Assessing the Effectiveness of Large Language Model (LLM)-Enabled Nurse Treatment Planning in 2 Indian Districts
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSarah Nabia
About this trial
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 criteria
Qualifiers
Adults aged ≥18 years
Presenting to participating primary care facilities in study sites
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- AI-enabled clinical decision support tool (software) used by nurses
- Physician consultation
Treatment groups
672 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sarah Nabia
Lead sponsor
HEAL India
Sponsor institution
Liver Foundation, West Bengal
Collaborator
Endless Health
Collaborator
Source ClinicalTrials.gov