Clinical trial NCT04364529: Implementation of Pit Crew Resuscitation Model on the Training of Advanced Life Support: a Randomized Controlled Study
Official title: Impact of Pit Crew Resuscitation Model on Advanced Life Support Skills in a Simulated Setting: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cardiac Life Support
Keywords: non-technical skills
technical skills
Simulation Training
Patient simulation
CRM
Crew Recourse Management
team work
human factors
pit crew model
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Turku University of Applied Sciences
First posted: 2020-04-28
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: The difference in the total assessment score between the intervention and control groups after 6-months follow-up.
timeFrame: 6 months follow-up
Secondary outcomes:
measure: The difference in ALS skills after 6-months follow-up.
timeFrame: 6 months follow-up
Other outcomes:
measure: 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.
timeFrame: Baseline and 6 months
Locations:
city: Turku
country: Finland
facility: Turku University
Study officials:
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