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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Liver Foundation
RECRUITING
Kolkata
Contact Information
Primary
Sarah Nabia, MA, MPH, MBA
snabia24@gmail.com
4438503359
Backup
Anup Agarwal, MBBS
mailanupagarwal@gmail.com
5056207815
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 672
Treatments
Experimental: Nurse+Large language model clinical consultation
Participants in this arm receive a nurse-led primary care consultation supported by a large language model (LLM)-based clinical decision support tool. During the consultation, a trained nurse conducts routine history taking and clinical assessment and engages in a multi-turn interaction with the LLM via a digital interface to support differential diagnosis, clinical reasoning, and evidence-based treatment and follow-up planning. The nurse may ask additional questions of the patient based on LLM prompts. The final clinical recommendations are generated collaboratively by the nurse using the LLM outputs and documented as a treatment plan. This arm evaluates whether AI-assisted nurse-led care can deliver clinical quality comparable to standard physician-led care in primary health settings.
Active_comparator: Physician led clinical consultation (standard of care)
The doctor consultation represents standard-of-care clinical management that is already known and accepted to be effective for diagnosing and treating the study conditions. It is an active clinical intervention, not a placebo, sham, or no-intervention arm, and it serves as the comparator against the experimental nurse + LLM intervention.
Related Therapeutic Areas
Sponsors
Collaborators: Endless Health, Liver Foundation, West Bengal
Leads: Sarah Nabia

This content was sourced from clinicaltrials.gov

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