Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07302906

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

Led by Pedro Angelo Basei de Paula · Updated on 2026-04-01

300

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

Sponsors

P

Pedro Angelo Basei de Paula

Lead Sponsor

U

Universidade Federal do Paraná

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (18 years or older) attending participating outpatient clinics of Hospital de Clínicas - Federal University of Paraná during the study period
  • Under the care of a physician participating in the trial
  • Able to understand Portuguese and provide informed consent for audio recording and questionnaires
  • Able to complete post-consultation questionnaires during interview
  • Resident physicians working in participating outpatient clinics
  • Use hospital electronic medical record in routine care
  • Agree to audio recording and complete brief questionnaires after each encounter
  • Medical or health science students trained in consent and questionnaire administration linked to the research project
Not Eligible

You will not qualify if you...

  • Patients under 18 years old
  • Emergency consultations, urgent care, or inpatient care
  • Patients with significant cognitive impairment, acute distress, or clinical instability preventing consent or questionnaire completion, unless a legal guardian can consent
  • Patients under legal guardianship unable to consent unless guardian is present
  • Consultations where patient or physician refuses audio recording or study participation
  • Consultations where AI system is unavailable or malfunctioning (for protocol adherence analysis)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Complexo Hospital de Clínicas da UFPR (CHC-UFPR)

Curitiba, Paraná, Brazil, 80060-900

Actively Recruiting

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Research Team

G

Gustavo Lenci Marques, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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