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

Recruiting now · Not applicable

Conditions studied: Burnout, Professionals, Medical Records Systems, Computerized, Physician-Patient Relations, Ambulatory Care

In brief

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.

Key facts

Study ID: NCT07302906
Run by: Pedro Angelo Basei de Paula
People needed: 300
Starts: 2025-01-05
Expected to finish: 2026-09-28
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients:
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.
Physicians:
Resident physicians working in the participating outpatient clinics.
Use of the hospital's electronic medical record in routine care practice.
Agreement to the audio recording of consultations and to the completion of brief questionnaires after each included encounter.
Student Researchers:
Medical students or undergraduate health science students linked to the research project.
Trained in patient registration, collection of Informed Consent (ICF), and administration of questionnaires to the patient on the Infinity Research platform.

You may not qualify if…

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.
Consultations where either the patient or the physician refuses audio recording or participation in the study.
Consultations where the AI system is unavailable or malfunctioning (applicable only for protocol adherence analyses).

Where it is running

Complexo Hospital de Clínicas da UFPR (CHC-UFPR) — Curitiba, Paraná, Brazil (enrolling)

Full record on ClinicalTrials.gov

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