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 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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: OM1 Dell Shared Decision Making Tool; Other: Education material from OM1 Dell Shared Decision Making Tool

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • UT Health Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CollaboRATE	Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making.	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.	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.	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.	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.	Day 1

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Kevin Bozic, Dell Medical School at The University of Texas at Austin

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: osteoarthritis; shared decision making
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2018-11-0042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No