- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06654310
수술 의사소통의 기초 (FCS)
수술 의사소통의 기초(FCS): 임상 의사소통 커리큘럼의 확장성과 영향을 평가하기 위한 파일럿 연구
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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
-
-
Wisconsin
-
Madison, Wisconsin, 미국, 53706
- University of Wisconsin-Madison
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Participants will be from each participating site.
설명
Inclusion Criteria:
- surgical attendings with an interest in surgical education
- surgery trainees
Exclusion Criteria:
- none
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Trainee Reaction to the Training
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Trainee Self-Efficacy - Ability
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Margaret (Gretchen) L Schwarze, MD, MPP, University of Wisconsin, Madison
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2024-0620
- A539750 (기타 식별자: UW- Madison)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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