NCT05333354

Brief Summary

Delirium is a common symptom in the intensive care unit, which greatly affects the prognosis of critically ill patients and increases medical costs. Although many studies have implemented preventive measures, they have not been able to significantly improve the prevalence of delirium, because many medical measures devises in the intensive care unit are still necessary for patients. Therefore, early detection of patients with delirium symptoms, risk factors, and immediate Delirium management is important. Nurses are the first line of clinically important roles in assessing delirium symptoms. So, design a delirium simulation education for nurses is important.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Status
unknown

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

First Submitted

Initial submission to the registry

February 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

February 16, 2022

Last Update Submit

July 19, 2022

Conditions

Keywords

intensive care unit,nurses,delirium,simulation

Outcome Measures

Primary Outcomes (3)

  • Effectiveness change of delirium care knowledge after simulation teaching

    Effectiveness of participants with simulation teaching as assessed by delirium knowledge questioner, change from baseline in knowledge scores on delirium knowledge questioner at 3,6,12 months

    change from baseline in delirium knowledge and 3, 6, 12 months after intervention

  • Effectiveness change of delirium care self-efficacy after simulation teaching

    Effectiveness of participants with simulation teaching as assessed by delirium care self-efficacy questioner, change from baseline in self-efficacy scores on delirium care self-efficacy questioner at 3,6,12 months

    change from baseline in delirium care self-efficacy and 3, 6, 12 months after intervention

  • Effectiveness change of delirium critical thinking skills after simulation teaching

    Effectiveness of participants with simulation teaching as assessed by delirium critical thinking skills questioner, change from baseline in critical thinking skills scores on delirium critical thinking skills questioner at 3,6,12 months

    change from baseline in delirium critical thinking skills and 3, 6, 12 months after intervention

Study Arms (2)

Experimental(simulation education group)

EXPERIMENTAL

The experimental group (simulation teaching group), the content of simulation teaching is based on the simulation model, and includes five important elements: Instructor, student, educational practice, simulation situation design and characteristics, and result that design covering the four stages of learning, concrete experience, reflective observation, abstract conceptualization and action experience, and design lesson plans, which include delirium assessment and delirium risk factor detection. Delirium prevention and management (PADIS guidelines). The main objectives of the teaching plan design of the experimental group are: to be able to confirm delirium by assessment of the Delirium Assessment Scale; to confirm the risk factors by the history taking; to propose treatment and measures according to the assessment results. Secondary goals: Be able to perform handovers.

Other: education strategy

Control(traditional group)

NO INTERVENTION

Nurses in the control group did not receive simulated situational teaching, but received classroom teaching 3 times (once every other week) (delirium assessment, risk factor assessment; PADIS treatment), each session of about 2 hours. In order to avoid inconsistent teaching content, the control group and the experimental group are not to be together in classroom.

Interventions

The educational course of the experimental group will last for 6 weeks, including classroom teaching and simulated situational teaching. The classroom teaching will be divided into 3 times, a course of about 2 hours at a time; after the class, simulated situational teaching is also arranged for 4 hours at a time/ Caring for many patients with delirium, and performing related research. The simulated scenario lesson plan plans to design 3 major themes (delirium assessment, delirium risk factors, delirium prevention, each major theme will have 2 scenarios, each The simulation teaching exercise starts with pre-briefing, and after the end, debriefing reflection and discussion with the students.

Experimental(simulation education group)

Eligibility Criteria

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

You may qualify if:

  • Nurses who have worked in the intensive care unit for more than 3 months,
  • No physical or mental illness or recent major family events,
  • Never received delirium simulation training.

You may not qualify if:

  • Those who are not working in the intensive care unit for less than 3 months,
  • Those who have recently suffered from physical and mental illness or a major family event recently,
  • Those who have received delirium simulation training,
  • Those who are currently working as nursing supervisors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 16, 2022

First Posted

April 19, 2022

Study Start

August 1, 2022

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share