NCT04837053已完成不适用
An Individualized Decision Aid for Physicians and Patients for Total Knee Replacement in Osteoarthritis (Value-based TKR): Study Protocol for a Multi-center, Stepped Wedge, Cluster Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,092
- 试验地点
- 2
- 主要终点
- Decision quality
研究概览
简要总结
The aim of this trial is to investigate the effect of a medical decision aid (EKIT-Tool) on decision quality for knee arthroplasty.
详细描述
The tool will guide the SDM process and support the consultation, providing a systematic presentation of individual patient and disease-specific information and the fulfilment of indication criteria. Furthermore, it will present health information about knee replacement to empower the patient. To investigate the effect of the tool on decision quality, we choose a prospective multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT) design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with knee osteoarthritis who are candidates for knee replacement
- •capacity to consent
- •understanding of the German language (written and oral)
- •age of 18 years or older
- •informed consent
- •Exclusion criteria:
- •meeting not all inclusion criteria
排除标准
- 未提供
结局指标
主要结局
Decision quality
时间窗: immediately after the intervention/procedure/surgery
Decision quality measured by DQI-Knee Osteoarthritis v2.0
次要结局
- Fulfillment of patient expectations(12 months)
- Oxford Knee Score (OKS)(12 month)
研究者
研究点 (2)
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