Effects of Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium

• Sponsor: Taipei Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05623475
• Collaborator: (none)
• Enrollment: 116
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20.1
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium	Behavioral: OSCEs; Behavioral: Lecture; Behavioral: E-learning	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Health Services Research
• 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
• Actual Study Start Date: Oct 25, 2021
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group face-to-face delirium care session (30 minutes in duration); online learning delirium care activities (20 minutes in duration); and delirium care OSCE and reflective activity (30 minutes in duration).	Behavioral: OSCEs; Scenario-based education intervention, including objective structured clinical examinations (OSCEs); Behavioral: Lecture; Face-to-face Education using Delirium Care Flip Chart; Behavioral: E-learning; Including 7 parts of delirium care video
Active Comparator: control group face-to-face delirium care session (30 minutes in duration); online learning delirium care activities (20 minutes in duration)	Behavioral: Lecture; Face-to-face Education using Delirium Care Flip Chart; Behavioral: E-learning; Including 7 parts of delirium care video

Outcome Measures

Primary Outcome Measures

1. Delirium Knowledge and Skills Test (included 18 questions) [T0(Baseline), T1(Immediately after the intervention), T2(Six weeks after the intervention)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Registered nurse worked in acute care unit and care with critical patients

2. Licensed physician which undertake the post graduate year program worked in acute care unit and care with critical patients

Exclusion Criteria:

1.Unwilling to involved the research

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Medical University Hospital	Taipei		Taiwan	11031

Sponsors and Collaborators

• Taipei Medical University

Investigators

• Principal Investigator: Kee-Hsin Chen, PhD, Taipei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taipei Medical University
• ClinicalTrials.gov Identifier: NCT05623475
• Other Study ID Numbers: N20210318
• First Posted: Nov 21, 2022
• Last Update Posted: Nov 21, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Taipei Medical University: Intensive Care Unit Syndrome; Delirium; OSCE
• Additional relevant MeSH terms: Delirium

Study Results

No Results Posted as of Nov 21, 2022