Clinical trial NCT06056518: Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care
Official title: Prospective, Randomized Controlled Trial to Investigate the Impact of AI on Shared Decision Making in Post-kidney Transplant Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Transplant Failure
Keywords: Kidney Transplantation
Graft Loss
Kidney Transplant Failure
Riks Prediction System
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Conversation about kidney replacement therapy after graft loss
timeFrame: 12 months
Secondary outcomes:
measure: CollaboRATE mean score after 12 months
timeFrame: 12 months
measure: CollaboRATE mean score after 24 months
timeFrame: 24 months
measure: Control Preferences Scale mean after 12 months
timeFrame: 12 months
measure: Control Preferences Scale mean after 24 months
timeFrame: 24 months
measure: Kidney replacement therapy 12 months
timeFrame: 12 months
measure: Kidney replacement therapy 24 months
timeFrame: 24 months
measure: Emergency dialysis 12 months
timeFrame: 12 months
measure: Emergency dialysis 24 months
timeFrame: 24 months
measure: Dialysis initiation via AV-shunt 12 months
timeFrame: 12 months
measure: Dialysis initiation via AV-shunt 24 months
timeFrame: 24 months
measure: Dialysis initiation via permanent catheter 12 months
timeFrame: 12 months
measure: Dialysis initiation via permanent catheter 24 months
timeFrame: 24 months
measure: Retransplantation 12 months
timeFrame: 12 months
measure: Retransplantation 24 months
timeFrame: 24 months
measure: Conversation about kidney replacement therapy after graft loss
timeFrame: 24 months
Other outcomes:
measure: Qualitative analysis of semistructured interviews
timeFrame: 24 months
measure: Qualitative analysis of physician-patient conversations
timeFrame: 24 months
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Klemens Budde, MD
role: PRINCIPAL_INVESTIGATOR
References: