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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Withdrawn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
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma in Children focused on measuring albuterol, asthma exacerbation

Eligibility Criteria

4 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 1, 2020
    Last Updated
    August 13, 2021
    Sponsor
    The University of Texas Health Science Center, Houston
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    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    Withdrawn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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