Trial Outcomes & Findings for Effects of Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium (NCT NCT05623475)

NCT ID: NCT05623475

Last Updated: 2024-10-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

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

Results posted on

2024-10-26

Participant Flow

Participant milestones

Participant milestones
Measure
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). OSCEs: Scenario-based education intervention, including objective structured clinical examinations (OSCEs) Lecture: Face-to-face Education using Delirium Care Flip Chart E-learning: Delirium care video
Control Group
1. face-to-face delirium care session (30 minutes in duration); 2. online learning delirium care activities (20 minutes in duration) Lecture: Face-to-face Education using Delirium Care Flip Chart E-learning: Delirium care video
Overall Study
STARTED
61
39
Overall Study
COMPLETED
59
38
Overall Study
NOT COMPLETED
2
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Experimental Group
n=59 Participants
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). OSCEs: Scenario-based education intervention, including objective structured clinical examinations (OSCEs) Lecture: Face-to-face Education using Delirium Care Flip Chart E-learning: Delirium care video
Control Group
n=38 Participants
1. face-to-face delirium care session (30 minutes in duration); 2. online learning delirium care activities (20 minutes in duration) Lecture: Face-to-face Education using Delirium Care Flip Chart E-learning: Delirium care video
Total
n=97 Participants
Total of all reporting groups
Age, Customized
20-24 year-old
16 Participants
n=5 Participants
9 Participants
n=7 Participants
25 Participants
n=5 Participants
Age, Customized
25-34 year-old
39 Participants
n=5 Participants
25 Participants
n=7 Participants
64 Participants
n=5 Participants
Age, Customized
35-44 year-old
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Age, Customized
45-54 year-old
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Sex: Female, Male
Female
55 Participants
n=5 Participants
37 Participants
n=7 Participants
92 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
59 Participants
n=5 Participants
38 Participants
n=7 Participants
97 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Education
Associate Degree
9 Participants
n=5 Participants
5 Participants
n=7 Participants
14 Participants
n=5 Participants
Education
Bachelor Degree
49 Participants
n=5 Participants
32 Participants
n=7 Participants
81 Participants
n=5 Participants
Education
Master Degree
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
ICU training
Yes
51 Participants
n=5 Participants
34 Participants
n=7 Participants
85 Participants
n=5 Participants
ICU training
No
8 Participants
n=5 Participants
4 Participants
n=7 Participants
12 Participants
n=5 Participants

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Experimental Group
n=59 Participants
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). OSCEs: Scenario-based education intervention, including objective structured clinical examinations (OSCEs) Lecture: Face-to-face Education using Delirium Care Flip Chart E-learning: Delirium care video
Control Group
n=38 Participants
1. face-to-face delirium care session (30 minutes in duration); 2. online learning delirium care activities (20 minutes in duration) Lecture: Face-to-face Education using Delirium Care Flip Chart E-learning: Delirium care video
Delirium Knowledge
T0
12.40 point
Standard Deviation 1.72
13.26 point
Standard Deviation 1.50
Delirium Knowledge
T1
13.08 point
Standard Deviation 1.69
12.71 point
Standard Deviation 2.02
Delirium Knowledge
T2
13.10 point
Standard Deviation 1.81
13.78 point
Standard Deviation 1.33

Adverse Events

Experimental Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kee-Hsin Chen, R.N., Ph.D.

College of Nursing, Taipei Medical University, Taiwan

Phone: +886-2-27361661

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place