- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02135744
Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions
Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions and Emergency Department Visits: a Randomized, Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. A current gap in knowledge is whether a pre-discharge screening and educational tool, administered to patients with COPD, reduces readmissions and emergency department (ED) visits.
A single center, randomized trial of patients admitted with AECOPD. Patients will be randomized to control (standard care) or "bundle" group in which patients receive smoking cessation counseling, screening for gastroesophageal reflux disease and depression or anxiety, standardized inhaler teaching, and a 48-hour post-discharge phone call.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosis of COPD with the presence of an AECOPD
- Age > 40
- Current or ex-smoker with history of at least 20 pack-years
Exclusion Criteria:
- Past history of asthma, interstitial lung disease, bronchiectasis, presence of airway hardware (e.g. tracheal stents or tracheotomy), lung cancer, any other cancer with a life expectancy of less than 1 year
- Presence of a language barrier
- Residence in a nursing home
- Intensive care unit stay during the current admission
- Delirium or dementia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Group of patients undergo standard care as determined by the primary inpatient team
|
|
|
Experimental: Bundle
Group of patients that receive the screening and educational tool
|
Tool consists of 1. screening measures to identify the presence of various risk factors for COPD exacerbations and 2. Educational components for the disease of COPD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30 day readmission rate
Time Frame: 30 days
|
Time until readmission or ER visit, 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6174
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