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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant Failure
• Intervention / Treatment: Other: AI-based risk prediction for kidney graft loss

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klemens Budde, MD; Phone Number: 0049 30 450 614 086; Email: klemens.budde@charite.de
• Study Contact Backup: Name: Bilgin Osmanodja, MD; Phone Number: 0049 30 450 614368; Email: bilgin.osmanodja@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Klemens Budde, MD; Phone Number: 004930450614086; Email: klemens.budde@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative analysis of semistructured interviews	Qualitative analysis of semistructured interviews after 24 months	24 months
Qualitative analysis of physician-patient conversations	Qualitative analysis of physician-patient conversations after 24 months	24 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Klemens Budde, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Kidney Transplantation; Graft Loss; Kidney Transplant Failure; Riks Prediction System
• Other Study ID Numbers: CHA-PRIMA-AI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No