen J. Teach, MD, MPH, Children's Research Institute:
emergency department
randomized clinical trial

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases