Repeat Emergency Department Visits Among Patients With Asthma and COPD

Study Overview
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Brief Summary
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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.

Official Title
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Repeat Emergency Department Visits Among Patients With Asthma and COPD

Conditions
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Asthma, COPD

Intervention / Treatment
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* Drug: beclamethasone dipropionate
* Drug: albuterol
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>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. | Drug: albuterol<br>* Inhaler<br>* Other names: Ventolin;Drug: Prednisone<br>* Oral corticosteroid<br>|
| Experimental: Treatment<br>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. | Drug: beclamethasone dipropionate<br>* Inhaler<br>* Other names: Qvar;Drug: albuterol<br>* Inhaler<br>* Other names: Ventolin;Drug: Prednisone<br>* Oral corticosteroid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days |