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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

A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03956004
Enrollment
145
Registered
2019-05-20
Start date
2019-03-28
Completion date
2020-01-30
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

shared decision making, osteoarthritis

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.

Interventions

OTHEROM1 Dell Shared Decision Making Tool

Decision aid meant to improve shared decision making among patients and providers.

OTHEREducation material from OM1 Dell Shared Decision Making Tool

Investigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options.

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 89 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Knee Osteoarthritis Decision Quality InstrumentDay 1Decision 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

MeasureTime frameDescription
CollaboRATEDay 1Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making.
Numeric rating scale-satisfactionDay 1Patient 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 visitMeasure 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 notDay 1Decision 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 providerDay 1Minutes. Time of entire visit will be recorded in addition to time spent with primary provider.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026