Improving Asthma Outcomes in an Urban Pediatric Population

NCT ID: NCT00140439

Last Updated: 2015-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 488 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2005-06-30

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.

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).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Allergy, Asthma, and Immunology

OTHER

Sponsor Role: collaborator

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

Stephen J. Teach, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Stephen J. Teach, MD, MPH

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephen J Teach, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

Children's National Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

RWJ EDDP

Identifier Type: -

Identifier Source: org_study_id