NCT07432893

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 672 (estimated)
• Sponsor: Sarah Nabia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Diabete Mellitus
• Breathlessness
• Fever

Interventions

Type	Name	Description
OTHER	AI-enabled clinical decision support tool (software) used by nurses	A nurse-led primary care consultation supported by a large language model-based clinical decision support tool. The nurse uses the AI tool during the patient encounter to support clinical reasoning, differential diagnosis, and evidence-based treatment and follow-up planning.
OTHER	Physician consultation	Participants receive a routine physician-led primary care consultation conducted according to existing clinical practice. The physician independently performs history taking, clinical assessment, diagnosis, and treatment planning without use of the AI tool.

Timeline

• Start date: 2026-01-13
• Primary completion: 2026-07-15
• Completion: 2026-07-31
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: India