Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07432893

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

Led by Sarah Nabia · Updated on 2026-02-25

672

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

Sponsors

S

Sarah Nabia

Lead Sponsor

L

Liver Foundation, West Bengal

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether AI-enabled, nurse-led treatment planning can match or improve the quality of clinical reasoning and management compared to standard physician-led care in adults aged 18 years and older. The study focuses on patients in rural and semi-urban India presenting with hypertension, diabetes mellitus, fever, breathlessness, or musculoskeletal pain. It aims to determine if nurse consultations supported by a large language model (LLM) achieve clinical quality scores that are not worse than those of physician consultations and to assess patient acceptance and satisfaction with AI-assisted nurse care. Participants receive two consultations during the same visit: one led by a nurse using an AI-based clinical decision support tool and one by a physician providing standard care. The nurse-led consultation involves routine history taking and clinical assessment, with interaction through a digital interface to the LLM for assistance in diagnosis, reasoning, and treatment planning. The physician consultation follows usual clinical practice without AI support. The study compares these two approaches in a randomized order within each participant. Throughout the study visit, both consultations are audio recorded for blinded clinical quality evaluation. After the nurse + LLM consultation, participants complete an exit survey measuring communication, trust, and satisfaction. Researchers also gather nurse-reported feedback on acceptability and feasibility through interviews after nurses complete at least 10 AI-assisted consultations. The main outcome measured is the clinical quality of the consultations immediately after both visits, with additional assessments of patient experience and nurse perspectives over up to nine months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Presenting to participating primary care facilities in the study sites
  • Have at least one of the following: known hypertension, known diabetes mellitus or lab evidence of diabetes, fever as a main complaint, breathlessness without fever as a main complaint, or musculoskeletal pain without fever as a main complaint
  • Able and willing to provide written informed consent
  • Willing to participate in two sequential consultations and complete an exit survey
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent due to cognitive impairment such as dementia or intellectual disability
  • Medically unstable or requiring immediate emergency referral
  • Participated in this study during a previous visit

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - 1 day

Participants receive two sequential primary care consultations: one nurse-led consultation supported by a large language model clinical decision support tool, and one standard physician-led consultation. These consultations assess clinical management and reasoning quality.

1 study visit including both consultations and an exit survey

Follow-up

Duration - Up to 9 months

Nurses complete a minimum of 10 AI-assisted consultations, and acceptability and feasibility are assessed through interviews over time.

Interviews conducted after minimum 10 AI-assisted consultations

Trial Site Locations

Total: 1 location

1

Liver Foundation

Kolkata, West Bengal, India

Actively Recruiting

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Research Team

S

Sarah Nabia, MA, MPH, MBA

A

Anup Agarwal, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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