The primary objectives of this study are to: 1) develop an educational tool known as the Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine what to expect if they choose either option; 2) assess the extent that the PROM-DA improves patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA in multiple sites and more patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
163
Edmonton Bone and Joint Centre
Edmonton, Alberta, Canada
Decision quality
Hip and Knee Decision Quality Instrument (HK-DQI)
Time frame: 40 to 52 weeks after baseline
Quality of life (generic)
Euroqol Five Dimensions Questionnaire (EQ-5D-5L)
Time frame: 40 to 52 weeks after baseline
Quality of life (condition-specific)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 40 to 52 weeks after baseline
Depression
The Patient Health Questionnaire (PHQ-9)
Time frame: 40 to 52 weeks after baseline
Knowledge about total knee arthroplasty surgery
HK-DQI
Time frame: Baseline
Values
HK-DQI
Time frame: Baseline
Decisional conflict
Decisional Conflict Scale (SURE)
Time frame: Baseline
Treatment Preference
Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks? Yes No Unsure
Time frame: Baseline
Preference for involvement in decision making
Control Preferences Scale (CPS)
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Time frame: Baseline
Willingness to have surgery
Single item question: Based on your current understanding of the risks and benefits of knee replacement surgery of your knee arthritis, what is your current preference between having joint replacement surgery or non-surgical treatments? I would definitely consider having knee joint replacement surgery now. I would probably consider having knee joint replacement surgery now. I am not sure. I would probably not consider having knee joint replacement surgery now. I would definitely not consider having knee joint replacement surgery now.
Time frame: Baseline
Patient-reported shared decision-making
CollaboRATE
Time frame: 3 to 6 weeks after baseline
Decisional regret
Decision Regret Scale
Time frame: 40 to 52 weeks after baseline
Satisfaction with knee replacement surgery
Three item questionnaire: 1. Overall, how satisfied are you with the results of your knee replacement surgery? 2. How satisfied are you with your knee replacement surgery for reducing your pain when walking on a flat surface? Going up or down stairs? Sitting or lying down? 3. How satisfied are you with your most recent knee replacement surgery for improving your ability to perform five functions: Going up stairs? Getting in/out of a car or on/off a bus? Rising from bed? Lying in bed? Performing light domestic duties? Responses from 'very dissatisfied' to ' very satisfied'
Time frame: 40 to 52 weeks after baseline
Expectations
Single item question from Bourne et al. 2010. Clin Orthop Relat Res. related to whether expectations were met; not met; or whether they had no expectations.
Time frame: 40 to 52 weeks after baseline
Surgical consult
Electronic Medical Records (EMR)
Time frame: 1 to 4 weeks after baseline
Surgery
EMR
Time frame: 27 to 30 weeks after baseline
Concordance
HK-DQI
Time frame: 40 to 52 weeks after baseline