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OpenTrials
Completed

NCT Number: NCT04070066

Educational Strategy in Exchange Transfusion

Abstract

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

Methods/design: 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 nonsuperior 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 14 ® 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.

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Key information

Conditions

Newborn Morbidity Assessment, Self Simulation Training Telemedicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de La Sabana

Chía, Cundinamarca, 140013, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • o Men and women of legal age who are students enrolled in a paediatrics specialization programme at Colombian university medical schools.
  • Students in any year of specialization in paediatrics.

Exclusion criteria

  • Students who are, as part of their curriculum, in a rotation outside the country.

Treatment and study plan

Digital didactic environment

Other

Students assigned to this group will receive access to a digital didactic environment where they will have at their disposal the exchange transfusion guide and a complete video explaining the indications, the preparation of supplies and the newborn for the procedure, the management of medical devices required and a step-by-step description of the exchange transfusion technique. Finally, the student will see an integrated clinical case. This video will be developed by the neonatology and paediatric medical education teaching team in the simulation laboratory of the university using neonatal high-fidelity simulators, a simulated mother and the necessary medical equipment and supplies.

• Simulated scenario

Other

The educational intervention will be developed with the students, led by the neonatology teacher, in the simulation laboratory. For the training, neonatal high-fidelity simulators, clinical history and paraclinical exams, necessary supplies for the procedure, a simulated mother, a professional nurse and a nursing assistant will be available. Training will take place in individual skill stations (identification of indications, communication, management of medical devices and procedures) and in integrated clinical scenarios.

Primary outcomes

  1. Overall result of the OSCE evaluation (checklist).

    Time frame: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios

    The performance score will be the score obtained for the evaluation divided by the maximum possible score of the test and multiplied by 100. A superior performance is defined as a score greater than or equal to 85%, and a nonsuperior performance is defined as a score equal to or less than 84%.

Secondary outcomes

  1. Performance on the OSCE checklist in sub-areas: Clinical History

    Time frame: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios

    Clinical history and approach to patient risk and indication for exchange transfusion

  2. Performance on the OSCE checklist in sub-areas: assesment

    Time frame: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios

    Comprehensive assessment of the patient with neonatal jaundice

  3. Performance on the OSCE checklist in sub-areas: exchange transfusion

    Time frame: The checklist was applied by a reviewer blinded to the assignment of the type of intervention by reviewing the video, on average 4 week after of the participation of the groups in the scenarios

    Management of the patient with neonatal jaundice and indication for exchange transfusion

Sponsors and collaborators

Lead sponsor

Universidad de la Sabana

Other

Registry information

Official study title

Educational Strategy for the Development of Skills in Exchange Trnasfusion: a Randomized Clinical Trial Protocol

Acronym: INTEXUS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2019
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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