Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Care | No Intervention | Patients in the "Routine Care" arm are will undergo regular follow-up at the kidney transplant center. | |
| AI-supported Care | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-based risk prediction for kidney graft loss | Other | Implementation of AI-based risk prediction tool for the 1-year risk of kidney graft loss. |
|
| 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 |
| 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 |
| Control Preferences Scale mean after 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
All genders (male, female, and others) are eligible for this study.
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Klemens Budde, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | State of Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38557315 | Derived | Osmanodja B, Sassi Z, Eickmann S, Hansen CM, Roller R, Burchardt A, Samhammer D, Dabrock P, Moller S, Budde K, Herrmann A. Investigating the Impact of AI on Shared Decision-Making in Post-Kidney Transplant Care (PRIMA-AI): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 1;13:e54857. doi: 10.2196/54857. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Mean Control Preferences Scale of all study visits from study inclusion until month 12 (values 1 - 5, higher values indicating better outcome)
| 12 months |
| Kidney replacement therapy 12 months | Frequency of kidney replacement therapy after graft loss 12 months | 12 months |
| Emergency dialysis 12 months | Frequency of emergency dialysis after graft loss 12 months | 12 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 permanent catheter 12 months | Frequency of dialysis initiation via permanent catheter after graft loss 12 months | 12 months |
| Retransplantation 12 months | Frequency of retransplantation after graft loss 12 months | 12 months |