Effectiveness of Delirium Simulation Education of Nurses in Intensive Care Unit

July 19, 2022 updated by: Yu-Ling Chang, Chang Gung Memorial Hospital

Effectiveness of Delirium Simulation Education on the Self-efficacy and Critical Thinking Skill of Nurses in Intensive Care Unit- Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Through literature review, the investigators found that research on delirium in the intensive care unit simulated education interventions are insufficient, and longitudinal studies to explore how long the effect can be maintained or delirium assessment and delirium management are designed dependent on theory are lacking. Therefore, the purpose of this study was to investigate the effect of delirium simulation education on delirium knowledge, delirium critical thinking, delirium care self-efficacy and satisfaction among nurses in intensive care units, and to explore the influencing factors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental(simulation education group)
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
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.
No Intervention: Control(traditional group)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness change of delirium care knowledge after simulation teaching
Time Frame: change from baseline in delirium knowledge and 3, 6, 12 months after intervention
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
Time Frame: change from baseline in delirium care self-efficacy and 3, 6, 12 months after intervention
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
Time Frame: change from baseline in delirium critical thinking skills and 3, 6, 12 months after intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOST109-2314-B-182-009-MY3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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