ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
1 other identifier
interventional
410
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jun 2025
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2025
CompletedFirst Posted
Study publicly available on registry
May 20, 2025
CompletedStudy Start
First participant enrolled
June 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
June 10, 2025
June 1, 2025
1.1 years
May 12, 2025
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient perceived understanding of breast reconstruction
The patient will choose an answer ranging from 0-100 (strongly disagree to strongly agree). The higher the score, the more perceived understanding the patient had.
Pre-surgical consultation (day 1)
Secondary Outcomes (5)
Patient satisfaction with education regarding breast reconstruction
Pre-surgical consultation (day 1)
Surgeon satisfaction with the consultation process
Pre-surgical consultation (day 1)
Surgeon perception of patient preparedness
Pre-surgical consultation (day 1)
Surgeon views on the efficiency of the consultation
Pre-surgical consultation (day 1)
Surgeon overall experience with the consultation
Pre-surgical consultation (day 1)
Study Arms (3)
ChatGPT-generated patient education
EXPERIMENTAL* 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.
Usual education
ACTIVE COMPARATOR\- Patients will not receive any additional information prior to their consultation.
Surgeons
NO INTERVENTION* 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.
Interventions
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 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.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saif M Badran, M.D., Ph.D., FRCS
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- The surgeons will be blinded to the patient's randomization arm prior to the in-person consultation.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2025
First Posted
May 20, 2025
Study Start
June 3, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
June 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share