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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Usual Care; Other: COPD Clinical Pathway

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.

• Study Type: Interventional
• Enrollment (Actual): 4832
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Charlotte, North Carolina, United States, 28210
      • Carolinas Healthcare System - Pineville
    • Charlotte, North Carolina, United States, 28262
      • Carolinas Healthcare System - University
    • Concord, North Carolina, United States, 28025
      • Carolinas Healthcare System - NorthEast
    • Kings Mountain, North Carolina, United States, 28086
      • Carolinas Healthcare System - Kings Mountain
    • Lincolnton, North Carolina, United States, 28092
      • Carolinas Healthcare System Lincoln
    • Monroe, North Carolina, United States, 28112
      • Carolinas Healthcare System - Union
    • Shelby, North Carolina, United States, 28150
      • Carolinas Healthcare System - Cleveland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care).	Other: Usual Care; Treatment of patients in the usual manner based on their diagnosis and resources available at that site.
Other: Intervention; 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).	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Utilization	Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality, Comfort, and Care (QCC) Defined Readmission Rate	Readmission to the same facility	30 days
Patient-centric (Protocol Defined) Readmission Rate	Readmission to any facility within Carolinas HealthCare System	30 days
30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System		30 day

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Daniel Howard, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): February 12, 2018
• Study Completion (Actual): August 13, 2018

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 00021790

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No