CClinicalTrials.gg
CompletedNCT03642249Updated Mar 21, 2023

Education for Recognition and Management of Delirium

An interventional study of OSCEs and Lecture in Delirium, Intensive Care Unit Syndrome and Nurse-Patient Relations, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-21.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Delirium
  • Intensive Care Unit Syndrome
  • Nurse-Patient Relations

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Keywords

  • delirium
  • knowledge translation
  • Objective Structured Clinical Examination
  • evidence-based practice
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 72 is below the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Registered nurse worked in acute care unit and care with critical patients
  • Age > 20 years old.

Exclusion criteria

Exclusion Criteria:

  • Unwilling to involved the research
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    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).

    Behavioral: OSCEs · Behavioral: Lecture · Behavioral: E-learning

  • Active comparator
    control group

    1. face-to-face delirium care session (30 minutes in duration); 2. online learning delirium care activities (20 minutes in duration)

    Behavioral: Lecture · Behavioral: E-learning

Interventions

  • BehavioralOSCEs

    Scenario-based education intervention, including objective structured clinical examinations (OSCEs)

  • BehavioralLecture

    Face-to-face Education using Delirium Care Flip Chart

  • BehavioralE-learning

    delirium care video

06

What researchers measure

Primary outcomes

  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)

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

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Study locations

1 site
  • Wan Fang Hospital
    Taipei, 116, Taiwan
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References and documents

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 ↗
  • Pierre RB, Wierenga A, Barton M, Branday JM, Christie CD. Student evaluation of an OSCE in paediatrics at the University of the West Indies, Jamaica. BMC Med Educ. 2004 Oct 16;4:22. doi: 10.1186/1472-6920-4-22. PubMed 15488152 ↗
  • Salluh JI, Wang H, Schneider EB, Nagaraja N, Yenokyan G, Damluji A, Serafim RB, Stevens RD. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ. 2015 Jun 3;350:h2538. doi: 10.1136/bmj.h2538. PubMed 26041151 ↗
  • Siddiqi N, Harrison JK, Clegg A, Teale EA, Young J, Taylor J, Simpkins SA. Interventions for preventing delirium in hospitalised non-ICU patients. Cochrane Database Syst Rev. 2016 Mar 11;3(3):CD005563. doi: 10.1002/14651858.CD005563.pub3. PubMed 26967259 ↗
  • Tamune H, Yasugi D. How can we identify patients with delirium in the emergency department?: A review of available screening and diagnostic tools. Am J Emerg Med. 2017 Sep;35(9):1332-1334. doi: 10.1016/j.ajem.2017.05.026. Epub 2017 May 22. PubMed 28571901 ↗
  • Traynor V, Inoue K, Crookes P. Literature review: understanding nursing competence in dementia care. J Clin Nurs. 2011 Jul;20(13-14):1948-60. doi: 10.1111/j.1365-2702.2010.03511.x. Epub 2011 Mar 15. PubMed 21401762 ↗
  • Wong CL, Holroyd-Leduc J, Simel DL, Straus SE. Does this patient have delirium?: value of bedside instruments. JAMA. 2010 Aug 18;304(7):779-86. doi: 10.1001/jama.2010.1182. PubMed 20716741 ↗
  • Ytterberg SR, Harris IB, Allen SS, Anderson DC, Kofron PM, Kvasnicka JH, McCord JP, Moller JH. Clinical confidence and skills of medical students: use of an OSCE to enhance confidence in clinical skills. Acad Med. 1998 Oct;73(10 Suppl):S103-5. doi: 10.1097/00001888-199810000-00060. No abstract available. PubMed 9795667 ↗
  • Zaal IJ, Slooter AJ. Delirium in critically ill patients: epidemiology, pathophysiology, diagnosis and management. Drugs. 2012 Jul 30;72(11):1457-71. doi: 10.2165/11635520-000000000-00000. PubMed 22804788 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03642249
Lead sponsor
Taipei Medical University
Responsible party
Sponsor
First posted
Aug 22, 2018
Start date
Nov 5, 2019
Primary completion
Dec 24, 2019
Completion
Dec 31, 2019
Last update
Mar 21, 2023

Study contacts

Kee-Hsin Chen, PhD
study director · Taipei Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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