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

Compliant Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03828526
• Other study ID #: U1111-1227-7554
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• Source: University of Brasilia
• Contact: Marcia CS Magro, PhD
• Phone: 5561982690888
• Email: marciamagro[@]unb.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Compliant Behavior
• Learning Process in Nursing Graduation

Intervention

Other:
• High Fidelity Simulation
Teaching strategy based on high fidelity simulation, which simulates the reality of health care to promote meaningful learning.
• Traditional teaching strategy
Classroom-based strategy

Locations

Country	Name	City	State
Brazil	Breno de Sousa Santana	Brasília	Federal District

Sponsors (1)

Lead Sponsor	Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. English, Portuguese, Spanish. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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.
Secondary	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.