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

NCT03956004 | Completed

• 1 other identifier: 2018-11-0042
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

shared decision making; osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• CollaboRATE

  Day 1

• Numeric rating scale-satisfaction

  Day 1

• Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR)

  6 months after baseline visit

• Undergoing joint replacement surgery or not

  Day 1

• Average time of patient visit and average time spent with provider

  Day 1

Study Arms (2)

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

Control

ACTIVE COMPARATOR

Education component of the decision aid only.

Other: Education material from OM1 Dell Shared Decision Making Tool

Interventions

OM1 Dell Shared Decision Making Tool OTHER

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

Experimental

Education material from OM1 Dell Shared Decision Making Tool OTHER

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

Control

Eligibility Criteria

• Age: 45 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

UT Health Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• 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.

  PMID: 33599773 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kevin Bozic

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: May 20, 2019
• Study Start: March 28, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)