Improving Asthma Outcomes in an Urban Pediatric Population

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140439
• Other study ID #: RWJ EDDP
• Status: Completed
• Phase: N/A
• First received: August 31, 2005
• Last updated: August 21, 2015
• Start date: April 2002
• Est. completion date: June 2005

Study information

• Verified date: August 2015
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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: 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. 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. 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

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Stephen J. Teach, MD, MPH	American Academy of Allergy, Asthma, and Immunology, Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unscheduled visits for asthma		6 months following enrollment	No
Secondary	Hospitalizations for asthma		6 months following enrollment	No
Secondary	Compliance		6 months following enrollment	No
Secondary	Quality of Life		6 months following enrollment	No
Secondary	Morbidity		6 months following enrollment

External Links

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