NCT06647303

Improving Surgical Communication for Patients in Wisconsin

Better Conversations for Better Informed Consent: A Pilot Study to Automate Surgeon Training and Evaluate Patient-Reported Outcomes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 580 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Surgeons
• Surgical Procedure, Unspecified

Interventions

Type	Name	Description
BEHAVIORAL	Training on communication framework	Surgeons will receive training on the Better Conversations framework
OTHER	Focus Group	Participants will attend a focus group to discuss the survey instruments used in this study which will help with future study design
OTHER	Surveys	Participants will complete surveys regarding the surgeon's communication skills

Timeline

• Start date: 2024-11-18
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2024-10-17
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States