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NCT Number: NCT07432893

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-enabled clinical decision support tool (software) used by nurses

Other

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.

Physician consultation

Other

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.

Primary outcomes

  1. Clinical Quality of Consultation (Clinical Management and Clinical Reasoning Score)

    Time frame: Day 1 (same study visit, immediately after completion of both consultations)

    This outcome assesses the quality of clinical care by comparing AI-assisted, nurse-led consultations with standard physician-led consultations. For patients with hypertension or diabetes mellitus, clinical quality is measured using a clinical management rubric with a raw score range of -2 to 7, assessing data review, complication screening, medication adherence, counseling, and treatment planning, with penalties for inappropriate counseling or treatment. For patients presenting with fever, breathlessness, or musculoskeletal pain, clinical quality is measured using a clinical reasoning rubric with a raw score range of -5 to 10, assessing differential diagnoses, final diagnosis, and next steps, with negative scores for harmful recommendations. Consultations are audio recorded, de-identified, and scored by blinded physicians. Higher scores indicate better alignment with evidence-based, context-appropriate care.

Secondary outcomes

  1. Patient Experience Score on Exit Survey (Likert Scale Composite Score)

    Time frame: Day 1 (immediately after completion of the nurse + LLM consultation during the study visit)

    Composite patient experience score derived from an 9-item Likert-scale exit survey adapted from the WHO Health System Responsiveness framework and PSQ-18. Items assess communication, understanding, dignity/respect, trust in AI use, and overall satisfaction. Responses are scored 1-5 per item and averaged to generate a composite score (range 1-5), with higher scores indicating more positive experience.

  2. Nurse-Reported Acceptability and Feasibility Themes from Semi-Structured Interviews

    Time frame: Through study completion (after nurses complete a minimum of 10 AI-assisted consultations; up to 9 months)

    Qualitative assessment of nurse-reported usability, trust in AI recommendations, workflow impact, barriers, facilitators, and willingness to continue use. Interviews are audio recorded and thematically analyzed. Outcomes will be reported as identified themes with representative quotations and frequency of theme occurrence across participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Anup Agarwal, MBBS

CONTACT

[email protected]

5056207815

Sarah Nabia, MA, MPH, MBA

CONTACT

[email protected]

4438503359

Sponsors and collaborators

Lead sponsor

Sarah Nabia

Other

Collaborators

  • Endless Health
  • Liver Foundation, West Bengal

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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