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
Sarah Nabia
672 participants
Jan 13, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- Adults aged ≥18 years
- Presenting to participating primary care facilities in study sites
- Meeting criteria for at least one of the following conditions or symptoms:
- Hypertension: Known diagnosis
- Diabetes mellitus: Known diagnosis or laboratory evidence (HbA1c ≥6.5%, fasting blood glucose ≥126 mg/dL, or post-prandial glucose ≥200 mg/dL)
- Fever: Presenting as chief complaint
- Breathlessness: Presenting as chief complaint, without evidence of fever
- Musculoskeletal pain: Presenting as chief complaint, without evidence of fever
- Able and willing to provide written informed consent
- Willing to participate in two sequential consultations and complete an exit survey
Exclusion Criteria3
- Inability to provide informed consent due to cognitive impairment (e.g., dementia or intellectual disability)
- Medical instability or condition requiring immediate emergency referral
- Prior participation in the study during an earlier visit
Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07432893