Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Liver Foundation, West Bengal | UNKNOWN |
| Endless Health | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse+Large language model clinical consultation | Experimental | 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. |
|
| Physician led clinical consultation (standard of care) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Quality of Consultation (Clinical Management and Clinical Reasoning Score) | 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. | Day 1 (same study visit, immediately after completion of both consultations) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Experience Score on Exit Survey (Likert Scale Composite Score) | 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. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Nabia, MA, MPH, MBA | Contact | 4438503359 | snabia24@gmail.com | |
| Anup Agarwal, MBBS | Contact | 5056207815 | mailanupagarwal@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver Foundation | Recruiting | Kolkata | West Bengal | India |
This study involves audio-recorded clinical consultations, detailed transcripts, and qualitative interviews collected in small, identifiable clinic populations. Even after de-identification, there is a meaningful risk of re-identification, particularly from narrative data and voice-derived content. In addition, participant consent forms and ethics approvals are designed for aggregate reporting only, not public IPD sharing.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study protocol & consent (English only) |
Not provided
This study uses a randomized, within-participant crossover interventional design. Each enrolled patient participates in two sequential clinical consultations during a single visit: (1) an AI-assisted, nurse-led consultation (intervention) and (2) a standard physician-led consultation (control). The order of consultations is randomized to minimize order effects. Both consultations address the same clinical condition or symptom and result in independent treatment plans. Because each participant serves as their own control, this design reduces between-subject variability and improves statistical efficiency. Clinical interactions are audio recorded and de-identified, and resulting treatment plans are independently scored by blinded physicians using standardized rubrics to assess clinical reasoning and management quality. In addition, patient experience is assessed via a post-consultation exit survey, and nurse experiences are explored through qualitative interviews.
Not provided
Not provided
Not provided
|
| 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. |
|
| Day 1 (immediately after completion of the nurse + LLM consultation during the study visit) |
| Nurse-Reported Acceptability and Feasibility Themes from Semi-Structured Interviews | 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. | Through study completion (after nurses complete a minimum of 10 AI-assisted consultations; up to 9 months) |
| Aug 19, 2025 |
| Jan 12, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D004417 | Dyspnea |
| D005334 | Fever |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
Not provided
Not provided