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

August 31, 2005
December 13, 2011
April 2002
June 2005   (final data collection date for primary outcome measure)
Unscheduled visits for asthma [ Time Frame: 6 months following enrollment ] [ Designated as safety issue: No ]
Unscheduled visits for asthma
Complete list of historical versions of study NCT00140439 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Hospitalizations for asthma
  • Compliance
  • Quality of Life
  • Morbidity
Not Provided
Not Provided
 
Improving Asthma Outcomes in an Urban Pediatric Population
Improving Asthma Outcomes in a High Morbidity Urban Pediatric Population: an Emergency Department-based Randomized Clinical Trial

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Asthma
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
June 2005
June 2005   (final data collection date for primary outcome measure)

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.
Both
12 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00140439
RWJ EDDP
No
Children's Research Institute
Children's Research Institute
  • American Academy of Allergy, Asthma, and Immunology
  • Robert Wood Johnson Foundation
Principal Investigator: Stephen J Teach, MD Children's Research Institute
Children's Research Institute
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP