Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07302906

The SOAR Trial: Ambient Artificial Intelligence Scribe Using Voa Health to Generate Medical Documentation from Outpatient Visit Audio - A Randomized Controlled Trial

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

300

Participants Needed

1

Research Sites

8 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

This research aims to evaluate whether using an ambient artificial intelligence (AI) scribe called Voa Health can reduce documentation workload and improve physician well-being and patient experience in outpatient clinics. The study compares usual documentation methods with documentation assisted by the AI scribe. The trial is randomized and conducted in multiple outpatient clinics across various medical specialties. The AI scribe records the audio of consultations and generates a draft clinical note using specialty-specific templates that match the clinic's workflow. Physicians then review, edit, and sign this draft in the electronic medical record. In the control group, physicians document visits using their usual methods without AI support, though audio may still be recorded for study purposes. After each visit, both physicians and patients complete brief questionnaires about workload, well-being, communication, empathy, and satisfaction. Participants will have their consultations audio recorded and complete questionnaires immediately after visits. Physicians' documentation workload, professional fulfillment, burnout, and note quality are measured, along with patient-reported experience and satisfaction. Additional monitoring includes timing for documentation and any AI-related errors. Data are securely stored, and an independent committee monitors safety and protocol adherence. The study will provide insight into the practical use and impact of ambient AI scribes in real-world outpatient care.

CONDITIONS

Brief 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 aged 18 years or older attending participating outpatient clinics 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 brief questionnaires immediately after consultation
  • Resident physicians working in participating outpatient clinics
  • Physicians using the hospital's electronic medical record in routine care
  • Physicians agreeing to audio recording and questionnaire completion after each consultation
  • Medical or undergraduate health science students trained to collect consent and administer questionnaires
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years
  • Emergency consultations, urgent care, or inpatient care visits
  • Patients with significant cognitive impairment, acute distress, or clinical instability preventing consent or questionnaire completion unless accompanied by a legal guardian
  • Patients under legal guardianship unable to provide consent unless the guardian provides consent
  • Consultations where patient or physician refuses audio recording or participation
  • Consultations where the AI system is unavailable or malfunctioning (for adherence analyses only)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and eligibility confirmation

Treatment

Duration - During outpatient consultations over the study period

Participants attend outpatient consultations where documentation is either assisted by the ambient AI scribe or performed using usual methods without AI support. Audio of the consultation is recorded and after each visit, both patient and physician complete brief questionnaires about workload, well-being, communication, empathy, and satisfaction.

1 visit per outpatient consultation (in-person) with immediate post-visit questionnaires

Trial Site Locations

Total: 1 location

1

Complexo Hospital de Clínicas da UFPR (CHC-UFPR)

Curitiba, Paraná, Brazil, 80060-900

Actively Recruiting

Loading map...

Research Team

G

Gustavo Lenci Marques, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

Similar Trials

Implementing Individualized Patient Reported Outcome Measure...

Coronary Artery Disease

Actively Recruiting

2 locations

Efficacy of an Exercise-based Secondary Prevention Program i...

Cardiovascular Diseases

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

A Pragmatic Randomized Controlled Trial of Ambient Artificial Intelligence to Improve Health Practitioner Well-Being.

Majid Afshar, Mary Ryan Baumann, Felice Resnik...

https://pubmed.ncbi.nlm.nih.gov/41625485

A Novel Playbook for Pragmatic Trial Operations to Monitor and Evaluate Ambient Artificial Intelligence in Clinical Practice.

Majid Afshar, Felice Resnik, Mary Ryan Baumann...

https://pubmed.ncbi.nlm.nih.gov/40959192