Communication ResearchFCSNCT06654310
The Fundamentals of Communication in Surgery
An observational study of Communication Research and Communication Programs, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication Research, Communication Programs
- What is being tested?
- Delivery of FCS Skills Curriculum
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be from each participating site.
Who may be able to join
- surgical attendings with an interest in surgical education
- surgery trainees
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53706
About this study
Official title: The Fundamentals of Communication in Surgery (FCS): A Pilot Study to Evaluate the Scalability and Impact of A Clinical Communication Curriculum
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
Read the detailed description
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.
- Conditions
- Communication Research, Communication Programs
- Being tested
- Delivery of FCS Skills Curriculum
- Keywords
- Surgical Trainees, Fundamentals of Communication in Surgery, FCS, Best Case/Worst Case, BC/WC, Better Conversations
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery of FCS Skills CurriculumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Delivery of FCS Skills Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of training through 2 months post-training
Secondary outcomes (5)
Trainee Self-Efficacy - Ability
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.
Measured: Before training, directly after training, and 2 months post-training
Receipt of Curriculum
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.
Measured: 1 day of training
Performance of Skills
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
Measured: Baseline (before training), directly after training, and 2 months post-training
Fidelity to the Intervention
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.
Measured: 1 day of training
Trainee Self-Efficacy - Preparedness
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.
Measured: Before training, directly after training, and 2 months post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start16 Sep 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication ResearchStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Josiah Macy, Jr. Foundation, University of Oklahoma, University of Pittsburgh, University of South Florida, West Virginia University, Duke University, Association for Academic Surgery, Inova Fairfax Medical Campus
- Responsible party
- Sponsor
- Investigators
- Margaret (Gretchen) L Schwarze, MD, MPP, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654310
- Sponsor's protocol ID
- 2024-0620
- Other IDs
- A539750
- Acronym
- FCS
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fundamentals of Communication in Surgery (FCS): A Pilot Study to Evaluate the Scalability and Impact of A Clinical Communication Curriculum
- ClinicalTrials.gov ID
- NCT06654310
- Acronym / sponsor ID
- FCS / 2024-0620
- Conditions
- Communication Research, Communication Programs
- Keywords
- Surgical Trainees, Fundamentals of Communication in Surgery, FCS, Best Case/Worst Case, BC/WC, Better Conversations
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Josiah Macy, Jr. Foundation, University of Oklahoma, University of Pittsburgh, University of South Florida, West Virginia University, Duke University, Association for Academic Surgery, Inova Fairfax Medical Campus
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Learners | – | Behavioral: Delivery of FCS Skills CurriculumAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be from each participating site.
Key inclusion criteria (2 listed)
- surgical attendings with an interest in surgical education
- surgery trainees
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delivery of FCS Skills CurriculumThe 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. | Behavioural | Learners |
Primary outcome
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.
5 secondary outcomes
Trainee Self-Efficacy - Ability
Time frame: Before training, directly after training, and 2 months post-training
Receipt of Curriculum
Time frame: 1 day of training
Performance of Skills
Time frame: Baseline (before training), directly after training, and 2 months post-training
Fidelity to the Intervention
Time frame: 1 day of training
Trainee Self-Efficacy - Preparedness
Time frame: Before training, directly after training, and 2 months post-training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret (Gretchen) L Schwarze, MD, MPP principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Communication Research and Communication Programs, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trainee Reaction to the Training (time frame: Day of training through 2 months post-training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.