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

María José Maldonado, Sergio Iván Agudelo, Juan David Suarez, Oscar Gamboa, María José Maldonado, Sergio Iván Agudelo, Juan David Suarez, Oscar Gamboa

Abstract

Background: Exchange transfusion is a highly complex procedure that requires high levels of expertise. Trainee paediatricians do not have adequate training in exchange transfusion because opportunities to perform this procedure in practice are scarce. This protocol seeks to compare two educational interventions for exchange transfusion that allow students to develop competencies to perform the technique in an appropriate and safe way.

Methods/design: This is a randomized parallel single-blind clinical trial with allocation by simple randomization to the educational intervention (simulation or a digital didactic environment). Students from the paediatric specialization who volunteer to participate will be included. A practical evaluation of the procedure will be performed through a simulated scenario using a standardized clinical case. The main outcome is defined as the result of evaluation using the Objective Structured Clinical Examination; superior performance will be defined when the percentage is greater than or equal to 85%, and non-superior performance will be defined when the result is less than 84%. The chi-square independence test or the Fisher exact test will be used to evaluate the effect of the interventions. Multivariate analysis will be performed using a non-conditional logistic regression model. Stata 15® software will be used.

Discussion: Exchange transfusion is a procedure that requires expertise to achieve adequate outcomes. The inclusion of new educational strategies, such as simulation and digital didactic environments, is seen as a training option that can improve performance in clinical skills, reduce adverse events and increase the level of trust.

Trial registration: ClinicalTrials.gov: NCT04070066. Registered on 28 August 2019. https://clinicaltrials.gov.

Keywords: Individual assessment; Newborn; Objective Structured Clinical Examination (OSCE); Safety training; Simulation centre; Simulation training; Telemedicine; Virtual.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of enrolment, intervention, and assessment. OSCE, Objective Structured Clinical Examination
Fig. 2
Fig. 2
Schedule protocol. OSCE, Objective Structured Clinical Examination

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