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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Usual Care
* Other: COPD Clinical Pathway


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |