Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol

Exchange transfusion is a highly complex procedure, performed in neonatal intensive care units under specific medical indications, that requires a high level of expertise [1]. It should be performed only by trained personnel in a neonatal or paediatric intensive care unit equipped with complete monitoring and with the capacity to perform resuscitation if necessary [2]. The need for exchange transfusion has notably decreased with the prevention of haemolytic disease due to rhesus (Rh) incompatibility and with the systematic application of the clinical practice guidelines of the American Academy of Pediatrics (AAP), published in 2004, for the identification and treatment of new-born babies at risk of severe hyperbilirubinemia [3]. Because exchange transfusion is a rare procedure, paediatricians in training do not have experience with it. Opportunities in daily practice to develop skills in exchange transfusion are rare, and professionals in paediatrics do not reach a sufficient level of competence to master this procedure in the clinical setting [4].

Clinical simulation scenarios and digital teaching environments are postulated as valid and effective teaching options for the development of competencies in medical personnel in training at the postgraduate level [5]. The use of simulation-based training as an educational tool has become an increasingly accepted method for improving the skills of health personnel in a safe learning environment [6]. Simulation standardizes and guarantees exposure to a specific event, allows the teaching of specific clinical skills, decreases the generation of error, increases the safety of the patient and the student, and improves clinical judgement [7‐10]. On the other hand, the use of digital environments facilitates learning through interactive tools and is postulated as an effective model for the acquisition of knowledge in medical schools.

We are not aware of reports on the use of simulated learning strategies compared to strategies based on digital didactic environments, particularly in the evaluation of competencies in exchange transfusion.

The implementation of educational strategies related to exchange transfusion during the training of future paediatricians could positively impact the health outcomes of patients who require this procedure [11]. This protocol, through a controlled clinical trial, seeks to compare two educational interventions in exchange transfusion, one based on simulation and another based on the development of a digital didactic environment, for the development of competencies in exchange transfusion performed by postgraduate students in paediatrics.

The use of simulation to teach the knowledge, skills and behaviours necessary for effective paediatric resuscitation has become widespread and has been massively adopted by paediatric institutions; it is of vital importance in topics such as neonatal resuscitation. Studies such as that of Sawyer [12] suggest that simulation education is associated with improved performance in neonatal resuscitation skills and propose the use of simulation in training. Gaies [13], using a randomized controlled trial, compared the standard teaching method with simulation-based modules for training in the performance of frequent paediatric procedures, such as bag mask ventilation, venipuncture, peripherally inserted central catheter and lumbar puncture; it was shown that the participants in the simulation group performed the peripheral insertion of the central catheter more successfully than the controls (78% vs. 35%; P = 0.01) and obtained significantly higher scores on the knowledge tests for various procedures and on checklists for the peripheral insertion of a central catheter (81% vs. 61%; P = 0.003) and lumbar puncture (77% vs. 68%; P = 0.04) in the initial evaluation [13]. Sudikoff studied and evaluated the effectiveness of a simulation session and teamwork in the management of the paediatric airway by paediatric residents in comparison with a group that did not receive the simulation intervention, and found that the intervention group had higher scores (P < 0.05), fewer adverse events and more positive teamwork [14].

On the other hand, in relation to teaching in digital didactic environments in paediatrics, Kessler et al. conducted a randomized controlled trial in paediatric residents and proposed that there is no difference in the effects of lumbar puncture audiovisual training combined with simulation versus audiovisual training alone. Despite better success rates in the first simulated attempt immediately after audiovisual training, with control 6–8 months later, no statistically significant differences were found between the groups in their comfort, knowledge base or performance on the Objective Structured Clinical Examination (OSCE) [15]. Tofil et al. conducted a prospective observational cohort study to evaluate the comfort and performance of second-year residents in simulated resuscitation scenarios and procedural skills, particularly intraosseous needle insertion and intubation, as a result of weekly 1-h sessions during paediatric intensive care rotations accompanied by video simulation assistance; their study showed that the intervention increased the residents’ general confidence in the management of various paediatric resuscitation events and their perceived capability [16].

This is a randomized, parallel, single-blind trial with 1:1 allocation to the interventions studied.

Students in the paediatrics specialization, who meet the inclusion criteria and who wish to participate voluntarily and sign informed consent, will be included. In Colombia, there are currently 700 students in the paediatrics specialization, who are members of the Colombian Society of Pediatrics, and all of them are going to be invited by e-mail, to participate in the study. The inclusion criteria are as follows:

The exclusion criterion is participation in rotation outside Columbia as part of the curriculum.

No previous studies were identified that compared simulation to a digital platform in the development of exchange transfusion competencies. A randomized trial that compared success rates in the performance of frequent paediatric procedures, such as bag mask ventilation, venipuncture, peripherally inserted central catheter and lumbar puncture, identified advantages with simulation compared to standard teaching. This study identifies absolute differences in the likelihood of success of 33%, 20% and 9% in favour of the simulation for the insertion of a central line, peripheral catheter and lumbar puncture, respectively [13]. A 30% difference in the probability of having an acceptable exchange transfusion procedure is considered acceptable when comparing the two teaching interventions [13]. Based on this difference, and for power of 80% and a type I error level of 5%, 80 participants are required (40 per group).

Students will be assigned to the study groups using a computer-generated randomization sequence. This process will be centralized in the paediatric office of the Universidad de La Sabana (University of La Sabana). The sequence will be generated through the Research Randomizer page (www.​randomizer.​org), and a permuted blocks strategy with a block size of 8 will be used. The permuted blocks strategy and the size of the blocks will not be known by the researcher. The random sequence be concealed by placing the allocation in opaque envelopes at the time of assignment.

The researcher and the student cannot be masked to the allocation due to the nature of the interventions. However, the research team responsible for data analysis will be blinded to the allocation as will the expert neonatologist who evaluates the video-recorded procedures using the checklist. The database will be coded and the identification code will not be available to the analyst.

The participants will be described using descriptive statistics. Quantitative variables will be presented as measures of central tendency and dispersion, and qualitative variables as absolute and relative frequencies.

Effect of the intervention: the outcome of the study will be a score equal to or greater than 85% on the OSCE; therefore, the outcome variable will be dichotomous. The chi-square independence test (or the Fisher exact test if the assumption of at least 5 counts per cell is violated) will be performed to evaluate the effect of the interventions. Additionally, relative risk and the respective 95% confidence interval will be estimated as a measure of effect.

Multivariate analysis will be performed using a non-conditional logistic regression model, with the outcome of the study as the dependent variable and the intervention and year of training as the independent variables. Interim analyses will not be performed. Two-tailed analyses will be performed for a type I error level of 5%. The Stata 15® programme will be used in the analyses.