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/Actively Recruiting
Led by Pedro Angelo Basei de Paula · Updated on 2026-07-06
300
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether an ambient artificial intelligence AI scribe called Voa Health can reduce the time and effort physicians spend documenting outpatient clinic visits and improve both physician well-being and patient experience. This randomized controlled trial compares usual documentation methods without AI to documentation assisted by the AI scribe, focusing on adult patients and their physicians in various outpatient specialties. The study aims to gather evidence to guide safe and effective use of ambient AI scribes in everyday clinical practice. The trial randomly assigns individual outpatient consultations to either usual documentation or AI-assisted documentation. In the AI group, the Voa Health system records the consultation audio and produces a structured draft clinical note based on specialty-specific templates. Physicians then review, edit, and finalize the note in the electronic medical record. In the control group, documentation is done by physicians using their regular methods without AI support, though audio recording may still occur for study purposes. Both physicians and patients complete brief questionnaires immediately after each consultation. Participants are involved by having their outpatient visits recorded and completing short questionnaires about workload, well-being, communication, empathy, and satisfaction right after the visit. Physicians also complete questionnaires assessing professional fulfillment, burnout, documentation burden, and note quality. Researchers measure physician documentation workload and well-being as primary outcomes, along with patient experience and satisfaction, documentation quality, time spent on notes, and potential AI-related documentation errors. Data are securely stored and monitored for quality and safety throughout the study, which runs until September 2026.
CONDITIONS
Ambient AI Scribe (Voa Health) in Outpatient Clinics: Draft Notes, Documentation Burden, and Well-Being
G
Gustavo Lenci Marques, MD, PhD
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Pedro Angelo Basei de Paula
Lead Sponsor
Universidade Federal do Paraná
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Throughout the study period until September 2026
Participants attend outpatient clinic visits where consultations are randomly assigned to either usual documentation or AI-assisted documentation using the Voa Health scribe. After each visit, physicians and patients complete brief questionnaires about workload, well-being, communication, empathy, and satisfaction.
Questionnaires completed immediately after each consultation
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Lead Sponsor
Universidade Federal do Paraná
Collaborating Sponsor