AI-Assisted vs Usual Follow-up in Kidney Transplantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUPECLIN HC FM Botucatu Unesp
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Have a working kidney transplant
Received the kidney transplant at least 6 months ago
Able to take part in a routine follow-up visit on their own
Disqualifiers
Have a sudden or serious illness that needs urgent care
Have a thinking or sensory problem that means they need another person's help during the visit
Cannot communicate in Portuguese, the language used in the study
Are taking part in another study that would conflict with this one
Trial design
Design model
Parallel
Treatments tested in this trial
AI-Assisted Follow-up Consultation
Other interventionA 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
Other interventionStandard 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: AI-Assisted Follow-up ConsultationExperimental treatment 1 intervention
Group B: Usual Physician-Led Follow-upActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Consultation quality measured by the MAAS-Global global score
Overall quality of the follow-up consultation, scored with the MAAS-Global instrument, a validated tool for rating clinician consultation skills. Consultation quality is reported as the MAAS-Global global score, which ranges from 0 to 6, where 0 indicates the poorest consultation quality and 6 indicates the highest consultation quality (higher scores indicate better quality). Consultations are audio-recorded and scored by trained raters who are blinded to group allocation. This is the primary endpoint for the non-inferiority comparison between the AI-assisted consultation and the usual physician-led consultation.
Time frame
Consultation quality measured at Day 1Secondary outcomes
1
Patient satisfaction measured by the VSQ-9
Participant satisfaction with the consultation, measured with the Visit-Specific Satisfaction Questionnaire (VSQ-9), self-administered on a tablet immediately after the visit without staff assistance. Each item is scored on a 5-point scale and transformed to a 0 to 100 metric; the total score is the mean of the answered items and ranges from 0 to 100, where 0 indicates the lowest satisfaction and 100 indicates the highest satisfaction (higher scores indicate greater satisfaction).
Time frame
Patient satisfaction at day 1Sponsors and contacts
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Source ClinicalTrials.gov
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