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Utility of ChatGPT in Pre-vasectomy Counselling in an Office-based Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06009783
Recruitment Status : Recruiting
First Posted : August 24, 2023
Last Update Posted : August 24, 2023
Sponsor:
Information provided by (Responsible Party):
PremalPatel, University of Manitoba

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Vasectomy Contraception Other: ChatGPT Language Model Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Real World Utility of ChatGPT in Pre-vasectomy Counselling in an Office-based Setting
Estimated Study Start Date : August 30, 2023
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : October 5, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasectomy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention arm - ChatGPT
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.
 Other: ChatGPT Language Model
ChatGPT Language Model - ability to converse with the model and ask questions regarding vasectomies
No Intervention: Control arm - no ChatGPT
No intervention - standard of care


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)


Secondary Outcome Measures :
  1. Commonly asked questions [ Time Frame: Through study completion period, estimated to be 2 months ]
    Chat logs will be reviewed to examine common themes or questions and reported using descriptive statistics.

  2. Incidence of inaccurate ChatGPT responses [ Time Frame: Through study completion period, estimated to be 2 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing vasectomies interested in participating
  • Adult (>18 years old)
  • Consenting

Exclusion Criteria:

  • Do not consent, uninterested in participating
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06009783


Contacts
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Contact: Premal Patel, MD 204-221-4476 ppatel5@hsc.mb.ca

Locations
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Canada, Manitoba
Men's Health Clinic Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3K 1M3
Contact: Premal Patel, MD    204-221-4476    ppatel5@hsc.mb.ca   
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Premal Patel, MD Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education
More Information
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Responsible Party: PremalPatel, Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education, University of Manitoba
ClinicalTrials.gov Identifier: NCT06009783    
Other Study ID Numbers: HS25978 (H2023:136)
First Posted: August 24, 2023    Key Record Dates
Last Update Posted: August 24, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PremalPatel, University of Manitoba:
vasectomy
ChatGPT