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Clinical Trials/NCT03956004
NCT03956004
Completed
N/A

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

University of Texas at Austin1 site in 1 country145 target enrollmentMarch 28, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
University of Texas at Austin
Enrollment
145
Locations
1
Primary Endpoint
Knee Osteoarthritis Decision Quality Instrument
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2019
End Date
January 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kevin Bozic

Professor of Surgery

University of Texas at Austin

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)

Outcomes

Primary Outcomes

Knee Osteoarthritis Decision Quality Instrument

Time Frame: Day 1

Concordance subscore (A summary score (0-100%) indicating the percentage of patients who received treatment that matched their stated preference will be generated.)

Secondary Outcomes

  • CollaboRATE(Day 1)
  • Numeric rating scale-satisfaction(Day 1)
  • Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR)(6 months after baseline visit)
  • Undergoing joint replacement surgery or not(Day 1)
  • Average time of patient visit and average time spent with provider(Day 1)

Study Sites (1)

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