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DeliriumNCT03642249

Education for Recognition and Management of Delirium

A study testing OSCEs, Lecture and E-learning in people with Delirium and Intensive Care Unit Syndrome, run by Taipei Medical University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
OSCEs, Lecture and E-learning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTaiwan
Study dates
5 Nov 2019to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

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
  • Age > 20 years old.

Who cannot join

  • Unwilling to involved the research

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Wan Fang Hospital

    Taipei, 116

Other trials in Taiwan

About this study

Official title: Evaluating the Effects of Implementing an Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium in Adult Intensive Care Unit: Randomised 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.

Being tested
OSCEs, Lecture, E-learning
Keywords
delirium, knowledge translation, Objective Structured Clinical Examination, evidence-based practice
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 groups in NCT03642249
Study groupRoleWhat they receive
experimental groupExperimental1. 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 groupActive comparator1. 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.

  1. Change from Baseline Delirium Knowledge and Skills at the time Immediately after the intervention and Six weeks

    Delirium Knowledge and Skills Test (included 18 questions)

    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.

  1. First posted22 Aug 2018
  2. Study start5 Nov 2019
  3. Primary completion24 Dec 2019
  4. Study completion31 Dec 2019

Resources

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
Single blind
Who is masked
Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03642249
Sponsor's protocol ID
N201803104
Status last verified
Sep 2019
First submitted
16 Aug 2018
Last updated
21 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bellelli G, Morandi A, Davis DH, Mazzola P, Turco R, Gentile S, Ryan T, Cash H, Guerini F, Torpilliesi T, Del Santo F, Trabucchi M, Annoni G, Maclullich AM. Corrigendum to 'Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people'. Age Ageing. 2015 Jan;44(1):175. doi: 10.1093/ageing/afu181. No abstract available.

    PubMed 25477307

  • Campbell N, Boustani MA, Ayub A, Fox GC, Munger SL, Ott C, Guzman O, Farber M, Ademuyiwa A, Singh R. Pharmacological management of delirium in hospitalized adults--a systematic evidence review. J Gen Intern Med. 2009 Jul;24(7):848-53. doi: 10.1007/s11606-009-0996-7. Epub 2009 May 8.

    PubMed 19424763

  • Coyle H, Traynor V, Solowij N. Computerized and virtual reality cognitive training for individuals at high risk of cognitive decline: systematic review of the literature. Am J Geriatr Psychiatry. 2015 Apr;23(4):335-359. doi: 10.1016/j.jagp.2014.04.009. Epub 2014 May 14.

    PubMed 24998488

  • Coyle MA, Burns P, Traynor V. Is it My Job? The Role of RNs in the Assessment and Identification of Delirium in Hospitalized Older Adults: An Exploratory Qualitative Study. J Gerontol Nurs. 2017 Apr 1;43(4):29-37. doi: 10.3928/00989134-20170111-02. Epub 2017 Jan 18.

    PubMed 28095583

  • De J, Wand APF, Smerdely PI, Hunt GE. Validating the 4A's test in screening for delirium in a culturally diverse geriatric inpatient population. Int J Geriatr Psychiatry. 2017 Dec;32(12):1322-1329. doi: 10.1002/gps.4615. Epub 2016 Oct 20.

    PubMed 27766672

  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PubMed 17695343

  • Fox MT, Persaud M, Maimets I, Brooks D, O'Brien K, Tregunno D. Effectiveness of early discharge planning in acutely ill or injured hospitalized older adults: a systematic review and meta-analysis. BMC Geriatr. 2013 Jul 6;13:70. doi: 10.1186/1471-2318-13-70.

    PubMed 23829698

  • Han JH, Wilson A, Graves AJ, Shintani A, Schnelle JF, Dittus RS, Powers JS, Vernon J, Storrow AB, Ely EW. Validation of the Confusion Assessment Method for the Intensive Care Unit in older emergency department patients. Acad Emerg Med. 2014 Feb;21(2):180-7. doi: 10.1111/acem.12309.

    PubMed 24673674

  • Hsu LL, Huang YH, Hsieh SI. The effects of scenario-based communication training on nurses' communication competence and self-efficacy and myocardial infarction knowledge. Patient Educ Couns. 2014 Jun;95(3):356-64. doi: 10.1016/j.pec.2014.03.010. Epub 2014 Mar 20.

    PubMed 24718019

  • Hu RF, Jiang XY, Chen J, Zeng Z, Chen XY, Li Y, Huining X, Evans DJ. Non-pharmacological interventions for sleep promotion in the intensive care unit. Cochrane Database Syst Rev. 2015 Oct 6;2015(10):CD008808. doi: 10.1002/14651858.CD008808.pub2.

    PubMed 26439374

  • Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.

    PubMed 10053175

  • Kuladee S, Prachason T. Development and validation of the Thai version of the 4 'A's Test for delirium screening in hospitalized elderly patients with acute medical illnesses. Neuropsychiatr Dis Treat. 2016 Feb 24;12:437-43. doi: 10.2147/NDT.S97228. eCollection 2016.

    PubMed 26966365

  • Lahariya S, Grover S, Bagga S, Sharma A. Delirium in patients admitted to a cardiac intensive care unit with cardiac emergencies in a developing country: incidence, prevalence, risk factor and outcome. Gen Hosp Psychiatry. 2014 Mar-Apr;36(2):156-64. doi: 10.1016/j.genhosppsych.2013.10.010. Epub 2013 Oct 16.

    PubMed 24295565

  • O'Sullivan D, Brady N, Manning E, O'Shea E, O'Grady S, O 'Regan N, Timmons S. Validation of the 6-Item Cognitive Impairment Test and the 4AT test for combined delirium and dementia screening in older Emergency Department attendees. Age Ageing. 2018 Jan 1;47(1):61-68. doi: 10.1093/ageing/afx149.

    PubMed 28985260

  • Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. doi: 10.1007/s00134-006-0399-8. Epub 2006 Nov 11.

    PubMed 17102966

Questions about this trial

What is this clinical trial studying?

A study testing OSCEs, Lecture and E-learning in people with Delirium and Intensive Care Unit Syndrome, 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 21 Mar 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline Delirium Knowledge and Skills at the time Immediately after the intervention and Six weeks (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?

On the ClinicalTrials.gov record for NCT03642249, which also lists 23 linked publications.

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 21 Mar 2023.

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