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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956004
• Other study ID #: 2018-11-0042
• Status: Completed
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: August 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• OM1 Dell Shared Decision Making Tool
Decision aid meant to improve shared decision making among patients and providers.
• Education material from OM1 Dell Shared Decision Making Tool
Investigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options.

Locations

Country	Name	City	State
United States	UT Health Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	CollaboRATE	Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making.	Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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