Compliance BehaviorNCT02653781
Implementation of Realistic Simulation as Patient Safety Improvement Method
A study testing Realistic simulation, Simulation workshop and Test realistic simulation in people with Compliance Behavior, run by University of Brasilia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Compliance Behavior
- What is being tested?
- Realistic simulation, Simulation workshop and Test realistic simulation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Implementation of Realistic Simulation as Patient Safety Improvement Method: Controlled Trial
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.
Read the detailed description
Currently, the issue of patient safety has been hotly debated both nationally and internationally, because this is a relevant issue for the health professionals' practice and to improve the quality of patient care. According to the Institute of Medicine (IOM) report released in 2000, a significant number of deaths in hospitals every year were related to preventable causes and medical errors. These deaths were equal to mortality numbers due to diseases such as cancer and HIV and car acidentes.
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
- Compliance Behavior
- Being tested
- Realistic simulation, control group, Simulation workshop, Test realistic simulation
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Realistic simulationBehavioural
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 groupBehavioural
The control group will have contents exposed solely from the dialogue-exhibition.
Simulation workshopBehavioural
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 simulationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: control group; Behavioral: Test realistic simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Assess the efficiency of using high fidelity simulation in the process of teaching and learning until for 3 months later to begin the study with questionnaire and scale from 0 (no efficiency) to 5 (with efficiency)
Measured: The outcome measures are assessed as up to six months rather than the specific dates provided
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Compliance BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Cristina da Silva Magro, University of Brasilia
- Investigators
- Marcia Cristina S. Magro, PhD, Principal investigator, Brasilia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653781
- Sponsor's protocol ID
- ECR222015
- Status last verified
- Oct 2017
- First submitted
- 17 Dec 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aebersold M, Tschannen D. Simulation in nursing practice: the impact on patient care. Online J Issues Nurs. 2013 May 31;18(2):6.
PubMed 23758424Boutron 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.
PubMed 18283207Frith 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.
PubMed 23198612Gaba 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.
PubMed 15465951Godson 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.
PubMed 17851322Harden 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.
PubMed 763183Jeffries 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.
PubMed 19007713Lewis 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.
PubMed 22893783Liaw 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.
PubMed 25230684
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Realistic Simulation as Patient Safety Improvement Method: Controlled Trial
- ClinicalTrials.gov ID
- NCT02653781
- Acronym / sponsor ID
- ECR222015
- Conditions
- Compliance Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Currently, the issue of patient safety has been hotly debated both nationally and internationally, because this is a relevant issue for the health professionals' practice and to improve the quality of patient care. According to the Institute of Medicine (IOM) report released in 2000, a significant number of deaths in hospitals every year were related to preventable causes and medical errors. These deaths were equal to mortality numbers due to diseases such as cancer and HIV and car acidentes.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Realistic simulation; Performance | Experimental | Behavioral: Realistic simulation, Behavioral: control group, Behavioral: Simulation workshop, Behavioral: Test realistic simulationStudent 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. |
| theoretical-practical classes | Other | Behavioral: control group, Behavioral: Test realistic simulationWill be to give a theoretical-practical classes for students of control group the provision of similar opportunities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Realistic simulationThe 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. | Behavioural | Realistic simulation; Performance |
| control groupThe control group will have contents exposed solely from the dialogue-exhibition. | Behavioural | Realistic simulation; Performance, theoretical-practical classes |
| Simulation workshopCheck 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. | Behavioural | Realistic simulation; Performance |
| Test realistic simulationOccurs 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). | Behavioural | Realistic simulation; Performance, theoretical-practical classes |
Primary outcome
Effectiveness assessed using questionnaire and scale with the scores range from 0 (no effectiveness) to 5 (with effectiveness)
Time frame: The outcome measures are assessed as up to six months rather than the specific dates provided
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)
1 secondary outcome
Efficiency assessed by using questionnaire and scale from 0 (no efficiency) to 5 (with efficiency)
Time frame: The outcome measures are assessed as up to six months rather than the specific dates provided
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Background: PubMed 23758424Aebersold M, Tschannen D. Simulation in nursing practice: the impact on patient care. Online J Issues Nurs. 2013 May 31;18(2):6.
- Background: PubMed 18283207Boutron 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.
- Background: PubMed 23198612Frith 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.
- Background: PubMed 15465951Gaba 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.
- Background: PubMed 17851322Godson 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.
- Background: PubMed 763183Harden 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.
- Background: PubMed 19007713Jeffries 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.
- Background: PubMed 22893783Lewis 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.
- Background: PubMed 25230684Liaw 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia Cristina S. Magro, PhD principal investigator
Brasilia University
Questions about this trial
What is this clinical trial studying?
A study testing Realistic simulation, Simulation workshop and Test realistic simulation in people with Compliance Behavior, run by University of Brasilia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness assessed using questionnaire and scale with the scores range from 0 (no effectiveness) to 5 (with effectiveness) (time frame: The outcome measures are assessed as up to six months rather than the specific dates provided). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653781, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.