Learning Process in Nursing GraduationNCT03828526
Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care
A study testing High Fidelity Simulation and Traditional teaching strategy in people with Learning Process in Nursing Graduation and Compliant Behavior, run by University of Brasilia at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Learning Process in Nursing Graduation, Compliant Behavior
- What is being tested?
- High Fidelity Simulation and Traditional teaching strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2019to 31 Dec 2019
- 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
- Students enrolled in the undergraduate nursing course of a public university in Brazil; Students coursing or who have completed critical care discipline.
Who cannot join
- Students with previous training in health.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Breno de Sousa Santana
Brasília, Federal District, 71938360
Breno S Santana, Graduate, 5561982085031, bresousas@outlook.com
About this study
Official title: Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care: Randomized Clinical Trial
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.
Read the detailed 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.
- Being tested
- High Fidelity Simulation, Traditional teaching strategy
- Keywords
- Patient Safety, Medication Errors, Critical Care, Nursing Education, High Fidelity Simulation Training
- Medical subject headings
- Cooperative Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fidelity SimulationOther
Teaching strategy based on high fidelity simulation, which simulates the reality of health care to promote meaningful learning.
Traditional teaching strategyOther
Classroom-based strategy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional teaching strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Questionnaire application three months after intervention (1st retention)
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: The scale will be applied immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Learning Process in Nursing GraduationStudies 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
- 76 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 CS Magro, PhD, Study director, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828526
- Sponsor's protocol ID
- U1111-1227-7554
- Status last verified
- Mar 2019
- First submitted
- 31 Jan 2019
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26002536Bingham 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.
PubMed 25741028Choi 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.
PubMed 26361821Cortegiani 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.
PubMed 25955760Institute 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/
PubMed 25077248Marvanova 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.
PubMed 28436158Negri 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.
PubMed 28793125Renata 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.
PubMed 24933543
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03828526
- Acronym / sponsor ID
- U1111-1227-7554
- Keywords
- Patient Safety, Medication Errors, Critical Care, Nursing Education, High Fidelity Simulation Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 4 Feb 2019 (actual)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Fidelity Simulation | Experimental | Other: High Fidelity SimulationStudents 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. |
| Traditional teaching strategy | Active comparator | Other: Traditional teaching strategyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Students enrolled in the undergraduate nursing course of a public university in Brazil; Students coursing or who have completed critical care discipline.
Key exclusion criteria (1 listed)
- Students with previous training in health.
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 |
|---|---|---|
| High Fidelity SimulationTeaching strategy based on high fidelity simulation, which simulates the reality of health care to promote meaningful learning. | Other | High Fidelity Simulation |
| Traditional teaching strategyClassroom-based strategy | Other | Traditional teaching strategy |
Primary outcome
Previous knowledge about the preparation and administration of intravenous drugs in intensive care (pre-test)
Time frame: Questionnaire application prior to the intervention (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).
Knowledge about the preparation and administration of intravenous drugs in intensive care (post-test)
Time frame: Questionnaire application immediately after the intervention (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).
Knowledge about the preparation and administration of intravenous drugs in intensive care (1st retention)
Time frame: Questionnaire application one month after intervention (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).
Knowledge about the preparation and administration of intravenous drugs in intensive care (2nd retention)
Time frame: Questionnaire application three months after intervention (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).
2 secondary outcomes
Student Satisfaction and Self-Confidence in Learning
Time frame: 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
Time frame: The scale will be applied immediately after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Background: PubMed 26002536Adams 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.
- Background: PubMed 25741028Bingham 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.
- Background: PubMed 26361821Choi 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.
- Background: PubMed 25955760Cortegiani 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.
- Background: PubMed 25077248Institute 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/
- Background: PubMed 28436158Marvanova 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.
- Background: PubMed 28793125Negri 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.
- Background: PubMed 24933543Renata 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.
- Individual participant dataSharing planned: No
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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 CS Magro, PhD study director
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fidelity Simulation and Traditional teaching strategy in people with Learning Process in Nursing Graduation and Compliant Behavior, run by University of Brasilia at 1 site in Brazil.
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 1 inclusion and 1 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 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Marcia CS Magro, PhD (5561982690888, marciamagro@unb.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Previous knowledge about the preparation and administration of intravenous drugs in intensive care (pre-test) (time frame: Questionnaire application prior to the intervention (pre-test)). The study lists 4 primary outcomes in all. 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 NCT03828526, which also lists 8 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 18 Mar 2019.