Implementation of Realistic Simulation as Patient Safety Improvement Method

NCT02653781 | Unknown DMC

• 1 other identifier: ECR222015
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

Realistic simulation is an effective teaching strategy for the acquisition and retention of knowledge and increased self-confidence of students, which contribute to safety in performing nursing actions.Considering the need to adopt safe practices in health since professional training, there are deficiencies in health teaching and weaknesses in the acquisition of practical skills guided by safety principles and critical clinical reasoning. The purpose is to compare the use of high fidelity simulation with traditional education as innovative method in the process of teaching and learning. This is a prospective, randomized, controlled and single-blind study, of pre-test and post-test experimental type, with application of high fidelity simulation in the theme of patient safety in administration of parenteral drugs.

Conditions

Compliance Behavior

Outcome Measures

Primary Outcomes (1)

• Effectiveness assessed using questionnaire and scale with the scores range from 0 (no effectiveness) to 5 (with effectiveness)

  Assess the effectiveness of using high fidelity simulation in the process of teaching and learning using questionnaire and scale with the scores range from 0 (no effectiveness) to 5 (with effectiveness)

  The outcome measures are assessed as up to six months rather than the specific dates provided

Secondary Outcomes (1)

• Efficiency assessed by using questionnaire and scale from 0 (no efficiency) to 5 (with efficiency)

  The outcome measures are assessed as up to six months rather than the specific dates provided

Other Outcomes (2)

• Gains in theoretical learning and in self-confidence of nursing assessed using a scale from 0 to 5.

  The outcome measures are assessed as up to six months rather than the specific dates provided

• Gains in practical learning and in self-confidence of nursing assessed using a scale from 0 to 5.

  The outcome measures are assessed as up to six months rather than the specific dates provided

Study Arms (2)

Realistic simulation; Performance

EXPERIMENTAL

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.

Behavioral: Realistic simulation; Behavioral: control group; Behavioral: Simulation workshop; Behavioral: Test realistic simulation

theoretical-practical classes

OTHER

Will be to give a theoretical-practical classes for students of control group the provision of similar opportunities

Behavioral: control group; Behavioral: Test realistic simulation

Interventions

Realistic simulation BEHAVIORAL

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.

Realistic simulation; Performance

control group BEHAVIORAL

The control group will have contents exposed solely from the dialogue-exhibition.

Realistic simulation; Performance; theoretical-practical classes

Simulation workshop BEHAVIORAL

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.

Realistic simulation; Performance

Test realistic simulation BEHAVIORAL

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).

Realistic simulation; Performance; theoretical-practical classes

Eligibility Criteria

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

You may qualify if:

• Older than 18 years
• 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

You may not qualify if:

• Less than 18 years
• 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

Sponsors & Collaborators

• University of Brasilia: lead

Related Publications (9)

• Aebersold M, Tschannen D. Simulation in nursing practice: the impact on patient care. Online J Issues Nurs. 2013 May 31;18(2):6.

  PMID: 23758424 BACKGROUND

• 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.

  PMID: 18283207 BACKGROUND

• 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.

  PMID: 23198612 BACKGROUND

• 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.

  PMID: 15465951 BACKGROUND

• 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.

  PMID: 17851322 BACKGROUND

• 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.

  PMID: 763183 BACKGROUND

• 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.

  PMID: 19007713 BACKGROUND

• 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.

  PMID: 22893783 BACKGROUND

• 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.

  PMID: 25230684 BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marcia Cristina S. Magro, PhD

  Brasilia University

  PRINCIPAL INVESTIGATOR

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: PhD

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: January 12, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10