Clinical trial NCT04070066: Educational Strategy in Exchange Transfusion
Official title: Educational Strategy for the Development of Skills in Exchange Trnasfusion: a Randomized Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Morbidity
Simulation Training
Telemedicine
Assessment, Self
Keywords: Newborn, infant
exchange-transfusion
Lead sponsor: Universidad de la Sabana
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For the assignment of the students to the study groups, a randomization sequence will be generated through a computer-generated process. 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 block size of eight (8) will be used. The permuted blocks strategy and the size of the blocks will not be known by the researcher. To ensure the concealment of the random sequence, it will be placed in opaque envelopes at the time of assignment.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall result of the OSCE evaluation (checklist).
timeFrame: 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 outcomes:
measure: Performance on the OSCE checklist in sub-areas: Clinical History
timeFrame: 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
measure: Performance on the OSCE checklist in sub-areas: assesment
timeFrame: 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
measure: Performance on the OSCE checklist in sub-areas: exchange transfusion
timeFrame: 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
Other outcomes:
Locations:
city: Chía
country: Colombia
facility: Universidad de La Sabana
state: Cundinamarca
Study officials:
affiliation: Universidad de la Sabana
name: Maria J Maldonado, Pediatrician
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maldonado MJ, Agudelo SI, Suarez JD, Gamboa O. Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol. Trials. 2020 May 7;21(1):387. doi: 10.1186/s13063-020-04312-3.