Improving Asthma Outcomes in an Urban Pediatric Population

This study has been completed.
Sponsor:
Collaborators:
American Academy of Allergy, Asthma, and Immunology
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00140439
First received: August 31, 2005
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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 Intervention
Asthma
Behavioral: Emergency Department based asthma follow-up clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Asthma Outcomes in a High Morbidity Urban Pediatric Population: an Emergency Department-based Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • Unscheduled visits for asthma [ Time Frame: 6 months following enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospitalizations for asthma [ Time Frame: 6 months following enrollment ] [ Designated as safety issue: No ]
  • Compliance [ Time Frame: 6 months following enrollment ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months following enrollment ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: 6 months following enrollment ]

Enrollment: 488
Study Start Date: April 2002
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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
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

Ages Eligible for Study:   12 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140439

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

Additional Information:
No publications provided

Responsible Party: Children's Research Institute
ClinicalTrials.gov Identifier: NCT00140439     History of Changes
Other Study ID Numbers: RWJ EDDP
Study First Received: August 31, 2005
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
asthma
emergency department
compliance
randomized clinical trial

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

ClinicalTrials.gov processed this record on August 21, 2014