NCT06009783

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

June 19, 2023

Last Update Submit

August 20, 2023

Conditions

Keywords

vasectomyChatGPT

Outcome Measures

Primary Outcomes (3)

  • Length of Consultation

    Length of pre-vasectomy consultation as measured from beginning to end of telephone call

    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

    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)

    Through study completion, estimated to be 2 months measured for each patient

Secondary Outcomes (2)

  • Commonly asked questions

    Through study completion period, estimated to be 2 months

  • Incidence of inaccurate ChatGPT responses

    Through study completion period, estimated to be 2 months

Study Arms (2)

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.

Other: ChatGPT Language Model

Control arm - no ChatGPT

NO INTERVENTION

No intervention - standard of care

Interventions

ChatGPT Language Model - ability to converse with the model and ask questions regarding vasectomies

Intervention arm - ChatGPT

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Do not consent, uninterested in participating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Men's Health Clinic Manitoba

Winnipeg, Manitoba, R3K 1M3, Canada

RECRUITING

Study Officials

  • Premal Patel, MD

    Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Premal Patel, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Study Record Dates

First Submitted

June 19, 2023

First Posted

August 24, 2023

Study Start

August 30, 2023

Primary Completion

September 30, 2023

Study Completion

October 5, 2023

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations