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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Physician documentation workload during the visit
Study Overview
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 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.
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 routine outpatient care.
The intervention consists of using the Voa Health ambient AI scribe during clinical encounters. The system records the audio of the consultation and generates a structured draft clinical note in real time, aligned with specialty-specific templates that reflect the routine workflow of each clinic (for example, different templates for general cardiology, heart failure, dyslipidemia, etc.). At the end of the visit, the physician reviews, edits, and signs the draft in the electronic medical record (EMR), remaining fully responsible for the accuracy and completeness of the documentation. In the control condition, physicians conduct consultations and document encounters using their usual methods without AI support. For study purposes, audio may still be recorded in the control arm, but no AI-generated note is displayed or used by the clinician.
The unit of randomization is the individual consultation. For participating physicians, eligible visits are automatically allocated to one of two parallel arms: (1) usual documentation without AI and (2) documentation assisted by the ambient AI scribe. Randomization is designed to preserve the existing organization of each clinic and to avoid interference with scheduling or patient flow. Clinical care, diagnostic and therapeutic decisions, and follow-up procedures are not dictated by the protocol and follow usual practice; the only experimental element is the use (or non-use) of the AI scribe for documentation and the collection of audio and questionnaires.
Adult patients seen in participating outpatient clinics, and their physicians, are invited to take part. After informed consent, the entire consultation is audio-recorded. Immediately after each visit, both patient and physician are asked to complete brief, structured questionnaires that capture the main outcomes of interest. To keep data collection feasible in a busy ambulatory setting, the instruments were built from subsets of items derived from internationally used scales, while keeping the number of questions per consultation small.
For physicians, items are drawn from the Professional Fulfillment Index (PFI), the Mini-Z 2.0 survey, and the 4-item Physician Task Load / NASA-TLX. These items assess professional fulfillment and burnout (physical and emotional exhaustion), perceived sufficiency of time for documentation, work in the EMR outside direct patient contact, perceived documentation burden, and temporal demand of the visit. Additional study-specific items evaluate the perceived quality and completeness of the final note, time required to edit the AI-generated draft, confidence that key clinical details were captured, occurrence of potential AI "hallucinations" (information not actually stated in the visit), and the perceived impact of documentation on attention to the patient.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
Open-label pragmatic trial; physicians and patients are aware of the use of the AI scribe
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Arms & Interventions
Ambient AI scribe (Voa Health)
Outpatient consultations in which the Voa Health ambient AI scribe is active. The system records the audio of the visit and generates a structured draft clinical note based on specialty-specific templates. The physician reviews, edits, and signs the note in the EMR. After the visit, the physician and the patient complete brief questionnaires about workload, well-being, communication, empathy, and satisfaction.
Intervention: Ambient AI scribe for clinical documentation (Voa Health) (Other)
Usual documentation without AI scribe
Outpatient consultations in which documentation is performed using usual methods without AI support (standard clinical practice). Audio of the visit may be recorded for study purposes, but no AI-generated note is shown to the clinician. After the visit, the physician and the patient complete the same brief questionnaires about workload, well-being, communication, empathy, and satisfaction.
Intervention: Usual documentation without AI scribe (standard care) (Other)
Outcomes
Primary Outcomes
Physician documentation workload during the visit
Time Frame: Immediately after each outpatient consultation (same day)
Physician-reported documentation burden, measured immediately after each consultation using brief 5-point Likert-type items adapted from internationally used instruments (NASA-TLX, Mini-Z) and study-specific items. Items assess: (1) administrative burden of the consultation, (2) time available to focus on the patient, (3) mental demand of the consultation (adapted NASA-TLX), (4) interference of the documentation process with patient interaction, and (5) disruption of workflow due to documentation adjustments. Individual item scores and a composite burden score (mean of items; higher values = greater burden) will be compared between consultations with the ambient AI scribe and consultations with usual documentation without AI.
Physician well-being / exhaustion during the visit
Time Frame: Immediately after each outpatient consultation (same day)
Physician physical exhaustion immediately after the consultation, assessed with a single item derived from the Professional Fulfillment Index (PFI): "I feel physically exhausted after this consultation," rated on a 5-point agreement scale (strongly disagree to strongly agree; higher values = greater exhaustion). Scores will be compared between consultations with the ambient AI scribe and consultations with usual documentation without AI.
Secondary Outcomes
- Patient experience of communication and empathy(Immediately after each outpatient consultation (same day))
- Patient understanding of diagnosis and treatment(Immediately after each outpatient consultation (same day))
- Time required for documentation outside direct patient contact(Immediately after each outpatient consultation (same day))
- Physician-rated quality and completeness of clinical notes(Immediately after finalizing documentation for each consultation (same day))
- Proportion of consultations with AI-related hallucinations in documentation(Immediately after each AI-assisted consultation (same day))
- Proportion of clinical notes with documentation errors in blinded external review(Within 30 days after finalizing each clinical note)
Investigators
Pedro Angelo Basei de Paula
Research Coordinator
Universidade Federal do Paraná