<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03828526</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1227-7554</org_study_id>
    <nct_id>NCT03828526</nct_id>
  </id_info>
  <brief_title>Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care</brief_title>
  <official_title>Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Brasilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Brasilia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nursing plays an important role in the medication process in intensive care units. The&#xD;
      application of active methodologies guided by the simulation strategy can help in the&#xD;
      formation of qualified professionals and in the safer promotion of health care. The&#xD;
      objectives to evaluate the effectiveness of the high fidelity simulation applied to nursing&#xD;
      students in the process of administering drugs to critical patients in the intensive care&#xD;
      setting; evaluate knowledge acquisition, satisfaction and self-confidence after the&#xD;
      simulation. This is a prospective, single-blinded, controled clinical trial, with a&#xD;
      quantitative approach. The sample will be composed of nursing students who are attending or&#xD;
      have completed the discipline of critical care. The students will be randomized&#xD;
      electronically to the experimental group, whose intervention will be guided by the high&#xD;
      fidelity simulation method and, to the control group, the handling of static dummies /&#xD;
      traditional teaching will be adopted as teaching strategy. Both strategies will emphasize the&#xD;
      safety process during medication administration to critical patients hospitalized in the&#xD;
      intensive care unit and will have an expository class dialogued prior to the intervention.&#xD;
      Pre and post-tests will be applied at different times to evaluate the evolution of the level&#xD;
      of knowledge and its retention and also, scales of satisfaction and self-confidence in&#xD;
      learning. Descriptive and inferential statistics will be performed, as appropriate. It is&#xD;
      believed that students submitted to simulation will have the opportunity to better&#xD;
      consolidate knowledge during the training process, improve clinical and critical thinking,&#xD;
      and decision-making, which will positively influence the safety of critically ill patients of&#xD;
      the intensive care unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective&#xD;
&#xD;
      To evaluate the effectiveness of the high fidelity simulation for learning related to the&#xD;
      drug preparation and administration process in the scenario of critical patient care in the&#xD;
      cognitive, psychomotor and affective domains for undergraduate students of the nursing&#xD;
      course.&#xD;
&#xD;
      Hypothesis of the study&#xD;
&#xD;
      Null hypothesis&#xD;
&#xD;
      There will be no difference between learning through high fidelity simulation and traditional&#xD;
      teaching / low fidelity simulation.&#xD;
&#xD;
      Alternative hypothesis&#xD;
&#xD;
      The high fidelity simulation strategy improves the performance of nursing students in drug&#xD;
      administration more significantly when compared to traditional teaching / low fidelity&#xD;
      simulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Previous knowledge about the preparation and administration of intravenous drugs in intensive care (pre-test)</measure>
    <time_frame>Questionnaire application prior to the intervention (pre-test)</time_frame>
    <description>It will be measured by applying a &quot;Knowledge Questionnaire&quot; 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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge about the preparation and administration of intravenous drugs in intensive care (post-test)</measure>
    <time_frame>Questionnaire application immediately after the intervention (post-test)</time_frame>
    <description>It will be measured by applying a &quot;Knowledge Questionnaire&quot; 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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge about the preparation and administration of intravenous drugs in intensive care (1st retention)</measure>
    <time_frame>Questionnaire application one month after intervention (1st retention)</time_frame>
    <description>It will be measured by applying a &quot;Knowledge Questionnaire&quot; 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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge about the preparation and administration of intravenous drugs in intensive care (2nd retention)</measure>
    <time_frame>Questionnaire application three months after intervention (1st retention)</time_frame>
    <description>It will be measured by applying a &quot;Knowledge Questionnaire&quot; 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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Student Satisfaction and Self-Confidence in Learning</measure>
    <time_frame>The scale will be applied in two distinct times: Time 1 - before the intervention; Time 2 - immediately after the intervention.</time_frame>
    <description>It will be measured through the application of the &quot;Student Satisfaction and Self-Confidence in Learning&quot; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived gains from high fidelity simulation</measure>
    <time_frame>The scale will be applied immediately after the intervention.</time_frame>
    <description>It will be measured through the application of the &quot;High-fidelity simulation gains on nursing education&quot; 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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Learning Process in Nursing Graduation</condition>
  <condition>Compliant Behavior</condition>
  <arm_group>
    <arm_group_label>High Fidelity Simulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional teaching strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Fidelity Simulation</intervention_name>
    <description>Teaching strategy based on high fidelity simulation, which simulates the reality of health care to promote meaningful learning.</description>
    <arm_group_label>High Fidelity Simulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional teaching strategy</intervention_name>
    <description>Classroom-based strategy</description>
    <arm_group_label>Traditional teaching strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students enrolled in the undergraduate nursing course of a public university in&#xD;
             Brazil; Students coursing or who have completed critical care discipline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students with previous training in health.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcia CS Magro, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Brasilia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marcia CS Magro, PhD</last_name>
    <phone>5561982690888</phone>
    <email>marciamagro@unb.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Breno S Santana, Graduate</last_name>
    <phone>5561982085031</phone>
    <email>bresousas@outlook.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Breno de Sousa Santana</name>
      <address>
        <city>Brasília</city>
        <state>Federal District</state>
        <zip>71938360</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Breno S Santana, Graduate</last_name>
      <phone>5561982085031</phone>
      <email>bresousas@outlook.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26002536</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25741028</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26361821</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25955760</PMID>
  </reference>
  <reference>
    <citation>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/</citation>
    <PMID>25077248</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28436158</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28793125</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24933543</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Brasilia</investigator_affiliation>
    <investigator_full_name>Marcia Cristina da Silva Magro</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Patient Safety</keyword>
  <keyword>Medication Errors</keyword>
  <keyword>Critical Care</keyword>
  <keyword>Nursing Education</keyword>
  <keyword>High Fidelity Simulation Training</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03828526
org study id: U1111-1227-7554
nct id: NCT03828526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
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)
description: 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).
measure: Knowledge about the preparation and administration of intravenous drugs in intensive care (post-test)
time frame: Questionnaire application immediately after the intervention (post-test)
description: 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).
measure: Knowledge about the preparation and administration of intravenous drugs in intensive care (1st retention)
time frame: Questionnaire application one month after intervention (1st retention)
description: 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).
measure: Knowledge about the preparation and administration of intravenous drugs in intensive care (2nd retention)
time frame: Questionnaire application three months after intervention (1st retention)
description: 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).
measure: 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.
description: 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.
measure: Perceived gains from high fidelity simulation
time frame: The scale will be applied immediately after the intervention.
description: 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.
arm group label: High Fidelity Simulation
arm group type: Experimental
description: 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.
arm group label: Traditional teaching strategy
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: High Fidelity Simulation
description: Teaching strategy based on high fidelity simulation, which simulates the reality of health care to promote meaningful learning.
arm group label: High Fidelity Simulation
intervention type: Other
intervention name: Traditional teaching strategy
description: Classroom-based strategy
arm group label: Traditional teaching strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marcia CS Magro, PhD
role: Study Director
affiliation: University of Brasilia
last name: Marcia CS Magro, PhD
phone: 5561982690888
email: marciamagro@unb.br
last name: Breno S Santana, Graduate
phone: 5561982085031
email: bresousas@outlook.com
facility: 
status: Recruiting
contact: 
country: Brazil
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: University of Brasilia
investigator full name: Marcia Cristina da Silva Magro
investigator title: Principal Investigator
sharing ipd: No