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Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee
NCT04805554 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2023-05-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04805554
The ClinicalTrials.gov registry entry for NCT04805554 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas at Austin, which has 225 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04805554 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04805554?
The interventions under investigation include: Joint Insights decision aid (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04805554?
This trial is sponsored by University of Texas at Austin, which has 225 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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