Phase 1 Trial of the Implementation of an Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Diagnostic performance
Study Overview
Brief Summary
This study examines the use of an AI-powered virtual assistant for quickly identifying and handling neurological emergencies, particularly in places with limited medical resources. The research aimed to check if this AI tool is safe and accurate enough to move on to more advanced testing stages. In a first-of-its-kind trial, the virtual assistant was tested with patients having urgent neurological issues. Neurologists first reviewed the AI's recommendations using clinical records and then assessed its performance directly with patients. The findings were as follows: neurologists agreed with the AI's decisions nearly all the time, and the AI outperformed earlier versions of Chat GPT in every tested aspect. Patients and doctors found the AI to be highly effective, rating it as excellent or very good in most cases. This suggests the AI could significantly enhance how quickly and accurately neurological emergencies are dealt with, although further trials are needed before it can be widely used.
Detailed Description
Background and Objectives: Neurological emergencies pose significant challenges in medical care, especially in resource-limited countries. Artificial Intelligence (AI), particularly health chatbots, offers a promising solution. However, rigorous validation is required to ensure safety and accuracy. The objective of our work is to evaluate the diagnostic accuracy and resolution effectiveness of an AI-powered virtual assistant designed for the triage of emergency neurological pathologies, to ensure the minimum standard of safety that allows for the progression to successive validation tests.
Methods: This Phase 1 trial evaluates the performance of an AI-powered virtual assistant for emergency neurological triage. Ten patients over 18 years old with urgent neurological pathologies were selected. In the first stage, nine neurologists assessed the safety of the virtual assistant using their clinical records. In the second part, the assistant's accuracy when used by patients was evaluated. Finally, its performance was compared with Chat GPT 3.5 and 4.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients over 18 years old consulting in the ER due to a neurological emergency
Exclusion Criteria
- •Pregnancy
Outcomes
Primary Outcomes
Diagnostic performance
Time Frame: The first interaction between participants and the virtual assistant occurred within less than a year after the event. Outcome measures were evaluated immediately after the interaction between patients and the virtual assistant.
Refers to the accuracy and effectiveness of medical tests or diagnostic tools in correctly identifying a disease or condition in patients. Syndromic diagnosis agreement: evaluating neurologists considered a syndromic diagnosis accurate when AI tools could identify a condition based on a set of commonly coexisting signs and symptoms, rather than identifying a specific disease. This method is applied when the precise disease causing the symptoms is not immediately identifiable, allowing healthcare providers to effectively monitor and treat the patient's presenting symptoms. Differential diagnosis agreement: a differential diagnosis was considered accurate when the differentials provided by each AI tool matched those presented by the participants. The gold standard for diagnosis was considered to be the one given in the emergency department, unchanged over a one-month period.
Secondary Outcomes
- Appropriate medical conduct or recommendation(The first interaction between participants and the virtual assistant occurred within less than a year after the event. Outcome measures were evaluated immediately after the interaction between patients and the virtual assistant.)
- Assessment of Usability and Satisfaction(The first interaction between participants and the virtual assistant occurred within less than a year after the event. Outcome measures were evaluated immediately after the interaction between patients and the virtual assistant.)
Investigators
Mauricio F. Farez
PI
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia