NCT04805554

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

Completed NA Last updated 5 January 2024

What this trial tests

NA trial testing Joint Insights decision aid in Osteo Arthritis Knee in 200 participants. Completed in 30 May 2023.

Timeline

22 February 2021

Primary endpoint
30 May 2023

30 May 2023

Quick facts

Lead sponsor	University of Texas at Austin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	200
Start date	22 February 2021
Primary completion	30 May 2023
Estimated completion	30 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Joint Insights decision aid

Conditions studied

• Osteo Arthritis Knee — all drugs for Osteo Arthritis Knee →

Sponsor

University of Texas at Austin

Who can join

Adults 45 to 89, any sex, with Osteo Arthritis Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Decision aids for people facing health treatment or screening decisions.
   Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6
2. Incorporating patient-reported outcomes into shared decision-making in the management of patients with osteoarthritis of the knee: a hybrid effectiveness-implementation study protocol.
   Lin E, Uhler LM, Finley EP, Jayakumar P, et al · · 2022 · cited 10× · PMID 35190439 · DOI 10.1136/bmjopen-2021-055933
3. Shared decision making using digital twins in knee osteoarthritis care: a randomized clinical trial of an AI-enabled decision aid versus education alone on decision quality, physical function, and user experience.
   Jayakumar P, Rathouz PJ, Lin E, Trutner Z, et al · · 2025 · cited 2× · PMID 41112505 · DOI 10.1016/j.eclinm.2025.103545