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/41625485Actively Recruiting
Led by Pedro Angelo Basei de Paula · Updated on 2026-04-01
300
Participants Needed
1
Research Sites
8 weeks
Total Duration
P
Pedro Angelo Basei de Paula
Lead Sponsor
U
Universidade Federal do Paraná
Collaborating Sponsor
This research aims to evaluate whether using an ambient artificial intelligence (AI) scribe called Voa Health can reduce documentation workload and improve physician well-being and patient experience in outpatient clinics. The study compares usual documentation methods with documentation assisted by the AI scribe. The trial is randomized and conducted in multiple outpatient clinics across various medical specialties. The AI scribe records the audio of consultations and generates a draft clinical note using specialty-specific templates that match the clinic's workflow. Physicians then review, edit, and sign this draft in the electronic medical record. In the control group, physicians document visits using their usual methods without AI support, though audio may still be recorded for study purposes. After each visit, both physicians and patients complete brief questionnaires about workload, well-being, communication, empathy, and satisfaction. Participants will have their consultations audio recorded and complete questionnaires immediately after visits. Physicians' documentation workload, professional fulfillment, burnout, and note quality are measured, along with patient-reported experience and satisfaction. Additional monitoring includes timing for documentation and any AI-related errors. Data are securely stored, and an independent committee monitors safety and protocol adherence. The study will provide insight into the practical use and impact of ambient AI scribes in real-world outpatient care.
CONDITIONS
Ambient AI Scribe (Voa Health) in Outpatient Clinics: Draft Notes, Documentation Burden, and Well-Being
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and eligibility confirmation
Duration - During outpatient consultations over the study period
Participants attend outpatient consultations where documentation is either assisted by the ambient AI scribe or performed using usual methods without AI support. Audio of the consultation is recorded and after each visit, both patient and physician complete brief questionnaires about workload, well-being, communication, empathy, and satisfaction.
1 visit per outpatient consultation (in-person) with immediate post-visit questionnaires
Total: 1 location
1
Complexo Hospital de Clínicas da UFPR (CHC-UFPR)
Curitiba, Paraná, Brazil, 80060-900
Actively Recruiting
G
Gustavo Lenci Marques, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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