Telemedicine Clinical Trial
— INTEXUSOfficial title:
Educational Strategy for the Development of Skills in Exchange Trnasfusion: A Randomized Clinical Trial Protocol
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.
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. |
Country | Name | City | State |
---|---|---|---|
Colombia | Universidad de La Sabana | Chía | Cundinamarca |
Lead Sponsor | Collaborator |
---|---|
Universidad de la Sabana |
Colombia,
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 |
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