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

NCT03828526 | Unknown

• 1 other identifier: U1111-1227-7554
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Learning Process in Nursing Graduation; Compliant Behavior

Keywords

Patient Safety; Medication Errors; Critical Care; Nursing Education; High Fidelity Simulation Training

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Student Satisfaction and Self-Confidence in Learning

  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

  The scale will be applied immediately after the intervention.

Study Arms (2)

High Fidelity Simulation

EXPERIMENTAL

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

Traditional teaching strategy

ACTIVE COMPARATOR

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

Interventions

High Fidelity Simulation OTHER

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

High Fidelity Simulation

Traditional teaching strategy OTHER

Classroom-based strategy

Traditional teaching strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Students with previous training in health.

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Breno de Sousa Santana

Brasília, Federal District, 71938360, Brazil

RECRUITING

Related 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.

  PMID: 26002536 BACKGROUND

• 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.

  PMID: 25741028 BACKGROUND

• 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.

  PMID: 26361821 BACKGROUND

• 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.

  PMID: 25955760 BACKGROUND

• 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/

  PMID: 25077248 BACKGROUND

• 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.

  PMID: 28436158 BACKGROUND

• 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.

  PMID: 28793125 BACKGROUND

• 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.

  PMID: 24933543 BACKGROUND

MeSH Terms

Conditions

Cooperative Behavior

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Marcia CS Magro, PhD

  University of Brasilia

  STUDY DIRECTOR

Central Study Contacts

Marcia CS Magro, PhD

CONTACT

5561982690888; marciamagro@unb.br

Breno S Santana, Graduate

CONTACT

5561982085031; bresousas@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 4, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)