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Clinical Trials/NCT04805554
NCT04805554
Completed
Not Applicable

Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee

University of Texas at Austin1 site in 1 country200 target enrollmentFebruary 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteo Arthritis Knee
Sponsor
University of Texas at Austin
Enrollment
200
Locations
1
Primary Endpoint
Patient perception of decision process and quality as measured by the Knee Decision Quality Instrument (Knee-DQI)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Osteoarthritis (OA) of the knee constitutes a major public health problem. Treatment options for knee OA range from lifestyle changes to pharmacological management to total knee replacement surgery. As a "preference-sensitive" condition, management of OA of the knee is ideally suited for shared decision making (SDM), taking into consideration benefits, risks, and patients' health status, values, and goals. Patient-reported outcomes (PROs) reflect health status from the patient's perspective. For knee OA, relevant PROs include pain and other symptoms, functional status and limitations, and overall health. Prior research indicates that patients with higher baseline physical function and/or poor baseline mental health do not benefit as much from total knee replacement. Still, due to logistical challenges, costs, and disruptions in workflow, PROs have not yet achieved their full potential in clinical care.

Musculoskeletal providers at Dell Medical School and UT Health Austin currently collect general and condition-specific PROs from every patient seen in their Musculoskeletal Institute. PROs are collected via an electronic interface and results are pulled into the Athena electronic health record (EHR). Given the promise of combining PRO data with clinical and demographic data, musculoskeletal providers at UT Health Austin have begun utilizing an innovative electronic PRO-based predictive analytic tool at the point of care to guide SDM in patients with knee OA.

This project plans to evaluate the clinical effectiveness and impact of the PRO-guided predictive analytic SDM tool and process in a randomized controlled trial in Austin. Outcomes will include decision quality, as reported by patients; treatment decision (surgical vs. non-surgical); and decisional conflict and regret.

Our project contributes to AHRQ's strategy to use health IT to improve quality and outcomes by evaluating a tool and process for the use of PRO data at the point of care. The model being tested puts patients at the center of their care by enabling them to participate in informed decision making by using their personal health data, preferences, and prognostic models. Knowledge gained will be critical to scaling and spreading use of this PRO-guided SDM tool among patients with knee OA nationally.

Registry
clinicaltrials.gov
Start Date
February 22, 2021
End Date
May 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kevin Bozic

Professor and Chair

University of Texas at Austin

Eligibility Criteria

Inclusion Criteria

  • New patients
  • Presumptive diagnosis of knee OA
  • Aged 45 to 89
  • K-L Joint OA severity grade 3 to 4 (moderate to severe)
  • KOOS JR score 0-85
  • Able to consent

Exclusion Criteria

  • Prior total knee replacement (TKR)
  • Prior consultation with orthopaedic surgeons for TKR
  • Prior experience with Joint Insights
  • Trauma condition or psoriatic/rheumatoid arthritis
  • Non-English or Non-Spanish speakers
  • BMI \<20 or \>46

Outcomes

Primary Outcomes

Patient perception of decision process and quality as measured by the Knee Decision Quality Instrument (Knee-DQI)

Time Frame: Immediately following enrollment visit

Patients are asked about whether they were offered a choice between treatments (yes/no), to what extent the pros and cons were discussed (a lot/some/a little/not at all), and whether the health care provider asked for their preferences (yes/no). 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 Outcomes

  • Concordance between patient preferences and actual outcomes(3 months and 6 months following enrollment visit)

Study Sites (1)

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