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Improving Asthma Outcomes in an Urban Pediatric Population

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emergency Department based asthma follow-up clinic
Sponsored by
Stephen J. Teach, MD, MPH
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, emergency department, compliance, randomized clinical trial

Eligibility Criteria

12 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age between 12 months and 17 years, inclusive; prior physician-diagnosed asthma; ≥1 other unscheduled visit for asthma in the previous 6 months and/or ≥1 hospitalization for asthma in the prior 12 months; a parent/guardian available for interview; residence in Washington, DC or a contiguous Maryland county; and requirement for ≥3 doses of nebulized albuterol in the ED at the time of enrollment. Exclusion Criteria: significant medical co-morbidities affecting the cardiorespiratory system; a visit to an allergist or a pulmonologist in the prior 6 months; ≥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; enrollment in another asthma research study; unavailability for telephone follow-up; or primary language other than English or Spanish.

Sites / Locations

  • Children's National Medical Center

Outcomes

Primary Outcome Measures

Unscheduled visits for asthma

Secondary Outcome Measures

Hospitalizations for asthma
Compliance
Quality of Life
Morbidity

Full Information

First Posted
August 31, 2005
Last Updated
August 21, 2015
Sponsor
Stephen J. Teach, MD, MPH
Collaborators
American Academy of Allergy, Asthma, and Immunology, Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00140439
Brief Title
Improving Asthma Outcomes in an Urban Pediatric Population
Official Title
Improving Asthma Outcomes in a High Morbidity Urban Pediatric Population: an Emergency Department-based Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephen J. Teach, MD, MPH
Collaborators
American Academy of Allergy, Asthma, and Immunology, Robert Wood Johnson Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, emergency department, compliance, randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
488 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Emergency Department based asthma follow-up clinic
Intervention Description
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
Primary Outcome Measure Information:
Title
Unscheduled visits for asthma
Time Frame
6 months following enrollment
Secondary Outcome Measure Information:
Title
Hospitalizations for asthma
Time Frame
6 months following enrollment
Title
Compliance
Time Frame
6 months following enrollment
Title
Quality of Life
Time Frame
6 months following enrollment
Title
Morbidity
Time Frame
6 months following enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 12 months and 17 years, inclusive; prior physician-diagnosed asthma; ≥1 other unscheduled visit for asthma in the previous 6 months and/or ≥1 hospitalization for asthma in the prior 12 months; a parent/guardian available for interview; residence in Washington, DC or a contiguous Maryland county; and requirement for ≥3 doses of nebulized albuterol in the ED at the time of enrollment. Exclusion Criteria: significant medical co-morbidities affecting the cardiorespiratory system; a visit to an allergist or a pulmonologist in the prior 6 months; ≥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; enrollment in another asthma research study; unavailability for telephone follow-up; or primary language other than English or Spanish.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Teach, MD
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.impact-dc.org
Description
Related Info

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Improving Asthma Outcomes in an Urban Pediatric Population

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