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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07302906 on ClinicalTrials.gov