Assessing the Effectiveness of Large Language Model (LLM)-Enabled Nurse Treatment Planning in 2 I… (NCT07432893) | Clinical Trial Compass
RecruitingNot Applicable
Assessing the Effectiveness of Large Language Model (LLM)-Enabled Nurse Treatment Planning in 2 Indian Districts
India672 participantsStarted 2026-01-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Quality of Consultation (Clinical Management and Clinical Reasoning Score)
Timeframe: Day 1 (same study visit, immediately after completion of both consultations)