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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Osteo Arthritis Knee

Treatments

Other: Joint Insights decision aid

Study type

Interventional

Funder types

Other

Identifiers

NCT04805554
R21HS027037

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

45 to 89 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Joint Insights Decision Aid
Experimental group
Description:
Participants view the entire Joint Insights decision aid for knee osteoarthritis including: Education Module with information about knee osteoarthritis and risks and benefits of various treatment options, Preferences and Values elicitation questions, and Personalized Risk/Benefit Report.
Treatment:
Other: Joint Insights decision aid
Education Module Only
Active Comparator group
Description:
Participants view the Joint Insights Education Module only
Treatment:
Other: Joint Insights decision aid

Trial contacts and locations

1

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Central trial contact

Lauren Uhler, MPH

Data sourced from clinicaltrials.gov

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