- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07801170
Integrated PBL-CBL-CTTM Teaching to Enhance Clinical Self-Efficacy in Endocrine Critical Illness Among Internal Medicine Residents: An RCT (PBL-CBL-CTTM)
Online-Offline Integrated Multimodal Teaching Combining PBL, CBL, and CTTM to Enhance Clinical Self-Efficacy in Endocrine and Metabolic Critical Illness Among Internal Medicine Residents: A Convergent Parallel Mixed-Methods Randomized Controlled Trial
This randomized controlled trial evaluates whether an integrated online-offline multimodal teaching approach combining Problem-Based Learning (PBL), Case-Based Learning (CBL), and Case Three-Dimensional Teaching Method (CTTM) improves clinical self-efficacy and hands-on proficiency in managing endocrine and metabolic critical illness among internal medicine residents, compared to traditional lecture-based learning (LBL).
Ninety internal medicine residents on their first endocrine rotation will be randomly assigned in a 1:1:1 ratio to three groups: (1) Control group receiving traditional LBL alone; (2) Experimental group 1 receiving PBL plus LBL; (3) Experimental group 2 receiving the integrated PBL-CBL-CTTM closed-loop teaching program. All groups receive a standardized 12-hour curriculum on endocrine and metabolic critical illness, including diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, thyroid storm, and refractory hypoglycemia.
The primary outcome is the clinical skills assessment score (0-50 points). Secondary outcomes include theoretical examination scores, General Self-Efficacy Scale (GSES) scores, a self-developed Endocrine High-Risk Management Self-Efficacy Source Questionnaire (four dimensions based on Bandura's self-efficacy theory), teaching satisfaction, and semi-structured focus group interviews.
The study was conducted from September 2025 to August 2026 at the Fourth Affiliated Hospital of Anhui Medical University, Chaohu, China. This study aims to establish an evidence-based, replicable teaching model that addresses the gap between theoretical knowledge and clinical confidence in managing endocrine emergencies among residents.
Обзор исследования
Статус
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Anhui
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Chaohu, Anhui, Китай, 238000
- The fourth affiliated hospital of Anhui medical university
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Full-time internal medicine residents undergoing their first endocrine rotation at the Fourth Affiliated Hospital of Anhui Medical University
- No prior endocrine remedial training or advanced study experience
- No independent management experience with endocrine and metabolic critical cases
- Ability to complete all 12 hours of standardized curriculum and all post-intervention assessments
- Voluntary participation with written informed consent
Exclusion Criteria:
- Prior completion of an endocrine rotation or specialized endocrine training
- Prior independent management experience in diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, thyroid storm, or refractory hypoglycemia
- Inability to complete the full 12-hour teaching schedule due to clinical duties, leave, or rotation transfer
- Concurrent participation in other teaching intervention research projects
- Decline to provide written informed consent or withdrawal before randomization
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Control Group (LBL Alone)
Received only in-person one-way didactic lectures (lecture-based learning, LBL) with self-directed review after class.
No online discussions, ward-based training, CTTM resources, or post-class debriefing.
Total 12-hour standardized curriculum on endocrine and metabolic critical illness.
n=30.
|
In-person one-way didactic lectures with self-directed review after class.
Total 12-hour standardized curriculum on endocrine and metabolic critical illness, including diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, thyroid storm, and refractory hypoglycemia.
|
|
Экспериментальный: Experimental Group 1 (PBL+LBL)
Received pre-class online problem-based learning (PBL) via DingTalk (open-ended critical case questions, independent literature search, online group discussion) plus standardized in-person lectures (LBL), with self-directed review after class.
No ward-based CTTM training or post-class debriefing.
Total 12-hour standardized curriculum.
n=30.
|
Pre-class online problem-based learning (PBL) via DingTalk (open-ended critical case questions, independent literature search, online group discussion) plus standardized in-person lectures (LBL), with self-directed review after class.
Total 12-hour standardized curriculum.
|
|
Экспериментальный: Experimental Group 2 (Integrated PBL-CBL-CTTM)
Received integrated closed-loop teaching: pre-class PBL (identical to experimental group 1) plus standardized in-person lectures plus post-class ward-based case-based learning (CBL) with attending-supervised hands-on critical case training, case three-dimensional teaching method (CTTM) resources, and post-class debriefing.
Total 12-hour standardized curriculum.
n=30.
|
Integrated closed-loop teaching: pre-class online PBL (identical to experimental group 1) plus standardized in-person lectures plus post-class ward-based case-based learning (CBL) with attending-supervised hands-on critical case training, case three-dimensional teaching method (CTTM) resources, and post-class debriefing.
Total 12-hour standardized curriculum.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Clinical skills assessment score
Временное ограничение: Immediately post-intervention (upon completion of the 12-hour curriculum)
|
Assessed by group-blinded evaluators using a standardized clinical skills checklist immediately after the 12-hour intervention.
Total score range: 0-50 points.
Higher scores indicate better clinical proficiency in managing endocrine and metabolic critical illness.
|
Immediately post-intervention (upon completion of the 12-hour curriculum)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Theoretical examination score
Временное ограничение: Immediately post-intervention
|
Closed-book written examination graded by blinded faculty.
Total score range: 0-50 points, covering endocrine and metabolic critical illness knowledge.
|
Immediately post-intervention
|
|
General Self-Efficacy Scale (GSES) score
Временное ограничение: Baseline (pre-intervention) and immediately post-intervention
|
10-item standardized self-efficacy scale (Cronbach's α=0.89), completed anonymously.
Higher scores indicate greater general self-efficacy.
|
Baseline (pre-intervention) and immediately post-intervention
|
|
Endocrine High-Risk Management Self-Efficacy Source Questionnaire score
Временное ограничение: Baseline (pre-intervention) and immediately post-intervention
|
Self-developed 4-dimension questionnaire based on Bandura's self-efficacy theory (mastery experience, vicarious learning, verbal persuasion, positive affect; Cronbach's α=0.81,
CVI=0.92), completed anonymously.
|
Baseline (pre-intervention) and immediately post-intervention
|
|
Teaching satisfaction scale score
Временное ограничение: Immediately post-intervention
|
5-dimension teaching satisfaction scale (recognition rate and mean score), completed anonymously.
|
Immediately post-intervention
|
|
Focus group interview themes
Временное ограничение: Within 1 week post-intervention
|
Semi-structured focus group interviews (30-40 minutes each) with 24 residents selected via stratified purposive sampling, analyzed using Braun & Clarke six-step thematic analysis method.
Explores residents' experiences and psychological mechanisms underlying changes in clinical self-efficacy.
|
Within 1 week post-intervention
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KYXM-202508-021 (Другой идентификатор: Ethics Approval Number)
- AHWJ2025BAp20022 (Другой номер гранта/финансирования: Anhui Provincial Health Commission)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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