VasectomyNCT06009783
Utility of ChatGPT in Pre-vasectomy Counselling in an Office-based Setting
A study testing ChatGPT Language Model in people with Vasectomy and Contraception, run by University of Manitoba at 1 site in Canada.
Trial summary
The investigators wish to perform a pilot study at the Manitoba Men's Health Clinic to assess if pre-vasectomy counseling with ChatGPT can safely streamline the consultation process by reducing visit times, while increasing patient satisfaction with the consultation process. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vasectomy, Contraception
- What is being tested?
- ChatGPT Language Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 30 Aug 2023to 5 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing vasectomies interested in participating
- Adult (>18 years old)
- Consenting
Who cannot join
- Do not consent, uninterested in participating
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Men's Health Clinic Manitoba
Winnipeg, Manitoba, R3K 1M3
Premal Patel, MD, 204-221-4476, ppatel5@hsc.mb.ca
About this study
Official title: Real World Utility of ChatGPT in Pre-vasectomy Counselling in an Office-based Setting
The investigators wish to perform a pilot study at the Manitoba Men's Health Clinic to assess if pre-vasectomy counseling with ChatGPT can safely streamline the consultation process by reducing visit times, while increasing patient satisfaction with the consultation process.
Read the detailed description
The release of ChatGPT, a natural language AI chat bot, has recently captured the attention of the general public and medical professionals world-wide. ChatGPT is a conversational AI language model designed by OpenAI that utilizes deep learning techniques to generate human like responses to questions. There has been increasing interest among the medical community on developing new ways to harness this technology to aid medical professionals. New applications have included writing scientific manuscripts, drafting correspondents, as well as testing its ability on standardized medical licensing examinations. ChatGPT was able to perform at or near passing threshold on the United States Medical Licensing Exam (USMLE). Despite ChatGPT demonstrating good medical knowledge, it is still unclear if this translates to real world clinical practice.
Physician burnout is becoming an increasing problem. Per a recent Canadian Urologic Association (CUA) census, burnout was identified in 39% of urologists, with high number of patient visits/week to be cited as a predictor predictive of burnout. That begs the question, can ChatGPT be used for patient counseling and to improve patient flow in one's practice? ChatGPT has been shown to provide effective and safe responses to medical questions and even "curbside" consultations. However its ability to counsel patients in real time has not yet been studied.
As such, the investigators wish to perform a pilot study at the Manitoba Men's Health Clinic to assess if pre-vasectomy counseling with ChatGPT can safely streamline the consultation process by reducing visit times, while increasing patient satisfaction with the consultation process. If the hypothesis provides true, further implementation of ChatGPT in a healthcare practice may work to reduce the burden on health care providers.
There are no predicted adverse events of this study. There are no identified potential harms of this study.
- Conditions
- Vasectomy, Contraception
- Being tested
- ChatGPT Language Model
- Keywords
- vasectomy, ChatGPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatGPT Language ModelOther
ChatGPT Language Model - ability to converse with the model and ask questions regarding vasectomies
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm - ChatGPT | Experimental | Patient's interested in participating in the intervention group will be provided a secure ChatGPT account. They will have the opportunity to converse with ChatGPT to ask any potential questions they may have regarding their upcoming vasectomy. Patient's will then be seen for the standard pre-vasectomy consultation. Receives: Other: ChatGPT Language Model |
| Control arm - no ChatGPT | No intervention | No intervention - standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Consultation
Length of pre-vasectomy consultation as measured from beginning to end of telephone call
Measured: Through study completion, estimated to be 2 months measured for each phone call
Number of questions asked
Number of questions asked during pre-vasectomy consultation
Measured: Through study completion, estimated to be 2 months measured for each phone call
Satisfaction of patients assessed by Likert scale
Satisfaction of patients as measured by questionnaire with 10-point Likert Scale ([0-10] higher score correlates with higher satisfaction)
Measured: Through study completion, estimated to be 2 months measured for each patient
Secondary outcomes (2)
Commonly asked questions
Chat logs will be reviewed to examine common themes or questions and reported using descriptive statistics.
Measured: Through study completion period, estimated to be 2 months
Incidence of inaccurate ChatGPT responses
ChatGPT responses will be reviewed by two licensed clinicians experienced in vasectomies to determine rates of inaccurate responses by the language models responses to patient questions. Incidence of inaccurate ChatGPT responses will be reported and through descriptive analysis this will be described and inaccurate responses will be conveyed.
Measured: Through study completion period, estimated to be 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion5 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasectomyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PremalPatel, University of Manitoba
- Investigators
- Premal Patel, MD, Principal investigator, Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009783
- Sponsor's protocol ID
- HS25978 (H2023:136)
- Status last verified
- Aug 2023
- First submitted
- 19 Jun 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Utility of ChatGPT in Pre-vasectomy Counselling in an Office-based Setting
- ClinicalTrials.gov ID
- NCT06009783
- Acronym / sponsor ID
- HS25978 (H2023:136)
- Conditions
- Vasectomy, Contraception
- Keywords
- vasectomy, ChatGPT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 5 Oct 2023 (estimated)
- First posted
- 24 Aug 2023 (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.
The investigators wish to perform a pilot study at the Manitoba Men's Health Clinic to assess if pre-vasectomy counseling with ChatGPT can safely streamline the consultation process by reducing visit times, while increasing patient satisfaction with the consultation process.
Detailed description
The release of ChatGPT, a natural language AI chat bot, has recently captured the attention of the general public and medical professionals world-wide. ChatGPT is a conversational AI language model designed by OpenAI that utilizes deep learning techniques to generate human like responses to questions. There has been increasing interest among the medical community on developing new ways to harness this technology to aid medical professionals. New applications have included writing scientific manuscripts, drafting correspondents, as well as testing its ability on standardized medical licensing examinations. ChatGPT was able to perform at or near passing threshold on the United States Medical Licensing Exam (USMLE). Despite ChatGPT demonstrating good medical knowledge, it is still unclear if this translates to real world clinical practice.
Physician burnout is becoming an increasing problem. Per a recent Canadian Urologic Association (CUA) census, burnout was identified in 39% of urologists, with high number of patient visits/week to be cited as a predictor predictive of burnout. That begs the question, can ChatGPT be used for patient counseling and to improve patient flow in one's practice? ChatGPT has been shown to provide effective and safe responses to medical questions and even "curbside" consultations. However its ability to counsel patients in real time has not yet been studied.
As such, the investigators wish to perform a pilot study at the Manitoba Men's Health Clinic to assess if pre-vasectomy counseling with ChatGPT can safely streamline the consultation process by reducing visit times, while increasing patient satisfaction with the consultation process. If the hypothesis provides true, further implementation of ChatGPT in a healthcare practice may work to reduce the burden on health care providers.
There are no predicted adverse events of this study. There are no identified potential harms of this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm - ChatGPT | Experimental | Other: ChatGPT Language ModelPatient's interested in participating in the intervention group will be provided a secure ChatGPT account. They will have the opportunity to converse with ChatGPT to ask any potential questions they may have regarding their upcoming vasectomy. Patient's will then be seen for the standard pre-vasectomy consultation. |
| Control arm - no ChatGPT | No intervention | –No intervention - standard of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing vasectomies interested in participating
- Adult (>18 years old)
- Consenting
Key exclusion criteria (1 listed)
- Do not consent, uninterested in participating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatGPT Language ModelChatGPT Language Model - ability to converse with the model and ask questions regarding vasectomies | Other | Intervention arm - ChatGPT |
Primary outcome
Length of Consultation
Time frame: Through study completion, estimated to be 2 months measured for each phone call
Length of pre-vasectomy consultation as measured from beginning to end of telephone call
Number of questions asked
Time frame: Through study completion, estimated to be 2 months measured for each phone call
Number of questions asked during pre-vasectomy consultation
Satisfaction of patients assessed by Likert scale
Time frame: Through study completion, estimated to be 2 months measured for each patient
Satisfaction of patients as measured by questionnaire with 10-point Likert Scale ([0-10] higher score correlates with higher satisfaction)
2 secondary outcomes
Commonly asked questions
Time frame: Through study completion period, estimated to be 2 months
Incidence of inaccurate ChatGPT responses
Time frame: Through study completion period, estimated to be 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Premal Patel, MD principal investigator
Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChatGPT Language Model in people with Vasectomy and Contraception, run by University of Manitoba 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 1 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: status not confirmed, as of the sponsor's last update on 24 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Premal Patel, MD (204-221-4476, ppatel5@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Consultation (time frame: Through study completion, estimated to be 2 months measured for each phone call). The study lists 3 primary outcomes in all. 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 24 Aug 2023.