- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Anhui
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Chaohu, Anhui, Kina, 238000
- The fourth affiliated hospital of Anhui medical university
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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.
|
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Eksperimentell: 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.
|
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Eksperimentell: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical skills assessment score
Tidsramme: Immediately post-intervention (upon completion of the 12-hour curriculum)
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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.
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Immediately post-intervention (upon completion of the 12-hour curriculum)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Theoretical examination score
Tidsramme: Immediately post-intervention
|
Closed-book written examination graded by blinded faculty.
Total score range: 0-50 points, covering endocrine and metabolic critical illness knowledge.
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Immediately post-intervention
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General Self-Efficacy Scale (GSES) score
Tidsramme: 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.
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Baseline (pre-intervention) and immediately post-intervention
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Endocrine High-Risk Management Self-Efficacy Source Questionnaire score
Tidsramme: Baseline (pre-intervention) and immediately post-intervention
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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.
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Baseline (pre-intervention) and immediately post-intervention
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Teaching satisfaction scale score
Tidsramme: Immediately post-intervention
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5-dimension teaching satisfaction scale (recognition rate and mean score), completed anonymously.
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Immediately post-intervention
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Focus group interview themes
Tidsramme: 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.
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Within 1 week post-intervention
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KYXM-202508-021 (Annen identifikator: Ethics Approval Number)
- AHWJ2025BAp20022 (Annet stipend/finansieringsnummer: Anhui Provincial Health Commission)
Plan for individuelle deltakerdata (IPD)
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