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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04542005
Collaborator
(none)
0
2
30.9

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: q3h albuterol
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
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
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: q3h albuterol

Using q3h as discharge criteria from hospital

Behavioral: q3h albuterol
Using q3h albuterol as discharge criteria from hospital

No Intervention: q4h albuterol

Using q4h as discharge criteria from hospital

Outcome Measures

Primary Outcome Measures

  1. Total Treatment Days [Hospitalization to 15 days after discharge]

Secondary Outcome Measures

  1. Total Costs [Hospitalization to 15 days after discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Children with Primary Reason for Hospitalization of Asthma Exacerbation
Exclusion Criteria:
  • Those that never needed q3h albuterol treatments

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Raymond Parlar-Chun, Assistant Professor of Pediatrics, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT04542005
Other Study ID Numbers:
  • HSC-MS-20-0604
First Posted:
Sep 9, 2020
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Raymond Parlar-Chun, Assistant Professor of Pediatrics, The University of Texas Health Science Center, Houston
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2021