Clinical trial NCT03207776: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 4832
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Healthcare Utilization
timeFrame: 60 days
Secondary outcomes:
measure: Quality, Comfort, and Care (QCC) Defined Readmission Rate
timeFrame: 30 days
measure: Patient-centric (Protocol Defined) Readmission Rate
timeFrame: 30 days
measure: 30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System
timeFrame: 30 day
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Healthcare System - Pineville
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Healthcare System - University
state: North Carolina
city: Concord
country: United States
facility: Carolinas Healthcare System - NorthEast
state: North Carolina
city: Kings Mountain
country: United States
facility: Carolinas Healthcare System - Kings Mountain
state: North Carolina
city: Lincolnton
country: United States
facility: Carolinas Healthcare System Lincoln
state: North Carolina
city: Monroe
country: United States
facility: Carolinas Healthcare System - Union
state: North Carolina
city: Shelby
country: United States
facility: Carolinas Healthcare System - Cleveland
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Daniel Howard, MD
role: PRINCIPAL_INVESTIGATOR
References: