About this trial
The goal of this randomized clinical trial is to learn whether an "ambient AI scribe" (Voa Health) can reduce documentation burden and improve physician well-being and patient experience in outpatient clinics. The AI scribe listens to the audio of the consultation and produces a draft of the clinical note that the physician reviews and edits.
In this study, consultations are randomized to 2 groups: usual documentation (without AI) or documentation assisted by the AI scribe. Adult patients seen in participating clinics, and their physicians, are invited to take part. For both groups, the consultation audio is recorded and, at the end of the visit, physicians and patients complete short questionnaires about well-being, workload, communication, empathy, and satisfaction. The questionnaires are based on internationally used scales (such as PFI, Mini-Z, NASA-TLX, CARE, PSQ-18, and CAT) but adapted to keep them brief and feasible in routine care.
The main questions are whether the AI scribe lowers the time and effort needed to document the visit, improves physician professional fulfillment and reduces burnout, and whether it affects how patients perceive the communication, empathy, and overall quality of the consultation. No drugs or devices are being tested. The results are expected to guide hospitals on the safe and effective use of ambient AI scribes in real-world clinical practice.
Eligibility criteria
Qualifiers
Adults (≥18 years) attended at the participating outpatient clinics of the Hospital de Clínicas - Federal University of Paraná during the study period.
Under the care of a physician participating in the trial.
Ability to understand Portuguese and provide informed consent for the audio recording of the consultation and completion of brief questionnaires.
Ability to complete post-consultation questionnaires during interview.
Disqualifiers
Patients under 18 years of age.
Emergency consultations, urgent care, or inpatient care.
Patients with significant cognitive impairment, acute distress, or clinical instability that, in the opinion of the treating physician, precludes providing consent or completing questionnaires, except when accompanied by a legal guardian capable of providing consent on their behalf.
Patients under legal guardianship or who, for any reason, cannot provide consent on their own, except when the guardian or legal representative is present and can provide informed consent.
Trial design
Treatments tested in this trial
- Ambient AI scribe for clinical documentation (Voa Health)
- Usual documentation without AI scribe (standard care)
Treatment groups
Sponsors and collaborators
Pedro Angelo Basei de Paula
Lead sponsor
Universidade Federal do Paraná
Sponsor institution
Universidade Federal do Paraná
Collaborator