Artificial Intelligence (AI)NCT06911398
AMIE's Clinical Conversational Abilities in an Urgent Care Setting
An observational study of Artificial Intelligence (AI) and Clinical Reasoning, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Artificial Intelligence (AI), Clinical Reasoning
- What is being tested?
- Articulate Medical Intelligence Explorer (AMIE)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2025to 6 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is all patients meeting the inclusion and exclusion criteria undergoing an episodic care visit at Healthcare Associates (HCA), the primary care clinic of BIDMC.
Who may be able to join
- Age > 18
- English included as a primary language in the electronic health record
- Patient is seeking episodic (urgent) care at HCA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Artificial Intelligence (AI), Clinical Reasoning
- Being tested
- Articulate Medical Intelligence Explorer (AMIE)
- Keywords
- artificial intelligence, chatbot, clinical conversation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articulate Medical Intelligence Explorer (AMIE)Other
AMIE is an AI system for having clinical conversations with patients
| Study group | Role | What they receive |
|---|---|---|
| Urgent care patients | Not described Receives: Other: Articulate Medical Intelligence Explorer (AMIE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chat terminations
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.
Measured: Day 1
Patient-centered evaluation of clinical dialogue
The researchers will use the General Medical Council Patient Questionnaire (GMCPQ) standardized rubric to rate the quality of clinical dialogue.
Measured: Day 3
Clinical skills-based assessment of clinical dialogue
The researchers will use the Practical Assessment of Clinical Examination Skills (PACES) standardized rubric to rate the quality of clinical dialogue.
Measured: Day 3
Communication skills evaluation of clinical dialogue
The researchers will use the Patient-Centered Communication Best Practice (PCCBP) standardized rubric to rate the quality of clinical dialogue.
Measured: Day 3
Patient satisfaction pre-AMIE encounter
Patients will receive a pre-AMIE encounter questionnaire.
Measured: Day 1
Patient satisfaction post-AMIE encounter
Patients will receive a post-AMIE encounter questionnaire.
Measured: Day 1
PCP satisfaction
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.
Measured: Day 3
Patient satisfaction post-PCP encounter
Patients will receive a post-PCP encounter questionnaire.
Measured: Day 3
Secondary outcomes (4)
Semi-structured interviews of patients
The researchers will perform semi-structured interviews of select patients participating in the study.
Measured: Up to 8 weeks
Diagnostic accuracy
The researchers will compare AMIE's differential diagnosis to the final diagnosis.
Measured: Up to 4 weeks
Management plan quality
The researchers will compare AMIE's management plan to the final management plan using the Management Reasoning Essential Key Features (MXEKF) rubric.
Measured: Up to 4 weeks
Semi-structured interviews of PCPs
The researchers will complete semi-structured interviews with all of the PCPs participating in the study.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start2 Apr 2025
- Primary completion5 Jan 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Artificial Intelligence (AI)Studies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Google LLC.
- Responsible party
- Principal investigator, Marc Cohen, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911398
- Sponsor's protocol ID
- 2024P000095
- Status last verified
- May 2025
- First submitted
- 9 Mar 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brodeur PG, Koshy JM, Palepu A, Saab K, Homiar A, Ruparel R, Wu C, Tanno R, Xu J, Wang A, Stutz D, Weng WH, Ferrera HM, Barrett D, Crowley L, Lee J, Rittner SE, Wulczyn E, Zhang SK, Vedadi E, Kohn CG, Kulkarni K, Kadiyala V, Mahdavi SS, Du W, Williams JM, Feinbloom D, Wong R, Tu T, Sirkovic P, Orlandi A, Semturs C, Liu Y, Gottweis J, Webster DR, Barral J, Chou K, Kohli P, Hassidim A, Matias Y, Manyika J, Fields R, Li JX, Cohen ML, Natarajan V, Schaekermann M, Karthikesalingam A, Rodman A. Conversational diagnostic artificial intelligence in ambulatory primary care: a prospective feasibility study. Lancet. 2026 Oct 8:S0140-6736(26)01535-7. doi: 10.1016/S0140-6736(26)01535-7. Online ahead of print.
PubMed 42849491
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06911398
- Acronym / sponsor ID
- 2024P000095
- Conditions
- Artificial Intelligence (AI), Clinical Reasoning
- Keywords
- artificial intelligence, chatbot, clinical conversation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Google LLC.
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urgent care patients | – | Other: Articulate Medical Intelligence Explorer (AMIE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is all patients meeting the inclusion and exclusion criteria undergoing an episodic care visit at Healthcare Associates (HCA), the primary care clinic of BIDMC.
Key inclusion criteria (3 listed)
- Age > 18
- English included as a primary language in the electronic health record
- Patient is seeking episodic (urgent) care at HCA
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Articulate Medical Intelligence Explorer (AMIE)AMIE is an AI system for having clinical conversations with patients | Other | Urgent care patients |
Primary outcome
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.
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.
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.
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.
Patient satisfaction pre-AMIE encounter
Time frame: Day 1
Patients will receive a pre-AMIE encounter questionnaire.
Patient satisfaction post-AMIE encounter
Time frame: Day 1
Patients will receive a post-AMIE encounter questionnaire.
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.
Patient satisfaction post-PCP encounter
Time frame: Day 3
Patients will receive a post-PCP encounter questionnaire.
4 secondary outcomes
Semi-structured interviews of patients
Time frame: Up to 8 weeks
Diagnostic accuracy
Time frame: Up to 4 weeks
Management plan quality
Time frame: Up to 4 weeks
Semi-structured interviews of PCPs
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 42849491Brodeur PG, Koshy JM, Palepu A, Saab K, Homiar A, Ruparel R, Wu C, Tanno R, Xu J, Wang A, Stutz D, Weng WH, Ferrera HM, Barrett D, Crowley L, Lee J, Rittner SE, Wulczyn E, Zhang SK, Vedadi E, Kohn CG, Kulkarni K, Kadiyala V, Mahdavi SS, Du W, Williams JM, Feinbloom D, Wong R, Tu T, Sirkovic P, Orlandi A, Semturs C, Liu Y, Gottweis J, Webster DR, Barral J, Chou K, Kohli P, Hassidim A, Matias Y, Manyika J, Fields R, Li JX, Cohen ML, Natarajan V, Schaekermann M, Karthikesalingam A, Rodman A. Conversational diagnostic artificial intelligence in ambulatory primary care: a prospective feasibility study. Lancet. 2026 Oct 8:S0140-6736(26)01535-7. doi: 10.1016/S0140-6736(26)01535-7. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Artificial Intelligence (AI) and Clinical Reasoning, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chat terminations (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06911398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.