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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 Osteoarthritis, Knee, sponsored by University of Texas at Austin.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04805554: Completed NA study of Osteoarthritis, Knee, sponsored by University of Texas at Austin.
NCT04805554 is a NA study of Osteoarthritis, Knee that has completed, run by University of Texas at Austin. The registered enrollment target is 200 participants, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04805554, a NA study of Osteoarthritis, 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
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Joint Insights decision aid
Study Locations (1)
Texas
- UT Health Austin Musculoskeletal Institute - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2023-05-30 |
| Phase | NA |
What the finished NCT04805554 record still lists
NCT04805554 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 1 intervention - of which Joint Insights decision aid is the first listed.
NCT04805554 reports a single indexed study location in 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: Osteoarthritis, 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.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04805554's enrollment target sits among peer trials
200 32nd of 112 higher than 78 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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