Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care

NCT ID: NCT03828526

Last Updated: 2019-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-12-31

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.

Conditions

Learning Process in Nursing Graduation; Compliant Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

High Fidelity Simulation

Students will be exposed to the intensive care setting where they will have to solve issues related to general nursing care, including the stages of the medication process that involve the nurses' performance and their complexity.

During the experience of the scenario will be provoked external factors, such as telephone ringing, visit of the professional of the infection commission, to evaluate the reactions of the student and the strategies adopted to minimize the occurrence of adverse events against such external factors.

Subsequently, they will participate in the debriefing, where they will be reflected on the positives and those that should be adjusted to promote safer nursing care related to drug administration.

Group Type: EXPERIMENTAL

High Fidelity Simulation

Intervention Type: OTHER

Teaching strategy based on high fidelity simulation, which simulates the reality of health care to promote meaningful learning.

Traditional teaching strategy

Participants will be submitted to an expository-dialogue class, which will be given based on the recent literature and subdivided into the following axes: 1) patient safety; 2) medication process; 3) adverse drug events; 4) the critical patient in intensive care and its specificities. Afterwards, students will be directed to an environment with an anatomical piece for drug preparation and administration training.

Group Type: ACTIVE_COMPARATOR

Traditional teaching strategy

Intervention Type: OTHER

Classroom-based strategy

Interventions

High Fidelity Simulation

Teaching strategy based on high fidelity simulation, which simulates the reality of health care to promote meaningful learning.

Intervention Type: OTHER

Traditional teaching strategy

Classroom-based strategy

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Brasilia

OTHER

Sponsor Role: lead

Responsible Party

Marcia Cristina da Silva Magro

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcia CS Magro, PhD

Role: STUDY_DIRECTOR

University of Brasilia

Locations

Breno de Sousa Santana

Brasília, Federal District, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Marcia CS Magro, PhD

Role: CONTACT

marciamagro@unb.br

5561982690888

Breno S Santana, Graduate

Role: CONTACT

bresousas@outlook.com

5561982085031

Facility Contacts

Breno S Santana, Graduate

Role: primary

bresousas@outlook.com

5561982085031

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Other Identifiers

U1111-1227-7554

Identifier Type: -

Identifier Source: org_study_id