Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations
Primary Purpose
Asthma in Children
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
q3h albuterol
Sponsored by

About this trial
This is an interventional health services research trial for Asthma in Children focused on measuring albuterol, asthma exacerbation
Eligibility Criteria
Inclusion Criteria:
- Children with Primary Reason for Hospitalization of Asthma Exacerbation
Exclusion Criteria:
- Those that never needed q3h albuterol treatments
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
q3h albuterol
q4h albuterol
Arm Description
Using q3h as discharge criteria from hospital
Using q4h as discharge criteria from hospital
Outcomes
Primary Outcome Measures
Total Treatment Days
Secondary Outcome Measures
Total Costs
Full Information
NCT ID
NCT04542005
First Posted
September 1, 2020
Last Updated
August 13, 2021
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04542005
Brief Title
Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations
Official Title
Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not obtained
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
albuterol, asthma exacerbation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
q3h albuterol
Arm Type
Experimental
Arm Description
Using q3h as discharge criteria from hospital
Arm Title
q4h albuterol
Arm Type
No Intervention
Arm Description
Using q4h as discharge criteria from hospital
Intervention Type
Behavioral
Intervention Name(s)
q3h albuterol
Intervention Description
Using q3h albuterol as discharge criteria from hospital
Primary Outcome Measure Information:
Title
Total Treatment Days
Time Frame
Hospitalization to 15 days after discharge
Secondary Outcome Measure Information:
Title
Total Costs
Time Frame
Hospitalization to 15 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with Primary Reason for Hospitalization of Asthma Exacerbation
Exclusion Criteria:
Those that never needed q3h albuterol treatments
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations
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