- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03642249
Education for Recognition and Management of Delirium
March 19, 2023 updated by: Taipei Medical University
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 116
- Wan Fang Hospital
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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
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Registered nurse worked in acute care unit and care with critical patients
- Age > 20 years old.
Exclusion Criteria:
- Unwilling to involved the research
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
|
Scenario-based education intervention, including objective structured clinical examinations (OSCEs)
Face-to-face Education using Delirium Care Flip Chart
delirium care video
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Active Comparator: control group
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Face-to-face Education using Delirium Care Flip Chart
delirium care video
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Delirium Knowledge and Skills Test (included 18 questions)
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T0(Baseline), T1(Immediately after the intervention), T2(Six weeks after the intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kee-Hsin Chen, PhD, Taipei Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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:CD005563. doi: 10.1002/14651858.CD005563.pub3.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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 (Actual)
November 5, 2019
Primary Completion (Actual)
December 24, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
August 16, 2018
First Submitted That Met QC Criteria
August 20, 2018
First Posted (Actual)
August 22, 2018
Study Record Updates
Last Update Posted (Actual)
March 21, 2023
Last Update Submitted That Met QC Criteria
March 19, 2023
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201803104
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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