CommunicationSBARNCT02289001
Simulation Training in Undergraduate Nursing Education as a Means to Improve Awareness of Team Member Roles
A study testing Education on SBAR worksheet in people with Communication, run by Universitat de Girona.
Trial summary
Based on investigator's hypothesis, that incorporating the SBAR worksheet into the training of undergraduate Nursing students will increase their capacity to work in an interdisciplinary team, the investigators will assess whether introducing the SBAR improves the students' knowledge of their own role and that of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication
- What is being tested?
- Education on SBAR worksheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to May 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Passing grade on the emergency care topics in the required course "Adult Patient II", which focuses on nursing care planning related to various clinical pathologies or syndromes and surgical procedures
- Current student in the required course "Techniques and Procedures III", which incorporates simulation related to Clinical Nursing II and Psychology course content
Who cannot join
- No signed informed consent to participate
About this study
Official title: Study to Evaluate the Use of the SBAR (Situation-Background-Assessment-Recommendation) Checklist as a Means to Help Undergraduate Nursing Students Understand Team Member Roles and Improve Healthcare Team Communication
Based on investigator's hypothesis, that incorporating the SBAR worksheet into the training of undergraduate Nursing students will increase their capacity to work in an interdisciplinary team, the investigators will assess whether introducing the SBAR improves the students' knowledge of their own role and that of others on the team (medical students), strengthens communication between team members, and enhances the quality of the patient assessment and interventions demonstrated by the nursing students caring for a critical patient (represented by a high-fidelity mannequin, a Human Patient Simulator).
Read the detailed description
Students assigned to the intervention group will receive one hour of additional training in teamwork skills, communication between team members, and the relationship with patient safety, as well as how to distribute roles and responsibilities and how to use the SBAR worksheet. They will not be given the materials used to present the training session (PowerPoint slides, videos, and the SBAR worksheet) in order to avoid their sharing this information directly with students in the control group.
Training provided the Intervention Group
- Basic competencies of healthcare professionals (Institute of Medicine, IOM, 2003) and of working as a team member (Interprofessional Education Collaborative (IPEC). Core competencies for Interprofessional Collaborative Practice. 2011. Available at: http://www.aacn.nche.edu/education-resources/ipecreport.pdf)
- Use of the SBAR (Situation-Background-Assessment-Recommendation) worksheet in accordance with the Kaiser Permanente Guidelines for Communicating with Physicians Using the SBAR Process. Available at: http://fliptheclinic.org/wordpress/wp-content/uploads/community_uploads/1598/SBAR%20Guidelines%20Kaiser%20Permanente.pdf. Accessed Oct 17, 2014):
- Distribution of roles and responsibilities of the interdisciplinary care team for a critical patient (airway management, assessment nurse/physician, medication nurse, procedure nurse, documenting nurse)
On a day when clinical practice is scheduled, according to the 2014-2015 academic year, the students will report to the simulation laboratory. All students in both study arms will participate in a simulated scenario, with cases validated by the National League for Nursing, in a setting that mimics an emergency department with a critical patient (HPS) in a state of shock. Three nursing students and a medical student will intervene in each scenario. If the scenario requires an additional intervention to guide the students or redirect situations that reach an impasse, a professor will be prepared to take on the role of an emergency room physician or nursing supervisor.
Students who do not receive the complementary training (i.e., the control group) will be directed to a different laboratory than the intervention group while they wait to be called for their participation in the simulated scenario.
Ten minutes before beginning the scenario, each group (control and intervention) will receive the documents corresponding to the simulated patient's clinical history. Students in the intervention group will also have a printed SBAR worksheet, which they will be familiar with because of the complementary training. This worksheet will be mixed with the documents related to the patient's clinical history so that the professors participating in the scenario and those doing the evaluation will not be readily able to identify which study arm in participating in a given scenario.
A professor will randomize the scenarios, following the codes delivered in sealed envelopes and that were previously assigned a number directly linked to the corresponding study arm (intervention, control). The envelopes will be kept in a locked box in the simulation laboratory, and will be opened each day of clinical practice by a professor not involved in the study.
Sample size To calculate the necessary sample, we considered the difference in medians observed in a previous study in the same population (Raurell-Torredà M, Olivet-Pujol J, Romero-Collado A, Malagon-Aguilera MC, Patiño-Masó, J, Baltasar-Bagué A. Case-based learning and simulation: useful tools to enhance nurses' education? Non-randomized controlled trial". J Nurs Scholarsh. 2014, Oct 25. doi: 10.1111/jnu.12113). The standardized median difference was 0.9 points. With the aim of obtaining the same difference in the present study, accepting an alpha risk of 0.05 and beta risk less than 20% in a two-tailed test, the estimated sample size 21 scenarios in each arm of the study.
Statistical analysis Qualitative variables will be expressed as frequency and percentage, using the Chi square or Fisher test to compare groups, as appropriate. Quantitative variables will be shown mean and standard deviation (SD) or median and interquartile range (P25-P75), depending on the normality of the distribution, and groups will be compared using Student t or Mann-Whitney U test, respectively. A P-value <0.05 will be considered significant. All analyses will be done using IBM SPSS Statistics (IBM Statistics®, Markham, ON, Canada).
Given the impossibility of predicting how students who do not participate in the simulation would have behaved, losses to follow-up will be managed per protocol rather than intention to treat.
- Conditions
- Communication
- Being tested
- Education on SBAR worksheet
- Keywords
- patient simulation, simulation, teamwork, interdisciplinary health team, healthcare team, nursing, training programs
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on SBAR worksheetBehavioural
The intervention group will receive one hour of training in teamwork skills, distribution of roles and use of the SBAR worksheet before participating in the simulated scenario using a human patient simulator (HPS).
| Study group | Role | What they receive |
|---|---|---|
| Education on SBAR worksheet | Experimental | Training in the use of the SBAR worksheet created to structure information exchange between healthcare professionals Receives: Behavioral: Education on SBAR worksheet |
| No education on SBAR worksheet | No intervention | The control group will participate in the simulation without any prior training in teamwork skills beyond those included in the undergraduate nursing degree curriculum, which the intervention group also received. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the use of the SBAR checklist as a means to help undergraduate nursing students identify their own role, understand the roles of other health professionals (assess skill level (KidSIM Team Performance Scale)
The study will use the KidSIM Team Performance Scale, designed and validated by Sigalet et al. for use in undergraduate nursing, medicine and physiotherapy degree programs. The KidSIM scale has 5 items about roles and 6 about communication.
Measured: During the 2-month data collection period, changes in skill level will be measured during the simulation scenario for each study arm, using an assessment scale (KidSIM Team Performance Scale) validated for this purpose.
Secondary outcomes (1)
Evaluation of the SBAR instrument to improve patient assessment and intervention skills of undergraduate nursing students using human patient simulators (assess skill level using the Wolf scale)
The Wolf scale was specifically designed to evaluate nontechnical skills (critical thinking and patient safety, communication, assessment, diagnosis and intervention).
Measured: During the 2-month data collection period, changes in skill level will be measured during the simulation scenario for each study arm, using an assessment scale (Wolf) validated for this purpose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat de Girona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Raurell-Torredà, Universitat de Girona
- Investigators
- Marta Raurell, RN, PhD, Principal investigator, Universitat de Girona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289001
- Sponsor's protocol ID
- SBAR-1
- Acronym
- SBAR
- Status last verified
- May 2015
- First submitted
- 4 Nov 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sigalet E, Donnon T, Cheng A, Cooke S, Robinson T, Bissett W, Grant V. Development of a team performance scale to assess undergraduate health professionals. Acad Med. 2013 Jul;88(7):989-96. doi: 10.1097/ACM.0b013e318294fd45.
PubMed 23702524Henneman EA, Cunningham H, Roche JP, Curnin ME. Human patient simulation: teaching students to provide safe care. Nurse Educ. 2007 Sep-Oct;32(5):212-7. doi: 10.1097/01.NNE.0000289379.83512.fc.
PubMed 17828022Raurell-Torreda M, Olivet-Pujol J, Romero-Collado A, Malagon-Aguilera MC, Patino-Maso J, Baltasar-Bague A. Case-based learning and simulation: useful tools to enhance nurses' education? Nonrandomized controlled trial. J Nurs Scholarsh. 2015 Jan;47(1):34-42. doi: 10.1111/jnu.12113. Epub 2014 Oct 25.
PubMed 25346329Wolf L, Dion K, Lamoureaux E, Kenny C, Curnin M, Hogan MA, Roche J, Cunningham H. Using simulated clinical scenarios to evaluate student performance. Nurse Educ. 2011 May-Jun;36(3):128-34. doi: 10.1097/NNE.0b013e318216120b.
PubMed 21502849
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Use of the SBAR (Situation-Background-Assessment-Recommendation) Checklist as a Means to Help Undergraduate Nursing Students Understand Team Member Roles and Improve Healthcare Team Communication
- ClinicalTrials.gov ID
- NCT02289001
- Acronym / sponsor ID
- SBAR / SBAR-1
- Conditions
- Communication
- Keywords
- patient simulation, simulation, teamwork, interdisciplinary health team, healthcare team, nursing, training programs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Universitat de GironaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Nov 2014 (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.
Based on investigator's hypothesis, that incorporating the SBAR worksheet into the training of undergraduate Nursing students will increase their capacity to work in an interdisciplinary team, the investigators will assess whether introducing the SBAR improves the students' knowledge of their own role and that of others on the team (medical students), strengthens communication between team members, and enhances the quality of the patient assessment and interventions demonstrated by the nursing students caring for a critical patient (represented by a high-fidelity mannequin, a Human Patient Simulator).
Detailed description
Students assigned to the intervention group will receive one hour of additional training in teamwork skills, communication between team members, and the relationship with patient safety, as well as how to distribute roles and responsibilities and how to use the SBAR worksheet. They will not be given the materials used to present the training session (PowerPoint slides, videos, and the SBAR worksheet) in order to avoid their sharing this information directly with students in the control group.
Training provided the Intervention Group
- Basic competencies of healthcare professionals (Institute of Medicine, IOM, 2003) and of working as a team member (Interprofessional Education Collaborative (IPEC). Core competencies for Interprofessional Collaborative Practice. 2011. Available at: http://www.aacn.nche.edu/education-resources/ipecreport.pdf)
- Use of the SBAR (Situation-Background-Assessment-Recommendation) worksheet in accordance with the Kaiser Permanente Guidelines for Communicating with Physicians Using the SBAR Process. Available at: http://fliptheclinic.org/wordpress/wp-content/uploads/community_uploads/1598/SBAR%20Guidelines%20Kaiser%20Permanente.pdf. Accessed Oct 17, 2014):
- Distribution of roles and responsibilities of the interdisciplinary care team for a critical patient (airway management, assessment nurse/physician, medication nurse, procedure nurse, documenting nurse)
On a day when clinical practice is scheduled, according to the 2014-2015 academic year, the students will report to the simulation laboratory. All students in both study arms will participate in a simulated scenario, with cases validated by the National League for Nursing, in a setting that mimics an emergency department with a critical patient (HPS) in a state of shock. Three nursing students and a medical student will intervene in each scenario. If the scenario requires an additional intervention to guide the students or redirect situations that reach an impasse, a professor will be prepared to take on the role of an emergency room physician or nursing supervisor.
Students who do not receive the complementary training (i.e., the control group) will be directed to a different laboratory than the intervention group while they wait to be called for their participation in the simulated scenario.
Ten minutes before beginning the scenario, each group (control and intervention) will receive the documents corresponding to the simulated patient's clinical history. Students in the intervention group will also have a printed SBAR worksheet, which they will be familiar with because of the complementary training. This worksheet will be mixed with the documents related to the patient's clinical history so that the professors participating in the scenario and those doing the evaluation will not be readily able to identify which study arm in participating in a given scenario.
A professor will randomize the scenarios, following the codes delivered in sealed envelopes and that were previously assigned a number directly linked to the corresponding study arm (intervention, control). The envelopes will be kept in a locked box in the simulation laboratory, and will be opened each day of clinical practice by a professor not involved in the study.
Sample size To calculate the necessary sample, we considered the difference in medians observed in a previous study in the same population (Raurell-Torredà M, Olivet-Pujol J, Romero-Collado A, Malagon-Aguilera MC, Patiño-Masó, J, Baltasar-Bagué A. Case-based learning and simulation: useful tools to enhance nurses' education? Non-randomized controlled trial". J Nurs Scholarsh. 2014, Oct 25. doi: 10.1111/jnu.12113). The standardized median difference was 0.9 points. With the aim of obtaining the same difference in the present study, accepting an alpha risk of 0.05 and beta risk less than 20% in a two-tailed test, the estimated sample size 21 scenarios in each arm of the study.
Statistical analysis Qualitative variables will be expressed as frequency and percentage, using the Chi square or Fisher test to compare groups, as appropriate. Quantitative variables will be shown mean and standard deviation (SD) or median and interquartile range (P25-P75), depending on the normality of the distribution, and groups will be compared using Student t or Mann-Whitney U test, respectively. A P-value <0.05 will be considered significant. All analyses will be done using IBM SPSS Statistics (IBM Statistics®, Markham, ON, Canada).
Given the impossibility of predicting how students who do not participate in the simulation would have behaved, losses to follow-up will be managed per protocol rather than intention to treat.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education on SBAR worksheet | Experimental | Behavioral: Education on SBAR worksheetTraining in the use of the SBAR worksheet created to structure information exchange between healthcare professionals |
| No education on SBAR worksheet | No intervention | –The control group will participate in the simulation without any prior training in teamwork skills beyond those included in the undergraduate nursing degree curriculum, which the intervention group also received. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Passing grade on the emergency care topics in the required course "Adult Patient II", which focuses on nursing care planning related to various clinical pathologies or syndromes and surgical procedures
- Current student in the required course "Techniques and Procedures III", which incorporates simulation related to Clinical Nursing II and Psychology course content
Key exclusion criteria (1 listed)
- No signed informed consent to participate
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 |
|---|---|---|
| Education on SBAR worksheetThe intervention group will receive one hour of training in teamwork skills, distribution of roles and use of the SBAR worksheet before participating in the simulated scenario using a human patient simulator (HPS). | Behavioural | Education on SBAR worksheet |
Primary outcome
To evaluate the use of the SBAR checklist as a means to help undergraduate nursing students identify their own role, understand the roles of other health professionals (assess skill level (KidSIM Team Performance Scale)
Time frame: During the 2-month data collection period, changes in skill level will be measured during the simulation scenario for each study arm, using an assessment scale (KidSIM Team Performance Scale) validated for this purpose.
The study will use the KidSIM Team Performance Scale, designed and validated by Sigalet et al. for use in undergraduate nursing, medicine and physiotherapy degree programs. The KidSIM scale has 5 items about roles and 6 about communication.
1 secondary outcome
Evaluation of the SBAR instrument to improve patient assessment and intervention skills of undergraduate nursing students using human patient simulators (assess skill level using the Wolf scale)
Time frame: During the 2-month data collection period, changes in skill level will be measured during the simulation scenario for each study arm, using an assessment scale (Wolf) validated for this purpose).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Background: PubMed 23702524Sigalet E, Donnon T, Cheng A, Cooke S, Robinson T, Bissett W, Grant V. Development of a team performance scale to assess undergraduate health professionals. Acad Med. 2013 Jul;88(7):989-96. doi: 10.1097/ACM.0b013e318294fd45.
- Background: PubMed 17828022Henneman EA, Cunningham H, Roche JP, Curnin ME. Human patient simulation: teaching students to provide safe care. Nurse Educ. 2007 Sep-Oct;32(5):212-7. doi: 10.1097/01.NNE.0000289379.83512.fc.
- Background: PubMed 25346329Raurell-Torreda M, Olivet-Pujol J, Romero-Collado A, Malagon-Aguilera MC, Patino-Maso J, Baltasar-Bague A. Case-based learning and simulation: useful tools to enhance nurses' education? Nonrandomized controlled trial. J Nurs Scholarsh. 2015 Jan;47(1):34-42. doi: 10.1111/jnu.12113. Epub 2014 Oct 25.
- Background: PubMed 21502849Wolf L, Dion K, Lamoureaux E, Kenny C, Curnin M, Hogan MA, Roche J, Cunningham H. Using simulated clinical scenarios to evaluate student performance. Nurse Educ. 2011 May-Jun;36(3):128-34. doi: 10.1097/NNE.0b013e318216120b.
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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.
Marta Raurell, RN, PhD principal investigator
Universitat de Girona
Questions about this trial
What is this clinical trial studying?
A study testing Education on SBAR worksheet in people with Communication, run by Universitat de Girona.
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 2 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: finished, as of the sponsor's last update on 27 May 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the use of the SBAR checklist as a means to help undergraduate nursing students identify their own role, understand the roles of other health professionals (assess skill level (KidSIM Team Performance Scale) (time frame: During the 2-month data collection period, changes in skill level will be measured during the simulation scenario for each study arm, using an assessment scale (KidSIM Team Performance Scale) validated for this purpose.). 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 NCT02289001, which also lists 4 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 May 2015.