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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03574480 -
Smartphone Applications to Improve Lifestyles in Olders Over 65 Years
|
N/A | |
Active, not recruiting |
NCT05043220 -
Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy
|
N/A | |
Recruiting |
NCT04045054 -
Home-based Transitional Telecare for Older Veterans
|
N/A | |
Completed |
NCT04652674 -
Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic
|
N/A | |
Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
Recruiting |
NCT05480930 -
Improving Nighttime Access to Care and Treatment; Part 4-Haiti
|
N/A | |
Completed |
NCT03025217 -
Total Lifestyle Coaching Pilot Study (TLC)
|
N/A | |
Completed |
NCT02196428 -
Medical Telemonitoring Plus Individual Teleconsultation in Elderly
|
N/A | |
Completed |
NCT01820234 -
Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
|
N/A | |
Recruiting |
NCT04392518 -
Telerehabilitation in Proximal Muscle Weakness
|
N/A | |
Completed |
NCT05147038 -
The Impact of Tele-coaching on the Physical Activity Level
|
N/A | |
Not yet recruiting |
NCT06466837 -
Just-In-Time Adaptive Interventions for Diabetic Patients
|
N/A | |
Not yet recruiting |
NCT05897710 -
Virtual World-Based Cardiac Rehabilitation
|
N/A | |
Not yet recruiting |
NCT04444297 -
3D Telemedicine During COVID-19: Non-clinical Validation
|
N/A | |
Not yet recruiting |
NCT04513496 -
Telemedicine in HIV Care in Buenos Aires
|
||
Completed |
NCT05895539 -
Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool
|
N/A | |
Active, not recruiting |
NCT03474692 -
Virta Health Registry
|
||
Recruiting |
NCT05046392 -
mHealth Facilitated Intervention to Improve Medication Adherence Among Persons Living With HIV
|
N/A | |
Recruiting |
NCT05231018 -
A Study on a Digital Platform for COVID19+ Patients, Designed to Facilitate Communication and Mental-health Care During and After Hospitalization.
|
N/A | |
Recruiting |
NCT05617560 -
Hospital@Home: Telemedical Care After Inpatient Hospital Stay
|
N/A |