NCT05623475

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

October 26, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

November 13, 2022

Results QC Date

March 16, 2023

Last Update Submit

August 13, 2024

Conditions

Keywords

Intensive Care Unit SyndromeDeliriumOSCE

Outcome Measures

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.

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

Study Arms (2)

experimental group

EXPERIMENTAL

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: OSCEsBehavioral: LectureBehavioral: E-learning

control group

ACTIVE COMPARATOR

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

Behavioral: LectureBehavioral: E-learning

Interventions

OSCEsBEHAVIORAL

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

experimental group
LectureBEHAVIORAL

Face-to-face Education using Delirium Care Flip Chart

control groupexperimental group
E-learningBEHAVIORAL

Delirium care video

control groupexperimental group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unwilling to involved the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, 11031, Taiwan

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Kee-Hsin Chen, R.N., Ph.D.
Organization
College of Nursing, Taipei Medical University, Taiwan

Study Officials

  • Kee-Hsin Chen, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2022

First Posted

November 21, 2022

Study Start

October 25, 2021

Primary Completion

February 21, 2023

Study Completion

February 21, 2023

Last Updated

October 26, 2024

Results First Posted

October 26, 2024

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations