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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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OM1 Dell Shared Decision Making Tool
Education material from OM1 Dell Shared Decision Making Tool
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis, Knee focused on measuring shared decision making, osteoarthritis

Eligibility Criteria

45 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UT Health Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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.

Education component of the decision aid only.

Outcomes

Primary Outcome Measures

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.
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.)

Secondary Outcome Measures

CollaboRATE
Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making.
Numeric rating scale-satisfaction
Patient satisfaction with management of condition. Range of 0-10 with 0 representing complete dissatisfaction and 10 representing complete satisfaction.
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.
Undergoing joint replacement surgery or not
Decision to undergo total knee replacement surgery (yes/no). Obtained by asking provider or through medical record note.
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.

Full Information

First Posted
March 25, 2019
Last Updated
August 14, 2020
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT03956004
Brief Title
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
Official Title
A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
shared decision making, osteoarthritis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Education component of the decision aid only.
Intervention Type
Other
Intervention Name(s)
OM1 Dell Shared Decision Making Tool
Intervention Description
Decision aid meant to improve shared decision making among patients and providers.
Intervention Type
Other
Intervention Name(s)
Education material from OM1 Dell Shared Decision Making Tool
Intervention Description
Investigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options.
Primary Outcome Measure Information:
Title
Knee Osteoarthritis Decision Quality Instrument
Description
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.
Time Frame
Day 1
Title
Knee Osteoarthritis Decision Quality Instrument
Description
Concordance subscore (A summary score (0-100%) indicating the percentage of patients who received treatment that matched their stated preference will be generated.)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
CollaboRATE
Description
Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making.
Time Frame
Day 1
Title
Numeric rating scale-satisfaction
Description
Patient satisfaction with management of condition. Range of 0-10 with 0 representing complete dissatisfaction and 10 representing complete satisfaction.
Time Frame
Day 1
Title
Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR)
Description
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.
Time Frame
6 months after baseline visit
Title
Undergoing joint replacement surgery or not
Description
Decision to undergo total knee replacement surgery (yes/no). Obtained by asking provider or through medical record note.
Time Frame
Day 1
Title
Average time of patient visit and average time spent with provider
Description
Minutes. Time of entire visit will be recorded in addition to time spent with primary provider.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Bozic
Organizational Affiliation
Dell Medical School at The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Health Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33599773
Citation
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.
Results Reference
derived

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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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