Status:

RECRUITING

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

Lead Sponsor:

Pedro Angelo Basei de Paula

Collaborating Sponsors:

Universidade Federal do Paraná

Conditions:

Burnout, Professionals

Medical Records Systems, Computerized

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

Detailed Description

This study is a randomized controlled trial designed to assess the impact of an ambient artificial-intelligence (AI) scribe on physician well-being, documentation workload, and patient experience in r...

Eligibility Criteria

Inclusion Criteria:

Patients:

  1. Adults (≥18 years) attended at the participating outpatient clinics of the Hospital de Clínicas - Federal University of Paraná during the study period.
  2. Under the care of a physician participating in the trial.
  3. Ability to understand Portuguese and provide informed consent for the audio recording of the consultation and completion of brief questionnaires.
  4. Ability to complete post-consultation questionnaires during interview.

Physicians:

  1. Resident physicians working in the participating outpatient clinics.
  2. Use of the hospital's electronic medical record in routine care practice.
  3. Agreement to the audio recording of consultations and to the completion of brief questionnaires after each included encounter.

Student Researchers:

  1. Medical students or undergraduate health science students linked to the research project.
  2. Trained in patient registration, collection of Informed Consent (ICF), and administration of questionnaires to the patient on the Infinity Research platform.

Exclusion Criteria:

  1. Patients under 18 years of age.
  2. Emergency consultations, urgent care, or inpatient care.
  3. 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.
  4. 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.
  5. Consultations where either the patient or the physician refuses audio recording or participation in the study.
  6. Consultations where the AI system is unavailable or malfunctioning (applicable only for protocol adherence analyses).

Key Trial Info

Start Date :

January 5 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 28 2026

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT07302906

Start Date

January 5 2025

End Date

June 28 2026

Last Update

April 1 2026

Active Locations (1)

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Complexo Hospital de Clínicas da UFPR (CHC-UFPR)

Curitiba, Paraná, Brazil, 80060-900