Improving Surgical Communication for Patients in Wisconsin

NCT ID: NCT06647303

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2028-11-30

Brief Summary

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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

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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

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Surgeons Surgical Procedure, Unspecified

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Surgical candidate

Participants who are undergoing surgical consultation

Group Type EXPERIMENTAL

Surveys

Intervention Type OTHER

Participants will complete surveys regarding the surgeon's communication skills

Stakeholder Focus Group

Participants have previous experience with surgery

Group Type EXPERIMENTAL

Focus Group

Intervention Type OTHER

Participants will attend a focus group to discuss the survey instruments used in this study which will help with future study design

Surgeons

Surgeons from the University of Wisconsin-Madison Department of Surgery with an outpatient surgical clinic who treat adult patients at UW Health

Group Type EXPERIMENTAL

Training on communication framework

Intervention Type BEHAVIORAL

Surgeons will receive training on the Better Conversations framework

Interventions

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Training on communication framework

Surgeons will receive training on the Better Conversations framework

Intervention Type BEHAVIORAL

Focus Group

Participants will attend a focus group to discuss the survey instruments used in this study which will help with future study design

Intervention Type OTHER

Surveys

Participants will complete surveys regarding the surgeon's communication skills

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret (Gretchen) Schwarze, MD, MPP

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kyle J Bushaw, MA

Role: CONTACT

608-265-2904

Margaret (Gretchen) L Schwarze, MD, MPP

Role: CONTACT

608-265-4420

Facility Contacts

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Kyle J Bushaw, MA

Role: primary

608-265-2904

Related Links

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Other Identifiers

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A539750

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 4/17/2025

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1354

Identifier Type: -

Identifier Source: org_study_id

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