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Clinical Trials/NCT06647303
NCT06647303
Recruiting
N/A

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

University of Wisconsin, Madison1 site in 1 country580 target enrollmentNovember 18, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Surgeons
Sponsor
University of Wisconsin, Madison
Enrollment
580
Locations
1
Primary Endpoint
Effect of automated training program
Status
Recruiting
Last Updated
6 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 18, 2024
End Date
November 1, 2028
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Surgeons from University of Wisconsin - Madison Department of Surgery who have an outpatient surgical clinic and treat adult patients at UW Health
  • Surgical candidates:
  • Age 18 or older
  • Present to an enrolled surgeon's clinic with a surgical problem
  • Decision making ability
  • Speak English
  • Stakeholders:
  • Must have previous experience with surgery (within 10 years)
  • Speak English

Exclusion Criteria

  • Solely treat minors (under age 18)
  • Surgical candidates:
  • Lacking decision making capacity
  • Unable to speak English
  • Stakeholders:
  • Unable to speak English

Outcomes

Primary Outcomes

Effect of automated training program

Time Frame: Up to 4 years

Specialists will train 10 surgeons, audio recording 150 surgical consultations with surgical candidates. 100 audio recordings will be used as a training set to develop an automated assessment and feedback program. 50 recordings will be used to measure fidelity to the intervention with a summative assessment. 10 additional surgeons will be trained using the automated training and researchers will audio record 150 more surgical consultations with surgical candidates. Automated feedback will be provided for 100 of the consultations and researchers will measure fidelity to the automated intervention with a summative assessment of 50 consultations. The effect of the automated training program will be tested by comparing summative assessments of surgeon performance between the two differently-trained groups. Summative assessments to identify strengths and weaknesses of the automated training program will be used to revise the training iteratively for future study.

Compare effectiveness of specialist-delivered training versus automated training on participant-reported measures of surgeon communication

Time Frame: Up to 4 years

Researchers will compare surgical candidate participant survey results between surgeons who received specialist-delivered training versus those who received automated training.

Study Sites (1)

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