Shared Decision Making and How It Impacts the Patient Understanding

Study Overview
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Brief Summary
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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?

Official Title
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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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Shared Decision Making Tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Aged 45 to 64 years Mild to moderate knee pain consistent with a diagnosis of osteoarthritis by the clinician Self-identified as African American and/or Hispanic At least one of the following comorbidities: Obesity (BMI ≥ 30), Hypertension (ICD10 codes below) Diabetes (ICD10 codes below) Exclusion Criteria: - Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis) Prior total knee replacement Recommended total knee replacement Acute knee trauma

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard patient information data sheet<br> | |
| Experimental: SDM Tool<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Information Survey | 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. | One month afterwards | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal Health Questionnaire (PHQ-8), | Depression Survey | One month post intervention | 
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR) | joint specific functional outcome survey | One month post intervention | 
| Patient Experience Survey |  | One month post intervention | 
| Patient Information Survey- Qualitative portion |  | One month post intervention | 
| Shared Decision Making (SDM) Survey |  | One month post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shared decision making