The Effects of Generative AI Virtual Patient in Serious Illness Communication Skills: Randomized Controlled Trial (Preprint)

Abstract

<sec> <title>BACKGROUND</title> Serious illness communication (SIC) is a critical skill in medical education, especially in end-of-life care, yet clinicians often lack sufficient opportunities for deliberate practice. Standardized patients (SPs) remain the gold standard for SIC training, but they are limited by cost, availability, and consistency. To support wider access to SIC training, scalable alternatives are needed. </sec> <sec> <title>OBJECTIVE</title> To evaluate whether an AI-powered virtual patient providing real-time dialogue and automated feedback (SOPHIE) improves SIC skills among clinicians and trainees. </sec> <sec> <title>METHODS</title> We conducted a single-blind parallel-group randomized controlled trial from June to December 2024 via videoconferencing. Participants were randomized 1:1 to intervention (SOPHIE training) or control (reading module). Blinded standardized patient actors and independent raters evaluated outcomes pre- and post-intervention. The intervention group completed three interactive SOPHIE modules (Empathize, Be Explicit, Empower) for 30 minutes, combining dialogue with an interactive virtual patient and automated feedback. Control participants reviewed reading materials covering the same framework for the same duration. The primary outcome was the change in communication skills (Empathize, Be Explicit, Empower) assessed by standardized patients and blinded raters using a validated rubric. Secondary outcomes included self-reported confidence in communication skills. </sec> <sec> <title>RESULTS</title> Fifty-one medical, nursing, and physician assistant students and practicing clinicians (mean age, 30.6 years; 78.4% women) from academic and clinical settings. Participants were stratified by training level and randomized; all completed the study. Compared with controls, SOPHIE participants demonstrated significantly greater improvement: Empower (Δ = 17% vs 6%; P = .004), Be Explicit (Δ = 13% vs 5%; P = .003), and Empathize (Δ = 14% vs 7%; P = .04). Here, Δ indicates mean improvement on the aggregate rubric score across 5 evaluators. The SOPHIE group demonstrated greater improvement, with effect sizes ranging from 0.59 to 0.92. SOPHIE participants also reported higher confidence in their skills (mean score: SOPHIE 4.31 vs Control 3.83 on a 5-point Likert scale; P = .009). </sec> <sec> <title>CONCLUSIONS</title> Training with an AI-powered virtual patient significantly improved serious illness communication skills and confidence compared with reading modules. Generative AI-based simulations may provide a scalable, accessible, and effective adjunct or alternative to traditional standardized patient training in clinical education. </sec> <sec> <title>CLINICALTRIAL</title> Retrospectively registered. ClinicalTrials.gov NCT07409233; http://clinicaltrials.gov/ct2/show/NCT07409233 </sec>

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