Trial Outcomes & Findings for Improving the Quality of End-of-Life Communication for Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00106080)
NCT ID: NCT00106080
Last Updated: 2019-10-11
Results Overview
The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
376 participants
Primary outcome timeframe
Measured at enrollment and 2 weeks after targeted clinic visit
Results posted on
2019-10-11
Participant Flow
Patients gave written informed consent before enrollment.
Participant milestones
| Measure |
Intervention (Audit and Feedback)
We solicited patients' preferences for health care communication and treatment in order to generate individualized summary reports of patient's preferences. These individualized summaries of patient's preferences regarding communication about end-of-life care and preferences for end-of-life care were used to activate patients, family members, and healthcare providers.
|
Control (Usual Care)
We solicited control patients' preferences but did not deliver study generated summary reports to patients, surrogates or providers.
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
182
|
|
Overall Study
COMPLETED
|
151
|
155
|
|
Overall Study
NOT COMPLETED
|
43
|
27
|
Reasons for withdrawal
| Measure |
Intervention (Audit and Feedback)
We solicited patients' preferences for health care communication and treatment in order to generate individualized summary reports of patient's preferences. These individualized summaries of patient's preferences regarding communication about end-of-life care and preferences for end-of-life care were used to activate patients, family members, and healthcare providers.
|
Control (Usual Care)
We solicited control patients' preferences but did not deliver study generated summary reports to patients, surrogates or providers.
|
|---|---|---|
|
Overall Study
Withdrew/Loss to follow-up
|
43
|
27
|
Baseline Characteristics
Improving the Quality of End-of-Life Communication for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Intervention
n=194 Participants
Audit and feedback
|
Control
n=182 Participants
Usual care
|
Total
n=376 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
69.4 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
97.9 percent
n=5 Participants
|
96.2 percent
n=7 Participants
|
97.1 percent
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
85.3 percent
n=5 Participants
|
87.0 percent
n=7 Participants
|
86.1 percent
n=5 Participants
|
|
Smoking Status
Never smoked
|
3.9 percent
n=5 Participants
|
3.1 percent
n=7 Participants
|
3.5 percent
n=5 Participants
|
|
Smoking Status
Past smoker
|
73.2 percent
n=5 Participants
|
65.0 percent
n=7 Participants
|
69.2 percent
n=5 Participants
|
|
Smoking Status
Current smoker
|
22.9 percent
n=5 Participants
|
31.9 percent
n=7 Participants
|
27.3 percent
n=5 Participants
|
|
Male Clinicians
|
50.0 percent
n=5 Participants
|
44.0 percent
n=7 Participants
|
47.1 percent
n=5 Participants
|
|
Clinician clinic
Geriatric
|
7.1 percent
n=5 Participants
|
8.0 percent
n=7 Participants
|
7.6 percent
n=5 Participants
|
|
Clinician clinic
Primary care/internal medicine
|
64.3 percent
n=5 Participants
|
68.0 percent
n=7 Participants
|
66.1 percent
n=5 Participants
|
|
Clinician clinic
Pulmonary
|
28.6 percent
n=5 Participants
|
24.0 percent
n=7 Participants
|
26.4 percent
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at enrollment and 2 weeks after targeted clinic visitThe quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.
Outcome measures
| Measure |
Intervention
n=194 Participants
Audit and Feedback
|
Control
n=182 Participants
Usual care
|
|---|---|---|
|
Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale
Pre-visit
|
23.3 units on a scale
Interval 19.9 to 26.8
|
19.2 units on a scale
Interval 15.9 to 22.4
|
|
Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale
Post-visit
|
34.0 units on a scale
Interval 28.5 to 39.4
|
25.5 units on a scale
Interval 20.4 to 30.5
|
SECONDARY outcome
Timeframe: Assessed 2 weeks after targeted clinic visitWe measured the difference between intervention and control group patients reporting having had a discussion with their clinician about treatment preferences at their last clinic visit.
Outcome measures
| Measure |
Intervention
n=194 Participants
Audit and Feedback
|
Control
n=182 Participants
Usual care
|
|---|---|---|
|
Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit.
|
0.30 Proportion of participants reporting
Interval 0.19 to 0.41
|
0.11 Proportion of participants reporting
Interval 0.06 to 0.16
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
David H. Au, MD, MS
Department of Veterans Affairs, Health Services Research and Development
Phone: 206-764-2430
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place