Evaluating the Effects of Implementing a Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium: a Cluster Randomized Controlled Trial
Phase: NA
Conditions: Delirium
Sponsor: Taipei Medical University

Study Protocol and Statistical Analysis Plan 
 
Title: Effects of Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium 
Protocol ID: N201803104 
ClinicalTial.gov ID: NCT05623475 
Date: 15th March 2023 
 
Study Protocol: 
Background: Delirium is an acute change in cognitive function. More than 80% of patients develop delirium 
on the first day of ICU admission. Delirium increases patients’ physical restraint, length of ventilator 
use, length of ICU stays, and mortality. Healthcare providers need to assess and provide appropriate 
interventions promptly.  
Objective(s): To evaluate the effectiveness of the Scenario-based Education Module and Objective Structured 
Clinical Skills Examination (SEM-OSCE) on delirium knowledge, confidence, and competence 
among ICUs nurses. 
Design: A cluster randomized controlled trial was conducted (IRB: N202103018). 
Method:  
1. The SEM-OSCE was jointly developed by the research team in Taiwan and the University of 
Wollongong, Australia.  
2. Eligible participants were recruited from a hospital in northern Taiwan. Eligible participants were: (1) 
Registered nurses who worked in the acute care unit and cared for critical patients. (2) Age more than 
20 years old. (3) Willing to be involved in the research. 
3. Setting: A teaching hospital in northern Taiwan. 
4. Intervention: The interventional group received an online delirium course, and face-to-face education 
using ‘Delirium Care Flip Chart’, and SEM-OSCE, while the control group received an online delirium 
course. The SEM-OSCE was jointly developed by the research team.  
5. Tools: The tools included a delirium questionnaire and clinical audit. Outcome data included ICU 
nurses' delirium knowledge, confidence, competence, and clinical performance.  
6. Data collection: Data were collected at baseline (T0), immediately after the intervention (SEM-OSCE) 
(T1), and 6 weeks after the intervention (SEM-OSCE) (T2).  
 
Statistical Analysis Plan: SPSS 22.0 (SPSS Inc., Chicago, IL, USA) was used for statistical analysis using 
descriptive analysis, t-test, Chi-Squared Test, ANOVA, and GEE.  
 
Informed Consent Form: Reviewed by TMU-JIRB committee members, written informed consent is not 
required.