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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 45 Years and 89 Years
Eligible Genders
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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental 		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
    Decision aid meant to improve shared decision making among patients and providers.
Active Comparator
Control 		Education component of the decision aid only.
  • Other: Education material from OM1 Dell Shared Decision Making Tool
    Investigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options.

More Details

Status
Completed
Sponsor
University of Texas at Austin

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.