Shared Decision Making and How It Impacts the Patient Understanding
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04011488|
Recruitment Status : Terminated (Low patient recruitment)
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Shared Decision Making (SDM) supports patient centered care and improves patient outcomes and satisfaction. Movement is Life (MIL) created an innovative SDM tool to provide a personalized framework for discussion of the projected impact to patients of their decisions regarding treatment options for knee osteoarthritis.
- Did use of the MIL SDM tool for knee osteoarthritis result in an increased level of self-reported physical activity at one month in African American and Hispanic women?
- Did use of the MIL SMD tool increase subject likeliness to recommend the physician?
- What is the qualitative feedback from subjects on ease of use of the MIL SDM tool?
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Other: Shared Decision Making Tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Shared Decision Making and How it Impacts Patient Understanding: Using an Interactive Knee Osteoarthritis App Based on a Cost Model to Generate a Patient Shared Decision Making Tool: Multi-center Randomized Clinical Trial Study Protocol|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||June 30, 2019|
|Actual Study Completion Date :||June 30, 2019|
|No Intervention: Standard patient information data sheet|
Experimental: SDM Tool
A simple, one-page tool that provides a framework for the patient discussion, which improves the consistency of the patient-provider communication. This SDM can also be customized to a specific patient based on gender, race/ethnicity, age, and select comorbidities (obesity, hypertension and diabetes).
Other: Shared Decision Making Tool
We've used the framework from this model and adapted it to the patient perspective to create a Patient Shared Decision Making Tool. The model is interactive so it can be customized to a specific patient. It has adjustments built in for gender, race/ethnicity, age, and select comorbidities (obesity, hypertension and diabetes).
The strongest, underlying message is that any treatment choice is better than not seeking treatment. To illustrate this, a "Do Nothing" pathway is included for comparison purposes.
- Patient Information Survey [ Time Frame: One month afterwards ]The primary outcome instrument is the Patient Information Survey administered shortly after the evaluation. There is both a qualitative and quantitative portion of the survey.
- Personal Health Questionnaire (PHQ-8), [ Time Frame: One month post intervention ]Depression Survey
- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR) [ Time Frame: One month post intervention ]joint specific functional outcome survey
- Patient Experience Survey [ Time Frame: One month post intervention ]
- Patient Information Survey- Qualitative portion [ Time Frame: One month post intervention ]
- Shared Decision Making (SDM) Survey [ Time Frame: One month post intervention ]
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): NCT04011488
|United States, New York|
|Michael L. Parks, MD|
|New York, New York, United States, 10021|
|Principal Investigator:||Michael L Parks, MD||Hospital for Special Surgery, New York|