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

Charité University Medicine Berlin

Status: Active, not recruiting

Conditions: Kidney Transplant Failure

Treatments: Other: AI-based risk prediction for kidney graft loss

Study type: Interventional

Funder types: Other

Identifiers

NCT06056518

CHA-PRIMA-AI

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Routine Care

No Intervention group

Description:

Patients in the "Routine Care" arm are will undergo regular follow-up at the kidney transplant center.

AI-supported Care

Experimental group

Description:

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.

Treatment:

Other: AI-based risk prediction for kidney graft loss