Knee Osteoarthritis, Total Knee Arthroplasty
Conditions
Brief summary
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.
Interventions
BEHAVIORALBaseline and Follow-up Surveys
(completed online)
OTHERPatient Reported Outcome Measure informed Decision Aid
(PROM-DA)
OTHERPamphlet
(usual care)
Sponsors
University of British Columbia
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (age≥30) patients with knee osteoarthritis (OA) * Have an appointment with a surgeon for consultation about Total Knee Arthroplasty at the Edmonton Bone and Joint Centre * Understands, speaks and reads English; and * Able to provide informed consent.
Exclusion criteria
* Individuals who have had prior total knee arthroplasty * Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Fibromyalgia, or Gout.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision quality | 40 to 52 weeks after baseline | Hip and Knee Decision Quality Instrument (HK-DQI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (generic) | 40 to 52 weeks after baseline | Euroqol Five Dimensions Questionnaire (EQ-5D-5L) |
| Quality of life (condition-specific) | 40 to 52 weeks after baseline | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
| Depression | 40 to 52 weeks after baseline | The Patient Health Questionnaire (PHQ-9) |
| Knowledge about total knee arthroplasty surgery | Baseline | HK-DQI |
| Values | Baseline | HK-DQI |
| Decisional conflict | Baseline | Decisional Conflict Scale (SURE) |
| Treatment Preference | Baseline | Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks? Yes No Unsure |
| Preference for involvement in decision making | Baseline | Control Preferences Scale (CPS) |
| Willingness to have surgery | Baseline | 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. |
| Patient-reported shared decision-making | 3 to 6 weeks after baseline | CollaboRATE |
| Decisional regret | 40 to 52 weeks after baseline | Decision Regret Scale |
| Satisfaction with knee replacement surgery | 40 to 52 weeks after baseline | 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' |
| Expectations | 40 to 52 weeks after baseline | 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. |
| Surgical consult | 1 to 4 weeks after baseline | Electronic Medical Records (EMR) |
| Surgery | 27 to 30 weeks after baseline | EMR |
| Concordance | 40 to 52 weeks after baseline | HK-DQI |
Countries
Canada
Outcome results
None listed