Purpose

In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT-generated patient education regarding possible reconstruction options) or the control group (usual patient education). All patients will complete a survey following their in-person consultation to assess their experience and overall satisfaction with the consultation process. Additionally, participating surgeons will complete a separate survey to evaluate their consultation experience, satisfaction, and to assess the accuracy and clinical utility of the ChatGPT-generated patient education materials. The surveys are designed to gather information on patient characteristics, organizational health literacy according to Brega et al. Other survey questions have been designed to meet the outcomes of this study and have not been based on previously published surveys.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Patient Eligibility Criteria:

- Scheduled for initial preoperative breast reconstruction consultation following
therapeutic or prophylactic mastectomy with a surgeon at Washington University
School of Medicine.

- At least 18 years of age.

- Can speak and understand English.

Surgeon Eligibility Criteria:

- Routinely performs breast reconstruction surgery at Washington University School of
Medicine.

- At least 18 years of age.

- Can speak and understand English.

- Surgeon must not be a resident or fellow at time of enrollment.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
Single (Care Provider)
Masking Description
The surgeons will be blinded to the patient's randomization arm prior to the in-person consultation.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ChatGPT-generated patient education
- Pre-consultation ChatGPT patient education: The patients randomized into the ChatGPT education group will receive a ChatGPT patient education on paper prior to their consultation. The ChatGPT will write a patient-tailored education regarding possible reconstruction options. The patient will review this independently, without additional input or guidance from a research team member - Patient post-consultation survey: All patients will receive a survey after the planned in-person consultation with the plastic surgeon.
  • Other: ChatGPT-generated patient education
    This is created by entering the patient's age, medical history, social history, and case-specific details into Washington University ChatGPT Beta (HIPAA and FERPA compliant) by a study team member.
Active Comparator
Usual education
- Patients will not receive any additional information prior to their consultation.
  • Other: Usual patient education
    Usual patient education will include description of breast reconstruction options, with further elaboration on which option are more suitable to the patient. This include also review of risk of complications and expected recovery after surgery.
No Intervention
Surgeons
- In order for the surgeon to be blinded to the study arm, all participants will have ChatGPT education created. Participating surgeons will review each patient education sheet prior to the consult and score the accuracy of the provided education sheet. The surgeon will proceed with the consultation as planned. The surgeon is blinded to the patient's study arm as they will be reviewing ChatGPT education for all patients. If any inaccuracies are identified in the patient education sheet, the surgeon will address this with the study team and have the errors fixed prior to providing to the patient. - The surgeon will receive a survey after each in-person consultation, covering patient experience, surgeon experience, and education material accuracy.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Saif M Badran, M.D., Ph.D., FRCS
314-273-1434
badran@wustl.edu

More Details

NCT ID
NCT06981208
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Saif M Badran, M.D., Ph.D., FRCS
314-273-1434
badran@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.