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Assessing the Effects of Including Health-Related Quality of Life (HRQL) Measures in Routine Clinical Care
This study is ongoing, but not recruiting participants.
First Received: April 4, 2007   Last Updated: April 5, 2007   History of Changes
Sponsors and Collaborators: University of Alberta
Institute of Health Economics
Hoffmann-La Roche
Information provided by: University of Alberta
ClinicalTrials.gov Identifier: NCT00457301
  Purpose

The objective of this study is to assess the effects of using HRQL measures in the clinical care of pre- and post-heart and lung transplant patients. The hypotheses are that the inclusion of HRQL measures, the Health Utilities Index System (HUI2 and HUI3), in routine clinical practice, will improve patient-clinician communication, patient management and patient outcome.


Condition Intervention
Lung Transplantation
Behavioral: HUI score card

Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 Transplant.

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • EuroQol, EQ-5D. It is completed at baseline at after every clinic visit by the patients.

Secondary Outcome Measures:
  • Clinician-patient communication. Clinician-patient encounter will be audio tape-recorded with the patient’s consent at every clinic visit.
  • Patient satisfaction is a measure of the patient’s experience with the health care received. The Consumers Association of Health Plans Study (CAHPS) clinician-group survey is a measure of satisfaction with care that focuses on individual clinicians with
  • Patient management. Chart review will be used to record the changes in clinical management, such as reduction/addition of medicines, change in treatment, number of test ordered, number of visits, and referrals to other healthcare providers.
  • The Hospital Anxiety and Depression Scale,HADS. Completed at baseline and end of the study.
  • Adherence measures:Godin’s survey measures physical activity monitoring daily activities and exercise. Godin’s measure is valid, reliable and easy to complete by patients. Morisky’s scale. Morisky’s medication adherence scale is a widely used meas
  • Patient’s sociodemographic characteristics. At the first study visit the patients will complete a brief sociodemographic questionnaire. Completed at baseline.
  • Clinician's expectation form. At the first study visit, clinicians will be invited to complete this form.
  • Clinician’s characteristics. Clinicians will complete a survey at the beginning of the study. Patients and clinicians evaluation of the intervention. At the end of the study period.

Estimated Enrollment: 212
Study Start Date: July 2005
Estimated Study Completion Date: April 2007
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 Health Utilities Index System 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457301

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Institute of Health Economics
Hoffmann-La Roche
Investigators
Principal Investigator: David H Feeny, PhD Professor Economics, University of Alberta
  More Information

No publications provided

Study ID Numbers: IHE-188
Study First Received: April 4, 2007
Last Updated: April 5, 2007
ClinicalTrials.gov Identifier: NCT00457301     History of Changes
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Quality of Life

ClinicalTrials.gov processed this record on September 02, 2009