Prospective, Randomized Controlled Trial to Investigate the Impact of AI on Shared Decision Making in Post-kidney Transplant Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Conversation about kidney replacement therapy after graft loss
研究概览
简要总结
This study aims to analyze the effects of AI-based risk prediction for graft loss on the frequency of conversations about the treatment after graft loss, as well as the associated shared decision making process in post-kidney transplant care in a German kidney transplant center (KTC), as perceived by the patient, their support person and the clinician/physician. Second, it aims to explore changes in patient and support person recall at 12 months follow-up. Implementation barriers and enablers will also be assessed. The protocol was amended so that the initially planned 24 months observation timeframe was removed from the study and it ended after 12 months due to high attrition and funding restrictions.
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
- 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
- •written informed consent
- •patients with functioning kidney allograft
- •> 12 months after transplantation
- •eGFR < 30 ml/min/1.73m2 according to CKD-EPI 2021 formula
- •at least 18 years of age
- •ability to communicate in German
- •regular follow-up at kidney transplant center
排除标准
- •multi-organ transplantation
- •eGFR > 30 ml/min/1.73m2 according to CKD-EPI 2021 formula
- •<= 12 months after transplantation
- •less than 18 years of age
- •not able to communicate in German
- •no regular follow-up at kidney transplant center
- •enrollment in another interventional study less than 1 month before participation in this study
研究组 & 干预措施
Routine Care
Patients in the "Routine Care" arm are will undergo regular follow-up at the kidney transplant center.
AI-supported Care
Patients in the "AI-supported Care" arm will undergo regular follow-up at the kidney transplant center. Treating physicians will be provided an AI-based risk prediction tool that predict 1-year risk of graft loss for patients in this group based on routine parameters.
干预措施: AI-based risk prediction for kidney graft loss (Other)
结局指标
主要结局
Conversation about kidney replacement therapy after graft loss
时间窗: 12 months
Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed
次要结局
- Retransplantation 12 months(12 months)
- CollaboRATE mean score after 24 months(24 months)
- Control Preferences Scale mean after 24 months(24 months)
- Kidney replacement therapy 12 months(12 months)
- Dialysis initiation via AV-shunt 12 months(12 months)
- Conversation about kidney replacement therapy after graft loss(24 months)
- Kidney replacement therapy 24 months(24 months)
- Dialysis initiation via AV-shunt 24 months(24 months)
- Emergency dialysis 24 months(24 months)
- Dialysis initiation via permanent catheter 24 months(24 months)
- CollaboRATE mean score after 12 months(12 months)
- Control Preferences Scale mean after 12 months(12 months)
- Emergency dialysis 12 months(12 months)
- Dialysis initiation via permanent catheter 12 months(12 months)
- Retransplantation 24 months(24 months)
研究者
Klemens Budde
Principal Investigator
Charite University, Berlin, Germany