Back to resultsRepeat Emergency Department Visits Among Patients With Asthma and COPD
Primary Purpose
Asthma, COPD
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
beclamethasone dipropionate
albuterol
Prednisone
Sponsored by
About this trial
This is an interventional health services research trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Treated in the ED at the Erie County Medical Center (ECMC) for acute symptoms of asthma or COPD during the study period
- Patient age ≥ 18 years
- Resident of the City of Buffalo or Erie County
- Discharged to home
- Patient expresses willingness to return to ECMC or own primary care provider for follow-up visits
- Able to provide informed consent
- Able to comprehend English language
Exclusion Criteria:
- Received oral or inhaled corticosteroids in the week before ED presentation
- Presented to the ED primarily for prescription refills
- Complicated comorbid conditions (e.g. renal disease, cardiovascular disease, CHF, HIV)
- Admitted to ECMC or discharged to another facility
- Previously enrolled during a prior visit to the ED during the study period
- For female patients--pregnant or pregnancy status indeterminate
- Antibiotics are prescribed to treat current asthma/COPD exacerbation.
Sites / Locations
- Erie County Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
Treatment
Arm Description
Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED) Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.
Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.
Outcomes
Primary Outcome Measures
Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge
Subjects' medical records will be reviewed for the 30 day period following ED discharge to determine if they return to the treating ED or another regional ED for treatment of an acute asthma/COPD exacerbation. Regional ED records will be queried by use of data maintained by HEALTHeLINK, our regional health information organization system. This will allow for more complete capture of ED return visits that could be obtained by looking only at a single ED.
Secondary Outcome Measures
Full Information
NCT ID
NCT02499887
First Posted
July 10, 2015
Last Updated
June 3, 2019
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT02499887
Brief Title
Repeat Emergency Department Visits Among Patients With Asthma and COPD
Official Title
Repeat Emergency Department Visits Among Patients With Asthma and COPD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Exclusion criteria prevented enrollment of adequate # of participants
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the proposed study is to determine whether the addition of inhaled corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat emergency department (ED) visits among patients treated for acute exacerbations of asthma and COPD discharged from the emergency department to home. The investigators hypothesize that patients treated with inhaled corticosteroids in addition to oral corticosteroids and albuterol will have lower rates of 30-day return visits to the emergency department than those patients treated with oral corticosteroids and albuterol only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED)
Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days
Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.
Intervention Type
Drug
Intervention Name(s)
beclamethasone dipropionate
Other Intervention Name(s)
Qvar
Intervention Description
Inhaler
Intervention Type
Drug
Intervention Name(s)
albuterol
Other Intervention Name(s)
Ventolin
Intervention Description
Inhaler
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Oral corticosteroid
Primary Outcome Measure Information:
Title
Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge
Description
Subjects' medical records will be reviewed for the 30 day period following ED discharge to determine if they return to the treating ED or another regional ED for treatment of an acute asthma/COPD exacerbation. Regional ED records will be queried by use of data maintained by HEALTHeLINK, our regional health information organization system. This will allow for more complete capture of ED return visits that could be obtained by looking only at a single ED.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Treated in the ED at the Erie County Medical Center (ECMC) for acute symptoms of asthma or COPD during the study period
Patient age ≥ 18 years
Resident of the City of Buffalo or Erie County
Discharged to home
Patient expresses willingness to return to ECMC or own primary care provider for follow-up visits
Able to provide informed consent
Able to comprehend English language
Exclusion Criteria:
Received oral or inhaled corticosteroids in the week before ED presentation
Presented to the ED primarily for prescription refills
Complicated comorbid conditions (e.g. renal disease, cardiovascular disease, CHF, HIV)
Admitted to ECMC or discharged to another facility
Previously enrolled during a prior visit to the ED during the study period
For female patients--pregnant or pregnancy status indeterminate
Antibiotics are prescribed to treat current asthma/COPD exacerbation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather A Lindstrom, PhD
Organizational Affiliation
University at Buffalo, Department of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erie County Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Repeat Emergency Department Visits Among Patients With Asthma and COPD
We'll reach out to this number within 24 hrs