NCT06654310

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress59%
Sep 2024Jul 2027

Study Start

First participant enrolled

September 16, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

October 9, 2024

Last Update Submit

September 24, 2025

Conditions

Keywords

Surgical TraineesFundamentals of Communication in SurgeryFCSBest Case/Worst CaseBC/WCBetter Conversations

Outcome Measures

Primary Outcomes (1)

  • Trainee Reaction to the 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.

    Day of training through 2 months post-training

Secondary Outcomes (5)

  • Trainee Self-Efficacy - Ability

    Before training, directly after training, and 2 months post-training

  • Receipt of Curriculum

    1 day of training

  • Performance of Skills

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

  • Fidelity to the Intervention

    1 day of training

  • Trainee Self-Efficacy - Preparedness

    Before training, directly after training, and 2 months post-training

Study Arms (1)

Learners

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.

Behavioral: Delivery of FCS Skills Curriculum

Interventions

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.

Learners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be from each participating site.

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Margaret (Gretchen) L Schwarze, MD, MPP

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 23, 2024

Study Start

September 16, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations