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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|ClinicalTrials.gov Identifier: NCT03956004|
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis|
|Actual Study Start Date :||March 28, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
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.
- Knee Osteoarthritis Decision Quality Instrument [ Time Frame: 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 [ Time Frame: 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.)
- CollaboRATE [ Time Frame: Day 1 ]Level of shared decision making. Range of 0-9. Higher scores represent more shared decision making.
- Numeric rating scale-satisfaction [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 ]Minutes. Time of entire visit will be recorded in addition to time spent with primary provider.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956004
|Contact: Lauren Uhlerfirstname.lastname@example.org|
|United States, Texas|
|UT Health Austin||Recruiting|
|Austin, Texas, United States, 78712|
|Contact: Lauren Uhler 512-495-5090 email@example.com|
|Principal Investigator:||Kevin Bozic||Dell Medical School at The University of Texas at Austin|