Implementation of Realistic Simulation as Patient Safety Improvement Method
NCT ID: NCT02653781
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
82 participants
INTERVENTIONAL
2016-05-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In this scenario, death due to errors in the process of care achieved world relevance and in 2002, the World Health Organization (WHO) released the World Health Assembly (WHA) Resolution 55.18, addressing the priorities related to patient safety in the quality of care. In 2004, was created the World Alliance for Patient Safety on the occasion of the 57th World Health Assembly. The World Alliance has defined programs for patient safety that must be adopted by all member countries and therefore, by Brazil.
The general actions proposed by the WHO World Alliance for Patient Safety are oriented in five activities among which, the efforts to strengthen the training in patient safety worldwide. It stimulates the inclusion of a curriculum guide for patient safety in health professional training courses .
Aspects of patient safety in medicine administration involve many health professionals. However, nurses have an important role because they are responsible for administration and thus, occupy the last stage between the medication and the error. For all these reasons, safety in medication administration is a compulsory and transversal theme in the training of nursing professionals.
In this context of search for improvements in health care planning, a new practice concept of teaching and learning has been developed, aiming at training professionals and training the health professionals who have already graduated.
Interests in using realistic simulation techniques have emerged lately with the objective to encourage improvements in safety on patient care. The simulation technique amplifies the experience of health professionals through educational actions guided by experiences that happen in the real world, therefore, interactions must happen in a way that preserves the most realistic aspects as possible. The adoption of simulation in health comes from successful references of using this technique for industrial purposes and in the armed forces. It is considered an innovative technique in health.
In high fidelity simulation, students and professionals experience clinical cases that replicate real-world scenarios. This strategy enables teaching innovations, improves clinical thinking in stressful situations, and prevents the exposure of patients to risks.
The realistic simulation has been integrated in the education of nurses and doctors over the last years, but is not fully implemented yet. Despite the recommendations for using simulation, its increasing integration in education, and the concrete evidence that its use promotes a better prepare of health professionals for performance in clinical practice, the empirical evidences of its impact on patient outcomes are still under developed.
Besides the realistic manikin-based simulation, virtual simulation is another way of simulation that has been proven effective in learning strategies, contributing to the retention of knowledge and improvement of nursing students' clinical performance.
From the increasing use of technology in health and the complexity of patients, new ways of learning have been shaped and developed as innovative teaching methods in health care . All these alternatives have the promising intention of reducing the deterioration of learning and of clinical performance over time, making professionals and students able to monitor patients in the best possible way, establish goals, priorities and better treatments.
An advantage is the possibility of students practicing their skills in an environment where mistakes can be made and corrected without causing damages and risks to patient safety. In addition, the construction of knowledge is established through representative situations of day-to-day reality in professional practice, when students themselves participate as patient-actors in a totally controlled environment, as well as protected from risks. At the end of the activity, students and/or professionals involved in the simulation can give feedback of their learning and, from group discussions and those with the teacher, is formed knowledge based on self-knowledge and confidence .
PURPOSE
Primary purpose
To compare the use of high fidelity simulation with traditional education as innovative method in the process of teaching and learning.
Secondary purpose
To propose the creation of a high fidelity scenario related to nursing care in medication administration;
To identify the gains in theoretical and practical learning and in self-confidence of nursing undergraduate students after undergoing high fidelity simulation in medication administration;
To assess the effectiveness and efficiency of using high fidelity simulation in the process of teaching and learning.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Realistic simulation; Performance
Student participation in the study will happen on demand by enrollment in activities of dialogue-exhibition (workshop) on realistic simulation in the context of patient safety. Check the performance of students in face of simulation workshop for test realistic simulation.
Realistic simulation
The students enrolled and selected according to the inclusion criteria will be randomized into two groups. The experimental group will experience the combined teaching methodology: dialogue-exhibition and realistic simulation.
control group
The control group will have contents exposed solely from the dialogue-exhibition.
Simulation workshop
Check the performance of students in face of simulated situations on medication administration by intramuscular and intravenous routes experienced in the Skills and Care Simulation Laboratory.
Test realistic simulation
Occurs after the end of the three-month intervention. At that time, students from the control and intervention groups will be asked to take a knowledge retention test in cognitive assessment format and OSCE format (objective structured clinical examination).
theoretical-practical classes
Will be to give a theoretical-practical classes for students of control group the provision of similar opportunities
control group
The control group will have contents exposed solely from the dialogue-exhibition.
Test realistic simulation
Occurs after the end of the three-month intervention. At that time, students from the control and intervention groups will be asked to take a knowledge retention test in cognitive assessment format and OSCE format (objective structured clinical examination).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Realistic simulation
The students enrolled and selected according to the inclusion criteria will be randomized into two groups. The experimental group will experience the combined teaching methodology: dialogue-exhibition and realistic simulation.
control group
The control group will have contents exposed solely from the dialogue-exhibition.
Simulation workshop
Check the performance of students in face of simulated situations on medication administration by intramuscular and intravenous routes experienced in the Skills and Care Simulation Laboratory.
Test realistic simulation
Occurs after the end of the three-month intervention. At that time, students from the control and intervention groups will be asked to take a knowledge retention test in cognitive assessment format and OSCE format (objective structured clinical examination).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Regularly enrolled in the nursing undergraduate course at the Universidade de Brasília - Ceilândia Institute
* Attending between the sixth and tenth semester of the nursing undergraduate course at the Universidade of Brasília
* Already took the 'Semiology I' discipline
Exclusion Criteria
* Student with another formation of secondary or higher level in the area of victims service or health care (eg: nursing technician, firefighter, paramedic, physical therapist, etc)
* Missing at least one of the study steps: pre-test, workshop, post-test, experience in realistic simulation, retest
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Brasilia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marcia Cristina da Silva Magro
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marcia Cristina S. Magro, PhD
Role: PRINCIPAL_INVESTIGATOR
Brasilia University
References
Explore related publications, articles, or registry entries linked to this study.
Aebersold M, Tschannen D. Simulation in nursing practice: the impact on patient care. Online J Issues Nurs. 2013 May 31;18(2):6.
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008 Feb 19;148(4):295-309. doi: 10.7326/0003-4819-148-4-200802190-00008.
Frith KH, Anderson EF, Tseng F, Fong EA. Nurse staffing is an important strategy to prevent medication error in community hospitals. Nurs Econ. 2012 Sep-Oct;30(5):288-94.
Gaba DM. The future vision of simulation in health care. Qual Saf Health Care. 2004 Oct;13 Suppl 1(Suppl 1):i2-10. doi: 10.1136/qhc.13.suppl_1.i2.
Godson NR, Wilson A, Goodman M. Evaluating student nurse learning in the clinical skills laboratory. Br J Nurs. 2007 Aug 9-Sep 12;16(15):942-5. doi: 10.12968/bjon.2007.16.15.24520.
Harden RM, Gleeson FA. Assessment of clinical competence using an objective structured clinical examination (OSCE). Med Educ. 1979 Jan;13(1):41-54. No abstract available.
Jeffries PR, McNelis AM, Wheeler CA. Simulation as a vehicle for enhancing collaborative practice models. Crit Care Nurs Clin North Am. 2008 Dec;20(4):471-80. doi: 10.1016/j.ccell.2008.08.005.
Lewis R, Strachan A, Smith MM. Is high fidelity simulation the most effective method for the development of non-technical skills in nursing? A review of the current evidence. Open Nurs J. 2012;6:82-9. doi: 10.2174/1874434601206010082. Epub 2012 Jul 27.
Liaw SY, Chan SW, Chen FG, Hooi SC, Siau C. Comparison of virtual patient simulation with mannequin-based simulation for improving clinical performances in assessing and managing clinical deterioration: randomized controlled trial. J Med Internet Res. 2014 Sep 17;16(9):e214. doi: 10.2196/jmir.3322.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ECR222015
Identifier Type: -
Identifier Source: org_study_id