Overview
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 Criteria:
- 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 Criteria:
- 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