Integrating ChatGPT in Anesthesia

October 18, 2024 updated by: Ottawa Hospital Research Institute

Implementation of Large Language Models in Anesthesia to Answer Patients' Questions During Pre-Anesthesia Visits: A Prospective, Observational Study

Patients are waiting for surgery longer than ever before. While hospitals are trying to get patients access to surgery as quickly as possible, a shortage of anesthesia doctors (called anesthesiologists) prevents this. Every surgery needs an anesthesiologist, but anesthesiologists also assess patients beforehand to ensure they can safely undergo surgery and help patients understand what to expect and the risks involved. Ensuring that patients move through surgery as safely and efficiently as possible requires that the limited number of anesthesiologists in Canada work as efficiently as possible. Technology like Artificial Intelligence (AI), in programs such as ChatGPT, might assist by answering common questions patients have, allowing anesthesiologists to focus their limited time on addressing complex and personalized issues for each patient. However, studies conducted so far on how well AI can answer questions about anesthesia and surgery have been poorly designed and have not included patients as members of the research team. This study will determine whether AI can answer patients' questions before surgery as effectively as both patients and expert anesthesiologists would expect, which could be beneficial to patients and the healthcare system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Arnaud Romeo, Mbadjeu Hondjeu, MD
  • Phone Number: 613-737-8187
  • Email: ambadjeu@toh.ca

Study Contact Backup

  • Name: Daniel McIsaac, MD
  • Phone Number: 613-737-8187
  • Email: dmcisaac@toh.ca

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, ON K1Y 4E9
        • Ottawa Hospital Research Institute
        • Contact:
        • Contact:
          • Arnaud Romeo Mbadjeu Hondjeu, MD
          • Phone Number: 613-737-8187
          • Email: ambadjeu@toh.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adults having an in-person preoperative anesthesiology consultation before elective surgery at The Ottawa Hospital

Description

Inclusion Criteria:

Patients

  • 1. Age > 18 years 2. Elective non-cardiac surgery 3. In-person preoperative anesthesiology consultation 4. Ability to participate and provide informed consent independently.

Exclusion Criteria:

  • 1. Unable to communicate in English or French 2. Nurse consultation only

Physicians

Inclusion Criteria:

Anesthesiology residents or staff providing service at the PAU at TOH

Exclusion Criteria:

Anesthesiology residents or staff unwilling to participate in the research study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patient scheduled for a pre-surgery consultation with a physician anesthesiologist
After obtaining consent, patients will be asked to respond to the following query: "What is the most important question you had hoped to ask your anesthesiologist today about your anesthesia care, pain management or the time immediately around surgery?'.
Specialty-trained anesthesiologists in independent practice within the pre-admission
anesthesiologists will be designated as either "response generators" or "response raters." Response generators will craft answers to patient queries, while response raters-anesthesiologists with over five years of clinical experience-will evaluate the quality of these responses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
knowledge
Time Frame: From the date of the pre-anesthesia consultation until 2 weeks after the consultation, assessed over a period of up to 2 weeks post-consultation
Patients will be blinded to the source of the two responses (GPT-4 and Anesthesiologist). After reading both responses, they will complete a questionnaire that includes an 11-point Likert-scale question for the primary outcome of knowledge: "To what extent does the response address the knowledge or information you hoped to gain?" (0 = not at all addressed; 10 = fully addressed)
From the date of the pre-anesthesia consultation until 2 weeks after the consultation, assessed over a period of up to 2 weeks post-consultation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: From the date of the pre-anesthesia consultation until 2 weeks after the consultation, assessed over a period of up to 2 weeks post-consultation
Secondary Outcome: Patient satisfaction, Patient satisfaction will be assessed using a likelihood to recommend measurement based on a 11-point Likert scale (Question: Thinking about the response you received to your question, how likely are you to recommend the response's provider to a family member or friend going for a similar surgery? 0-not at all likely; 10-extremely likely).
From the date of the pre-anesthesia consultation until 2 weeks after the consultation, assessed over a period of up to 2 weeks post-consultation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tertiary outcomes
Time Frame: From the date of the pre-anesthesia consultation until 2 weeks after the consultation, assessed over a period of up to 2 weeks post-consultation
Three tertiary outcomes will be assessed using an 11-point Likert scale: 1. Health Literacy:Assessed through the prompt: "I have sufficient information to make decisions about my surgery." 2. Perceived Empathy:Evaluated with the question: "To what extent did you find the response empathetic?" 3. Completeness: Measured by the question: "To what extent did you find the response complete?
From the date of the pre-anesthesia consultation until 2 weeks after the consultation, assessed over a period of up to 2 weeks post-consultation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20240526-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data collected from this study will not be shared with other researchers, however the data may be used to inform and guide future research on the integration of AI technologies in clinical practice, particularly in improving patient communication and decision-making during pre-anesthesia consultations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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