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Effectiveness of Routine Measurement of HRQOL

The University of Hong Kong · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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clinical-outcomeshealth-related-quality-of-lifenaoutcomequality-of-liferandomized-controlled-trial
Aim and Objectives: This is an effectiveness-implementation hybrid trial that aims to find out whether the implementation of routine measurement and reporting on the patient's EQ-5D-5L HRQOL data with an electronic platform can improve HRQOL and pain in patients with chronic knee or back problems in primary care. The investigators will also assess the acceptability of routine electronic measurement and reporting of the EQ-5D-5L in real-world primary care. Method: This is a multi-center prospective cluster-randomized controlled trial in six public primary care clinics in Hong Kong. The six clinics will be randomized to the intervention or control group. We shall recruit 1374 (229 from each clinic) subjects with symptomatic chronic knee or back problems through the attending doctors in the clinics. Subjects of the Intervention clinics will complete the electronic EQ-5D-5L at recruitment and every follow up during the next 12 months, and a report on their longitudinal EQ-5D-5L data will be shown to the doctors during the consultations. Subjects of the control clinics will receive care as usual. All subjects will complete a set of patient reported outcome measures (PRO) including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on HRQOL and a 10-point Pain Rating Scale (PRS), and a structured questionnaire on sociodemographics, morbidity and service utilization rates at recruitment, and at 3, 6 and 12 months by telephone. Outcome Measures and Data Analysis: The primary outcome is change in WOMAC total score. The secondary outcomes are change in pain, other PRO scores and doctor rated severity of disease. Group difference in changes of WOMAC and other outcome scores over time will be analyzed using generalized estimating equation model under intention-to-treat principle. The acceptability of routine measurement of HRQOL by electronic EQ-5D-5L will be analyzed by descriptive statistics. Potential application: Routine measurement of HRQOL by an
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