- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07358793
Effectiveness of In-Situ Simulation Training in Adult Non-Trauma Resuscitation: A Comparison of ISS and OSS Team Performance Using the A-C-L-S Model
Effectiveness of In Situ and Off-site Simulation on A-C-L-S Teamwork Model Implementation for Adult Non-trauma Resuscitation: A Two-group Pre-post Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Liang-wei Wang
- Phone Number: +886 972 656 326
- Email: m5867481@gmail.com
Study Locations
-
-
Yunlin
-
Douliu, Yunlin, Taiwan, 64047
- Recruiting
- National Taiwan University Hospital Yunlin Branch (Douliu)
-
Contact:
- Dr. Wang
- Phone Number: +886 972 656 326
- Email: m5867481@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The Adult Non-Traumatic Resuscitation Teams in the emergency departments of the Douliu and Huwei (branches consist of approximately 2 to 7 healthcare professionals per team). The healthcare professionals include attending physicians, resident physicians, specialized nurses, and registered nurses from the National Taiwan University Hospital system.
Exclusion Criteria:
- Medical students and emergency medical technicians (EMTs) observing resuscitation in the emergency room.
- Healthcare professionals who have not obtained a valid ACLS certification.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: In-situ Simulation (ISS) Group
|
The ISS group will undergo high-fidelity simulation training conducted in a real clinical environment, such as the emergency department.
This training will involve a structured scenario with a briefing (20 minutes), a simulation exercise (10 minutes), and a debriefing session (30 minutes).
The goal is to enhance teamwork and improve non-technical skills (e.g., communication, coordination) during adult non-trauma cardiac arrest resuscitation.
The training follows the A-C-L-S (Airway-Circulation-Leadership-Support) model for team role structuring.
|
|
Active Comparator: Off-site Simulation (OSS) Group
|
The OSS group will participate in simulation training at a dedicated simulation center, using high-fidelity mannequins and equipment.
Similar to the ISS group, the training involves a briefing (20 minutes), a simulation scenario (10 minutes), and a debriefing (30 minutes).
However, this training is conducted in a controlled environment away from the real clinical setting.
The training follows the same A-C-L-S model for team role structuring and focuses on improving teamwork and technical skills for resuscitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non-Technical Skills Evaluation Using the TEAM Scale
Time Frame: Through study completion, an average of 1 year
|
The Team Emergency Assessment Measure (TEAM) scale will be used to evaluate non-technical skills.
The scale consists of 11 items across three categories (leadership, teamwork, and task management) and a global rating.
Total scores range from 0 to 44, where higher scores represent better team performance and non-technical skills.
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Key Resuscitation Interventions
Time Frame: Through study completion, an average of 1 year.
|
This measure assesses the efficiency of the ACLS team. We will measure the time intervals (in seconds/minutes) for critical steps, including:
|
Through study completion, an average of 1 year.
|
|
CPR Quality - Chest Compression Fraction (CCF)
Time Frame: Through study completion, an average of 1 year.
|
The Chest Compression Fraction (CCF) is defined as the proportion of total resuscitation time during which active chest compressions are performed.
It is calculated by dividing the total chest compression time by the total duration of the resuscitation event.
This indicator is used to evaluate the resuscitation team's ability to minimize interruptions during cardiopulmonary resuscitation (CPR).
Data will be collected through systematic observation and analysis of resuscitation performance during both in-situ and off-site simulation training, as well as actual clinical events, to assess the effectiveness of the A-C-L-S teamwork model.
|
Through study completion, an average of 1 year.
|
|
Patient Outcomes - Rate of Return of Spontaneous Circulation (ROSC)
Time Frame: Through study completion, an average of 1 year.
|
The percentage of patients achieving Return of Spontaneous Circulation (ROSC) after cardiac arrest.
ROSC is defined as the restoration of a palpable pulse and measurable blood pressure during the resuscitation process.
This measure evaluates the clinical outcome of the A-C-L-S teamwork model.
Data collection includes comprehensive analysis of patient outcomes and factors influencing resuscitation success, such as initial cardiac rhythm, cause of arrest, and pre-hospital interventions, to assess the overall effectiveness of the simulation training.
|
Through study completion, an average of 1 year.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.
- Issenberg SB, McGaghie WC, Petrusa ER, Lee Gordon D, Scalese RJ. Features and uses of high-fidelity medical simulations that lead to effective learning: a BEME systematic review. Med Teach. 2005 Jan;27(1):10-28. doi: 10.1080/01421590500046924.
- Panagioti M, Khan K, Keers RN, Abuzour A, Phipps D, Kontopantelis E, Bower P, Campbell S, Haneef R, Avery AJ, Ashcroft DM. Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta-analysis. BMJ. 2019 Jul 17;366:l4185. doi: 10.1136/bmj.l4185.
- Mei Q, Zhang T, Chai J, Liu A, Liu Y, Zhu H. Application of In Situ Scenario Simulation in Advanced Cardiac Life Support Training for Eight-year Medicinal Students. Medical Journal of Peking Union Medical College Hospital. 2023;14(3):660-664. doi:10.12290/xhyxzz.2022-0676
- Cooper S, Cant R, Connell C, Sims L, Porter JE, Symmons M, Nestel D, Liaw SY. Measuring teamwork performance: Validity testing of the Team Emergency Assessment Measure (TEAM) with clinical resuscitation teams. Resuscitation. 2016 Apr;101:97-101. doi: 10.1016/j.resuscitation.2016.01.026. Epub 2016 Feb 11.
- Maignan M, Koch FX, Chaix J, Phellouzat P, Binauld G, Collomb Muret R, Cooper SJ, Labarere J, Danel V, Viglino D, Debaty G. Team Emergency Assessment Measure (TEAM) for the assessment of non-technical skills during resuscitation: Validation of the French version. Resuscitation. 2016 Apr;101:115-20. doi: 10.1016/j.resuscitation.2015.11.024. Epub 2015 Dec 17.
- Cooper S, Connell C, Cant R. Review article: Use of the Team Emergency Assessment Measure in the rating of emergency teams' non-technical skills: A mapping review. Emerg Med Australas. 2023 Jun;35(3):375-383. doi: 10.1111/1742-6723.14184. Epub 2023 Feb 27.
- Smidt A, Balandin S, Sigafoos J, Reed VA. The Kirkpatrick model: A useful tool for evaluating training outcomes. J Intellect Dev Disabil. 2009 Sep;34(3):266-74. doi: 10.1080/13668250903093125.
- Cortegiani A, Ippolito M, Abelairas-Gomez C, Nabecker S, Olaussen A, Lauridsen KG, Lin Y, Sawyer T, Yeung J, Lockey AS, Cheng A, Greif R; International Liaison Committee on Resuscitation Education, Implementation and Teams Task Force (EIT) Task Force. In situ simulation for cardiopulmonary resuscitation training: A systematic review. Resusc Plus. 2025 Jan 3;21:100863. doi: 10.1016/j.resplu.2024.100863. eCollection 2025 Jan.
- Riley W, Davis S, Miller K, Hansen H, Sainfort F, Sweet R. Didactic and simulation nontechnical skills team training to improve perinatal patient outcomes in a community hospital. Jt Comm J Qual Patient Saf. 2011 Aug;37(8):357-64. doi: 10.1016/s1553-7250(11)37046-8.
- Hunt EA, Hohenhaus SM, Luo X, Frush KS. Simulation of pediatric trauma stabilization in 35 North Carolina emergency departments: identification of targets for performance improvement. Pediatrics. 2006 Mar;117(3):641-8. doi: 10.1542/peds.2004-2702.
- Hunt EA, Heine M, Hohenhaus SM, Luo X, Frush KS. Simulated pediatric trauma team management: assessment of an educational intervention. Pediatr Emerg Care. 2007 Nov;23(11):796-804. doi: 10.1097/PEC.0b013e31815a0653.
- Steinemann S, Berg B, Skinner A, DiTulio A, Anzelon K, Terada K, Oliver C, Ho HC, Speck C. In situ, multidisciplinary, simulation-based teamwork training improves early trauma care. J Surg Educ. 2011 Nov-Dec;68(6):472-7. doi: 10.1016/j.jsurg.2011.05.009. Epub 2011 Aug 3.
- Carayon P, Schoofs Hundt A, Karsh BT, Gurses AP, Alvarado CJ, Smith M, Flatley Brennan P. Work system design for patient safety: the SEIPS model. Qual Saf Health Care. 2006 Dec;15 Suppl 1(Suppl 1):i50-8. doi: 10.1136/qshc.2005.015842.
- Weaver SJ, Rosen MA, Salas E, Baum KD, King HB. Integrating the science of team training: guidelines for continuing education. J Contin Educ Health Prof. 2010 Fall;30(4):208-20. doi: 10.1002/chp.20085.
- Zendejas B, Cook DA, Bingener J, Huebner M, Dunn WF, Sarr MG, Farley DR. Simulation-based mastery learning improves patient outcomes in laparoscopic inguinal hernia repair: a randomized controlled trial. Ann Surg. 2011 Sep;254(3):502-9; discussion 509-11. doi: 10.1097/SLA.0b013e31822c6994.
- Issenberg SB, McGaghie WC, Hart IR, Mayer JW, Felner JM, Petrusa ER, Waugh RA, Brown DD, Safford RR, Gessner IH, Gordon DL, Ewy GA. Simulation technology for health care professional skills training and assessment. JAMA. 1999 Sep 1;282(9):861-6. doi: 10.1001/jama.282.9.861.
- Merien AER, van de Ven J, Mol BW, Houterman S, Oei SG. Multidisciplinary team training in a simulation setting for acute obstetric emergencies: a systematic review. Obstet Gynecol. 2010 May;115(5):1021-1031. doi: 10.1097/AOG.0b013e3181d9f4cd.
- Weaver SJ, Salas E, Lyons R, Lazzara EH, Rosen MA, Diazgranados D, Grim JG, Augenstein JS, Birnbach DJ, King H. Simulation-based team training at the sharp end: A qualitative study of simulation-based team training design, implementation, and evaluation in healthcare. J Emerg Trauma Shock. 2010 Oct;3(4):369-77. doi: 10.4103/0974-2700.70754.
- Eppich W, Howard V, Vozenilek J, Curran I. Simulation-based team training in healthcare. Simul Healthc. 2011 Aug;6 Suppl:S14-9. doi: 10.1097/SIH.0b013e318229f550.
- Chong KM, Chou EH, Chiang WC, Wang HC, Liu YP, Ko PC, Huang EP, Hsieh MJ, Lin HY, Lien WC, Huang CH, Fang CC, Chen SC, Bhanji F, Yang CW, Ma MH. Development and Evaluation of a Novel Resuscitation Teamwork Model for Out-of-Hospital Cardiac Arrest in the Emergency Department. Ann Emerg Med. 2025 Feb;85(2):163-178. doi: 10.1016/j.annemergmed.2024.09.008. Epub 2024 Nov 8.
- Aitken M, Gorokhovich L. Advancing the Responsible Use of Medicines: Applying Levers for Change. SSRN Electronic Journal. Sep 17 2012;doi:10.2139/ssrn.2222541
- National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Board on Global Health; Committee on Improving the Quality of Health Care Globally. Crossing the Global Quality Chasm: Improving Health Care Worldwide. Washington (DC): National Academies Press (US); 2018 Aug 28. Available from http://www.ncbi.nlm.nih.gov/books/NBK535653/
Helpful Links
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
Other Study ID Numbers
- 202510146RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Adult Non-trauma Cardiac Arrest Resuscitation
-
Far Eastern Memorial HospitalNational Health Research Institutes, TaiwanRecruitingOut-of-hospital Cardiac Arrest (OHCA) | Cardiopulmonary Resuscitation (CPR) | Aortic Valve Compression | Precision ResuscitationTaiwan
-
Felix BrinkmannEnrolling by invitationEmergency Medical Services | First Aid | Resuscitation | Cardiac Arrest With Successful Resuscitation | Cardiac Arrest (CA) | Survival Rate | Bystander Effect | Defibrillators | Critical Care Medicine | Paramedical Professionals | Cardiopulmonary Resuscitation (CPR)Switzerland
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI); Food and Drug Administration... and other collaboratorsCompletedExtracorporeal Membrane Oxygenation | Heart Arrest | Cardiac Arrest | Cardiopulmonary Resuscitation | Death, Sudden, Cardiac | Sudden Cardiac Arrest | Cardiopulmonary Arrest | CPR | Extracorporeal Cardiopulmonary ResuscitationUnited States
-
Stefano Malinverni, MDAndre Vesale AssociationCompletedCardiac Arrest With Successful ResuscitationBelgium
-
Medical University of ViennaCompletedCardiac Arrest With Successful ResuscitationAustria
-
National Taiwan University HospitalUnknownCardiac Arrest | Cardiopulmonary ResuscitationTaiwan
-
Mario Negri Institute for Pharmacological ResearchRecruitingCardiac Arrest With Successful Resuscitation | Cardiac Arrest, Out-Of-HospitalItaly
-
Norwegian University of Science and TechnologyUllevaal University Hospital; Haukeland University Hospital; St. Olavs Hospital; Rikshospitalet University Hospital and other collaboratorsCompletedCardiopulmonary Resuscitation | Cardiac Arrest (CA) | Doppler UltrasoundNorway, Sweden
-
Assistance Publique - Hôpitaux de ParisURC Necker Cochin, FranceRecruitingOut-of-Hospital Cardiac Arrest | Extracorporeal Cardiopulmonary ResuscitationFrance
-
General University Hospital, PragueRecruitingOut of Hospital Cardiac Arrest | Extracorporeal Cardiopulmonary ResuscitationCzech Republic
Clinical Trials on In-situ Simulation (ISS) Training
-
Universidade do PortoHospital Pedro Hispano, ULS Matosinhos; Faculty of Medicine of the University... and other collaboratorsNot yet recruitingin Situ Simulation | Simulation in Training CenterPortugal
-
University of Sao PauloCompletedExclusive Breastfeeding | Breastfeeding Self-EfficacyBrazil
-
Rigshospitalet, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention ResearchCompletedSimulation | Education | Obstetrics | 'In Situ Simulation'Denmark
-
Mehmet Akif Ersoy UniversityCompleted
-
Prehospital Center, Region ZealandCompletedDrowning | Drowning, Near | Drowning and Nonfatal Submersion | Drowning and Submersion While in Natural Water | Drowning/SubmersionDenmark
-
National University Hospital, SingaporeCompleted
-
Selçuk GörücüNot yet recruitingPatient SafetyTurkey (Türkiye)
-
Memorial University of NewfoundlandWithdrawnLaceration | Sutured Laceration
-
Selçuk GörücüNot yet recruitingPatient Safety | Peripheral Intravenous Catheter-Related İnfiltration
-
Hospices Civils de LyonUnknown