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NCT04805554 · ClinicalTrials.gov registry record · NA

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

A NA study of Osteo Arthritis Knee, sponsored by University of Texas at Austin.

Completed
Registry status
NA
Development phase
200
Enrollment target
1
Study location

NCT04805554 is a NA study of Osteo Arthritis Knee that has completed, run by University of Texas at Austin. The registered enrollment target is 200 participants, above the 129-participant average among 22 other Osteo Arthritis Knee trials with a reported enrollment target (55% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT04805554, a NA study of Osteo Arthritis Knee, has completed, sponsored by University of Texas at Austin.

COMPLETED
Registry status
NA
Development phase
200 participants
Enrollment target
1
Study location

Study 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 p

Conditions Studied

Interventions

  • OTHER Joint Insights decision aid

Study Locations (1)

Texas

  • UT Health Austin Musculoskeletal Institute - Austin

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2021-02-22
Est. Completion 2023-05-30
Phase NA

Sponsor

University of Texas at Austin

257 total trials

What the Registry Record Tells You About NCT04805554

The ClinicalTrials.gov registry entry for NCT04805554 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 129-participant average among 22 other Osteo Arthritis Knee trials with a reported enrollment target (55% higher). The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Osteo Arthritis Knee appearing as the primary indexed condition, and to 1 intervention - of which Joint Insights decision aid is the first listed.

NCT04805554 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04805554 about?

NCT04805554 is a clinical study titled "Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee". 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 deci...

What is the current status of trial NCT04805554?

This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2021-02-22. Estimated completion is 2023-05-30.

What conditions does trial NCT04805554 study?

This clinical trial studies the following conditions: Osteo Arthritis Knee.

What interventions are being tested in trial NCT04805554?

The interventions under investigation include: Joint Insights decision aid (OTHER).

Who is sponsoring clinical trial NCT04805554?

This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04805554 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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