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

NCT04542005 | Withdrawn

• 1 other identifier: HSC-MS-20-0604
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Asthma in Children

Keywords

albuterol; asthma exacerbation

Outcome Measures

Primary Outcomes (1)

• Total Treatment Days

  Hospitalization to 15 days after discharge

Secondary Outcomes (1)

• Total Costs

  Hospitalization to 15 days after discharge

Study Arms (2)

q3h albuterol

EXPERIMENTAL

Using q3h as discharge criteria from hospital

Behavioral: q3h albuterol

q4h albuterol

NO INTERVENTION

Using q4h as discharge criteria from hospital

Interventions

q3h albuterol BEHAVIORAL

Using q3h albuterol as discharge criteria from hospital

q3h albuterol

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with Primary Reason for Hospitalization of Asthma Exacerbation

You may not qualify if:

• Those that never needed q3h albuterol treatments

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: August 19, 2021

Record last verified: 2021-08