Osteoarthritis, KneeNCT03956004
The Impact of a Technology-enabled Decision Aid, for Patients With Hip and Knee Osteoarthritis on Decision Quality, Level of Shared Decision-making, Patient Satisfaction and Magnitude of Limitations
A study testing OM1 Dell Shared Decision Making Tool and Education material from OM1 Dell Shared Decision Making Tool in people with Osteoarthritis, Knee, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study evaluates a technology-enabled decision aid that provides evidence-based education (i.e. on understanding the condition, treatment options and comparisons, patient values and question \& answer quiz) and personalized, quantifiable benefit-risk ratio alongside the level of potential benefit in relation to… Read more about this study
- Who is it for?
- Ages 45 to 89 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- OM1 Dell Shared Decision Making Tool and Education material from OM1 Dell Shared Decision Making Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2019to 30 Jan 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with a presumptive diagnosis of knee OA aged between 45 and 89 (in-line with the decision aid algorithm)
- Radiographic evidence of moderate to severe osteoarthritis (Kellgren and Lawrence grade 3-4)
- KOOS Jr scores between 0-85 (in-line with the decision-aid algorithm)
- Participant able to give informed consent for participation in the study
Who cannot join
- Kellgren and Lawrence scale for classification of osteoarthritis grade 0-2
- Patients with a prior experience of total joint replacement
- Patient with experience with the pilot form of the decision aid
- Patients undergoing consideration for revision joint replacement
- Patients seeking care for trauma condition or psoriatic/rheumatoid arthritis
- Non-English or Non-Spanish speakers
- Patients with BMI below 20 or above 46 (in-line with the decision-aid algorithm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis
This study evaluates a technology-enabled decision aid that provides evidence-based education (i.e. on understanding the condition, treatment options and comparisons, patient values and question \& answer quiz) and personalized, quantifiable benefit-risk ratio alongside the level of potential benefit in relation to joint stiffness, joint pain and quality of life. The study will be performed in the setting of an integrated care system providing patient-centered care for hip and knee osteoarthritis over the full cycle of care. The impact of a technology-enabled decision aid incorporating predictive analytics with machine learning capabilities on decision quality, activation, experience \& limitations of patients in this setting is relatively unknown.
- Conditions
- Osteoarthritis, Knee
- Being tested
- OM1 Dell Shared Decision Making Tool, Education material from OM1 Dell Shared Decision Making Tool
- Keywords
- shared decision making, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM1 Dell Shared Decision Making ToolOther
Decision aid meant to improve shared decision making among patients and providers.
Education material from OM1 Dell Shared Decision Making ToolOther
Investigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Full decision aid, consisting of education on osteoarthritis and treatment options, preferences and values elicitation, and personalized risk/benefit estimates based on patient's response to patient-reported outcome measures. Receives: Other: OM1 Dell Shared Decision Making Tool |
| Control | Active comparator | Education component of the decision aid only. Receives: Other: Education material from OM1 Dell Shared Decision Making Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Osteoarthritis Decision Quality Instrument
Decision process subscore. 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: Day 1
Knee Osteoarthritis Decision Quality Instrument
Concordance subscore (A summary score (0-100%) indicating the percentage of patients who received treatment that matched their stated preference will be generated.)
Measured: Day 1
Secondary outcomes (5)
CollaboRATE
Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making.
Measured: Day 1
Numeric rating scale-satisfaction
Patient satisfaction with management of condition. Range of 0-10 with 0 representing complete dissatisfaction and 10 representing complete satisfaction.
Measured: Day 1
Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR)
Measure of patient-reported, knee-related stiffness, pain, and function. Raw score range 0-28, converted to interval score of 0-100, where 0 represents total knee disability and 100 represents perfect knee health.
Measured: 6 months after baseline visit
Undergoing joint replacement surgery or not
Decision to undergo total knee replacement surgery (yes/no). Obtained by asking provider or through medical record note.
Measured: Day 1
Average time of patient visit and average time spent with provider
Minutes. Time of entire visit will be recorded in addition to time spent with primary provider.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start28 Mar 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 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
- Investigators
- Kevin Bozic, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956004
- Sponsor's protocol ID
- 2018-11-0042
- Status last verified
- Aug 2020
- First submitted
- 25 Mar 2019
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jayakumar P, Moore MG, Furlough KA, Uhler LM, Andrawis JP, Koenig KM, Aksan N, Rathouz PJ, Bozic KJ. Comparison of an Artificial Intelligence-Enabled Patient Decision Aid vs Educational Material on Decision Quality, Shared Decision-Making, Patient Experience, and Functional Outcomes in Adults With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2037107. doi: 10.1001/jamanetworkopen.2020.37107.
PubMed 33599773
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03956004
- Acronym / sponsor ID
- 2018-11-0042
- Conditions
- Osteoarthritis, Knee
- Keywords
- shared decision making, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 20 May 2019 (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.
This study evaluates a technology-enabled decision aid that provides evidence-based education (i.e. on understanding the condition, treatment options and comparisons, patient values and question \& answer quiz) and personalized, quantifiable benefit-risk ratio alongside the level of potential benefit in relation to joint stiffness, joint pain and quality of life. The study will be performed in the setting of an integrated care system providing patient-centered care for hip and knee osteoarthritis over the full cycle of care. The impact of a technology-enabled decision aid incorporating predictive analytics with machine learning capabilities on decision quality, activation, experience \& limitations of patients in this setting is relatively unknown.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: OM1 Dell Shared Decision Making ToolFull decision aid, consisting of education on osteoarthritis and treatment options, preferences and values elicitation, and personalized risk/benefit estimates based on patient's response to patient-reported outcome measures. |
| Control | Active comparator | Other: Education material from OM1 Dell Shared Decision Making ToolEducation component of the decision aid only. |
Who may qualify
- Ages
- 45 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with a presumptive diagnosis of knee OA aged between 45 and 89 (in-line with the decision aid algorithm)
- Radiographic evidence of moderate to severe osteoarthritis (Kellgren and Lawrence grade 3-4)
- KOOS Jr scores between 0-85 (in-line with the decision-aid algorithm)
- Participant able to give informed consent for participation in the study
Key exclusion criteria (7 listed)
- Kellgren and Lawrence scale for classification of osteoarthritis grade 0-2
- Patients with a prior experience of total joint replacement
- Patient with experience with the pilot form of the decision aid
- Patients undergoing consideration for revision joint replacement
- Patients seeking care for trauma condition or psoriatic/rheumatoid arthritis
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 |
|---|---|---|
| OM1 Dell Shared Decision Making ToolDecision aid meant to improve shared decision making among patients and providers. | Other | Experimental |
| Education material from OM1 Dell Shared Decision Making ToolInvestigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options. | Other | Control |
Primary outcome
Knee Osteoarthritis Decision Quality Instrument
Time frame: Day 1
Decision process subscore. 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.
Knee Osteoarthritis Decision Quality Instrument
Time frame: Day 1
Concordance subscore (A summary score (0-100%) indicating the percentage of patients who received treatment that matched their stated preference will be generated.)
5 secondary outcomes
CollaboRATE
Time frame: Day 1
Numeric rating scale-satisfaction
Time frame: Day 1
Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR)
Time frame: 6 months after baseline visit
Undergoing joint replacement surgery or not
Time frame: Day 1
Average time of patient visit and average time spent with provider
Time frame: Day 1
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 17 Aug 2020.
- Derived from this study: PubMed 33599773Jayakumar P, Moore MG, Furlough KA, Uhler LM, Andrawis JP, Koenig KM, Aksan N, Rathouz PJ, Bozic KJ. Comparison of an Artificial Intelligence-Enabled Patient Decision Aid vs Educational Material on Decision Quality, Shared Decision-Making, Patient Experience, and Functional Outcomes in Adults With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2037107. doi: 10.1001/jamanetworkopen.2020.37107.
- 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.
Kevin Bozic principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OM1 Dell Shared Decision Making Tool and Education material from OM1 Dell Shared Decision Making Tool in people with Osteoarthritis, 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 4 inclusion and 7 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 17 Aug 2020. 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?
Knee Osteoarthritis Decision Quality Instrument (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT03956004, which also lists 1 linked publication.
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 17 Aug 2020.