Back to resultsPre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions
Primary Purpose
Chronic Obstructive Pulmonary Disease, Exacerbation of Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bundle tool
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, COPD, Readmissions
Eligibility Criteria
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.
Sites / Locations
- Henry Ford Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Bundle
Arm Description
Group of patients undergo standard care as determined by the primary inpatient team
Group of patients that receive the screening and educational tool
Outcomes
Primary Outcome Measures
30 day readmission rate
Time until readmission or ER visit, 30 days
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02135744
Brief Title
Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to determine whether a screening and educational tool, administered prior to discharge, would result in a decrease in the rate of hospital readmissions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Exacerbation of Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Readmissions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Group of patients undergo standard care as determined by the primary inpatient team
Arm Title
Bundle
Arm Type
Experimental
Arm Description
Group of patients that receive the screening and educational tool
Intervention Type
Behavioral
Intervention Name(s)
Bundle tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
30 day readmission rate
Description
Time until readmission or ER visit, 30 days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25940250
Citation
Jennings JH, Thavarajah K, Mendez MP, Eichenhorn M, Kvale P, Yessayan L. Predischarge bundle for patients with acute exacerbations of COPD to reduce readmissions and ED visits: a randomized controlled trial. Chest. 2015 May;147(5):1227-1234. doi: 10.1378/chest.14-1123.
Results Reference
derived
Learn more about this trial
Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions
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