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CompletedNCT05623475Updated Oct 26, 2024Results posted

Effects of Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium

An interventional study of OSCEs and Lecture in Delirium, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Oct 2021, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

Delirium is a disturbance in consciousness with reduced ability to focus, sustain, or shift attention that occurs over a short period of time and tends to fluctuate over the course of the day. 50% to 81.7% had delirium during their ICU hospitalization. Delirium is associated with increased physical restraint, ventilation use, length of ICU stay, and mortality. However, there is no established delirium care pathway in target hospital. Chen et al. (2014) demonstrated that structured assessment stations with immediate feedback may improve overall learning efficiency over an EBP workshop alone. However, no published delirium care education study has used OSCEs as an intervention for healthcare professionals. The aim is to evaluate the effects of implementing a Scenario- based education intervention, including objective structured clinical examinations (OSCEs) on delirium care among healthcare professionals. This is a knowledge translation research, builds on eight years of delirium care research in University of Wollongong, Australia. The research will be undertaken at ICUs in a medical center in northern of Taiwan. There are two phases: (1) systematic review to identify delirium screen tool, and (2) a randomized controlled trial was conducted to determine the effects of implementing a Scenario-based education intervention, including OSCE (experimental group), and on-line education only (control group) focused on recognition and management of delirium. The hypothesis is: Scenario-based education intervention, including OSCE can increase the competence and self-efficacy among healthcare professionals in delirium care.

Read the detailed description

OSCEs are an integral aspect of all levels of medical education but limited to undergraduate nursing and allied health education. OSCEs are rarely used in the workplace as learning activities with nursing and allied health clinicians. This is the reason why this education initiative was innovative. OSCEs are simulated 'real life' clinical scenarios presented to clinicians who are required to demonstrate to an assessor the clinical tasks which form an OSCE scenario.

02

Conditions studied

  • Delirium

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Keywords

  • Intensive Care Unit Syndrome
  • Delirium
  • OSCE
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 100 is below the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Registered nurse worked in acute care unit and care with critical patients
  2. Licensed physician which undertake the post graduate year program worked in acute care unit and care with critical patients

Exclusion criteria

Exclusion Criteria:

1.Unwilling to involved the research

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    experimental group

    1. face-to-face delirium care session (30 minutes in duration); 2. online learning delirium care activities (20 minutes in duration); and 3. delirium care OSCE and reflective activity (30 minutes in duration).

    Behavioral: OSCEs · Behavioral: Lecture · Behavioral: E-learning

  • Active comparator
    control group

    1. face-to-face delirium care session (30 minutes in duration); 2. online learning delirium care activities (20 minutes in duration)

    Behavioral: Lecture · Behavioral: E-learning

Interventions

  • BehavioralOSCEs

    Scenario-based education intervention, including objective structured clinical examinations (OSCEs)

  • BehavioralLecture

    Face-to-face Education using Delirium Care Flip Chart

  • BehavioralE-learning

    Delirium care video

06

What researchers measure

Primary outcomes

  1. Delirium Knowledge

    1. The "ICU Delirium Care Knowledge Quiz" (Traditional Chinese version ) developed by Ho et al. (2021) was used in this study. 2. The "ICU Delirium Care Knowledge Quiz" (Traditional Chinese version ) consists of 16 multiple-choice questions, with 1 point awarded for each correct answer, and a maximum score of 16 points. The total score of the participants is analyzed as a continuous variable. The total range from 0 to 16 (minimum score: 0 point; and maximum score 16 points). Higher points represent better ICU Delirium Care Knowledge. 3. The overall KR-20 coefficient of the questionnaire is 0.85, the intra-class correlation coefficient over a 30-day interval is 0.97, the content validity index (CVI) is 83%, and the exploratory factor analysis (EFA) demonstrates appropriate structural validity, with four factors explaining 60.87% of the total variance, indicating good reliability and validity.

    Time frame: T0(Baseline), T1(Immediately after the intervention), T2(Six weeks after the intervention)

07

Results

Posted Oct 26, 2024

Participant flow

Participant flow — Overall Study
MilestoneExperimental GroupControl Group
Started6139
Completed5938
Not completed21

Outcome measures

PrimaryDelirium Knowledge

1. The "ICU Delirium Care Knowledge Quiz" (Traditional Chinese version ) developed by Ho et al. (2021) was used in this study. 2. The "ICU Delirium Care Knowledge Quiz" (Traditional Chinese version ) consists of 16 multiple-choice questions, with 1 point awarded for each correct answer, and a maximum score of 16 points. The total score of the participants is analyzed as a continuous variable. The total range from 0 to 16 (minimum score: 0 point; and maximum score 16 points). Higher points represent better ICU Delirium Care Knowledge. 3. The overall KR-20 coefficient of the questionnaire is 0.85, the intra-class correlation coefficient over a 30-day interval is 0.97, the content validity index (CVI) is 83%, and the exploratory factor analysis (EFA) demonstrates appropriate structural validity, with four factors explaining 60.87% of the total variance, indicating good reliability and validity.

Time frame:
T0(Baseline), T1(Immediately after the intervention), T2(Six weeks after the intervention)
Reported as:
Mean · point
Delirium Knowledge
pointExperimental GroupControl Group
T012.40 ± 1.7213.26 ± 1.50
T113.08 ± 1.6912.71 ± 2.02
T213.10 ± 1.8113.78 ± 1.33

Adverse events

Collected over 6months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental Group0/59 (0%)0/59 (0%)0/59 (0%)
Control Group0/38 (0%)0/38 (0%)0/38 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)Experimental GroupControl GroupTotal
20-24 year-old16925
25-34 year-old392564
35-44 year-old325
45-54 year-old123
Sex: Female, Male
Sex: Female, Male(Participants)Experimental GroupControl GroupTotal
Female553792
Male415
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental GroupControl GroupTotal
American Indian or Alaska Native000
Asian593897
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Education
Education(Participants)Experimental GroupControl GroupTotal
Associate Degree9514
Bachelor Degree493281
Master Degree112
ICU training
ICU training(Participants)Experimental GroupControl GroupTotal
Yes513485
No8412
08

Study locations

1 site
  • Taipei Medical University Hospital
    Taipei, 11031, Taiwan
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 15, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05623475
Lead sponsor
Taipei Medical University
Responsible party
Sponsor
First posted
Nov 21, 2022
Start date
Oct 25, 2021
Primary completion
Feb 21, 2023
Completion
Feb 21, 2023
Results posted
Oct 26, 2024
Last update
Oct 26, 2024

Study contacts

Kee-Hsin Chen, PhD
principal investigator · Taipei Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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