Using Health-related Quality of Life (HRQL) in Routine Clinical Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00457301
Recruitment Status : Completed
First Posted : April 6, 2007
Results First Posted : September 22, 2009
Last Update Posted : September 22, 2009
Institute of Health Economics, Canada
Roche Pharma AG
Information provided by:
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Pulmonary Fibrosis Pulmonary Hypertension Cystic Fibrosis Behavioral: HUI score card Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : July 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Communication Score [ Time Frame: Baseline and end of study (6 months) ]
  2. Management Composite [ Time Frame: At baseline and end of study (6 months) ]
  3. EuroQol, EQ-5D. [ Time Frame: At baseline and end of study (6 months). ]

Secondary Outcome Measures :
  1. The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study. [ Time Frame: Baseline and end of study (6 months) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00457301

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Institute of Health Economics, Canada
Roche Pharma AG
Principal Investigator: David H Feeny, PhD Professor Economics, University of Alberta

Responsible Party: Maria Jose Santana, Lung transplant program University of Alberta Hospital Identifier: NCT00457301     History of Changes
Other Study ID Numbers: IHE-188
First Posted: April 6, 2007    Key Record Dates
Results First Posted: September 22, 2009
Last Update Posted: September 22, 2009
Last Verified: August 2009

Keywords provided by University of Alberta:
Lung transplantation, health-related quality of life.

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cystic Fibrosis
Hypertension, Pulmonary
Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases