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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Patient Information Survey
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- 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)
排除标准
- •- Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis)
- •Prior total knee replacement
- •Recommended total knee replacement
- •Acute knee trauma
研究组 & 干预措施
Standard patient information data sheet
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).
干预措施: Shared Decision Making Tool (Other)
结局指标
主要结局
Patient Information Survey
时间窗: 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.
次要结局
- Personal Health Questionnaire (PHQ-8),(One month post intervention)
- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)(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)