Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647303
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Improving Surgical Communication for Patients in Wisconsin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Better Conversations for Better Informed Consent a Pilot Study to Automate Surgeon Training and Evaluate Patient-Reported Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 patients disease and treatment and an overly simplified narrative that surgery will fix the patients problem They omit critical information about the goals and downsides of surgery and struggle to actualize the patients 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None