Chronic Obstructive Pulmonary Disease
Conditions
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.
Interventions
OTHERUsual Care
Treatment of patients in the usual manner based on their diagnosis and resources available at that site.
OTHERCOPD 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Utilization | 60 days | Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2,479 |
| 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. | 2,353 |
| Total | 4,832 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 11.5 | 67.3 years STANDARD_DEVIATION 11.4 | 66.8 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 12 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 535 Participants | 910 Participants | 375 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 45 Participants | 88 Participants | 43 Participants |
| Race (NIH/OMB) White | 1885 Participants | 3813 Participants | 1928 Participants |
| Region of Enrollment United States | 2479 participants | 4832 participants | 2353 participants |
| Sex: Female, Male Female | 1360 Participants | 2726 Participants | 1366 Participants |
| Sex: Female, Male Male | 1119 Participants | 2106 Participants | 987 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,479 | 0 / 2,353 |
| other Total, other adverse events | 0 / 2,479 | 0 / 2,353 |
| serious Total, serious adverse events | 0 / 2,479 | 0 / 2,353 |
Outcome results
Primary
Healthcare Utilization
Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual
Time frame: 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Healthcare Utilization | 1080 Participants |
| Intervention | Healthcare Utilization | 920 Participants |
p-value: 0.04195% CI: [0.64, 0.99]Mixed Models Analysis
Secondary
30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System
Time frame: 30 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | 30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System | 240 Participants |
| Intervention | 30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System | 179 Participants |
p-value: 0.54495% CI: [0.74, 1.77]Mixed Models Analysis
Secondary
Patient-centric (Protocol Defined) Readmission Rate
Readmission to any facility within Carolinas HealthCare System
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Patient-centric (Protocol Defined) Readmission Rate | 753 Participants |
| Intervention | Patient-centric (Protocol Defined) Readmission Rate | 659 Participants |
p-value: 0.47295% CI: [0.71, 1.17]Mixed Models Analysis
Secondary
Quality, Comfort, and Care (QCC) Defined Readmission Rate
Readmission to the same facility
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Quality, Comfort, and Care (QCC) Defined Readmission Rate | 321 Participants |
| Intervention | Quality, Comfort, and Care (QCC) Defined Readmission Rate | 286 Participants |
p-value: 0.95295% CI: [0.69, 1.42]Mixed Models Analysis