Osteo Arthritis KneeNCT04805554
Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee
A study testing Joint Insights decision aid in people with Osteo Arthritis Knee, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Joint Insights decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
UT Health Austin Musculoskeletal Institute
Austin, Texas, 78712
About this study
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.
Read more
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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Joint Insights decision aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint Insights decision aidOther
The Joint Insights decision aid was developed by Dell Medical School faculty in collaboration with OM1, a health outcomes and predictive analytics company. This decision aid uses patient-report outcome measures (PROMs) - specifically, the PROMIS Global and the KOOS JR - along with patient clinical and demographic information (age, sex, race, ethnicity, chronic narcotic use, body mass index), in machine-learning-based predictive analytic models to provide personalized estimates of likely benefit or harm from total knee replacement surgery. The tool is designed to collect PROMs or pull in PROMs collected through other systems (e.g., an EHR or a third-party PROM platform). It also provides condition-specific education to patients with knee OA and allows a patient to reflect on and document their preferences and goals. The personalized risk/benefit report generated by the decision aid is meant to be discussed with the patient's provider to enhance shared decision making.
| Study group | Role | What they receive |
|---|---|---|
| Joint Insights Decision Aid | Experimental | 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. Receives: Other: Joint Insights decision aid |
| Education Module Only | Active comparator | Participants view the Joint Insights Education Module only Receives: Other: Joint Insights decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient perception of decision process and quality as measured by the Knee Decision Quality Instrument (Knee-DQI)
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.
Measured: Immediately following enrollment visit
Secondary outcomes (1)
Concordance between patient preferences and actual outcomes
A binary (yes/no) measure of whether a patient's response to the Knee Decision Quality Instrument question #1.6 (asking whether a patient wants surgical or non-surgical treatment) matches the observed outcome of whether the patient had TKA within 6 months (based on medical record review). A "yes" indicates greater concordance.
Measured: 3 months and 6 months following enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start22 Feb 2021
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Bozic, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805554
- Sponsor's protocol ID
- R21HS027037
- Status last verified
- Jan 2024
- First submitted
- 15 Mar 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jayakumar P, Rathouz PJ, Lin E, Trutner Z, Uhler LM, Andrawis J, Koenig KM, Tsevat J, Bozic KJ. 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. EClinicalMedicine. 2025 Oct 4;89:103545. doi: 10.1016/j.eclinm.2025.103545. eCollection 2025 Nov.
PubMed 41112505Lin E, Uhler LM, Finley EP, Jayakumar P, Rathouz PJ, Bozic KJ, Tsevat J. Incorporating patient-reported outcomes into shared decision-making in the management of patients with osteoarthritis of the knee: a hybrid effectiveness-implementation study protocol. BMJ Open. 2022 Feb 21;12(2):e055933. doi: 10.1136/bmjopen-2021-055933.
PubMed 35190439
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee
- ClinicalTrials.gov ID
- NCT04805554
- Acronym / sponsor ID
- R21HS027037
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joint Insights Decision Aid | Experimental | Other: Joint Insights decision aidParticipants 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. |
| Education Module Only | Active comparator | Other: Joint Insights decision aidParticipants view the Joint Insights Education Module only |
Who may qualify
- Ages
- 45 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint Insights decision aidThe Joint Insights decision aid was developed by Dell Medical School faculty in collaboration with OM1, a health outcomes and predictive analytics company. This decision aid uses patient-report outcome measures (PROMs) - specifically, the PROMIS Global and the KOOS JR - along with patient clinical and demographic information (age, sex, race, ethnicity, chronic narcotic use, body mass index), in machine-learning-based predictive analytic models to provide personalized estimates of likely benefit or harm from total knee replacement surgery. The tool is designed to collect PROMs or pull in PROMs collected through other systems (e.g., an EHR or a third-party PROM platform). It also provides condition-specific education to patients with knee OA and allows a patient to reflect on and document their preferences and goals. The personalized risk/benefit report generated by the decision aid is meant to be discussed with the patient's provider to enhance shared decision making. | Other | Education Module Only, Joint Insights Decision Aid |
Primary outcome
Patient perception of decision process and quality as measured by the Knee Decision Quality Instrument (Knee-DQI)
Time frame: Immediately following enrollment visit
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.
1 secondary outcome
Concordance between patient preferences and actual outcomes
Time frame: 3 months and 6 months following enrollment visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 41112505Jayakumar P, Rathouz PJ, Lin E, Trutner Z, Uhler LM, Andrawis J, Koenig KM, Tsevat J, Bozic KJ. 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. EClinicalMedicine. 2025 Oct 4;89:103545. doi: 10.1016/j.eclinm.2025.103545. eCollection 2025 Nov.
- Derived from this study: PubMed 35190439Lin E, Uhler LM, Finley EP, Jayakumar P, Rathouz PJ, Bozic KJ, Tsevat J. Incorporating patient-reported outcomes into shared decision-making in the management of patients with osteoarthritis of the knee: a hybrid effectiveness-implementation study protocol. BMJ Open. 2022 Feb 21;12(2):e055933. doi: 10.1136/bmjopen-2021-055933.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Insights decision aid in people with Osteo Arthritis Knee, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient perception of decision process and quality as measured by the Knee Decision Quality Instrument (Knee-DQI) (time frame: Immediately following enrollment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805554, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.