NCT04364529

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

1.4 years

First QC Date

March 4, 2020

Last Update Submit

November 5, 2021

Conditions

Keywords

non-technical skillstechnical skillsSimulation TrainingPatient simulationCRMCrew Recourse Managementteam workhuman factorspit crew model

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The difference in ALS skills after 6-months follow-up.

    6 months follow-up

Other Outcomes (1)

  • 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.

    Baseline and 6 months

Study Arms (2)

Intervention (pit crew model group)

EXPERIMENTAL

13 groups being taught the pit crew model

Other: The pit crew model

control (traditional ALS education)

NO INTERVENTION

13 groups being taught along traditional ALS education

Interventions

The pit crew model

Intervention (pit crew model group)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • participated more than two real-life ALS-situations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University

Turku, Finland

Location

Related Publications (13)

  • 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.

    PMID: 24819576BACKGROUND
  • 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.

    PMID: 26563963BACKGROUND
  • 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.

    PMID: 24733867BACKGROUND
  • 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.

    PMID: 23283253BACKGROUND
  • 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.

    PMID: 23294744BACKGROUND
  • 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.

    PMID: 22655144BACKGROUND
  • 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. doi: 10.1378/chest.07-0131. Epub 2007 Jun 15.

    PMID: 17573509BACKGROUND
  • 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.

    PMID: 25860822BACKGROUND
  • 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.

    PMID: 26148301BACKGROUND
  • 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.

    PMID: 18362635BACKGROUND
  • 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.

    PMID: 25957942BACKGROUND
  • Gjeraa K, Moller TP, Ostergaard 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.

    PMID: 24828210BACKGROUND
  • 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.

    PMID: 16147767BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The partisipants are unknown of the study design. They are told that they have been randomized in two groups who receive ALS education in two different ways. Two senior anesthetists analyse the ALS-performance of the video recordings. They are unaware of the study design. They analyze the videos independently and in random order.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The students are divided into 26 four-person resuscitation teams: one medical student, one student paramedic and two student nurses. These 26 teams are randomidez in two study arms: intervention (pit-crew group) and the control Group.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

April 28, 2020

Study Start

August 14, 2017

Primary Completion

December 30, 2018

Study Completion

January 30, 2020

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Participants in the videos can be recognized. Video material can not be shared due to patient privacy. Other data is possible to share.

Locations