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

The University of Texas System (UT)

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Other: Education material from OM1 Dell Shared Decision Making Tool; Other: OM1 Dell Shared Decision Making Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT03956004

2018-11-0042

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: All

Ages: 45 to 89 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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145 participants in 2 patient groups

Experimental

Experimental group

Description:

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.

Treatment:

Other: OM1 Dell Shared Decision Making Tool

Control

Active Comparator group

Description:

Education component of the decision aid only.

Treatment:

Other: Education material from OM1 Dell Shared Decision Making Tool