xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06009783</url>
    </required_header>
    <id_info>
      <org_study_id>HS25978 (H2023:136)</org_study_id>
      <nct_id>NCT06009783</nct_id>
    </id_info>
    <brief_title>Utility of ChatGPT in Pre-vasectomy Counselling in an Office-based Setting</brief_title>
    <official_title>Real World Utility of ChatGPT in Pre-vasectomy Counselling in an Office-based Setting</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Manitoba</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Manitoba</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators wish to perform a pilot study at the Manitoba Men's Health Clinic to assess&#xD;
        if pre-vasectomy counseling with ChatGPT can safely streamline the consultation process by&#xD;
        reducing visit times, while increasing patient satisfaction with the consultation process.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The release of ChatGPT, a natural language AI chat bot, has recently captured the attention&#xD;
        of the general public and medical professionals world-wide. ChatGPT is a conversational AI&#xD;
        language model designed by OpenAI that utilizes deep learning techniques to generate human&#xD;
        like responses to questions. There has been increasing interest among the medical community&#xD;
        on developing new ways to harness this technology to aid medical professionals. New&#xD;
        applications have included writing scientific manuscripts, drafting correspondents, as well&#xD;
        as testing its ability on standardized medical licensing examinations. ChatGPT was able to&#xD;
        perform at or near passing threshold on the United States Medical Licensing Exam (USMLE).&#xD;
        Despite ChatGPT demonstrating good medical knowledge, it is still unclear if this translates&#xD;
        to real world clinical practice.&#xD;
  &#xD;
        Physician burnout is becoming an increasing problem. Per a recent Canadian Urologic&#xD;
        Association (CUA) census, burnout was identified in 39% of urologists, with high number of&#xD;
        patient visits/week to be cited as a predictor predictive of burnout. That begs the question,&#xD;
        can ChatGPT be used for patient counseling and to improve patient flow in one's practice?&#xD;
        ChatGPT has been shown to provide effective and safe responses to medical questions and even&#xD;
        &quot;curbside&quot; consultations. However its ability to counsel patients in real time has not yet&#xD;
        been studied.&#xD;
  &#xD;
        As such, the investigators wish to perform a pilot study at the Manitoba Men's Health Clinic&#xD;
        to assess if pre-vasectomy counseling with ChatGPT can safely streamline the consultation&#xD;
        process by reducing visit times, while increasing patient satisfaction with the consultation&#xD;
        process. If the hypothesis provides true, further implementation of ChatGPT in a healthcare&#xD;
        practice may work to reduce the burden on health care providers.&#xD;
  &#xD;
        There are no predicted adverse events of this study. There are no identified potential harms&#xD;
        of this study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">October 5, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Length of Consultation</measure>
      <time_frame>Through study completion, estimated to be 2 months measured for each phone call</time_frame>
      <description>Length of pre-vasectomy consultation as measured from beginning to end of telephone call</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of questions asked</measure>
      <time_frame>Through study completion, estimated to be 2 months measured for each phone call</time_frame>
      <description>Number of questions asked during pre-vasectomy consultation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Satisfaction of patients assessed by Likert scale</measure>
      <time_frame>Through study completion, estimated to be 2 months measured for each patient</time_frame>
      <description>Satisfaction of patients as measured by questionnaire with 10-point Likert Scale ([0-10] higher score correlates with higher satisfaction)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Commonly asked questions</measure>
      <time_frame>Through study completion period, estimated to be 2 months</time_frame>
      <description>Chat logs will be reviewed to examine common themes or questions and reported using descriptive statistics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of inaccurate ChatGPT responses</measure>
      <time_frame>Through study completion period, estimated to be 2 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Vasectomy</condition>
    <condition>Contraception</condition>
    <arm_group>
      <arm_group_label>Intervention arm - ChatGPT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm - no ChatGPT</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention - standard of care</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>ChatGPT Language Model</intervention_name>
      <description>ChatGPT Language Model - ability to converse with the model and ask questions regarding vasectomies</description>
      <arm_group_label>Intervention arm - ChatGPT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing vasectomies interested in participating&#xD;
  &#xD;
            -  Adult (&gt;18 years old)&#xD;
  &#xD;
            -  Consenting&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Do not consent, uninterested in participating&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Premal Patel, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Premal Patel, MD</last_name>
      <phone>204-221-4476</phone>
      <email>ppatel5@hsc.mb.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Men's Health Clinic Manitoba</name>
        <address>
          <city>Winnipeg</city>
          <state>Manitoba</state>
          <zip>R3K 1M3</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Premal Patel, MD</last_name>
        <phone>204-221-4476</phone>
        <email>ppatel5@hsc.mb.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Manitoba</investigator_affiliation>
      <investigator_full_name>PremalPatel</investigator_full_name>
      <investigator_title>Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education</investigator_title>
    </responsible_party>
    <keyword>vasectomy</keyword>
    <keyword>ChatGPT</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06009783
  org study id: HS25978 (H2023:136)
  nct id: NCT06009783
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Single (Outcomes Assessor)
  measure: Length of Consultation
  time frame: Through study completion, estimated to be 2 months measured for each phone call
  description: Length of pre-vasectomy consultation as measured from beginning to end of telephone call
  measure: Number of questions asked
  time frame: Through study completion, estimated to be 2 months measured for each phone call
  description: Number of questions asked during pre-vasectomy consultation
  measure: Satisfaction of patients assessed by Likert scale
  time frame: Through study completion, estimated to be 2 months measured for each patient
  description: Satisfaction of patients as measured by questionnaire with 10-point Likert Scale ([0-10] higher score correlates with higher satisfaction)
  measure: Commonly asked questions
  time frame: Through study completion period, estimated to be 2 months
  description: Chat logs will be reviewed to examine common themes or questions and reported using descriptive statistics.
  measure: Incidence of inaccurate ChatGPT responses
  time frame: Through study completion period, estimated to be 2 months
  description: 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.
  arm group label: Intervention arm - ChatGPT
  arm group type: Experimental
  description: 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.
  arm group label: Control arm - no ChatGPT
  arm group type: No Intervention
  description: No intervention - standard of care
  intervention type: Other
  intervention name: ChatGPT Language Model
  description: ChatGPT Language Model - ability to converse with the model and ask questions regarding vasectomies
  arm group label: Intervention arm - ChatGPT
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Premal Patel, MD
  role: Principal Investigator
  affiliation: Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education
  last name: Premal Patel, MD
  phone: 204-221-4476
  email: ppatel5@hsc.mb.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of Manitoba
  investigator full name: PremalPatel
  investigator title: Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education
  sharing ipd: No