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:
- 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.
Exclusion Criteria:
- 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).
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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1
Complexo Hospital de Clínicas da UFPR (CHC-UFPR)
Curitiba, Paraná, Brazil, 80060-900