Clinical trial NCT03956004: 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
Official title: A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: shared decision making
osteoarthritis
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 145
Sex: ALL
Minimum age (years): 45
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Knee Osteoarthritis Decision Quality Instrument
timeFrame: Day 1
measure: Knee Osteoarthritis Decision Quality Instrument
timeFrame: Day 1
Secondary outcomes:
measure: CollaboRATE
timeFrame: Day 1
measure: Numeric rating scale-satisfaction
timeFrame: Day 1
measure: Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR)
timeFrame: 6 months after baseline visit
measure: Undergoing joint replacement surgery or not
timeFrame: Day 1
measure: Average time of patient visit and average time spent with provider
timeFrame: Day 1
Other outcomes:
Locations:
city: Austin
country: United States
facility: UT Health Austin
state: Texas
Study officials:
affiliation: Dell Medical School at The University of Texas at Austin
name: Kevin Bozic
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jayakumar P, Moore MG, Furlough KA, Uhler LM, Andrawis JP, Koenig KM, Aksan N, Rathouz PJ, Bozic KJ. Comparison of an Artificial Intelligence-Enabled Patient Decision Aid vs Educational Material on Decision Quality, Shared Decision-Making, Patient Experience, and Functional Outcomes in Adults With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2037107. doi: 10.1001/jamanetworkopen.2020.37107.