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Improving Asthma Outcomes in an Urban Pediatric Population - Article


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Clinical Trial: Improving Asthma Outcomes in an Urban Pediatric Population

This study is no longer recruiting patients.

Sponsored by: Children''''s Research Institute
Information provided by: Children''''s Research Institute
ClinicalTrials.gov Identifier: NCT00140439

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
 Behavior: Emergency Department based asthma follow-up clinic

MedlinePlus related topics:  Asthma

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: Unscheduled visits for asthma
Secondary Outcomes: Hospitalizations for asthma; Compliance; Quality of Life; Morbidity
Expected Total Enrollment:  600

Study start: April 2002;  Study completion: May 2005
Last follow-up: January 2005;  Data entry closure: February 2005

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   -   17 Years,  Genders Eligible for Study:  Both
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.

Location Information


District of Columbia
      Children''''s National Medical Center, Washington,  District of Columbia,  20010,  United States

Study chairs or principal investigators

Stephen J Teach, MD,  Principal Investigator,  Children''''s National Medical Center   

More Information

Study ID Numbers:  RWJ EDDP
Last Updated:  August 31, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00140439
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13

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Page Updated: September 6, 2005
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