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AI-Assisted vs Usual Follow-up in Kidney Transplantation
Sponsor: UPECLIN HC FM Botucatu Unesp
Summary
The goal of this clinical trial is to learn whether kidney transplant follow-up visits run by a health professional using an artificial intelligence (AI) computer helper are as good as usual follow-up visits with a doctor. People who receive a kidney transplant need check-up visits for the rest of their lives. These visits help keep the new kidney working well. As more people live longer with a transplant, clinics get busier. An AI helper may make visits more consistent and free up doctor time. This idea has not yet been tested well in real clinics. The main questions this study will answer are: Are AI-assisted visits as good as usual doctor visits? Trained reviewers will rate the quality of each visit. The reviewers will not know which type of visit they are rating. Are patients as satisfied with their visit? How long does the visit take, and how much time does the clinician spend on paperwork? Do the visits do a better job of checking key items, such as screening tests, vaccines, and transplant medicines? Are the visits safe for patients? Adults can take part if they have a working kidney transplant, if the transplant was at least 6 months ago, and if they can complete a routine visit on their own. Researchers will place 140 adults into two groups by chance, like flipping a coin. One group will have a visit run by a health professional who uses the AI helper. The other group will have a usual visit with a doctor. In both groups, the AI cannot order tests, change medicines, or make a diagnosis on its own. A clinician checks and approves everything. Participants will take part in one study follow-up visit. The visit will be audio-recorded so reviewers can rate it later. After the visit, participants will fill out a short satisfaction survey on a tablet.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2027-02-01
Completion Date
2028-06-01
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
AI-Assisted Follow-up Consultation
A specialized large language model (LLM) assistant supports the consulting health professional in real time during a routine kidney transplant follow-up consultation. The assistant uses a retrieval-augmented generation (RAG) pipeline indexed on KDIGO guidelines and clinic standard operating procedures, and provides a structured content checklist, guideline-anchored suggestions with source citations, uncertainty flags, and a draft structured clinical note and orders. Guardrails prevent the assistant from finalizing medication changes, orders, or diagnoses. The responsible clinician reviews and verifies all findings, corrects inaccuracies, and approves and co-signs the encounter before any action is enacted (human-in-the-loop).
Usual Physician-Led Follow-up Consultation
Standard physician-led kidney transplant follow-up according to routine clinic practice and current guidelines, without the AI assistant. The consultation comprises history-taking, medication reconciliation with a focus on immunosuppression, focused examination, and a management plan, following the same pre-specified content checklist as the experimental arm.
Locations (1)
UPECLIN
Botucatu, São Paulo, Brazil