Clinical Trial

Assessing the Effectiveness of Large Language Model (LLM)-Enabled Nurse Treatment Planning in 2 Indian Districts

Completed
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Summary
The goal of this clinical trial is to learn whether AI-enabled, nurse-led treatment planning can improve the quality of clinical reasoning and management compared with standard physician-led care in adult primary care patients (≥18 years) presenting with hypertension, diabetes mellitus, fever, breathlessness, or musculoskeletal pain in rural and semi-urban India. The main questions it aims to answer are: * Does a nurse + large language model (LLM) consultation achieve non-inferior clinical quality scores compared with a standard doctor consultation? * Is AI-assisted nurse-led care acceptable and satisfactory to patients in primary healthcare settings? Researchers will compare nurse + LLM-led consultations with physician-led standard-of-care consultations within the same participant to see if the AI-enabled nurse model delivers comparable or improved clinical reasoning and treatment planning. Participants will: * Receive two sequential consultations for the same visit (one with a nurse using an AI tool and one with a physician, order randomized). * Have both consultations audio recorded for blinded clinical quality assessment. * Complete a brief exit survey on communication, trust, and satisfaction after the AI-assisted nurse consultation.
Protocol Amendment History 1 change
critical Trial completed 2026-08-06
Trial Details
NCT Number NCT07432893
Lead Sponsor Sarah Nabia
Collaborators: Liver Foundation, West Bengal, Endless Health
Conditions Hypertension, Diabete Mellitus, Breathlessness, Fever
Enrollment 736 participants
Start Date 2026-01-13
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-05