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

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.

Inclusion Criteria:

1. Adults aged ≥18 years

2. Presenting to participating primary care facilities in study sites

3. 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

4. Able and willing to provide written informed consent

5. Willing to participate in two sequential consultations and complete an exit survey

Exclusion Criteria:

1. Inability to provide informed consent due to cognitive impairment (e.g., dementia or intellectual disability)
2. Medical instability or condition requiring immediate emergency referral
3. Prior participation in the study during an earlier visit