Clinical trial NCT00457301: Using Health-related Quality of Life (HRQL) in Routine Clinical Care
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Fibrosis
Pulmonary Hypertension
Cystic Fibrosis
Keywords: Lung transplantation, health-related quality of life.
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Institute of Health Economics, Canada
name: Roche Pharma AG
First posted: 2007-04-06
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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).

Eligibility criteria: 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

Primary outcomes:
measure: Communication Score
timeFrame: Baseline and end of study (6 months)
measure: Management Composite
timeFrame: At baseline and end of study (6 months)
measure: EuroQol, EQ-5D.
timeFrame: At baseline and end of study (6 months).
Secondary outcomes:
measure: The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.
timeFrame: Baseline and end of study (6 months)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: Professor Economics, University of Alberta
name: David H Feeny, PhD
role: PRINCIPAL_INVESTIGATOR
References: