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NCT07850700
Ambient AI Documentation in Oncology Consultations
Conditions: Neoplasms, Clinical Documentation, Artificial Intelligence in Medicine
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 250
Sponsor: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Location: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos Vilnius Vilnius City
Summary
This study tests whether an artificial intelligence (AI) system can help doctors write medical notes during cancer consultations.
After a cancer patient is seen by a multidisciplinary team (a group of specialists who decide on the best treatment), they have a consultation with their oncologist to discuss the treatment plan. During this consultation, doctors must write detailed medical notes, which takes significant time and effort.
In this study, an ambient AI system called VOCALI is used during oncology consultations at the National Cancer Center in Vilnius, Lithuania. Before the consultation begins, the doctor loads relevant pseudonymized clinical data from the electronic health record (such as diagnosis and treatment plan) into the system. During the consultation, VOCALI records the conversation (with the patient's consent) and combines it with the loaded clinical data to automatically generate a draft medical note in Lithuanian. Patients may ask the doctor to stop the recording at any time. The doctor then reviews the draft, makes any necessary corrections, and approves the final document. The AI does not make any medical decisions - the doctor is always responsible for the final note.
What the study measures:
The study has three main goals:
* To assess the quality of the AI-generated notes, rated by two independent reviewers using the PDQI-10, a standardized documentation quality instrument translated into Lithuanian using forward-backward translation
* To measure the time doctors spend reviewing and approving the AI-generated draft
* To monitor safety - whether any AI errors could affect patient care
The study also collects information on doctor workload, ease of use of the system, and patient satisfaction with the consultation.
Who can participate:
Adult patients (age 18 or older) attending a primary oncology consultation at the National Cancer Center in Vilnius, Lithuania, after a multidisciplinary team decision, who speak Lithuanian and provide written consent.
Study details:
250 patients will be enrolled over 12 months. Each participant attends one consultation and completes a short satisfaction questionnaire (about 5 minutes). No additional visits are required. There is no comparator group - all participants receive the AI-assisted documentation.
This is the first study to evaluate ambient AI documentation in the Lithuanian language and in the Lithuanian oncology setting.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older at the time of signing the informed consent form
* Primary oncologist consultation at the National Cancer Center following a multidisciplinary team (MDT) decision, with diagnosis and treatment plan established at the MDT meeting
* MDT protocol available in the electronic health record (EHR)
* Signed informed consent form, including consent to audio recording of the consultation
Exclusion Criteria:
* Absence of MDT protocol in the EHR
* Diagnosis or treatment plan not yet established
* MDT recommended additional diagnostic workup (treatment plan not yet defined)
* Palliative care consultation (not active oncological treatment planning)
* Non-Lithuanian speaking patients
* Cognitive impairment affecting ability to understand study information
* Hearing impairment affecting participation in verbal consultation
Source: ClinicalTrials.gov (NCT07850700). StuddyBuddy aggregates publicly available trial information.