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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04364529
Other study ID # T212/2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 14, 2017
Est. completion date January 30, 2020

Study information

Verified date November 2021
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, a pit crew model is implemented in advanced life support (ALS) simulation training to student groups. The hypothesis is that the tactic model could help to maintain the CPR skills during the six month follow-up period.


Description:

Introduction Technical skills (TS) and non-technical skills (NTS) are two sets of skills required by Crisis resource management (CRM). Sudden cardiac arrest is a time-critical emergency situation in which both skills are needed - it's handled by a team rather than by individual health-care workers. Because of the relatively rare nature of cardiac arrests in many wards and clinics, regular resuscitation training is necessary. However, the main part of the training is traditionally emphasized to technical skills. The recent research findings of the authors suggest that the TS and NTS seem to associate in a real life resuscitation. The authors wanted to investigate if pre-allocated tasks and positions (a pit crew model) helps to perform better ALS performance and helps to maintain the skills in simulated ALS situations. Simulation-based education (SBE) is a key tool for teaching CPR. It has demonstrated its effectiveness in promoting skill acquisition and has been suggested as an ideal tool for teaching medical skills allowing learners to engage actively in their learning process while doing no harm to their patients but its effectiveness on improving anesthesiologists NTS is unclear as the matter has not been studied. SBE is particularly good method to create trainees a realistic medical crisis situation (scenario) created within a physical space (simulator) replicating the real environment where trainees goal is to solve the problem, do the diagnose and treat the patient. Afterwards, the simulation debriefing is an crucial part of the whole letting trainees and the instructor to finish the learning process. Traditionally such training has been a standard in professions characterized by high risk caused by 'human factor' such as in aviation and other high risk industries. On the other hand the benefit for maintaining resuscitation skills learned after single SBE is modest thus short - only a few minutes a week - but frequent SBE appears to facilitate transfer of new knowledge and skills into clinical practice. SBE has been shown to improve the satisfaction of learners and skill performance in the simulated environment but it's still unclear whether it improves the patient outcome. Simulation training is expensive though so other teaching methods like mental practice and e-learning could be useful alongside it. Catchpole and colleagues aimed to improve the quality and safety of handover of pediatric patients from surgery to intensive care using the analogy of a Formula 1 pit stop and expertise from aviation. They introduced a new handover protocol which led to improvements in all aspects of the critical situation. Based on he same idea, a novel resuscitation tactic model (a pit crew model) was developed which predetermines the roles and responsibilities of each resuscitation team members. Purpose and hypothesis In this study, advanced life support (ALS) skills are trained to medical students (26 persons), student nurses (52 persons) and student paramedics (26 persons). A pit crew model is taught for every other four-person resuscitation team (intervention group) and for every other group not (control group). The hypothesis is that the pit crew model could improve the quality of advanced life support immidiately after the ALS education (primary outcome) and help to maintain the ALS metrics during the follow-up period (secondary outcome). Additionally, we analyze if the pit-crew model help team physician to take hands free earlier. Methods The students are divided into 26 four-person resuscitation teams: one medical student, one student paramedic and two student nurses. Each resuscitation team participates on an ALS course which is based on the 2015 European (the test group) Guidelines for Resuscitation. The participants are randomized in two study arms: intervention and control. The intervention group receives ALS education according the pit crew model while the control Group received traditional ALS training. In the end of the ALS course, the resuscitation team performs a simulated resuscitation situation which is video-recorded. The TS and NTS are later analyzed by the medical professionals using detailed instrument. The hands-on ratio and the time when the team physician takes hands-free analyzed visually from the videos. Later, after six months of the ALS course, the participants will run through a simulated CPR-situation again and the data will be collected as the the same way. The primary outcome was the difference in the total assessment score between the intervention and control groups after 6-months follow-up. The secondary outcome was the difference in ALS skills after 6-months follow-up. Ethics The study protocol was approved by the Ethics Committee of Turku University (31/2016).


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date January 30, 2020
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - medical student (fourth or fifth year) - paramedic student (third or fourth year) - nurse student (third or fourth year) - participated simulated ALS-situations e.g. in school before Exclusion Criteria: - participated more than two real-life ALS-situations

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The pit crew model
The pit crew model

Locations

Country Name City State
Finland Turku University Turku

Sponsors (2)

Lead Sponsor Collaborator
Turku University Hospital Turku University of Applied Sciences

Country where clinical trial is conducted

Finland, 

References & Publications (13)

Asarbakhsh M, Sandars J. E-learning: the essential usability perspective. Clin Teach. 2013 Feb;10(1):47-50. doi: 10.1111/j.1743-498X.2012.00627.x. — View Citation

Catchpole K, Mishra A, Handa A, McCulloch P. Teamwork and error in the operating room: analysis of skills and roles. Ann Surg. 2008 Apr;247(4):699-706. doi: 10.1097/SLA.0b013e3181642ec8. — View Citation

Cheng A, Auerbach M, Hunt EA, Chang TP, Pusic M, Nadkarni V, Kessler D. Designing and conducting simulation-based research. Pediatrics. 2014 Jun;133(6):1091-101. doi: 10.1542/peds.2013-3267. Epub 2014 May 12. Review. — View Citation

Cheng A, Lang TR, Starr SR, Pusic M, Cook DA. Technology-enhanced simulation and pediatric education: a meta-analysis. Pediatrics. 2014 May;133(5):e1313-23. doi: 10.1542/peds.2013-2139. Epub 2014 Apr 14. — View Citation

Didwania A, McGaghie WC, Cohen ER, Butter J, Barsuk JH, Wade LD, Chester R, Wayne DB. Progress toward improving the quality of cardiac arrest medical team responses at an academic teaching hospital. J Grad Med Educ. 2011 Jun;3(2):211-6. doi: 10.4300/JGME-D-10-00144.1. — View Citation

Eppich WJ, Nypaver MM, Mahajan P, Denmark KT, Kennedy C, Joseph MM, Kim I. The role of high-fidelity simulation in training pediatric emergency medicine fellows in the United States and Canada. Pediatr Emerg Care. 2013 Jan;29(1):1-7. doi: 10.1097/PEC.0b013e31827b20d0. — View Citation

Gjeraa K, Møller TP, Østergaard D. Efficacy of simulation-based trauma team training of non-technical skills. A systematic review. Acta Anaesthesiol Scand. 2014 Aug;58(7):775-87. doi: 10.1111/aas.12336. Epub 2014 May 14. Review. — View Citation

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. Review. — View Citation

Lorello GR, Hicks CM, Ahmed SA, Unger Z, Chandra D, Hayter MA. Mental practice: a simple tool to enhance team-based trauma resuscitation. CJEM. 2016 Mar;18(2):136-42. doi: 10.1017/cem.2015.4. Epub 2015 Apr 10. — View Citation

Mduma E, Ersdal H, Svensen E, Kidanto H, Auestad B, Perlman J. Frequent brief on-site simulation training and reduction in 24-h neonatal mortality--an educational intervention study. Resuscitation. 2015 Aug;93:1-7. doi: 10.1016/j.resuscitation.2015.04.019. Epub 2015 May 6. — View Citation

Nicastro E, Lo Vecchio A, Liguoro I, Chmielewska A, De Bruyn C, Dolinsek J, Doroshina E, Fessatou S, Pop TL, Prell C, Tabbers MM, Tavares M, Urenden-Elicin P, Bruzzese D, Zakharova I, Sandhu B, Guarino A. The Impact of E-Learning on Adherence to Guidelines for Acute Gastroenteritis: A Single-Arm Intervention Study. PLoS One. 2015 Jul 6;10(7):e0132213. doi: 10.1371/journal.pone.0132213. eCollection 2015. — View Citation

Rovamo L, Nurmi E, Mattila MM, Suominen P, Silvennoinen M. Effect of a simulation-based workshop on multidisplinary teamwork of newborn emergencies: an intervention study. BMC Res Notes. 2015 Nov 12;8:671. doi: 10.1186/s13104-015-1654-2. — View Citation

Wayne DB, Didwania A, Feinglass J, Fudala MJ, Barsuk JH, McGaghie WC. Simulation-based education improves quality of care during cardiac arrest team responses at an academic teaching hospital: a case-control study. Chest. 2008 Jan;133(1):56-61. Epub 2007 Jun 15. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Team physician hands-free from the hands-on work and the chest compression hands-on ratio (hands-on time divided by the total ALS time) between the groups. These are calculated visually from the videos. Baseline and 6 months
Primary The difference in the total assessment score between the intervention and control groups after 6-months follow-up. The NTS and TS are evaluated with a valid measurement tool developed for this purpose by two independent evaluators. The instrument consist of 59 items (28 items for TS and the rest for NTS) and the scale of +2 to -2 is used. Additionally, raters gave a total assessment score of performance on a scale from 0 to 10 (0=poor, 10=excellent) 6 months follow-up
Secondary The difference in ALS skills after 6-months follow-up. The NTS and TS are evaluated with a valid measurement tool developed for this purpose by two independent evaluators. The instrument consist of 59 items (28 items for TS and the rest for NTS) and the scale of +2 to -2 is used. 6 months follow-up
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