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

Sponsor

University of Texas at Austin (Other)

Overall Status

Completed

CT.gov ID

NCT03956004

Collaborator

(none)

145

Enrollment

Location

Arms

10.1

Actual Duration (Months)

14.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Other: OM1 Dell Shared Decision Making Tool Other: Education material from OM1 Dell Shared Decision Making Tool	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

145 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 28, 2019

Actual Primary Completion Date :

Jan 30, 2020

Actual Study Completion Date :

Jan 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Knee Osteoarthritis Decision Quality Instrument [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.
Knee Osteoarthritis Decision Quality Instrument [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 Outcome Measures

CollaboRATE [Day 1]
Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making.
Numeric rating scale-satisfaction [Day 1]
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) [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.
Undergoing joint replacement surgery or not [Day 1]
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 [Day 1]
Minutes. Time of entire visit will be recorded in addition to time spent with primary provider.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Health Austin	Austin	Texas	United States	78712

Sponsors and Collaborators

University of Texas at Austin

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kevin Bozic, Professor of Surgery, University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT03956004

Other Study ID Numbers:

2018-11-0042

First Posted:

May 20, 2019

Last Update Posted:

Aug 17, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kevin Bozic, Professor of Surgery, University of Texas at Austin

shared decision making

osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Aug 17, 2020