Trial Outcomes & Findings for Integrating Care After Exacerbation of COPD (NCT NCT02021955)
NCT ID: NCT02021955
Last Updated: 2023-07-27
Results Overview
Composite measure of hospital readmission for any cause at 180 days and all-cause mortality.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
717 participants
Primary outcome timeframe
180 days post-discharge
Results posted on
2023-07-27
Participant Flow
We grouped primary care teams into 30 clusters and randomly assigned each cluster to one of 30 30-day time periods at which time the team would moved from control to intervention. Teams gained and lost providers each month as indicated by addition and attrition below. We also have indicated the number of eligible patient discharges that occurred for each group.
Prior to randomization, 224 providers were invited with 7 refusing, leaving 217 providers included in randomization; 7 additional providers left primary care prior to Step 0, leaving 210 providers who initially participated in the control group in Step 0.
Unit of analysis: Clusters of primary care providers
Participant milestones
| Measure |
Usual Care
Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
|
Guideline Treatment Recommendations
Primary care clinicians receive treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
guideline treatment recommendations: Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
|
|---|---|---|
|
Step 0
STARTED
|
210 30
|
0 0
|
|
Step 0
COMPLETED
|
210 30
|
0 0
|
|
Step 0
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 1
STARTED
|
193 29
|
18 1
|
|
Step 1
COMPLETED
|
193 29
|
18 1
|
|
Step 1
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 2
STARTED
|
165 28
|
21 2
|
|
Step 2
COMPLETED
|
165 28
|
21 2
|
|
Step 2
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 3
STARTED
|
175 27
|
30 3
|
|
Step 3
COMPLETED
|
175 27
|
30 3
|
|
Step 3
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 4
STARTED
|
173 26
|
37 4
|
|
Step 4
COMPLETED
|
173 26
|
37 4
|
|
Step 4
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 5
STARTED
|
174 25
|
40 5
|
|
Step 5
COMPLETED
|
174 25
|
40 5
|
|
Step 5
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 6
STARTED
|
158 24
|
53 6
|
|
Step 6
COMPLETED
|
158 24
|
53 6
|
|
Step 6
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 7
STARTED
|
157 23
|
57 7
|
|
Step 7
COMPLETED
|
157 23
|
57 7
|
|
Step 7
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 8
STARTED
|
144 22
|
73 8
|
|
Step 8
COMPLETED
|
144 22
|
73 8
|
|
Step 8
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 9
STARTED
|
139 21
|
77 9
|
|
Step 9
COMPLETED
|
139 21
|
77 9
|
|
Step 9
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 10
STARTED
|
135 20
|
79 10
|
|
Step 10
COMPLETED
|
135 20
|
79 10
|
|
Step 10
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 11
STARTED
|
126 19
|
88 11
|
|
Step 11
COMPLETED
|
126 19
|
88 11
|
|
Step 11
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 12
STARTED
|
123 18
|
90 12
|
|
Step 12
COMPLETED
|
123 18
|
90 12
|
|
Step 12
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 13
STARTED
|
118 17
|
96 13
|
|
Step 13
COMPLETED
|
118 17
|
96 13
|
|
Step 13
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 14
STARTED
|
105 16
|
95 14
|
|
Step 14
COMPLETED
|
105 16
|
95 14
|
|
Step 14
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 15
STARTED
|
110 15
|
102 15
|
|
Step 15
COMPLETED
|
110 15
|
102 15
|
|
Step 15
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 16
STARTED
|
103 14
|
114 16
|
|
Step 16
COMPLETED
|
103 14
|
114 16
|
|
Step 16
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 17
STARTED
|
99 13
|
121 17
|
|
Step 17
COMPLETED
|
99 13
|
121 17
|
|
Step 17
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 18
STARTED
|
96 12
|
124 18
|
|
Step 18
COMPLETED
|
96 12
|
124 18
|
|
Step 18
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 19
STARTED
|
94 11
|
126 19
|
|
Step 19
COMPLETED
|
94 11
|
126 19
|
|
Step 19
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 20
STARTED
|
92 10
|
128 20
|
|
Step 20
COMPLETED
|
92 10
|
128 20
|
|
Step 20
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 21
STARTED
|
88 9
|
134 21
|
|
Step 21
COMPLETED
|
88 9
|
134 21
|
|
Step 21
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 22
STARTED
|
89 8
|
152 22
|
|
Step 22
COMPLETED
|
89 8
|
152 22
|
|
Step 22
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 23
STARTED
|
69 7
|
175 23
|
|
Step 23
COMPLETED
|
69 7
|
175 23
|
|
Step 23
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 24
STARTED
|
62 6
|
183 24
|
|
Step 24
COMPLETED
|
62 6
|
183 24
|
|
Step 24
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 25
STARTED
|
37 5
|
208 25
|
|
Step 25
COMPLETED
|
37 5
|
208 25
|
|
Step 25
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 26
STARTED
|
30 4
|
215 26
|
|
Step 26
COMPLETED
|
30 4
|
215 26
|
|
Step 26
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 27
STARTED
|
25 3
|
243 27
|
|
Step 27
COMPLETED
|
25 3
|
243 27
|
|
Step 27
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 28
STARTED
|
15 2
|
256 28
|
|
Step 28
COMPLETED
|
15 2
|
256 28
|
|
Step 28
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 29
STARTED
|
10 1
|
266 29
|
|
Step 29
COMPLETED
|
10 1
|
266 29
|
|
Step 29
NOT COMPLETED
|
0 0
|
0 0
|
|
Step 30
STARTED
|
0 0
|
277 30
|
|
Step 30
COMPLETED
|
0 0
|
277 30
|
|
Step 30
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Demographic information not collected from provider participants
Baseline characteristics by cohort
| Measure |
Provider Participants
n=365 Participants
all primary care providers: demographic information not collected
|
Control Patient Participants
n=191 Participants
data for all patients discharged under care of a provider in the control group
|
Intervention Patient Participants
n=161 Participants
data for all patients discharged under care of a provider in the intervention group
|
Total
n=717 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
—
|
69.7 years
STANDARD_DEVIATION 8.6 • n=191 Participants • Demographic information not collected from provider participants
|
69.7 years
STANDARD_DEVIATION 8.1 • n=161 Participants • Demographic information not collected from provider participants
|
69.7 years
STANDARD_DEVIATION 8.35 • n=352 Participants • Demographic information not collected from provider participants
|
|
Sex: Female, Male
Female
|
—
|
182 Participants
n=191 Participants • Demographic information not collected for provider participants
|
155 Participants
n=161 Participants • Demographic information not collected for provider participants
|
337 Participants
n=352 Participants • Demographic information not collected for provider participants
|
|
Sex: Female, Male
Male
|
—
|
9 Participants
n=191 Participants • Demographic information not collected for provider participants
|
6 Participants
n=161 Participants • Demographic information not collected for provider participants
|
15 Participants
n=352 Participants • Demographic information not collected for provider participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
1 Participants
n=191 Participants • Demographic information not collected from provider participants
|
3 Participants
n=161 Participants • Demographic information not collected from provider participants
|
4 Participants
n=352 Participants • Demographic information not collected from provider participants
|
|
Race (NIH/OMB)
Asian
|
—
|
2 Participants
n=191 Participants • Demographic information not collected from provider participants
|
3 Participants
n=161 Participants • Demographic information not collected from provider participants
|
5 Participants
n=352 Participants • Demographic information not collected from provider participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=191 Participants • Demographic information not collected from provider participants
|
5 Participants
n=161 Participants • Demographic information not collected from provider participants
|
5 Participants
n=352 Participants • Demographic information not collected from provider participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
8 Participants
n=191 Participants • Demographic information not collected from provider participants
|
14 Participants
n=161 Participants • Demographic information not collected from provider participants
|
22 Participants
n=352 Participants • Demographic information not collected from provider participants
|
|
Race (NIH/OMB)
White
|
—
|
166 Participants
n=191 Participants • Demographic information not collected from provider participants
|
120 Participants
n=161 Participants • Demographic information not collected from provider participants
|
286 Participants
n=352 Participants • Demographic information not collected from provider participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
NA Participants
n=191 Participants • Demographic information not collected from provider participants
|
NA Participants
n=161 Participants • Demographic information not collected from provider participants
|
NA Participants
n=352 Participants • Demographic information not collected from provider participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
14 Participants
n=191 Participants • Demographic information not collected from provider participants
|
16 Participants
n=161 Participants • Demographic information not collected from provider participants
|
30 Participants
n=352 Participants • Demographic information not collected from provider participants
|
|
Provider type
Nurse Practitioner/Physician Assistant
|
38 provider participants
n=139 Participants • Data are for those providers that had at least one patient discharged for COPD within the intervention period
|
—
|
—
|
38 provider participants
n=139 Participants • Data are for those providers that had at least one patient discharged for COPD within the intervention period
|
|
Provider type
Attending Physician
|
66 provider participants
n=139 Participants • Data are for those providers that had at least one patient discharged for COPD within the intervention period
|
—
|
—
|
66 provider participants
n=139 Participants • Data are for those providers that had at least one patient discharged for COPD within the intervention period
|
|
Provider type
Physician Fellow/Resident Physician
|
35 provider participants
n=139 Participants • Data are for those providers that had at least one patient discharged for COPD within the intervention period
|
—
|
—
|
35 provider participants
n=139 Participants • Data are for those providers that had at least one patient discharged for COPD within the intervention period
|
PRIMARY outcome
Timeframe: 180 days post-dischargePopulation: For 365 enrolled providers, we analyzed 352 patients discharged from hospital for COPD for readmission or mortality
Composite measure of hospital readmission for any cause at 180 days and all-cause mortality.
Outcome measures
| Measure |
Usual Care
n=191 Participants
Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
|
Guideline Treatment Recommendations
n=161 Participants
Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
|
|---|---|---|
|
Number of Patients With Hospital Re-admission and Mortality
|
84 Participants
|
61 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post-dischargePopulation: For 365 enrolled providers, we surveyed 352 patients discharged from hospital for COPD. Not all participants completed surveys.
self-report survey of patients' quality-of-life with scores ranging from 0-6 with lower scores representing better health; not all participants completed surveys.
Outcome measures
| Measure |
Usual Care
n=97 Participants
Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
|
Guideline Treatment Recommendations
n=70 Participants
Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
|
|---|---|---|
|
COPD-related Patient Quality-of-life (Clinical COPD Questionnaire)
|
3.50 CCQ total score
Standard Deviation 1.22
|
2.97 CCQ total score
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: 6 weeks post-dischargePopulation: For 365 enrolled providers, we surveyed 352 patients discharged from hospital for COPD. Not all participants completed surveys.
self-report survey of patients' general physical health quality-of-life scored from 0-100 with higher scores indicating better health.
Outcome measures
| Measure |
Usual Care
n=88 Participants
Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
|
Guideline Treatment Recommendations
n=62 Participants
Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
|
|---|---|---|
|
Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS)
|
29.92 units on a scale
Standard Deviation 12.22
|
33.25 units on a scale
Standard Deviation 11.94
|
Adverse Events
Usual Care
Serious events: 84 serious events
Other events: 20 other events
Deaths: 21 deaths
Guideline Treatment Recommendations
Serious events: 68 serious events
Other events: 38 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Usual Care
n=191 participants at risk
Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
|
Guideline Treatment Recommendations
n=161 participants at risk
Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
|
|---|---|---|
|
General disorders
Overall number
|
44.0%
84/191 • Number of events 152 • 180 days after index hospital discharge
Systematic adverse event review occurred after a patient's 180-day outcomes period when a coordinator reviewed the electronic health record (EHR) for pertinent events. Adverse events were not collected for provider participants. Adverse events are reported only for patient participants.
|
42.2%
68/161 • Number of events 115 • 180 days after index hospital discharge
Systematic adverse event review occurred after a patient's 180-day outcomes period when a coordinator reviewed the electronic health record (EHR) for pertinent events. Adverse events were not collected for provider participants. Adverse events are reported only for patient participants.
|
Other adverse events
| Measure |
Usual Care
n=191 participants at risk
Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
|
Guideline Treatment Recommendations
n=161 participants at risk
Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
|
|---|---|---|
|
General disorders
Non-serious Adverse events
|
10.5%
20/191 • Number of events 34 • 180 days after index hospital discharge
Systematic adverse event review occurred after a patient's 180-day outcomes period when a coordinator reviewed the electronic health record (EHR) for pertinent events. Adverse events were not collected for provider participants. Adverse events are reported only for patient participants.
|
23.6%
38/161 • Number of events 104 • 180 days after index hospital discharge
Systematic adverse event review occurred after a patient's 180-day outcomes period when a coordinator reviewed the electronic health record (EHR) for pertinent events. Adverse events were not collected for provider participants. Adverse events are reported only for patient participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place