Repeat Emergency Department Visits Among Patients With Asthma and COPD

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.

Study Overview

• Status: Terminated
• Conditions: Asthma; COPD
• Intervention / Treatment: Drug: albuterol; Drug: Prednisone; Drug: beclamethasone dipropionate

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 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; Inhaler; Other Names: Ventolin; Drug: Prednisone; Oral corticosteroid
Experimental: Treatment; 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: albuterol; Inhaler; Other Names: Ventolin; Drug: Prednisone; Oral corticosteroid; Drug: beclamethasone dipropionate; Inhaler; Other Names: Qvar

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Heather A Lindstrom, PhD, University at Buffalo, Department of Emergency Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Emergencies; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Prednisone; Albuterol
• Other Study ID Numbers: 754754