Using Health-related Quality of Life (HRQL) in Routine Clinical Care
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.
Chronic Obstructive Pulmonary Disease
Behavioral: HUI score card
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
|Official Title:||An Assessment of the Effects of the Use of Measures of Health-related Quality of Life in Routine Clinical Care:an Application to Lung Transplantation.|
- Communication Score [ Time Frame: Baseline and end of study (6 months) ] [ Designated as safety issue: No ]
- Management Composite [ Time Frame: At baseline and end of study (6 months) ] [ Designated as safety issue: No ]
- EuroQol, EQ-5D. [ Time Frame: At baseline and end of study (6 months). ] [ Designated as safety issue: No ]
- The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study. [ Time Frame: Baseline and end of study (6 months) ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||May 2008|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
|No Intervention: Control||
Behavioral: HUI 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
Other Name: Health Utilities Index Score Card
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457301
|University of Alberta Hospital|
|Edmonton, Alberta, Canada|
|Principal Investigator:||David H Feeny, PhD||Professor Economics, University of Alberta|