- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Anhui
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Chaohu, Anhui, Kiina, 238000
- The fourth affiliated hospital of Anhui medical university
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Clinical skills assessment score
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Theoretical examination score
Aikaikkuna: 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
|
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General Self-Efficacy Scale (GSES) score
Aikaikkuna: 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
|
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Endocrine High-Risk Management Self-Efficacy Source Questionnaire score
Aikaikkuna: 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
|
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Teaching satisfaction scale score
Aikaikkuna: Immediately post-intervention
|
5-dimension teaching satisfaction scale (recognition rate and mean score), completed anonymously.
|
Immediately post-intervention
|
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Focus group interview themes
Aikaikkuna: Within 1 week post-intervention
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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
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- KYXM-202508-021 (Muu tunniste: Ethics Approval Number)
- AHWJ2025BAp20022 (Muu apuraha/rahoitusnumero: Anhui Provincial Health Commission)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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