NCT03642249

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 21, 2023

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

August 16, 2018

Last Update Submit

March 19, 2023

Conditions

Keywords

deliriumknowledge translationObjective Structured Clinical Examinationevidence-based practice

Outcome Measures

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)

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

Study Arms (2)

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).

Behavioral: OSCEsBehavioral: LectureBehavioral: 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)

Behavioral: LectureBehavioral: E-learning

Interventions

OSCEsBEHAVIORAL

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

experimental group
LectureBEHAVIORAL

Face-to-face Education using Delirium Care Flip Chart

control groupexperimental group
E-learningBEHAVIORAL

delirium care video

control groupexperimental group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unwilling to involved the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wan Fang Hospital

Taipei, 116, Taiwan

Location

Related Publications (23)

  • 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.

    PMID: 25477307BACKGROUND
  • 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.

    PMID: 19424763BACKGROUND
  • 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.

    PMID: 24998488BACKGROUND
  • 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.

    PMID: 28095583BACKGROUND
  • 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.

    PMID: 27766672BACKGROUND
  • 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.

    PMID: 17695343BACKGROUND
  • 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.

    PMID: 23829698BACKGROUND
  • 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.

    PMID: 24673674BACKGROUND
  • 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.

    PMID: 24718019BACKGROUND
  • 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.

    PMID: 26439374BACKGROUND
  • 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.

    PMID: 10053175BACKGROUND
  • 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.

    PMID: 26966365BACKGROUND
  • 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.

    PMID: 24295565BACKGROUND
  • 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.

    PMID: 28985260BACKGROUND
  • 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.

    PMID: 17102966BACKGROUND
  • 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.

    PMID: 15488152BACKGROUND
  • 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.

    PMID: 26041151BACKGROUND
  • 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.

    PMID: 26967259BACKGROUND
  • 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.

    PMID: 28571901BACKGROUND
  • 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.

    PMID: 21401762BACKGROUND
  • 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.

    PMID: 20716741BACKGROUND
  • 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.

    PMID: 9795667BACKGROUND
  • 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.

    PMID: 22804788BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Kee-Hsin Chen, PhD

    Taipei Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 22, 2018

Study Start

November 5, 2019

Primary Completion

December 24, 2019

Study Completion

December 31, 2019

Last Updated

March 21, 2023

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations