- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06652854
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
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
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
- 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
-
-
Ontario
-
Ottawa, Ontario, Canada, ON K1Y 4E9
- Ottawa Hospital Research Institute
-
Contact:
- Daniel McIsaac, MD
- Phone Number: 613-737-8187
- Email: dmcisaac@toh.ca
-
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
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 |
|---|
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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
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
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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)
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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
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
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Other Outcome Measures
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?
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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.
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)
December 9, 2024
Primary Completion (Estimated)
May 30, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
October 17, 2024
First Submitted That Met QC Criteria
October 18, 2024
First Posted (Actual)
October 22, 2024
Study Record Updates
Last Update Posted (Actual)
October 22, 2024
Last Update Submitted That Met QC Criteria
October 18, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID 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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