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Enrolling by Invitation

NCT Number: NCT06654310

The Fundamentals of Communication in Surgery

The goal of this observational study is to evaluate the impact of the FCS curriculum on achieving the learning objectives and resident reported self-efficacy with communication skills and determine the scalability of the training across a range of general surgery training programs

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Key information

Conditions

Communication Research Behavior Communication Communication Programs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

About this study

The researchers have developed a 5-year curriculum for surgical trainees called the Fundamentals of Communication in Surgery (FCS). The training includes core communication skills, e.g., expressing empathy, and frameworks to support informed consent and serious illness conversations, specifically Best Case/Worst Case and Better Conversations. The curriculum provides one developmentally appropriate two-hour session for each of the five years of surgical training. Because the training is skills based (e.g., scenario planning) and not procedure based (e.g., goals of care conversations) exercises are focused on specific techniques that build over subsequent sessions.

Researchers will invite 1-3 surgical attendings per site with an interest in surgical education to serve as trainers for the FCS curriculum.

All general surgery trainees at each institution will have access to the training program as part of their regularly scheduled educational curriculum, regardless of training year or status as a categorical resident. If there is interest, researchers will provide access to the curriculum to fellows and residents in affiliated programs, e.g., plastic surgery.

Researchers will invite site personnel who have roles related to surgical education including the program director and associate program director (if applicable), 2 to 3 attending surgeons who have high contact with residents in urgent care settings (e.g., emergency general surgery), 1 to 2 members of the education coordination team.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • surgical attendings with an interest in surgical education
  • surgery trainees

Exclusion criteria

  • none

Treatment and study plan

Delivery of FCS Skills Curriculum

Behavioral

The UW study team will conduct two 2-hour train-the-trainer sessions with all surgical attendings who have committed to participation as a trainer in the FCS curriculum. The designated trainer will deliver each 2-hour session during the existing formal educational time for residents. If existing protected educational time will not allow for a 2-hour training session, the sessions can be delivered in two 1-hour sessions. These sessions will be incorporated into the curriculum similar to all other formal training provided to residents with the same expectations to attend.

Each 2-hour FCS session starts with a 30-minute exercise in empathic communication. The remaining 90 minutes are devoted to skills that support decision making about surgery.

Primary outcomes

  1. Trainee Reaction to the Training

    Time frame: Day of training through 2 months post-training

    Surgical trainees will complete a 5-item survey on a scale of 1-5 (1= strongly disagree, 5= strongly agree). Total scores range from 5-25, with higher scores indicating greater acceptability of the curriculum.

Secondary outcomes

  1. Trainee Self-Efficacy - Ability

    Time frame: Before training, directly after training, and 2 months post-training

    Surgical trainees will complete an 8-item ability survey on a scale of 1-5 (1= not at all able to do, 5= easily able to do). Total scores range from 8-40, with higher scores indicating a better ability to communicate.

  2. Receipt of Curriculum

    Time frame: 1 day of training

    Educational coordinators will provide a direct count of the number of categorical residents who attend their session, divided by the total number eligible to attend.

  3. Performance of Skills

    Time frame: Baseline (before training), directly after training, and 2 months post-training

    Trainers will observe surgical trainees to evaluate them on various items using a scoring rubric. Each item will be scored as not done, done, or exceptional.

    Binary Scoring (0/1) 0: Not Done

    1: Done

    Ternary Scoring (0/1/2) 0: Not Done

    • Done
    • Exceptional

  4. Fidelity to the Intervention

    Time frame: 1 day of training

    A member of the UW study team will travel to each institution once to observe one 2-hour educational session in person. The observer will use an implementation checklist (rubric) to record performance of discrete elements of the curriculum and the fidelity to the overall training program goals as described in the learning objectives.

  5. Trainee Self-Efficacy - Preparedness

    Time frame: Before training, directly after training, and 2 months post-training

    Surgical trainees will also complete a 6-item preparedness survey with a scale of 1-5 (1= not at all prepared, 5= very well prepared). Total scores range from 6-35, with higher scores indicating greater confidence in navigating treatment decisions.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Association for Academic Surgery
  • Duke University
  • Inova Fairfax Medical Campus
  • Josiah Macy, Jr. Foundation
  • University of Oklahoma
  • University of Pittsburgh
  • University of South Florida
  • West Virginia University

Registry information

Official study title

The Fundamentals of Communication in Surgery (FCS): A Pilot Study to Evaluate the Scalability and Impact of A Clinical Communication Curriculum

Acronym: FCS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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