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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-28

Study Completion Date

2020-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

OM1 Dell Shared Decision Making Tool

Intervention Type OTHER

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

Control

Education component of the decision aid only.

Group Type ACTIVE_COMPARATOR

Education material from OM1 Dell Shared Decision Making Tool

Intervention Type OTHER

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

Interventions

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OM1 Dell Shared Decision Making Tool

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

Intervention Type OTHER

Education material from OM1 Dell Shared Decision Making Tool

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

45 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No