Chronic Obstructive Pulmonary Disease, Cystic Fibrosis, Pulmonary Fibrosis, Pulmonary Hypertension
Conditions
Keywords
Lung transplantation, health-related quality of life.
Brief summary
The objective of this study is to assess the effects of using HRQL measures in the clinical care of pre- and post-lung transplant patients. The hypotheses are that the inclusion of HRQL measures, the Health Utilities Index System Mark 2(HUI2) and Mark 3 (HUI3), in routine clinical care of pre- and post-lung transplant patients, will: 1) improve patient-clinician communication;2) affect patient management; 3) improve patients' HRQL.
Detailed description
Recently there has been increasing interest in the use of health-related quality of life (HRQL) measures in routine clinical practice. Traditionally, patient care has been based on laboratory results, medical history, and signs and symptoms diagnosed by clinicians. The inclusion of HRQL measures in routine practice may provide important and often otherwise missing information, revealing the impact of the disease or its treatment on the patient's physical, emotional and social well-being, and may assist in patient management. HRQL assessments may assist in changing the medical paradigm from a disease-centered approach to a patient-centered one. Several studies in mental health and oncology discuss the application of HRQL measures in clinical practice. Taenzer et al (2000) and Detmar et al. (2002) provide evidence that using HRQL measures improves patient-clinician communication. Velikova et al (2004) detected impacts on communication and the emotional well-being of patients. Using a framework based on these previous studies and the methods for the health technology assessment of diagnostic technologies (Guyatt et al. 1986), we will assess the effects of including HRQL assessments in the routine clinical care of patients undergoing solid organ transplantation (lung). We expect that the routine use of HRQL measures in clinical practice will affect patient-clinician communication, patient management, and patient outcome. Lung transplantation trades a fatal disease (end-stage pulmonary disease) for a chance at prolonged survival and improved quality of life, albeit with immunosuppression. In this context, generic preference-based measures such as HUI2 and HUI3 are preferred to specific measures, because they measure a broader range of health dimensions, including pain, ambulation and emotional issues that are expected to be relevant. Preference-based measures provide scores on the conventional 0.00 (dead) to 1.00 (perfect health) scale that allows for the integration of morbidity and mortality effects and calculation of quality adjusted life years (QALYs) and health-adjusted life expectancy (HALE).
Interventions
BEHAVIORALHUI score card
Patients completed the HUI2 and HUI3 before the encounter with the clinician, the result was graphically represented in the HUI score card. Clinicians used the HUI score card as an extra tool to help them in the management of the patients
Sponsors
Institute of Health Economics, Canada
Roche Pharma AG
University of Alberta
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pre-lung transplant:subjects who are included on the waiting list and are being seen at the out-patient clinic * post-lung transplant subjects.
Exclusion criteria
* younger than 18 years of age * diagnosed as being cognitively impaired * unable to complete questionnaires in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Communication Score | Baseline and end of study (6 months) | 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. |
| Management Composite | At baseline and end of study (6 months) | 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. |
| EuroQol, EQ-5D. | At baseline and end of study (6 months). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study. | Baseline and end of study (6 months) | 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. |
Countries
Canada
Participant flow
Recruitment details
The recruitment started July 2005. Patients were recruited at the out patient clinic University of Alberta Hospital.
Pre-assignment details
Pre-transplant patients were censored out of the study once they had the lung transplant.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 105 |
| 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. | 108 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Censored out of the study | 15 | 14 |
| Overall Study | Death | 5 | 7 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | HUI2 and HUI3 Completion Without Feedback to Clinicians. | HUI2 and HUI3 Completion and Feedback to Clinicians | Total |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 12.9 | 53.2 years STANDARD_DEVIATION 12.6 | 53.3 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 53 Participants | 56 Participants | 109 Participants |
| Sex: Female, Male Male | 52 Participants | 52 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 105 | 0 / 108 |
| serious Total, serious adverse events | 0 / 105 | 0 / 108 |
Outcome results
Primary
Communication Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HUI2 and HUI3 Completion Without Feedback to Clinicians. | Communication Score | End-of-study | 1.36 Mean number of issues discussed | Standard Deviation 1 |
| HUI2 and HUI3 Completion Without Feedback to Clinicians. | Communication Score | baseline | 1.14 Mean number of issues discussed | Standard Deviation 1.16 |
| HUI2 and HUI3 Completion and Feedback to Clinicians | Communication Score | End-of-study | 1.75 Mean number of issues discussed | Standard Deviation 1.15 |
| HUI2 and HUI3 Completion and Feedback to Clinicians | Communication Score | baseline | 1.50 Mean number of issues discussed | Standard Deviation 1.1 |
Comparison: Sample size was calculated based on the EQ-5D index score. 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 and 80% power.p-value: 0.05ANCOVA
Primary
EuroQol, EQ-5D.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HUI2 and HUI3 Completion Without Feedback to Clinicians. | EuroQol, EQ-5D. | baseline | 0.76 mean EQ-5D index score | Standard Deviation 0.17 |
| HUI2 and HUI3 Completion Without Feedback to Clinicians. | EuroQol, EQ-5D. | end of study | 0.75 mean EQ-5D index score | Standard Deviation 0.23 |
| HUI2 and HUI3 Completion and Feedback to Clinicians | EuroQol, EQ-5D. | baseline | 0.76 mean EQ-5D index score | Standard Deviation 0.17 |
| HUI2 and HUI3 Completion and Feedback to Clinicians | EuroQol, EQ-5D. | end of study | 0.72 mean EQ-5D index score | Standard Deviation 0.25 |
Comparison: Sample size was calculated based on the EQ-5D index score. 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 and 80% power.p-value: 0.46ANCOVA
Primary
Management Composite
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.
Time frame: At baseline and end of study (6 months)
Population: Analysis was conducted using ITT, with 47 observations carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HUI2 and HUI3 Completion Without Feedback to Clinicians. | Management Composite | Baseline | 0.70 mean management composite | Standard Deviation 1.52 |
| HUI2 and HUI3 Completion Without Feedback to Clinicians. | Management Composite | End-of-study | 2.19 mean management composite | Standard Deviation 2.84 |
| HUI2 and HUI3 Completion and Feedback to Clinicians | Management Composite | Baseline | 1.20 mean management composite | Standard Deviation 2.5 |
| HUI2 and HUI3 Completion and Feedback to Clinicians | Management Composite | End-of-study | 3.27 mean management composite | Standard Deviation 3.35 |
p-value: 0.001ANCOVA
Secondary
The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.
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.
Time frame: Baseline and end of study (6 months)
Population: 47 observation were imputed by LOCF and analyzed as ITT.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HUI2 and HUI3 Completion Without Feedback to Clinicians. | 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 |
| HUI2 and HUI3 Completion Without Feedback to Clinicians. | 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 |
| HUI2 and HUI3 Completion Without Feedback to Clinicians. | 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 |
| HUI2 and HUI3 Completion Without Feedback to Clinicians. | 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 |
| HUI2 and HUI3 Completion and Feedback to Clinicians | The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study. | End-of-Study Depression | 4.07 mean anxiety and depression | Standard Deviation 3.61 |
| HUI2 and HUI3 Completion and Feedback to Clinicians | The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study. | Baseline anxiety | 5.81 mean anxiety and depression | Standard Deviation 3.95 |
| HUI2 and HUI3 Completion and Feedback to Clinicians | The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study. | End-of-Study Anxiety | 5.69 mean anxiety and depression | Standard Deviation 3.62 |
| HUI2 and HUI3 Completion and Feedback to Clinicians | The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study. | Baseline depression | 4.31 mean anxiety and depression | Standard Deviation 3.25 |
Comparison: ANCOVA adjuusting for baseline HADS anxiety scoresp-value: 0.34ANCOVA
Comparison: ANCOVA adjusting for baseline HADS depression scores.p-value: 0.55ANCOVA