The Impact of a Technology-enabled Decision Aid, for Patients With Hip and Knee Osteoarthritis on Decision Quality, Level of Shared Decision-making, Patient Satisfaction and Magnitude of Limitations

Study Overview
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Brief Summary
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This study evaluates a technology-enabled decision aid that provides evidence-based education (i.e. on understanding the condition, treatment options and comparisons, patient values and question & answer quiz) and personalized, quantifiable benefit-risk ratio alongside the level of potential benefit in relation to joint stiffness, joint pain and quality of life. The study will be performed in the setting of an integrated care system providing patient-centered care for hip and knee osteoarthritis over the full cycle of care. The impact of a technology-enabled decision aid incorporating predictive analytics with machine learning capabilities on decision quality, activation, experience & limitations of patients in this setting is relatively unknown.

Official Title
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A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: OM1 Dell Shared Decision Making Tool
* Other: Education material from OM1 Dell Shared Decision Making Tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with a presumptive diagnosis of knee OA aged between 45 and 89 (in-line with the decision aid algorithm) Radiographic evidence of moderate to severe osteoarthritis (Kellgren and Lawrence grade 3-4) KOOS Jr scores between 0-85 (in-line with the decision-aid algorithm) Participant able to give informed consent for participation in the study Exclusion Criteria: Kellgren and Lawrence scale for classification of osteoarthritis grade 0-2 Patients with a prior experience of total joint replacement Patient with experience with the pilot form of the decision aid Patients undergoing consideration for revision joint replacement Patients seeking care for trauma condition or psoriatic/rheumatoid arthritis Non-English or Non-Spanish speakers Patients with BMI below 20 or above 46 (in-line with the decision-aid algorithm)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 89 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Full decision aid, consisting of education on osteoarthritis and treatment options, preferences and values elicitation, and personalized risk/benefit estimates based on patient's response to patient-reported outcome measures. | Other: OM1 Dell Shared Decision Making Tool<br>* Decision aid meant to improve shared decision making among patients and providers.<br>|
| Active Comparator: Control<br>Education component of the decision aid only. | Other: Education material from OM1 Dell Shared Decision Making Tool<br>* Investigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Osteoarthritis Decision Quality Instrument | Decision process subscore. Participants receive 1 point for a response of yes or a lot/some. The total points are summed and then divided by the total number of items to result in scores from 0-100%, with higher scores indicated a more shared decision making process. | Day 1 | 
| Knee Osteoarthritis Decision Quality Instrument | Concordance subscore (A summary score (0-100%) indicating the percentage of patients who received treatment that matched their stated preference will be generated.) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CollaboRATE | Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making. | Day 1 | 
| Numeric rating scale-satisfaction | Patient satisfaction with management of condition. Range of 0-10 with 0 representing complete dissatisfaction and 10 representing complete satisfaction. | Day 1 | 
| Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR) | Measure of patient-reported, knee-related stiffness, pain, and function. Raw score range 0-28, converted to interval score of 0-100, where 0 represents total knee disability and 100 represents perfect knee health. | 6 months after baseline visit | 
| Undergoing joint replacement surgery or not | Decision to undergo total knee replacement surgery (yes/no). Obtained by asking provider or through medical record note. | Day 1 | 
| Average time of patient visit and average time spent with provider | Minutes. Time of entire visit will be recorded in addition to time spent with primary provider. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shared decision making, osteoarthritis