An Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of COPD
A Cluster Randomized, Stepped-Wedge Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disorder (COPD)
1 other identifier
interventional
4,832
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease
Started Jun 2017
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2017
CompletedFirst Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2018
CompletedResults Posted
Study results publicly available
October 14, 2019
CompletedApril 22, 2022
July 1, 2020
8 months
June 28, 2017
June 20, 2019
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Healthcare Utilization
Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual
60 days
Secondary Outcomes (3)
Quality, Comfort, and Care (QCC) Defined Readmission Rate
30 days
Patient-centric (Protocol Defined) Readmission Rate
30 days
30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System
30 day
Study Arms (2)
Control
OTHERTreatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care).
Intervention
OTHERA 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).
Interventions
Treatment of patients in the usual manner based on their diagnosis and resources available at that site.
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.
Eligibility Criteria
You may qualify if:
- Identified as having an acute exacerbation of COPD within 24 hours of admission
You may not qualify if:
- Death during the index encounter
- No initial discharge as of the end of the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Carolinas Healthcare System - Pineville
Charlotte, North Carolina, 28210, United States
Carolinas Healthcare System - University
Charlotte, North Carolina, 28262, United States
Carolinas Healthcare System - NorthEast
Concord, North Carolina, 28025, United States
Carolinas Healthcare System - Kings Mountain
Kings Mountain, North Carolina, 28086, United States
Carolinas Healthcare System Lincoln
Lincolnton, North Carolina, 28092, United States
Carolinas Healthcare System - Union
Monroe, North Carolina, 28112, United States
Carolinas Healthcare System - Cleveland
Shelby, North Carolina, 28150, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jason Roberge
- Organization
- Atrium Health
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Howard, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 5, 2017
Study Start
June 12, 2017
Primary Completion
February 12, 2018
Study Completion
August 13, 2018
Last Updated
April 22, 2022
Results First Posted
October 14, 2019
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share