- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Naile Alankaya, Associate Prof. PhD
- Telefonní číslo: +905334256510
- E-mail: naile.alankaya@gmail.com
Studijní místa
-
-
Kartal
-
Istanbul, Kartal, Turecko (Türkiye), 17100
- Nábor
- Kosuyolu High Specialization Training and Research Hospital
-
Kontakt:
- Huriye ARSLANER, PhD
- Telefonní číslo: +905053027009
- E-mail: arslanerhuriye@hotmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
|
|
Žádný zásah: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Arrhythmia Recognition and Awareness Test (ARAT)
Časové okno: 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.
|
Baseline and 3 months after randomization
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Safety Attitudes Questionnaire (SAQ)
Časové okno: 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.
|
Baseline and 3 months after randomization
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Naile Alankaya, Associate Prof. PhD, Çanakkale Onsekiz Mart University, Faculty of Health Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- COMU-SBF-NA-04
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .