[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06654310":3,"trial-entities:NCT06654310":95,"trial-summary:NCT06654310":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":46,"sex":65,"minimum_age":66,"maximum_age":29,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":75,"locations":78,"central_contacts":88,"overall_officials":89,"references":93,"see_also_links":94},"NCT06654310","2024-0620","The Fundamentals of Communication in Surgery","The Fundamentals of Communication in Surgery (FCS): A Pilot Study to Evaluate the Scalability and Impact of A Clinical Communication Curriculum","ENROLLING_BY_INVITATION","2027-07-01","2025-09","2025-09-30","2024-09-16","University of Wisconsin, Madison","OTHER",false,"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","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\u002FWorst 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.\n\nResearchers will invite 1-3 surgical attendings per site with an interest in surgical education to serve as trainers for the FCS curriculum.\n\nAll 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.\n\nResearchers 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.",[19,20],"Communication Research","Communication Programs",[22,23,24,25,26,27],"Surgical Trainees","Fundamentals of Communication in Surgery","FCS","Best Case\u002FWorst Case","BC\u002FWC","Better Conversations","OBSERVATIONAL",null,[],{"count":32,"type":33},600,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","Delivery of FCS Skills Curriculum","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.\n\nEach 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.",[40],"Learners",[42],{"measure":43,"description":44,"timeFrame":45},"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",[47,51,55,59,62],{"measure":48,"description":49,"timeFrame":50},"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.","Before training, directly after training, and 2 months post-training",{"measure":52,"description":53,"timeFrame":54},"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.","1 day of training",{"measure":56,"description":57,"timeFrame":58},"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.\n\nBinary Scoring (0\u002F1) 0: Not Done\n\n1: Done\n\nTernary Scoring (0\u002F1\u002F2) 0: Not Done\n\n1. Done\n2. Exceptional","Baseline (before training), directly after training, and 2 months post-training",{"measure":60,"description":61,"timeFrame":54},"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.",{"measure":63,"description":64,"timeFrame":50},"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.","ALL","18 Years",true,{"inclusion":69,"exclusion":72,"raw_text":74},[70,71],"surgical attendings with an interest in surgical education","surgery trainees",[73],"none","Inclusion Criteria:\n\n* surgical attendings with an interest in surgical education\n* surgery trainees\n\nExclusion Criteria:\n\n* none",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"city":81,"state":82,"zip":83,"country":84,"geoPoint":85},"University of Wisconsin-Madison","Madison","Wisconsin","53706","United States",{"lat":86,"lon":87},43.07305,-89.40123,[],[90],{"name":91,"affiliation":13,"role":92},"Margaret (Gretchen) L Schwarze, MD, MPP","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":96,"biomarkers":98},[97],"Surgical Education",[],{"nct_id":4,"found":15,"summary":29,"prompt_version":29}]