Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care
- Conditions
- Kidney Transplant Failure
- Interventions
- Other: AI-based risk prediction for kidney graft loss
- Registration Number
- NCT06056518
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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 and 24 months follow-up. Implementation barriers and enablers will also be assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 76
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AI-supported Care AI-based risk prediction for kidney graft loss 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.
- Primary Outcome Measures
Name Time Method Conversation about kidney replacement therapy after graft loss 12 months Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed
- Secondary Outcome Measures
Name Time Method CollaboRATE mean score after 24 months 24 months CollaboRATE mean score of all study visits from study inclusion until month 24 (values 0 - 9, higher values indicating better outcome)
Control Preferences Scale mean after 24 months 24 months Mean Control Preferences Scale of all study visits from study inclusion until month 24 (values 1 - 5, higher values indicating better outcome)
Kidney replacement therapy 12 months 12 months Frequency of kidney replacement therapy after graft loss 12 months
Dialysis initiation via AV-shunt 12 months 12 months Frequency of dialysis initiation via AV-shunt after graft loss 12 months
Conversation about kidney replacement therapy after graft loss 24 months Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed
Kidney replacement therapy 24 months 24 months Frequency of kidney replacement therapy after graft loss 24 months
Dialysis initiation via AV-shunt 24 months 24 months Frequency of dialysis initiation via AV-shunt after graft loss 24 months
Emergency dialysis 24 months 24 months Frequency of emergency dialysis after graft loss 24 months
Retransplantation 12 months 12 months Frequency of retransplantation after graft loss 12 months
Dialysis initiation via permanent catheter 24 months 24 months Frequency of dialysis initiation via permanent catheter after graft loss 24 months
CollaboRATE mean score after 12 months 12 months CollaboRATE mean score of all study visits from study inclusion until month 12 (values 0 - 9, higher values indicating better outcome)
Control Preferences Scale mean after 12 months 12 months Mean Control Preferences Scale of all study visits from study inclusion until month 12 (values 1 - 5, higher values indicating better outcome)
Emergency dialysis 12 months 12 months Frequency of emergency dialysis after graft loss 12 months
Dialysis initiation via permanent catheter 12 months 12 months Frequency of dialysis initiation via permanent catheter after graft loss 12 months
Retransplantation 24 months 24 months Frequency of retransplantation after graft loss 24 months
Trial Locations
- Locations (1)
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany