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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care). |
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| Intervention | Other | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Other | Treatment of patients in the usual manner based on their diagnosis and resources available at that site. |
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| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Utilization | Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual | 60 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Howard, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States | ||
| Carolinas Healthcare System - Pineville |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care). Usual Care: Treatment of patients in the usual manner based on their diagnosis and resources available at that site. |
| FG001 | Intervention |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2017 |
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| COPD Clinical Pathway | Other | 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. |
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| 30 days |
| 30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System | 30 day |
| Charlotte |
| North Carolina |
| 28210 |
| United States |
| Carolinas Healthcare System - University | Charlotte | North Carolina | 28262 | United States |
| Carolinas Healthcare System - NorthEast | Concord | North Carolina | 28025 | United States |
| Carolinas Healthcare System - Kings Mountain | Kings Mountain | North Carolina | 28086 | United States |
| Carolinas Healthcare System Lincoln | Lincolnton | North Carolina | 28092 | United States |
| Carolinas Healthcare System - Union | Monroe | North Carolina | 28112 | United States |
| Carolinas Healthcare System - Cleveland | Shelby | North Carolina | 28150 | United States |
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). 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. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care). Usual Care: Treatment of patients in the usual manner based on their diagnosis and resources available at that site. |
| BG001 | 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). 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Healthcare Utilization | Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual | Posted | Count of Participants | Participants | 60 days |
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| Secondary | Quality, Comfort, and Care (QCC) Defined Readmission Rate | Readmission to the same facility | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Patient-centric (Protocol Defined) Readmission Rate | Readmission to any facility within Carolinas HealthCare System | Posted | Count of Participants | Participants | 30 days |
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| Secondary | 30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System | Posted | Count of Participants | Participants | 30 day |
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We followed each patient for 90 days after the hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Treatment of patients in the usual manner based on their diagnosis and resources available at that site (Usual Care). Usual Care: Treatment of patients in the usual manner based on their diagnosis and resources available at that site. | 0 | 2,479 | 0 | 2,479 | 0 | 2,479 |
| EG001 | 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). 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. | 0 | 2,353 | 0 | 2,353 | 0 | 2,353 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Roberge | Atrium Health | 704-898-3855 | Jason.Roberge@AtriumHealth.org |
| Feb 1, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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