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临床试验/NCT06981208
NCT06981208招募中不适用

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

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2025年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
410
试验地点
1
主要终点
Patient perceived understanding of breast reconstruction

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Care Provider)

盲法说明

The surgeons will be blinded to the patient's randomization arm prior to the in-person consultation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • 未提供

研究组 & 干预措施

Usual education

Active Comparator

- Patients will not receive any additional information prior to their consultation.

干预措施: Usual patient education (Other)

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.

干预措施: ChatGPT-generated patient education (Other)

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.

结局指标

主要结局

Patient perceived understanding of breast reconstruction

时间窗: Pre-surgical consultation (day 1)

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.

次要结局

  • Surgeon satisfaction with the consultation process(Pre-surgical consultation (day 1))
  • Patient satisfaction with education regarding breast reconstruction(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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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