An Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
COPD Clinical Pathway
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Identified as having an acute exacerbation of COPD within 24 hours of admission
Exclusion Criteria:
- Death during the index encounter
- No initial discharge as of the end of the study period
Sites / Locations
- Carolinas Medical Center
- Carolinas Healthcare System - Pineville
- Carolinas Healthcare System - University
- Carolinas Healthcare System - NorthEast
- Carolinas Healthcare System - Kings Mountain
- Carolinas Healthcare System Lincoln
- Carolinas Healthcare System - Union
- Carolinas Healthcare System - Cleveland
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control
Intervention
Arm Description
Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care).
A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services (COPD Clinical Pathway).
Outcomes
Primary Outcome Measures
Healthcare Utilization
Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual
Secondary Outcome Measures
Quality, Comfort, and Care (QCC) Defined Readmission Rate
Readmission to the same facility
Patient-centric (Protocol Defined) Readmission Rate
Readmission to any facility within Carolinas HealthCare System
30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System
Full Information
NCT ID
NCT03207776
First Posted
June 28, 2017
Last Updated
April 20, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03207776
Brief Title
An Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of COPD
Official Title
A Cluster Randomized, Stepped-Wedge Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disorder (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
February 12, 2018 (Actual)
Study Completion Date
August 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients who are hospitalized at select Carolinas Healthcare System (CHS) sites with Chronic Obstructive Pulmonary Disorder (COPD) acute exacerbation symptoms will be treated per the CHS COPD Clinical Pathway. Patient outcomes will be followed, including but not limited to readmission. Patients on the pathway will also have access to navigator services.
Detailed Description
Patients hospitalized at participating CHS sites with COPD acute exacerbation symptoms, will be treated per the CHS COPD clinical pathway. The COPD clinical pathway will include four components: (i) discrete, evidence-based care steps (ii) patient navigation, (iii) daily data driven care gap identification, (iv) monthly leadership huddles. These components are all part of usual care for patients in this population, but each component is not applied to patients consistently across the System. For this reason, the pathway will be applied consistently and completely in patients meeting COPD acute exacerbation criteria at participating sites. Patients will be followed for 60 days in total after discharge from their COPD acute exacerbation symptoms to determine the potential effectiveness of complete implementation of all 4 components in the care of COPD patients. Patients on the pathway will also have access to navigator services.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4832 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care).
Arm Title
Intervention
Arm Type
Other
Arm Description
A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services (COPD Clinical Pathway).
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Treatment of patients in the usual manner based on their diagnosis and resources available at that site.
Intervention Type
Other
Intervention Name(s)
COPD Clinical Pathway
Intervention Description
A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services.
Primary Outcome Measure Information:
Title
Healthcare Utilization
Description
Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Quality, Comfort, and Care (QCC) Defined Readmission Rate
Description
Readmission to the same facility
Time Frame
30 days
Title
Patient-centric (Protocol Defined) Readmission Rate
Description
Readmission to any facility within Carolinas HealthCare System
Time Frame
30 days
Title
30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System
Time Frame
30 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Identified as having an acute exacerbation of COPD within 24 hours of admission
Exclusion Criteria:
Death during the index encounter
No initial discharge as of the end of the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Howard, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Carolinas Healthcare System - Pineville
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Carolinas Healthcare System - University
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Carolinas Healthcare System - NorthEast
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Carolinas Healthcare System - Kings Mountain
City
Kings Mountain
State/Province
North Carolina
ZIP/Postal Code
28086
Country
United States
Facility Name
Carolinas Healthcare System Lincoln
City
Lincolnton
State/Province
North Carolina
ZIP/Postal Code
28092
Country
United States
Facility Name
Carolinas Healthcare System - Union
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Carolinas Healthcare System - Cleveland
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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An Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of COPD
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