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

Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care: Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Learning Process in Nursing Graduation; Compliant Behavior
• Intervention / Treatment: Other: High Fidelity Simulation; Other: Traditional teaching strategy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Federal District
    • Brasília, Federal District, Brazil, 71938360
      • Recruiting
      • Breno de Sousa Santana
      • Contact: Breno S Santana, Graduate; Phone Number: 5561982085031; Email: bresousas@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: High Fidelity Simulation; Teaching strategy based on high fidelity simulation, which simulates the reality of health care to promote meaningful learning.
Active Comparator: 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.	Other: Traditional teaching strategy; Classroom-based strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Previous knowledge about the preparation and administration of intravenous drugs in intensive care (pre-test)	It will be measured by applying a "Knowledge Questionnaire" consisting of 5 objective questions to study participants. The minimum score on the test will be 0 points (worst score) and the maximum score will be 100 points (best score).	Questionnaire application prior to the intervention (pre-test)
Knowledge about the preparation and administration of intravenous drugs in intensive care (post-test)	It will be measured by applying a "Knowledge Questionnaire" consisting of 5 objective questions to study participants. The minimum score on the test will be 0 points (worst score) and the maximum score will be 100 points (best score).	Questionnaire application immediately after the intervention (post-test)
Knowledge about the preparation and administration of intravenous drugs in intensive care (1st retention)	It will be measured by applying a "Knowledge Questionnaire" consisting of 5 objective questions to study participants. The minimum score on the test will be 0 points (worst score) and the maximum score will be 100 points (best score).	Questionnaire application one month after intervention (1st retention)
Knowledge about the preparation and administration of intravenous drugs in intensive care (2nd retention)	It will be measured by applying a "Knowledge Questionnaire" consisting of 5 objective questions to study participants. The minimum score on the test will be 0 points (worst score) and the maximum score will be 100 points (best score).	Questionnaire application three months after intervention (1st retention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Student Satisfaction and Self-Confidence in Learning	It will be measured through the application of the "Student Satisfaction and Self-Confidence in Learning" scale, composed of 13 items. Each item should be marked on a scale from 1 (worst score) to 5 (best score), where 1 - strongly disagree with the statement; 2 - I disagree with the statement; 3 - I do not agree or disagree; 4 - I agree with the statement; 5 - strongly agree with the statement.	The scale will be applied in two distinct times: Time 1 - before the intervention; Time 2 - immediately after the intervention.
Perceived gains from high fidelity simulation	It will be measured through the application of the "High-fidelity simulation gains on nursing education" scale, composed of 26 items related to the skills developed through the simulation strategy. Each item should be marked on a scale from 1 (worst score) to 5 (best score), where 1 - I get worse; 2 - remained the same; 3 - I have improved little; 4 - I have improved considerably; 5 - I have improved immensely.	The scale will be applied immediately after the intervention.

Collaborators and Investigators

• Sponsor: University of Brasilia
• Investigators: Study Director: Marcia CS Magro, PhD, University of Brasilia

Publications and helpful links

General Publications

• Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/
• Adams AJ, Wasson EA, Admire JR, Pablo Gomez P, Babayeuski RA, Sako EY, Willis RE. A Comparison of Teaching Modalities and Fidelity of Simulation Levels in Teaching Resuscitation Scenarios. J Surg Educ. 2015 Sep-Oct;72(5):778-85. doi: 10.1016/j.jsurg.2015.04.011. Epub 2015 May 20.
• Bingham AL, Sen S, Finn LA, Cawley MJ. Retention of advanced cardiac life support knowledge and skills following high-fidelity mannequin simulation training. Am J Pharm Educ. 2015 Feb 17;79(1):12. doi: 10.5688/ajpe79112.
• Choi I, Lee SM, Flynn L, Kim CM, Lee S, Kim NK, Suh DC. Incidence and treatment costs attributable to medication errors in hospitalized patients. Res Social Adm Pharm. 2016 May-Jun;12(3):428-37. doi: 10.1016/j.sapharm.2015.08.006. Epub 2015 Aug 20.
• Cortegiani A, Russotto V, Montalto F, Iozzo P, Palmeri C, Raineri SM, Giarratano A. Effect of High-Fidelity Simulation on Medical Students' Knowledge about Advanced Life Support: A Randomized Study. PLoS One. 2015 May 8;10(5):e0125685. doi: 10.1371/journal.pone.0125685. eCollection 2015.
• Marvanova M, Henkel PJ. Collaborating on medication errors in nursing. Clin Teach. 2018 Apr;15(2):163-168. doi: 10.1111/tct.12655. Epub 2017 Apr 24.
• 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.
• Renata Grou Volpe C, Moura Pinho DL, Morato Stival M, Gomes de Oliveira Karnikowski M. Medication errors in a public hospital in Brazil. Br J Nurs. 2014 Jun 12-25;23(11):552, 553-9. doi: 10.12968/bjon.2014.23.11.552.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Patient Safety; Critical Care; Nursing Education; Medication Errors; High Fidelity Simulation Training
• Other Study ID Numbers: U1111-1227-7554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No