Trial Outcomes & Findings for Using Health-related Quality of Life (HRQL) in Routine Clinical Care (NCT NCT00457301)
NCT ID: NCT00457301
Last Updated: 2020-04-01
Results Overview
Each clinician-patient encounter was audio tape-recorded. The content of the tape-recordings was examined and results recorded on the communication form by three blinded raters. This form tallies the number of issues discussed. The number of issues is summed to produce a communication score. The issues discussed included health attributes included in the HUI2 and HUI3: ambulation, self-care, anxiety, depression, cognitive problems, pain (type and frequency), vision, hearing speech and dexterity problems.
COMPLETED
213 participants
Baseline and end of study (6 months)
2020-04-01
Participant Flow
The recruitment started July 2005. Patients were recruited at the out patient clinic University of Alberta Hospital.
Pre-transplant patients were censored out of the study once they had the lung transplant.
Participant milestones
| Measure |
HUI2 and HUI3 Completion Without Feedback to Clinicians.
Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
|
HUI2 and HUI3 Completion and Feedback to Clinicians
Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
108
|
|
Overall Study
COMPLETED
|
82
|
84
|
|
Overall Study
NOT COMPLETED
|
23
|
24
|
Reasons for withdrawal
| Measure |
HUI2 and HUI3 Completion Without Feedback to Clinicians.
Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
|
HUI2 and HUI3 Completion and Feedback to Clinicians
Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Censored out of the study
|
15
|
14
|
|
Overall Study
Death
|
5
|
7
|
Baseline Characteristics
Using Health-related Quality of Life (HRQL) in Routine Clinical Care
Baseline characteristics by cohort
| Measure |
HUI2 and HUI3 Completion Without Feedback to Clinicians.
n=105 Participants
Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
|
HUI2 and HUI3 Completion and Feedback to Clinicians
n=108 Participants
Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
53.2 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
53.3 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of study (6 months)Population: Traditional analysis of covariance, ANCOVA was conducted to explore the difference between control and intervention groups at 6 months adjusting for baseline scores and transplant status. ITT was conducted and missing values were imputed using the LOCF.
Each clinician-patient encounter was audio tape-recorded. The content of the tape-recordings was examined and results recorded on the communication form by three blinded raters. This form tallies the number of issues discussed. The number of issues is summed to produce a communication score. The issues discussed included health attributes included in the HUI2 and HUI3: ambulation, self-care, anxiety, depression, cognitive problems, pain (type and frequency), vision, hearing speech and dexterity problems.
Outcome measures
| Measure |
HUI2 and HUI3 Completion Without Feedback to Clinicians.
n=105 Participants
Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
|
HUI2 and HUI3 Completion and Feedback to Clinicians
n=108 Participants
Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
|
|---|---|---|
|
Communication Score
baseline
|
1.14 Mean number of issues discussed
Standard Deviation 1.16
|
1.50 Mean number of issues discussed
Standard Deviation 1.10
|
|
Communication Score
End-of-study
|
1.36 Mean number of issues discussed
Standard Deviation 1.00
|
1.75 Mean number of issues discussed
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: At baseline and end of study (6 months)Population: Analysis was conducted using ITT, with 47 observations carried forward.
Changes in clinical management were recorded in the chart review form. The number of referrals to other healthcare providers, tests ordered (X-rays, blood test, bronchoscopies) and changes in medication (reduction or increase dosage, addition or discontinuation) were summed to produce the management composite.
Outcome measures
| Measure |
HUI2 and HUI3 Completion Without Feedback to Clinicians.
n=105 Participants
Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
|
HUI2 and HUI3 Completion and Feedback to Clinicians
n=108 Participants
Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
|
|---|---|---|
|
Management Composite
Baseline
|
0.70 mean management composite
Standard Deviation 1.52
|
1.20 mean management composite
Standard Deviation 2.50
|
|
Management Composite
End-of-study
|
2.19 mean management composite
Standard Deviation 2.84
|
3.27 mean management composite
Standard Deviation 3.35
|
PRIMARY outcome
Timeframe: At baseline and end of study (6 months).Population: To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error, two-sided-test and 80% power. ITT was conducted for 213 recruited patients. 47 records were imputed using LOCF.
Generic preference-based measure. EQ-5D consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute ("no problem", "some problems" and "extreme problems").Using the US scoring function EQ-5D index scores range from -0.11 (all-worst health state, worse than dead), to 0.00 (dead) to 1.00 (perfect health). The EQ-5D is easy to complete, valid and reliable.
Outcome measures
| Measure |
HUI2 and HUI3 Completion Without Feedback to Clinicians.
n=105 Participants
Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
|
HUI2 and HUI3 Completion and Feedback to Clinicians
n=108 Participants
Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
|
|---|---|---|
|
EuroQol, EQ-5D.
end of study
|
0.75 mean EQ-5D index score
Standard Deviation 0.23
|
0.72 mean EQ-5D index score
Standard Deviation 0.25
|
|
EuroQol, EQ-5D.
baseline
|
0.76 mean EQ-5D index score
Standard Deviation 0.17
|
0.76 mean EQ-5D index score
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Baseline and end of study (6 months)Population: 47 observation were imputed by LOCF and analyzed as ITT.
HADS is a self-complete mental health measure. The scale consists of 14 items, seven of which assess anxiety and seven which assess depression. Each item is on a four point scale and the scores are added to give a total ranging from 0 to 21 for anxiety and 0 to 21 for depression. Higher scores indicate more severe anxiety or depression. A cut-point of 8 or 9 indicates mild burden for the two scales; 11 or 12 indicates severe . All the patients completed HADS at baseline and at the end of the study.
Outcome measures
| Measure |
HUI2 and HUI3 Completion Without Feedback to Clinicians.
n=105 Participants
Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
|
HUI2 and HUI3 Completion and Feedback to Clinicians
n=108 Participants
Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
|
|---|---|---|
|
The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.
Baseline anxiety
|
6.41 mean anxiety and depression
Standard Deviation 3.15
|
5.81 mean anxiety and depression
Standard Deviation 3.95
|
|
The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.
Baseline depression
|
4.87 mean anxiety and depression
Standard Deviation 3.48
|
4.31 mean anxiety and depression
Standard Deviation 3.25
|
|
The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.
End-of-Study Anxiety
|
5.70 mean anxiety and depression
Standard Deviation 3.36
|
5.69 mean anxiety and depression
Standard Deviation 3.62
|
|
The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.
End-of-Study Depression
|
4.21 mean anxiety and depression
Standard Deviation 3.71
|
4.07 mean anxiety and depression
Standard Deviation 3.61
|
Adverse Events
HUI2 and HUI3 Completion Without Feedback to Clinicians.
HUI2 and HUI3 Completion and Feedback to Clinicians
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Maria Jose Santana
Lung transplant program, University of Alberta Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place