Clinical trial NCT03828526: Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care
Official title: Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Learning Process in Nursing Graduation
Compliant Behavior
Keywords: Patient Safety
Medication Errors
Critical Care
Nursing Education
High Fidelity Simulation Training
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Nursing plays an important role in the medication process in intensive care units. The application of active methodologies guided by the simulation strategy can help in the formation of qualified professionals and in the safer promotion of health care. The objectives to evaluate the effectiveness of the high fidelity simulation applied to nursing students in the process of administering drugs to critical patients in the intensive care setting; evaluate knowledge acquisition, satisfaction and self-confidence after the simulation. This is a prospective, single-blinded, controled clinical trial, with a quantitative approach. The sample will be composed of nursing students who are attending or have completed the discipline of critical care. The students will be randomized electronically to the experimental group, whose intervention will be guided by the high fidelity simulation method and, to the control group, the handling of static dummies / traditional teaching will be adopted as teaching strategy. Both strategies will emphasize the safety process during medication administration to critical patients hospitalized in the intensive care unit and will have an expository class dialogued prior to the intervention. Pre and post-tests will be applied at different times to evaluate the evolution of the level of knowledge and its retention and also, scales of satisfaction and self-confidence in learning. Descriptive and inferential statistics will be performed, as appropriate. It is believed that students submitted to simulation will have the opportunity to better consolidate knowledge during the training process, improve clinical and critical thinking, and decision-making, which will positively influence the safety of critically ill patients of the intensive care unit.

Detailed description: Objective

To evaluate the effectiveness of the high fidelity simulation for learning related to the drug preparation and administration process in the scenario of critical patient care in the cognitive, psychomotor and affective domains for undergraduate students of the nursing course.

Hypothesis of the study

Null hypothesis

There will be no difference between learning through high fidelity simulation and traditional teaching / low fidelity simulation.

Alternative hypothesis

The high fidelity simulation strategy improves the performance of nursing students in drug administration more significantly when compared to traditional teaching / low fidelity simulation.

Eligibility criteria: Inclusion Criteria:

* Students enrolled in the undergraduate nursing course of a public university in Brazil; Students coursing or who have completed critical care discipline.

Exclusion Criteria:

* Students with previous training in health.

Primary outcomes:
measure: Previous knowledge about the preparation and administration of intravenous drugs in intensive care (pre-test)
timeFrame: Questionnaire application prior to the intervention (pre-test)
measure: Knowledge about the preparation and administration of intravenous drugs in intensive care (post-test)
timeFrame: Questionnaire application immediately after the intervention (post-test)
measure: Knowledge about the preparation and administration of intravenous drugs in intensive care (1st retention)
timeFrame: Questionnaire application one month after intervention (1st retention)
measure: Knowledge about the preparation and administration of intravenous drugs in intensive care (2nd retention)
timeFrame: Questionnaire application three months after intervention (1st retention)
Secondary outcomes:
measure: Student Satisfaction and Self-Confidence in Learning
timeFrame: The scale will be applied in two distinct times: Time 1 - before the intervention; Time 2 - immediately after the intervention.
measure: Perceived gains from high fidelity simulation
timeFrame: The scale will be applied immediately after the intervention.
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Breno de Sousa Santana
state: Federal District
Study officials:
affiliation: University of Brasilia
name: Marcia CS Magro, PhD
role: STUDY_DIRECTOR
References:
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citation: Negri EC, Mazzo A, Martins JCA, Pereira GA Junior, Almeida RGDS, Pedersoli CE. Clinical simulation with dramatization: gains perceived by students and health professionals. Rev Lat Am Enfermagem. 2017 Aug 3;25:e2916. doi: 10.1590/1518-8345.1807.2916.
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