Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department
Recruitment status was Not yet recruiting
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Purpose
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:
- Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period
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.
| Condition | Intervention |
|---|---|
|
Asthma |
Drug: Pulmicort Behavioral: TEDAS ED Educational Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department |
- Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period will be measured by comparisons of total number of ED visits (and unscheduled PCP visits) in each group
- Improved Quality of Life as measured by Bukstein’s ITG will utilize the scoring system developed by Bukstein to evaluate individual parameters as well as aggregate scores in the control and intervention group at each of the 3 month intervals. Significan
- Improved confidence in management will be measured utilizing confidence scores (a process delineated by the PI and referenced above).
| Estimated Enrollment: | 251 |
| Study Start Date: | November 2006 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The enrollees involved must be a child who is 1-18 years of age, with a diagnosis of persistent asthma or reactive airway disease and no other cardiovascular or pulmonary disease not currently on the NAEPP recommended chronic care regimen for controller medication therapy.
Exclusion Criteria:
- Patients without a physician’s confirmed diagnosis of asthma. Children with concurrent cardiovascular or pulmonary disease. Patients will also be excluded if they do not speak English or Spanish as their primary language.
Contacts and Locations| Contact: Troy Bush, B.S. | 832-824-5459 | tbush@bcm.edu |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Charles G Macias, MD, MPH 832-824-5416 cmacias@bcm.edu | |
| Principal Investigator: | Charles B Macias, MD, MPH | Baylor College of Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00388739 History of Changes |
| Other Study ID Numbers: | IRUSBUPR0045 |
| Study First Received: | October 13, 2006 |
| Last Updated: | October 13, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Baylor College of Medicine:
|
Pediatric Asthma Pulmicort TEDAS ED Acute exacerbation of asthma Chronic asthma |
Additional relevant MeSH terms:
|
Asthma Emergencies Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Disease Attributes Pathologic Processes Budesonide |
Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013