Educational Strategy IN Exchange Transfusion

Telemedicine Clinical Trial

— INTEXUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04070066
• Other study ID #: 451
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2019
• Source: Universidad de la Sabana
• Contact: Sergio I Agudelo, Professor
• Phone: 571-3105612142
• Email: sergioagpe[@]unisabana.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Assessment, Self
• Newborn Morbidity
• Simulation Training
• Telemedicine

Intervention

Other:
• Digital didactic environment
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
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.

Locations

Country	Name	City	State
Colombia	Universidad de La Sabana	Chía	Cundinamarca

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de la Sabana

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall result of the OSCE evaluation (checklist).	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%.	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
Secondary	Performance on the OSCE checklist in sub-areas: Clinical History	Clinical history and approach to patient risk and indication for exchange transfusion	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
Secondary	Performance on the OSCE checklist in sub-areas: assesment	Comprehensive assessment of the patient with neonatal jaundice	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
Secondary	Performance on the OSCE checklist in sub-areas: exchange transfusion	Management of the patient with neonatal jaundice and indication for exchange transfusion	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