- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07780448
Case-Based Collaborative Learning for Arrhythmia Recognition in Novice Intensive Care Nurses
Effect of Case-Based Collaborative Learning on Arrhythmia Recognition and Patient Safety Attitudes Among Novice Intensive Care Nurses: A Randomized Controlled Trial
This randomized controlled trial evaluates the effectiveness of case-based collaborative learning (CBCL) in improving arrhythmia recognition and patient safety attitudes among novice intensive care nurses. Newly graduated nurses with less than one year of professional nursing experience working in coronary or cardiovascular surgery intensive care units are randomly assigned to an intervention or control group.
Both groups participate in the institution's routine orientation process for newly employed intensive care nurses. In addition, the intervention group receives a structured CBCL-based arrhythmia education program delivered in two 120-minute sessions over two consecutive weeks. The program uses clinical case scenarios, ECG tracings, individual assessment, small-group collaborative discussion, shared clinical decision-making, and structured feedback. The control group receives no additional study-specific arrhythmia education during the study period.
The primary outcome is arrhythmia recognition and awareness, and the secondary outcome is patient safety attitudes. Outcomes are assessed at baseline and at the three-month follow-up in both groups. An additional immediate post-intervention assessment is conducted in the intervention group to examine short-term changes following the educational program.
Study Overview
Status
Intervention / Treatment
Detailed Description
Early recognition and appropriate interpretation of cardiac arrhythmias are important competencies for nurses working in intensive care settings, where changes in cardiac rhythm may require rapid clinical assessment and timely escalation of care. Novice nurses may have limited opportunities to develop these competencies through clinical experience alone. This study therefore evaluates a case-based collaborative learning (CBCL) approach designed to integrate arrhythmia recognition with clinical reasoning, nursing decision-making, and patient-safety principles.
The CBCL intervention uses clinically oriented arrhythmia scenarios accompanied by ECG tracings. Participants first assess each case individually and then work in small groups to discuss their interpretations and reach a shared clinical decision. Group conclusions are subsequently discussed with the educator, who facilitates analysis of the case, clarification of misconceptions, and structured feedback. Patient-safety principles, including recognition of hemodynamic instability, timely escalation of care, differentiation of true arrhythmias from monitoring artefacts, and assessment of the patient's clinical condition, are integrated throughout the educational activities.
The main effectiveness evaluation compares the intervention and control groups at the three-month follow-up while accounting for baseline outcome levels. An additional assessment immediately after completion of the educational program is conducted only in the intervention group to explore the immediate educational response and whether the observed improvement is maintained at three months.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Naile Alankaya, Associate Prof. PhD
- Phone Number: +905334256510
- Email: naile.alankaya@gmail.com
Study Locations
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Kartal
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Istanbul, Kartal, Turkey (Türkiye), 17100
- Recruiting
- Koşuyolu High Specialization Training and Research Hospital
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Contact:
- Huriye ARSLANER, PhD
- Phone Number: +905053027009
- Email: arslanerhuriye@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Newly graduated nurses with less than one year of professional nursing experience
- Currently working in the coronary intensive care unit or cardiovascular surgery intensive care unit
- Voluntary participation in the study
- Provision of written informed consent
Exclusion Criteria:
- Previous participation in a structured arrhythmia or ECG training program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Case-Based Collaborative Learning Group
Participants receive the institution's routine orientation for newly employed intensive care nurses in addition to a structured case-based collaborative learning (CBCL) program focused on arrhythmia recognition, ECG interpretation, clinical decision-making, and patient safety.
The CBCL program consists of two 120-minute sessions delivered over two consecutive weeks.
Each session incorporates clinical case scenarios, ECG tracings, individual assessment, small-group collaborative discussion, shared clinical decision-making, facilitator-guided analysis, and structured feedback.
|
The intervention consists of two 120-minute educational sessions delivered once weekly over two consecutive weeks by a researcher with formal ECG training and certification in ECG interpretation.
Each session uses clinically oriented arrhythmia cases accompanied by ECG tracings.
Participants first assess the case individually and then work in small groups of 5-6 nurses to discuss their interpretations and reach a shared clinical decision.
Groups present their conclusions, followed by facilitator-guided whole-group analysis, clarification of misconceptions, and structured feedback.
The program addresses ECG interpretation, life-threatening rhythms, bradyarrhythmias, atrioventricular blocks, atrial tachyarrhythmias, medication- and electrolyte-related ECG changes, QT prolongation, and monitoring problems.
Patient-safety principles and appropriate nursing responses and escalation of care are integrated throughout the cases.
Other Names:
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No Intervention: Control Group
Participants undergo the institution's routine orientation process for newly employed intensive care nurses and continue their usual clinical practice.
They receive no study-specific CBCL intervention or additional arrhythmia-focused education from the research team during the study period.
After completion of the three-month follow-up and final data collection, participants in the control group are offered the same arrhythmia education program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arrhythmia Recognition and Awareness Test (ARAT)
Time Frame: Baseline and 3 months after randomization
|
The Arrhythmia Recognition and Awareness Test (ARAT) consists of 27 items assessing arrhythmia recognition and awareness.
Each correct response is scored as 1 and each incorrect response as 0, yielding a total score ranging from 0 to 27.
Higher scores indicate better arrhythmia recognition and awareness.
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Baseline and 3 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety Attitudes Questionnaire (SAQ)
Time Frame: Baseline and 3 months after randomization
|
The Safety Attitudes Questionnaire (SAQ) is used to assess participants' attitudes toward patient safety.
The questionnaire includes 46 items rated on a 5-point Likert scale and comprises six dimensions: teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions.
Higher scores indicate more positive attitudes toward patient safety.
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Baseline and 3 months after randomization
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Naile Alankaya, Associate Prof. PhD, Çanakkale Onsekiz Mart University, Faculty of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COMU-SBF-NA-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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