Clinical Trial

Ambient AI Scribe (Voa Health) in Outpatient Clinics: Draft Notes, Documentation Burden, and Well-Being

Study acronym: SOAR
Recruiting
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Summary
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.
Protocol Amendment History 3 changes
notable Primary completion pushed: 2026-04-28 -> 2026-09-28 2026-07-07
minor Completion pushed: 2026-06-28 -> 2026-09-28 2026-07-07
notable Primary completion pushed: 2026-03-28 -> 2026-04-28 2026-04-02
Trial Details
NCT Number NCT07302906
Lead Sponsor Pedro Angelo Basei de Paula
Collaborators: Universidade Federal do Paraná
Conditions Burnout, Professionals, Medical Records Systems, Computerized, Physician-Patient Relations, Ambulatory Care
Enrollment 300 participants
Start Date 2025-01-05
Primary Completion 2026-09-28 (estimated)
Study Completion 2026-09-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-06