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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06056518

Collaborator

(none)

122

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Failure	Other: AI-based risk prediction for kidney graft loss	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

CollaboRATE mean score 12 months [12 months]
CollaboRATE mean score 24 months [24 months]
Control Preferences Scale 12 months [12 months]
Control Preferences Scale 24 months [24 months]
Frequency of kidney replacement therapy after graft loss 12 months [12 months]
Frequency of kidney replacement therapy after graft loss 24 months [24 months]
Frequency of emergency dialysis after graft loss 12 months [12 months]
Frequency of emergency dialysis after graft loss 24 months [24 months]
Frequency of dialysis initiation via AV-shunt after graft loss 12 months [12 months]
Frequency of dialysis initiation via AV-shunt after graft loss 24 months [24 months]
Frequency of dialysis initiation via permanent catheter after graft loss 12 months [12 months]
Frequency of dialysis initiation via permanent catheter after graft loss 24 months [24 months]
Frequency of retransplantation after graft loss 12 months [12 months]
Frequency of retransplantation after graft loss 24 months [24 months]

Other Outcome Measures

Qualitative analysis of semistructured interviews [24 months]
Qualitative analysis of physician-patient conversations [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

written informed consent
patients with functioning kidney allograft
eGFR < 20 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 > 20 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator: Klemens Budde, MD, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Klemens Budde, Prof. Dr., Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT06056518

Other Study ID Numbers:

CHA-PRIMA-AI

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Klemens Budde, Prof. Dr., Charite University, Berlin, Germany

Kidney Transplantation

Graft Loss

Kidney Transplant Failure

Riks Prediction System

Study Results

No Results Posted as of Sep 28, 2023