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

Charite University, Berlin, Germany76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Kidney Transplant Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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)

Time frame: 12 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)

Time frame: 12 months

Kidney replacement therapy 12 months

Frequency of kidney replacement therapy after graft loss 12 months

Time frame: 12 months

Emergency dialysis 12 months

Frequency of emergency dialysis after graft loss 12 months

Time frame: 12 months

Dialysis initiation via AV-shunt 12 months

Frequency of dialysis initiation via AV-shunt after graft loss 12 months

Time frame: 12 months

Dialysis initiation via permanent catheter 12 months

Frequency of dialysis initiation via permanent catheter after graft loss 12 months

Time frame: 12 months

Retransplantation 12 months

Frequency of retransplantation after graft loss 12 months

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes