- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06654310
The Fundamentals of Communication in Surgery (FCS)
The Fundamentals of Communication in Surgery (FCS): A Pilot Study to Evaluate the Scalability and Impact of A Clinical Communication Curriculum
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53706
- University of Wisconsin-Madison
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- surgical attendings with an interest in surgical education
- surgery trainees
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day of training through 2 months post-training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Before training, directly after training, and 2 months post-training
|
|
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.
|
1 day of training
|
|
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
|
Baseline (before training), directly after training, and 2 months post-training
|
|
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.
|
1 day of training
|
|
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.
|
Before training, directly after training, and 2 months post-training
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Margaret (Gretchen) L Schwarze, MD, MPP, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0620
- A539750 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Communication Research
-
Insel Gruppe AG, University Hospital BernSwiss National Science Foundation; University of Bern; Fachhochschule NordwestschweizRecruitingCommunication Research | Communication, MultidisciplinarySwitzerland, Austria
-
University of MinnesotaNational Cancer Institute (NCI)CompletedCommunication ResearchUnited States
-
Boston Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingCommunication ResearchUnited States
-
University of AlbertaCompleted
-
University of Wisconsin, MadisonCompletedCommunication ResearchUnited States
-
Duke-NUS Graduate Medical SchoolCompletedCommunication ResearchSingapore
-
St. Jude Children's Research HospitalRecruitingCancer Patients | Communication ResearchUnited States
-
University of Texas at AustinCompletedCommunication Research | Physician-Patient RelationsUnited States
-
Abu Dhabi Health Services CompanyCompletedKnowledge, Attitudes, Practice | Behavior, Consumer | Research, CommunicationUnited Arab Emirates
-
Abramson Cancer Center at Penn MedicineUniversity of FloridaCompletedCommunication Research | Adolescent Behavior | VapingUnited States
Clinical Trials on Delivery of FCS Skills Curriculum
-
The Cleveland ClinicCompletedResident Communication Skills Rated by PatientsUnited States
-
Centre for the AIDS Programme of Research in South...MIET Africa; KwaZulu-Natal Department of Education; Embassy of the Kingdom of...Completed
-
National University Hospital, SingaporeMinistry of Health, Singapore; National University of Singapore, Saw Swee Hock...Active, not recruitingAutism Spectrum DisorderSingapore
-
The Center for Mind-Body MedicineSilicon Valley Community FoundationCompleted
-
London School of Economics and Political ScienceBill and Melinda Gates Foundation; Aga Khan UniversityCompletedDepression | Domestic Violence | Intimate Partner Violence | Battered Women | Mental Health Issue | Gender-based Violence | Rape Sexual AssaultPakistan
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedExecutive Function | Language | Preschool Child
-
The University of Texas Health Science Center,...Completed
-
G. d'Annunzio UniversityNot yet recruiting
-
G. d'Annunzio UniversityRecruiting
-
Ondokuz Mayıs UniversityNot yet recruitingSurgical Education | Simulation-based Training | Resident TrainingTurkey (Türkiye)