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Recruiting NCT06647303

Improving Surgical Communication for Patients in Wisconsin

No phase Interventional Surgeons Surgical Procedure, Unspecified

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Training on communication framework, Focus Group, Surveys.
Who it may be relevant to
Registry conditions: Surgeons, Surgical Procedure, Unspecified. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Effect of automated training program [Time frame: Up to 4 years]
  • Compare effectiveness of specialist-delivered training versus automated training on participant-reported measures of surgeon communication [Time frame: Up to 4 years]

Eligibility criteria

Inclusion criteria

Surgeons:

  • 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

Surgeons:

  • Solely treat minors (under age 18)

Surgical candidates:

  • Lacking decision making capacity
  • Unable to speak English

Stakeholders:

  • Unable to speak English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Wisconsin — Madison

Identifiers

NCT: NCT06647303 · 2024-1354 · A539750 · Protocol Version 4/17/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗