An Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Cluster Randomized, Stepped-Wedge Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disorder (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207776
• Other study ID #: 00021790
• Status: Completed
• Phase: N/A
• Start date: June 12, 2017
• Est. completion date: August 13, 2018

Study information

• Verified date: July 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4832
• Est. completion date: August 13, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Usual Care
Treatment of patients in the usual manner based on their diagnosis and resources available at that site.
• COPD Clinical Pathway
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.

Locations

Country	Name	City	State
United States	Carolinas Healthcare System - Pineville	Charlotte	North Carolina
United States	Carolinas Healthcare System - University	Charlotte	North Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Carolinas Healthcare System - NorthEast	Concord	North Carolina
United States	Carolinas Healthcare System - Kings Mountain	Kings Mountain	North Carolina
United States	Carolinas Healthcare System Lincoln	Lincolnton	North Carolina
United States	Carolinas Healthcare System - Union	Monroe	North Carolina
United States	Carolinas Healthcare System - Cleveland	Shelby	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare Utilization	Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual	60 days
Secondary	Quality, Comfort, and Care (QCC) Defined Readmission Rate	Readmission to the same facility	30 days
Secondary	Patient-centric (Protocol Defined) Readmission Rate	Readmission to any facility within Carolinas HealthCare System	30 days
Secondary	30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System		30 day