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Completed

NCT Number: NCT03956004

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Health Austin

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

OM1 Dell Shared Decision Making Tool

Other

Decision aid meant to improve shared decision making among patients and providers.

Education material from OM1 Dell Shared Decision Making Tool

Other

Investigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 20, 2019
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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