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
- Conditions
- Osteoarthritis, Knee
- Interventions
- Other: OM1 Dell Shared Decision Making ToolOther: Education material from OM1 Dell Shared Decision Making Tool
- Registration Number
- NCT03956004
- Lead Sponsor
- University of Texas at Austin
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental OM1 Dell Shared Decision Making Tool 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. Control Education material from OM1 Dell Shared Decision Making Tool Education component of the decision aid only.
- Primary Outcome Measures
Name Time Method Knee Osteoarthritis Decision Quality Instrument Day 1 Concordance subscore (A summary score (0-100%) indicating the percentage of patients who received treatment that matched their stated preference will be generated.)
- Secondary Outcome Measures
Name Time Method CollaboRATE Day 1 Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making.
Numeric rating scale-satisfaction Day 1 Patient satisfaction with management of condition. Range of 0-10 with 0 representing complete dissatisfaction and 10 representing complete satisfaction.
Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR) 6 months after baseline visit 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.
Undergoing joint replacement surgery or not Day 1 Decision to undergo total knee replacement surgery (yes/no). Obtained by asking provider or through medical record note.
Average time of patient visit and average time spent with provider Day 1 Minutes. Time of entire visit will be recorded in addition to time spent with primary provider.
Trial Locations
- Locations (1)
UT Health Austin
🇺🇸Austin, Texas, United States