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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

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ClinicalTrials.gov Identifier: NCT03956004
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin Bozic, University of Texas at Austin

Brief 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 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: OM1 Dell Shared Decision Making Tool Other: Education material from OM1 Dell Shared Decision Making Tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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.
Other: OM1 Dell Shared Decision Making Tool
Decision aid meant to improve shared decision making among patients and providers.

Active Comparator: Control
Education component of the decision aid only.
Other: Education material from OM1 Dell Shared Decision Making Tool
Investigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options.




Primary Outcome Measures :
  1. 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.

  2. 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.)


Secondary Outcome Measures :
  1. CollaboRATE [ Time Frame: Day 1 ]
    Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making.

  2. Numeric rating scale-satisfaction [ Time Frame: Day 1 ]
    Patient satisfaction with management of condition. Range of 0-10 with 0 representing complete dissatisfaction and 10 representing complete satisfaction.

  3. Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR) [ Time Frame: 6 months after baseline visit ]
    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.

  4. Undergoing joint replacement surgery or not [ Time Frame: Day 1 ]
    Decision to undergo total knee replacement surgery (yes/no). Obtained by asking provider or through medical record note.

  5. Average time of patient visit and average time spent with provider [ Time Frame: Day 1 ]
    Minutes. Time of entire visit will be recorded in addition to time spent with primary provider.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956004


Contacts
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Contact: Lauren Uhler 512-495-5090 lauren.uhler@austin.utexas.edu

Locations
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United States, Texas
UT Health Austin Recruiting
Austin, Texas, United States, 78712
Contact: Lauren Uhler    512-495-5090    lauren.uhler@austin.utexas.edu   
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Kevin Bozic Dell Medical School at The University of Texas at Austin

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Responsible Party: Kevin Bozic, Professor of Surgery, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03956004     History of Changes
Other Study ID Numbers: 2018-11-0042
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kevin Bozic, University of Texas at Austin:
shared decision making
osteoarthritis

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases