Knowledge, Attitudes, PracticeNCT04063319
Nursing Students' Recognition of and Response to Deteriorating Patients
A study testing High-fidelity simulation in people with Knowledge, Attitudes, Practice, run by University of Agder.
Trial summary
The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention in undergraduate nursing education developed to identify recognizing and responding to patient deterioration. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice
- What is being tested?
- High-fidelity simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2016to 16 Dec 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All undergraduate nursing students at two universities enrolling in a specific course that includes high-fidelity simulation
Who cannot join
- None
About this study
The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention in undergraduate nursing education developed to identify recognizing and responding to patient deterioration. Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention.
Read the detailed description
Simulation-based nursing education is an increasingly used pedagogical approach.
The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention developed to identify how recognizing and responding to patient deterioration improves the knowledge and self-confidence of undergraduate nursing students.
Specific aims:
- To describe and estimate the change in undergraduate nursing students' knowledge and perceived self-confidence after an high-fidelity simulation intervention.
- To identify the barriers and enablers that may impact on a successful implementation of the high-fidelity simulation intervention.
Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention. All participants will answer a questionnaire developed to measure perceived knowledge and levels of self-confidence pre- and post-intervention or before and after a meeting (control group). Five students and six faculty members will also be interviewed as a part of a process evaluation.
The study is part of a PhD project.
- Conditions
- Knowledge, Attitudes, Practice
- Being tested
- High-fidelity simulation
- Keywords
- High-fidelity simulation, Self-confidence, Deteriorating patients, Ordinal data, Questionnaire
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fidelity simulationOther
The set up in the high-fidelity simulation intervention is a deteriorating patient scenario.
| Study group | Role | What they receive |
|---|---|---|
| High-fidelity simulation | Experimental | The participants in the intervention group will receive an high-fidelity simulation intervention Receives: Other: High-fidelity simulation |
| Control | No intervention | The participants in the control group will not receive any instructional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
Change in total score from 0-20 using 20 multiple choice questions about vital signs, clinical changes in vital signs after major acute blood loss, and nursing procedures. Higher scores at post-intervention represent a better outcome.
Measured: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
Secondary outcomes (1)
Levels of self-confidence
Change in total responses using 20 questions with five response alternatives (from not at all confident to very confident) about vital signs, clinical changes in vital signs after major acute blood loss, and nursing procedures . Higher scores at post-intervention represent a better outcome.
Measured: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start15 Aug 2016
- Primary completion16 Dec 2018
- Study completion16 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Agder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eli Andås, University of Agder
- Investigators
- Mariann Fossum, Professor, Study chair, University of Agder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063319
- Sponsor's protocol ID
- 52110
- Status last verified
- Aug 2019
- First submitted
- 21 Jun 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haddeland K, Slettebo A, Fossum M. Enablers of the successful implementation of simulation exercises: a qualitative study among nurse teachers in undergraduate nursing education. BMC Nurs. 2021 Nov 22;20(1):234. doi: 10.1186/s12912-021-00756-3.
PubMed 34802428
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Students' Recognition of and Response to Deteriorating Patients
- ClinicalTrials.gov ID
- NCT04063319
- Acronym / sponsor ID
- 52110
- Conditions
- Knowledge, Attitudes, Practice
- Keywords
- High-fidelity simulation, Self-confidence, Deteriorating patients, Ordinal data, Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of AgderUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 16 Dec 2018 (actual)
- Study completion
- 16 Dec 2018 (actual)
- First posted
- 21 Aug 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.
The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention in undergraduate nursing education developed to identify recognizing and responding to patient deterioration. Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention.
Detailed description
Simulation-based nursing education is an increasingly used pedagogical approach.
The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention developed to identify how recognizing and responding to patient deterioration improves the knowledge and self-confidence of undergraduate nursing students.
Specific aims:
- To describe and estimate the change in undergraduate nursing students' knowledge and perceived self-confidence after an high-fidelity simulation intervention.
- To identify the barriers and enablers that may impact on a successful implementation of the high-fidelity simulation intervention.
Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention. All participants will answer a questionnaire developed to measure perceived knowledge and levels of self-confidence pre- and post-intervention or before and after a meeting (control group). Five students and six faculty members will also be interviewed as a part of a process evaluation.
The study is part of a PhD project.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-fidelity simulation | Experimental | Other: High-fidelity simulationThe participants in the intervention group will receive an high-fidelity simulation intervention |
| Control | No intervention | –The participants in the control group will not receive any instructional intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All undergraduate nursing students at two universities enrolling in a specific course that includes high-fidelity simulation
Key exclusion criteria (1 listed)
- None
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 simulationThe set up in the high-fidelity simulation intervention is a deteriorating patient scenario. | Other | High-fidelity simulation |
Primary outcome
Knowledge
Time frame: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
Change in total score from 0-20 using 20 multiple choice questions about vital signs, clinical changes in vital signs after major acute blood loss, and nursing procedures. Higher scores at post-intervention represent a better outcome.
1 secondary outcome
Levels of self-confidence
Time frame: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
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 22 Aug 2019.
- Derived from this study: PubMed 34802428Haddeland K, Slettebo A, Fossum M. Enablers of the successful implementation of simulation exercises: a qualitative study among nurse teachers in undergraduate nursing education. BMC Nurs. 2021 Nov 22;20(1):234. doi: 10.1186/s12912-021-00756-3.
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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.
Mariann Fossum, Professor study chair
University of Agder
Questions about this trial
What is this clinical trial studying?
A study testing High-fidelity simulation in people with Knowledge, Attitudes, Practice, run by University of Agder.
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: finished, as of the sponsor's last update on 22 Aug 2019. 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?
Knowledge (time frame: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)). 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 NCT04063319, which also lists 1 linked publication.
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 22 Aug 2019.