Ambient AI Scribe (Voa Health) in Outpatient Clinics: Draft Notes, Documentation Burden, and Well-Being
NCT07302906 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-04-01
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.
Conditions
- Burnout, Professionals
- Medical Records Systems, Computerized
- Physician-Patient Relations
- Ambulatory Care
Interventions
- OTHER
-
Ambient AI scribe for clinical documentation (Voa Health)
Use of an ambient artificial-intelligence (AI) scribe during outpatient consultations. The Voa Health system records the audio of the visit and generates a structured draft clinical note based on specialty-specific templates that follow the usual flow of each clinic. After the consultation, the physician reviews, edits, and signs the note in the electronic medical record. The AI does not make diagnostic or therapeutic decisions; it only assists documentation. All other aspects of clinical care follow routine practice.
- OTHER
-
Usual documentation without AI scribe (standard care)
Clinical documentation performed using usual methods without AI support (standard care). Physicians document the encounter in the electronic medical record as they normally do (typing, dictation, or handwritten notes as applicable). Audio of the visit may be recorded for study purposes, but no AI-generated draft note is shown to the clinician. After the consultation, physicians and patients complete the same brief questionnaires about workload, well-being, communication, empathy, and satisfaction.
Sponsors & Collaborators
-
Universidade Federal do Paraná
collaborator OTHER -
Pedro Angelo Basei de Paula
lead OTHER
Principal Investigators
-
Gustavo Lenci Marques, MD, PhD · Universidade Federal do Paraná
-
Pedro Angelo Basei de Paula, Medical Student · Universidade Federal do Paraná
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-05
- Primary Completion
- 2026-04-28
- Completion
- 2026-06-28
Countries
- Brazil
Study Locations
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