Trial Outcomes & Findings for An Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of COPD (NCT NCT03207776)
NCT ID: NCT03207776
Last Updated: 2022-04-22
Results Overview
Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4832 participants
Primary outcome timeframe
60 days
Results posted on
2022-04-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
2479
|
2353
|
|
Overall Study
COMPLETED
|
2479
|
2353
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of Post Discharge Utilization Among Patients With an Acute Exacerbation of COPD
Baseline characteristics by cohort
| Measure |
Control
n=2479 Participants
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.
|
Intervention
n=2353 Participants
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.
|
Total
n=4832 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
66.8 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
67.3 years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1360 Participants
n=99 Participants
|
1366 Participants
n=107 Participants
|
2726 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1119 Participants
n=99 Participants
|
987 Participants
n=107 Participants
|
2106 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
535 Participants
n=99 Participants
|
375 Participants
n=107 Participants
|
910 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1885 Participants
n=99 Participants
|
1928 Participants
n=107 Participants
|
3813 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2479 participants
n=99 Participants
|
2353 participants
n=107 Participants
|
4832 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 60 daysOccurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual
Outcome measures
| Measure |
Control
n=2479 Participants
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.
|
Intervention
n=2353 Participants
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.
|
|---|---|---|
|
Healthcare Utilization
|
1080 Participants
|
920 Participants
|
SECONDARY outcome
Timeframe: 30 daysReadmission to the same facility
Outcome measures
| Measure |
Control
n=2479 Participants
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.
|
Intervention
n=2353 Participants
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.
|
|---|---|---|
|
Quality, Comfort, and Care (QCC) Defined Readmission Rate
|
321 Participants
|
286 Participants
|
SECONDARY outcome
Timeframe: 30 daysReadmission to any facility within Carolinas HealthCare System
Outcome measures
| Measure |
Control
n=2479 Participants
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.
|
Intervention
n=2353 Participants
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.
|
|---|---|---|
|
Patient-centric (Protocol Defined) Readmission Rate
|
753 Participants
|
659 Participants
|
SECONDARY outcome
Timeframe: 30 dayOutcome measures
| Measure |
Control
n=2479 Participants
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.
|
Intervention
n=2353 Participants
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.
|
|---|---|---|
|
30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System
|
240 Participants
|
179 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place