Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-03-07 @ 10:44 PM
Study NCT ID:
NCT06647303
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2024-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Surgical Communication for Patients in Wisconsin
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Better Conversations for Better Informed Consent: A Pilot Study to Automate Surgeon Training and Evaluate Patient-Reported Outcomes
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate a new training program to support communication between surgeons and their patients. The goal of the training program is to help patients get the information they need to make treatment decisions that are right for them.
Participants will complete surveys, attend a focus group, or receive training on Better Conversations, depending on the type of participant.
Participants will complete surveys, attend a focus group, or receive training on Better Conversations, depending on the type of participant.
Detailed Description:
Observational research shows that surgeons translate informed consent and shared decision-making standards into an overly complicated technical explanation of the patient's disease and treatment, and an overly simplified narrative that surgery will "fix" the patient's problem. They omit critical information about the goals and downsides of surgery and struggle to actualize the patient's role in medical decisions, while unintentionally concealing professional expertise. "Better Conversations" is a novel communication framework designed to address these problems. With this framework, surgeons provide context about clinical norms, clearly establish the goals of surgery, and comprehensively delineate the downsides of surgery as experienced by the patient to generate a deliberative space for patients to consider whether surgery is right for them. This paradigm-shifting framework meets the legal and ethical standards for informed consent, supports deliberation, and allows patients to anticipate and prepare for the experience of surgery.
The present study supports optimization of surgeon training and study procedures (Phase II) that is needed before large scale testing and dissemination (Phase III). Although this intervention is evidence based, collaborative efforts are needed to ultimately test and disseminate a major clinical shift. The long-term goal is for every surgeon to use Better Conversations with every patient, every time. The present study has two main objectives: 1) To make the education program scalable with automated assessment and feedback to surgeons using audio recordings from their clinical conversations, and 2) to evaluate patient and family reported outcome measures regarding surgeon communication.
The present study supports optimization of surgeon training and study procedures (Phase II) that is needed before large scale testing and dissemination (Phase III). Although this intervention is evidence based, collaborative efforts are needed to ultimately test and disseminate a major clinical shift. The long-term goal is for every surgeon to use Better Conversations with every patient, every time. The present study has two main objectives: 1) To make the education program scalable with automated assessment and feedback to surgeons using audio recordings from their clinical conversations, and 2) to evaluate patient and family reported outcome measures regarding surgeon communication.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: