A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.

Conditions
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Knee Osteoarthritis, Total Knee Arthroplasty

Intervention / Treatment
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* Behavioral: Baseline and Follow-up Surveys
* Other: Patient Reported Outcome Measure informed Decision Aid
* Other: Pamphlet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br> | Behavioral: Baseline and Follow-up Surveys<br>* (completed online)<br>Other: Patient Reported Outcome Measure informed Decision Aid<br>* (PROM-DA)<br>|
| Placebo Comparator: Non Treatment Group<br>Conventional information | Behavioral: Baseline and Follow-up Surveys<br>* (completed online)<br>Other: Pamphlet<br>* (usual care)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision quality | Hip and Knee Decision Quality Instrument (HK-DQI) | 40 to 52 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (generic) | Euroqol Five Dimensions Questionnaire (EQ-5D-5L) | 40 to 52 weeks after baseline | 
| Quality of life (condition-specific) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 40 to 52 weeks after baseline | 
| Depression | The Patient Health Questionnaire (PHQ-9) | 40 to 52 weeks after baseline | 
| Knowledge about total knee arthroplasty surgery | HK-DQI | Baseline | 
| Values | HK-DQI | Baseline | 
| Decisional conflict | Decisional Conflict Scale (SURE) | Baseline | 
| Treatment Preference | Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks? Yes No Unsure | Baseline | 
| Preference for involvement in decision making | Control Preferences Scale (CPS) | 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. | Baseline | 
| Patient-reported shared decision-making | CollaboRATE | 3 to 6 weeks after baseline | 
| Decisional regret | Decision Regret Scale | 40 to 52 weeks after baseline | 
| Satisfaction with knee replacement surgery | Three item questionnaire: Overall, how satisfied are you with the results of your knee replacement surgery? 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? 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' | 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. | 40 to 52 weeks after baseline | 
| Surgical consult | Electronic Medical Records (EMR) | 1 to 4 weeks after baseline | 
| Surgery | EMR | 27 to 30 weeks after baseline | 
| Concordance | HK-DQI | 40 to 52 weeks after baseline |