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

U

University of Alberta

Status

Completed

Conditions

Pulmonary Fibrosis
Chronic Obstructive Pulmonary Disease
Cystic Fibrosis
Pulmonary Hypertension

Treatments

Behavioral: HUI score card

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00457301
IHE-188

Details and patient eligibility

About

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.

Full 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).

Enrollment

213 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

213 participants in 1 patient group

Control
Treatment:
Behavioral: HUI score card

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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