MedTrace Logo

Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department

NCT00388739 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-07-20

No results posted yet for this study

Summary

Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in the pediatric Emergency Department (ED) with anti-inflammatory medication will result in an improvement of ED revisits (and unscheduled return visits). Chronic management intitiation in conjunction with an asthma educational intervention in the pediatric ED with anti-inflammatory medication will also result in improved Quality of Life measure.

Specific aims: 1. To demonstrate that the initiation controller medication therapy in conjunction with asthma education will result in:

1. Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period
2. Improved Quality of Life as measured by Bukstein's ITG Quality of Life measure.

2\. To describe the relationship of the initiation of controller medication therapy in conjunction with asthma education with well child visits, missed school/daycare days and behavioral capabilities.

Objective: To determine the impact of beginning chronic asthma medication regimens after an educational intervention in the ED in pediatric patients 1-18 years of age with mild to moderate persistent asthma.

Long-term goal/purpose: To demonstrate the success of a model of care that utilizes the emergency department physician to initiate National Asthma Education and Prevention Program (NAEPP) guided chronic asthma therapy in children 1-18 years of age. This model will attempt to bridge the gap in initiation of chronic asthma therapy currently left by a failure of both emergency department and primary care physicians.

Conditions

Interventions

DRUG

Intervention: Budesonide

Patients 1-5 years of age who are randomly assigned to the treatment arm will be given a one month supply as well as a prescription (for a 6 month supply) for Pulmicort respules (children with mild persistent disease will receive 0.25 mg bid whereas children with moderate or severe persistent disease will receive 0.5 mg bid).

DRUG

Usual care: albuterol + systemic steroids

All children (control and treatment arm) will be given a burst dose of steroids (4 days of prednisone, 1mg/kg/dose to a maximum of 40 mg/dose to be given twice a day) at discharge from the ED. All children 1-5 years of age will also receive standardized discharge medication instructions for using albuterol nebulizer treatments: they will receive a prescription for 2.5mg of albuterol in 3cc Normal Saline for aerosol use via compressor every 3 times a day as a chronic care regimen if they are either in the treatment arm and 1-5 years of age or if they are in the control group and already own a nebulization compressor.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Andrea T Cruz, MD, MPH · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-01
Primary Completion
2006-11-01
Completion
2006-11-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00388739 on ClinicalTrials.gov