Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations

Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations

Sponsors

Lead Sponsor: The University of Texas Health Science Center, Houston

Source The University of Texas Health Science Center, Houston
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. We aim to conduct a randomized control trial to compare q3h vs. q4h albuterol as hospital discharge criteria for patients admitted for acute asthma exacerbations. We also propose to conduct a costeffectiveness analysis of the trial. If our hypothesis that q3h albuterol is safe and as effective as q4h albuterol as discharge criteria, we would be able to argue for a new standard of care that is more costeffective for this very costly and common disease of children in the United States

Overall Status Not yet recruiting
Start Date December 2020
Completion Date July 2023
Primary Completion Date December 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Total Treatment Days Hospitalization to 15 days after discharge
Secondary Outcome
Measure Time Frame
Total Costs Hospitalization to 15 days after discharge
Enrollment 250
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: q3h albuterol

Description: Using q3h albuterol as discharge criteria from hospital

Arm Group Label: q3h albuterol

Eligibility

Criteria:

Inclusion Criteria: - Children with Primary Reason for Hospitalization of Asthma Exacerbation Exclusion Criteria: - Those that never needed q3h albuterol treatments

Gender: All

Minimum Age: 4 Years

Maximum Age: 17 Years

Healthy Volunteers: Accepts Healthy Volunteers

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The University of Texas Health Science Center, Houston

Investigator Full Name: Raymond Parlar-Chun

Investigator Title: Assistant Professor of Pediatrics

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: q3h albuterol

Type: Experimental

Description: Using q3h as discharge criteria from hospital

Label: q4h albuterol

Type: No Intervention

Description: Using q4h as discharge criteria from hospital

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Health Services Research

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov