AMIE's Clinical Conversational Abilities in an Urgent Care Setting

NCT06911398 | Completed

• 1 other identifier: 2024P000095
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Artificial Intelligence (AI); Clinical Reasoning

Keywords

artificial intelligence; chatbot; clinical conversation

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  Day 3

• Patient satisfaction pre-AMIE encounter

  Patients will receive a pre-AMIE encounter questionnaire.

  Day 1

• Patient satisfaction post-AMIE encounter

  Patients will receive a post-AMIE encounter questionnaire.

  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.

  Day 3

• Patient satisfaction post-PCP encounter

  Patients will receive a post-PCP encounter questionnaire.

  Day 3

Secondary Outcomes (4)

• Semi-structured interviews of patients

  Up to 8 weeks

• Diagnostic accuracy

  Up to 4 weeks

• Management plan quality

  Up to 4 weeks

• Semi-structured interviews of PCPs

  Up to 8 weeks

Study Arms (1)

Urgent care patients

Other: Articulate Medical Intelligence Explorer (AMIE)

Interventions

Articulate Medical Intelligence Explorer (AMIE) OTHER

AMIE is an AI system for having clinical conversations with patients

Urgent care patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Google LLC.: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: April 4, 2025
• Study Start: April 2, 2025
• Primary Completion: January 5, 2026
• Study Completion: April 6, 2026
• Last Updated: April 20, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)