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Completed

NCT Number: NCT06911398

AMIE's Clinical Conversational Abilities in an Urgent Care Setting

The purpose of this study is to determine the feasibility of a conversational artificial intelligence (AI) system to have a meaningful clinical conversation with a patient prior to an urgent care visit with their primary care physician. In this study, patients who are seeking an urgent care visit (that is, any type of medical visit with their primary care provider for a new complaint) will first have a conversation with an AI system. This interaction with the AI system will happen less than a week before their visit with their physician, and will be supervised by an independent physician who will interrupt in case there are any concerns about patient safety. After the interaction, a summary of the conversation will be sent to the patient's PCP, who will review prior to the in-person visit.

The researchers will investigate:

* Patient views on the AI system * PCP views on the AI system * Overall safety, as measured by the physician safety supervisor * Quality of clinical conversations, measured by standardized rubrics * Quality of diagnostic and management plans generated by the AI; these will not be shared with the patient or physician, but will be generated after the fact and compared with the actual diagnosis and management plan.

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Key information

Conditions

Artificial Intelligence (AI) Clinical Reasoning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

This study is a pilot study on the ability of the Articulate Medical Intelligence Explorer's ability to have a clinical conversation with urgent care patients. After recruitment into the study, but prior to seeing their primary care physician (PCP), patients will log in to the AMIE chat interface via a secure web application and share their screen via a secure, HIPAA-compliant video conferencing program. They will then interact with AMIE, having a clinical conversation. A physician safety supervisor will be on the call the entire time and will view the chat as it happens. This doctor will interrupt the chat if there are any potentially harmful interactions. At the end of the call, the safety supervisor will discuss with the patient and correct any errors, hallucinations, or problems with the AI. The patient's PCP will receive both a summary and a transcript of the chat prior to their appointment. The patient will then proceed to their urgent care appointment as previously scheduled. Four weeks after the visit, the researchers will perform a chart review to extract a "ground truth" diagnosis from the urgent care visit, if possible. As this is a pilot study, the primary endpoint will be recruitment; the target is between 100 to 200 patients and the study will continue until saturation of different diagnoses has been reached.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18
  • English included as a primary language in the electronic health record
  • Patient is seeking episodic (urgent) care at HCA

Exclusion criteria

  • Age < 18
  • English not listed as a primary language in the electronic health record
  • Visit reason is related to pregnancy
  • Visit reason is a psychiatric concern
  • Visit is to establish care, or for follow-up care

Treatment and study plan

Articulate Medical Intelligence Explorer (AMIE)

Other

AMIE is an AI system for having clinical conversations with patients

Primary outcomes

  1. Chat terminations

    Time frame: Day 1

    The researchers will collect the number of interruptions by the safety supervisor in response to safety concerns. There are four pre-specified interruption criteria; the researchers will connect the total number in each category, as well as a qualitative description of the type of error.

  2. Patient-centered evaluation of clinical dialogue

    Time frame: Day 3

    The researchers will use the General Medical Council Patient Questionnaire (GMCPQ) standardized rubric to rate the quality of clinical dialogue.

  3. Clinical skills-based assessment of clinical dialogue

    Time frame: Day 3

    The researchers will use the Practical Assessment of Clinical Examination Skills (PACES) standardized rubric to rate the quality of clinical dialogue.

  4. Communication skills evaluation of clinical dialogue

    Time frame: Day 3

    The researchers will use the Patient-Centered Communication Best Practice (PCCBP) standardized rubric to rate the quality of clinical dialogue.

  5. Patient satisfaction pre-AMIE encounter

    Time frame: Day 1

    Patients will receive a pre-AMIE encounter questionnaire.

  6. Patient satisfaction post-AMIE encounter

    Time frame: Day 1

    Patients will receive a post-AMIE encounter questionnaire.

  7. PCP satisfaction

    Time frame: Day 3

    The researchers will collect a post-encounter questionnaire from the patient's PCP, asking about views on AI in healthcare and how AMIE interaction may have changed the in-person visit.

  8. Patient satisfaction post-PCP encounter

    Time frame: Day 3

    Patients will receive a post-PCP encounter questionnaire.

Secondary outcomes

  1. Semi-structured interviews of patients

    Time frame: Up to 8 weeks

    The researchers will perform semi-structured interviews of select patients participating in the study.

  2. Diagnostic accuracy

    Time frame: Up to 4 weeks

    The researchers will compare AMIE's differential diagnosis to the final diagnosis.

  3. Management plan quality

    Time frame: Up to 4 weeks

    The researchers will compare AMIE's management plan to the final management plan using the Management Reasoning Essential Key Features (MXEKF) rubric.

  4. Semi-structured interviews of PCPs

    Time frame: Up to 8 weeks

    The researchers will complete semi-structured interviews with all of the PCPs participating in the study.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Google LLC.

Registry information

Official study title

A Prospective Cohort Study of the Articulate Medical Intelligence Explorer's Ability to Take an Initial Triage History From Patients Prior to an Urgent Care Visit

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Apr 20, 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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