Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized Controlled Trial to Investigate the Impact of AI on Shared Decision Making in Post-kidney Transplant Care

Conditions
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Kidney Transplant Failure

Intervention / Treatment
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* Other: AI-based risk prediction for kidney graft loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent patients with functioning kidney allograft 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 Exclusion Criteria: multi-organ transplantation eGFR > 30 ml/min/1.73m2 according to CKD-EPI 2021 formula 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Care<br>Patients in the Routine Care arm are will undergo regular follow-up at the kidney transplant center. | |
| Experimental: AI-supported Care<br>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. | Other: AI-based risk prediction for kidney graft loss<br>* Implementation of AI-based risk prediction tool for the 1-year risk of kidney graft loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversation about kidney replacement therapy after graft loss | Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CollaboRATE mean score after 12 months | CollaboRATE mean score of all study visits from study inclusion until month 12 (values 0 - 9, higher values indicating better outcome) | 12 months | 
| CollaboRATE mean score after 24 months | CollaboRATE mean score of all study visits from study inclusion until month 24 (values 0 - 9, higher values indicating better outcome) | 24 months | 
| Control Preferences Scale mean after 12 months | Mean Control Preferences Scale of all study visits from study inclusion until month 12 (values 1 - 5, higher values indicating better outcome) | 12 months | 
| Control Preferences Scale mean after 24 months | Mean Control Preferences Scale of all study visits from study inclusion until month 24 (values 1 - 5, higher values indicating better outcome) | 24 months | 
| Kidney replacement therapy 12 months | Frequency of kidney replacement therapy after graft loss 12 months | 12 months | 
| Kidney replacement therapy 24 months | Frequency of kidney replacement therapy after graft loss 24 months | 24 months | 
| Emergency dialysis 12 months | Frequency of emergency dialysis after graft loss 12 months | 12 months | 
| Emergency dialysis 24 months | Frequency of emergency dialysis after graft loss 24 months | 24 months | 
| Dialysis initiation via AV-shunt 12 months | Frequency of dialysis initiation via AV-shunt after graft loss 12 months | 12 months | 
| Dialysis initiation via AV-shunt 24 months | Frequency of dialysis initiation via AV-shunt after graft loss 24 months | 24 months | 
| Dialysis initiation via permanent catheter 12 months | Frequency of dialysis initiation via permanent catheter after graft loss 12 months | 12 months | 
| Dialysis initiation via permanent catheter 24 months | Frequency of dialysis initiation via permanent catheter after graft loss 24 months | 24 months | 
| Retransplantation 12 months | Frequency of retransplantation after graft loss 12 months | 12 months | 
| Retransplantation 24 months | Frequency of retransplantation after graft loss 24 months | 24 months | 
| Conversation about kidney replacement therapy after graft loss | Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, Graft Loss, Kidney Transplant Failure, Riks Prediction System