Preoperative CareNCT06652854
Integrating ChatGPT in Anesthesia
An observational study of Preoperative Care and Patient Education, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preoperative Care, Patient Education, Anesthesia
- How many people
- 190 participants
- Where
- 1 siteCanada
- Study dates
- 9 Dec 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults having an in-person preoperative anesthesiology consultation before elective surgery at The Ottawa Hospital
Who may be able to join
- 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.
- Anesthesiology residents or staff providing service at the PAU at TOH
Who cannot join
- 1. Unable to communicate in English or French 2. Nurse consultation only
- Physicians
- Anesthesiology residents or staff unwilling to participate in the research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Ottawa Hospital Research Institute
Ottawa, Ontario, ON K1Y 4E9
Arnaud Romeo Mbadjeu Hondjeu, MD, 613-737-8187, ambadjeu@toh.ca
Daniel McIsaac, MD, 613-737-8187, dmcisaac@toh.ca
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
knowledge
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)
Measured: 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 outcomes (1)
Patient satisfaction
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start9 Dec 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative CareStudies of the same condition, open and under way.
- 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
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652854
- Sponsor's protocol ID
- 20240526-01H
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Large Language Models in Anesthesia to Answer Patients' Questions During Pre-Anesthesia Visits: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06652854
- Acronym / sponsor ID
- 20240526-01H
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 9 Dec 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults having an in-person preoperative anesthesiology consultation before elective surgery at The Ottawa Hospital
Key inclusion criteria (3 listed)
- 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.
- Anesthesiology residents or staff providing service at the PAU at TOH
Key exclusion criteria (3 listed)
- 1. Unable to communicate in English or French 2. Nurse consultation only
- Physicians
- Anesthesiology residents or staff unwilling to participate in the research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No. 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.
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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.
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 Preoperative Care and Patient Education, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 3 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: opening soon, as of the sponsor's last update on 22 Oct 2024. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Romeo, Mbadjeu Hondjeu, MD (613-737-8187, ambadjeu@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2024.