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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: COPD Clinical Pathway; Other: Usual Care

• Registration Number: NCT03207776
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2017-06-12
• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-05
• Primary Completion: 2018-02-12
• Study Completion: 2018-08-13
• Results First Submitted: 2019-06-20
• Results First Submitted QC: 2019-09-24
• Results First Posted: 2019-10-14
• Status Verified: 2020-07
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4832

Inclusion Criteria

• Identified as having an acute exacerbation of COPD within 24 hours of admission

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Exclusion Criteria

• Death during the index encounter
• No initial discharge as of the end of the study period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention	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 (COPD Clinical Pathway).
Control	Usual Care	Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care).

Primary Outcome Measures

Name	Time	Method
Healthcare Utilization	60 days	Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Carolinas Healthcare System - Pineville; 🇺🇸 Charlotte, North Carolina, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Carolinas Healthcare System - Cleveland; 🇺🇸 Shelby, North Carolina, United States

Carolinas Healthcare System - University; 🇺🇸 Charlotte, North Carolina, United States

Carolinas Healthcare System Lincoln; 🇺🇸 Lincolnton, 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 - Union; 🇺🇸 Monroe, North Carolina, United States