ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06981208
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ChatGPT-generated patient education — OTHER
    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.
  • Usual patient education — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 3, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.
  • Active Comparator: Usual education
    \- Patients will not receive any additional information prior to their consultation.
  • 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.

Primary Outcome Measure

Patient perceived understanding of breast reconstruction [ Time Frame: Pre-surgical consultation (day 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Saif M Badran, M.D., Ph.D., FRCS
314-273-1434
Saif M Badran, M.D., Ph.D., FRCS (PRINCIPAL_INVESTIGATOR)
Justin M Sacks, M.D., MBA, FACS (SUB_INVESTIGATOR)

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