RecruitingNot ApplicableNCT07302906

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

The SOAR Trial (Scribe Optimization for Ambulatory Records): Ambient Artificial Intelligence Scribe With Voa Health for Generating Medical Documentation From Outpatient Visit Audio - A Randomized Controlled Trial

Sponsor

Pedro Angelo Basei de Paula

Enrollment

300 participants

Start Date

Jan 5, 2025

Study Type

INTERVENTIONAL

Conditions

Ambulatory Care Physician-Patient Relations Burnout, Professionals Medical Records Systems, Computerized

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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 Criteria6

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).

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Interventions

OTHERAmbient 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.

OTHERUsual 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.