A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 145
- Locations
- 2
- Primary Endpoint
- Knee Osteoarthritis Decision Quality Instrument
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Knee Osteoarthritis Decision Quality Instrument
Time Frame: Day 1
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.
Secondary Outcomes
- CollaboRATE(Day 1)
- Numeric rating scale-satisfaction(Day 1)
- Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR)(6 months after baseline visit)
- Undergoing joint replacement surgery or not(Day 1)
- Average time of patient visit and average time spent with provider(Day 1)
Investigators
Kevin Bozic
Professor of Surgery
University of Texas at Austin