DeliriumNCT05623475
Effects of Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium
A study testing OSCEs, Lecture and E-learning in people with Delirium, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- OSCEs, Lecture and E-learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Oct 2021to 21 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1.Unwilling to involved the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effects of Implementing a Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium: a Cluster Randomized Controlled Trial
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.
- Conditions
- Delirium
- Being tested
- OSCEs, Lecture, E-learning
- Keywords
- Intensive Care Unit Syndrome, Delirium, OSCE
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSCEsBehavioural
Scenario-based education intervention, including objective structured clinical examinations (OSCEs)
LectureBehavioural
Face-to-face Education using Delirium Care Flip Chart
E-learningBehavioural
Delirium care video
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: OSCEs; Behavioral: Lecture; Behavioral: 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) Receives: Behavioral: Lecture; Behavioral: E-learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium Knowledge
- The "ICU Delirium Care Knowledge Quiz" (Traditional Chinese version ) developed by Ho et al. (2021) was used in this study.
- 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.
- 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.
Measured: T0(Baseline), T1(Immediately after the intervention), T2(Six weeks after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start25 Oct 2021
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kee-Hsin Chen, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623475
- Sponsor's protocol ID
- N20210318
- Status last verified
- Oct 2022
- First submitted
- 13 Nov 2022
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Implementing a Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05623475
- Acronym / sponsor ID
- N20210318
- Conditions
- Delirium
- Keywords
- Intensive Care Unit Syndrome, Delirium, OSCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Posted 26 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: OSCEs, Behavioral: Lecture, Behavioral: E-learning1. 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). |
| control group | Active comparator | Behavioral: Lecture, Behavioral: E-learning1. face-to-face delirium care session (30 minutes in duration); 2. online learning delirium care activities (20 minutes in duration) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 1.Unwilling to involved the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSCEsScenario-based education intervention, including objective structured clinical examinations (OSCEs) | Behavioural | experimental group |
| LectureFace-to-face Education using Delirium Care Flip Chart | Behavioural | control group, experimental group |
| E-learningDelirium care video | Behavioural | control group, experimental group |
Primary outcome
Delirium Knowledge
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kee-Hsin Chen, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OSCEs, Lecture and E-learning in people with Delirium, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium Knowledge (time frame: T0(Baseline), T1(Immediately after the intervention), T2(Six weeks after the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.