NCT06647303

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
580

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Nov 2024Nov 2028

First Submitted

Initial submission to the registry

October 16, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

October 22, 2025

Status Verified

October 1, 2025

Enrollment Period

4 years

First QC Date

October 16, 2024

Last Update Submit

October 20, 2025

Conditions

Keywords

decision makingcommunication

Outcome Measures

Primary Outcomes (2)

  • Effect of automated training program

    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.

    Up to 4 years

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

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

    Up to 4 years

Other Outcomes (1)

  • To identify survey measures that have a strong baseline variance, the number of participants who evaluate communication skills of the surgeon in the top 10 percentile of scoring

    Up to 4 years

Study Arms (3)

Surgical candidate

EXPERIMENTAL

Participants who are undergoing surgical consultation

Other: Surveys

Stakeholder Focus Group

EXPERIMENTAL

Participants have previous experience with surgery

Other: Focus Group

Surgeons

EXPERIMENTAL

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

Behavioral: Training on communication framework

Interventions

Surgeons will receive training on the Better Conversations framework

Surgeons

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

Stakeholder Focus Group
SurveysOTHER

Participants will complete surveys regarding the surgeon's communication skills

Surgical candidate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Communication

Interventions

Focus GroupsSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Margaret (Gretchen) Schwarze, MD, MPP

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle J Bushaw, MA

CONTACT

Margaret (Gretchen) L Schwarze, MD, MPP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 17, 2024

Study Start

November 18, 2024

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

October 22, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations