Effectiveness of Routine Measurement of HRQOL

NCT03609762 | Completed

• 1 other identifier: HKUCTR-2418
• Study Type: interventional
• Target: 1,374
• Locations: 1 country
• Sites: 1

Brief Summary

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 electronic EQ-5D-5L platform can be applied to other outpatient clinics to improve care of MS problems and other conditions to facilitate more effective and patient-centered care.

Conditions

Quality of Life; Musculoskeletal Disease; Outcome

Keywords

Musculoskeletal Problems; Health-Related Quality of Life; Routine Measurement; Randomized Controlled Trial; Clinical Outcomes

Outcome Measures

Primary Outcomes (1)

• The change in HRQOL measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) global score

  The WOMAC is a widely used condition specific HRQOL measure to assess pain, stiffness and physical function of patients with MS problems. It has been applied to patients with hip and/or knee osteoarthritis, low back pain, rheumatoid arthritis and fibromyalgia. It consists of 24 items on 3 domains: pain (5 items), stiffness (2 items) and physical function (17 items). Each question is rated on a 5-point Likert scale from 0 to 4, with lower scores indicating lower levels of symptoms or impairment. The item scores in each domain subscale are summated to a domain score. The global WOMAC score is calculated by summating the three domain scores. A Chinese version of WOMAC is available and has been shown to be valid, reliable and sensitive in Chinese patients.

  At baseline, and 3 months, 6 months and 12 months after baseline

Secondary Outcomes (6)

• The change in pain score measured by the 10-point Pain Scale

  At baseline, and 3 months, 6 months and 12 months after baseline

• The change in patient-reported outcomes (PRO) - SF-6D utility score

  At baseline, and 3 months, 6 months and 12 months after baseline

• The change in patient-reported outcomes (PRO) - global health measured by the Global Rating Scale (GRS)

  At baseline, and 3 months, 6 months and 12 months after baseline

• The change in patient-reported outcomes (PRO) - patient enablement measured by the Patient Enablement Instrument (PEI) score

  At baseline, and 3 months, 6 months and 12 months after baseline

• The change in clinician-reported disease severity

  At baseline, and 3 months, 6 months and 12 months after baseline

Other Outcomes (3)

• Difference in the health service utilization rates between intervention group and control group

  At baseline, and 3 months, 6 months and 12 months after baseline

• Difference in the drug and other treatment utilization rates between intervention group and control group

  At baseline, and 3 months, 6 months and 12 months after baseline

• Difference in the patient acceptability of routine measurement of HRQOL by the electronic EQ-5D-5L between intervention group and control group

  At baseline, and 3 months, 6 months and 12 months after baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

EQ-5D-5L HRQOL results be available to the attending doctor

Behavioral: EQ-5D-5L HRQOL results be available to the attending doctor

Control group

NO INTERVENTION

usual care. All subjects attending the control clinics will not need to complete the electronic EQ-5D-5L before seeing the doctor during their follow-up visits. The doctor will manage the patient as usual, based on the usual clinical information. The doctor will complete the clinician-reported follow-up clinical data form (CRF) for each subject at the end of the consultation.

Interventions

EQ-5D-5L HRQOL results be available to the attending doctor BEHAVIORAL

all subjects attending the intervention clinics will complete the electronic EQ-5D-5L before seeing the doctor during each follow-up visit for the musculoskeletal problem, a print out of the longitudinal EQ-5D-5L data (Table 1) since recruitment will be given to the patients to show to the attending doctors during the consultation. The doctors will provide the management based on the usual clinical information and the additional EQ-5D-5L HRQOL results. The doctor will complete the clinician-reported follow-up clinical data form (CRF) of each eligible patient at the end of the consultation.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults aged 18 years or above
• b) has doctor-diagnosed symptomatic knee and/or back pain problem that is expected to last for one month or more
• scheduled for at least one follow-up visits in the clinic within 12 months
• has given written consent to participate in this study

You may not qualify if:

• life expectancy less than 12 months (judged by the doctor),
• has cancer
• too ill (both physically or cognitively) to complete a questionnaire
• unable to communicate in Chinese
• does not give consent to participate in the study

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (2)

• Ng APP, Liu KSN, Cheng WHG, Wong CKH, Cheng JKY, Lam JSM, Or CK, Tse ETY, Lam CLK. Feasibility and acceptability of electronic EQ-5D-5L for routine measurement of HRQOL in patients with chronic musculoskeletal problems in Hong Kong primary care. Health Qual Life Outcomes. 2022 Sep 20;20(1):137. doi: 10.1186/s12955-022-02047-0.

  PMID: 36127713 DERIVED

• Lam C, Chin WY, Wong CKH, Or K, Fong DYT, Cheung JPY, Chao DVK, Wong ELY, Kind P. Effectiveness of routine measurement of health-related quality of life in improving the outcomes of patients with musculoskeletal problems-a cluster randomised controlled trial: protocol paper. BMJ Open. 2020 Dec 15;10(12):e040373. doi: 10.1136/bmjopen-2020-040373.

  PMID: 33323434 DERIVED

Related Links

• protocol paper
• electronic EQ-5D-5L psychometrics
• Feasibility \& acceptability of electronic EQ-5D-5L
• Enablement mediates between pain and HRQOL

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Cindy L. K. LAM

  Professor and Head

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of Department

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 1, 2018
• Study Start: January 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: On completion of the trial, and after publication of the primary manuscript
• Access Criteria: Will be assessed by the corresponding author at The Department of Family Medicine and Primary Care, The University of Hong Kong

Locations

HK (1)