- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04542005
Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations
Asthma is the most common chronic condition among children, and the third leading reason for hospitalization of children in the United States. It exerts a large healthcare burden on the US with estimated annual direct healthcare cost of approximately $50.1 billion with indirect costs of $5.9 billion.
Asthma is characterized by airway inflammation and airway constriction. Albuterol and other betaagonists are first line standard of care for acute exacerbations and provide short acting smooth muscle relaxation and subsequent airway opening. The frequency of albuterol administration is dependent on the severity of the exacerbation. For hospitalized patients here at Children's Memorial Hermann (CMHH), patients may receive nebulized albuterol continuously or if the exacerbation is not as severe, receive albuterol intermittently. Intermittent albuterol frequency ranges from every two hour treatments, every three hour (q3h) treatments, or every four hour (q4h) treatments. As patients recover from their acute exacerbation, their frequency of albuterol administration is progressively titrated along this continuum. Expert consensus uses q4h albuterol as discharge criteria from the hospital. However, recent QI initiatives have studied the effect of q3h treatments as the discharge cutoff with no reported changes in safety or harm. There are no randomized controlled trials available. Furthermore, there are no economic evaluations available to see if costs saved by decreasing the length of hospital care are merely being shifted to subsequent clinic or emergency room care costs.
The investigators aim to conduct a randomized control trial to compare q3h vs. q4h albuterol as hospital discharge criteria for patients admitted for acute asthma exacerbations. The investigators also propose to conduct a costeffectiveness analysis of the trial. If the hypothesis that q3h albuterol is safe and as effective as q4h albuterol as discharge criteria, the investigators would be able to argue for a new standard of care that is more cost effective for this very costly and common disease of children in the United States
Study Overview
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with Primary Reason for Hospitalization of Asthma Exacerbation
Exclusion Criteria:
- Those that never needed q3h albuterol treatments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: q3h albuterol
Using q3h as discharge criteria from hospital
|
Using q3h albuterol as discharge criteria from hospital
|
No Intervention: q4h albuterol
Using q4h as discharge criteria from hospital
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Treatment Days
Time Frame: Hospitalization to 15 days after discharge
|
Hospitalization to 15 days after discharge
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Costs
Time Frame: Hospitalization to 15 days after discharge
|
Hospitalization to 15 days after discharge
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
Other Study ID Numbers
- HSC-MS-20-0604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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