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Completed

NCT Number: NCT00457301

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Cardiovascular Diseases Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Disease Attributes Fibrosis Genetic Diseases, Inborn Hypertension Hypertension, Pulmonary Infant, Newborn, Diseases Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta Hospital

Edmonton, Alberta, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HUI score card

Behavioral

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 names: Health Utilities Index Score Card

Primary outcomes

  1. Communication Score

    Time frame: 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.

  2. Management Composite

    Time frame: 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.

  3. EuroQol, EQ-5D.

    Time frame: 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 outcomes

  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)

    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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Institute of Health Economics, Canada
  • Roche Pharma AG

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Apr 6, 2007
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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