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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956004
|Contact: Lauren Uhleremail@example.com|
|United States, Texas|
|UT Health Austin||Recruiting|
|Austin, Texas, United States, 78712|
|Contact: Lauren Uhler 512-495-5090 firstname.lastname@example.org|
|Principal Investigator:||Kevin Bozic||Dell Medical School at The University of Texas at Austin|