Self-AssessmentNCT03412032
Comparison of Two Summative Assessment Methods in Advanced Life Support Courses
A study testing assessment in people with Self-Assessment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Several approaches for summative assessment during Advanced Life Support courses are used. The most commonly used method during European Resuscitation (ERC) Council Life Support Courses is that 1 instructor is miming a whole team, and the candidate has to lead this "team" through a scenario; another variant of the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Self-Assessment
- What is being tested?
- assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Dec 2017to 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All medical students at the University of Bern, study year 2017/2018, 5th and 6th study year
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Summative Assessment Methods in Advanced Life Support Courses - a Randomized Controlled Trial
Several approaches for summative assessment during Advanced Life Support courses are used. The most commonly used method during European Resuscitation (ERC) Council Life Support Courses is that 1 instructor is miming a whole team, and the candidate has to lead this "team" through a scenario; another variant of the summative assessment (mainly used by American Heart Association (AHA) Courses) is with a group of students, where one student is the team leader to be assessed and the others are his team not being assessed. The second approach might be more realistic; however there is no evidence around with regard to effectiveness (pass/fail rate, ability to test non-technical skills (NTS)) or participant/assessor satisfaction.
- Conditions
- Self-Assessment
- Being tested
- assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentOther
different assessments in both arms
| Study group | Role | What they receive |
|---|---|---|
| ERC | Other | Assessment as used by the European Resuscitation Council Receives: Other: assessment |
| AHA | Other | Assessment as used by the American Heart Association Receives: Other: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Team leadership
Subjective rating of team leadership
Measured: 1 minute after the assessment is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start2 Dec 2017
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-AssessmentStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Greif, Study chair, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412032
- Sponsor's protocol ID
- ILS_2017/2018
- Status last verified
- Feb 2020
- First submitted
- 11 Dec 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Summative Assessment Methods in Advanced Life Support Courses - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03412032
- Acronym / sponsor ID
- ILS_2017/2018
- Conditions
- Self-Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 2 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jan 2018 (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.
Several approaches for summative assessment during Advanced Life Support courses are used. The most commonly used method during European Resuscitation (ERC) Council Life Support Courses is that 1 instructor is miming a whole team, and the candidate has to lead this "team" through a scenario; another variant of the summative assessment (mainly used by American Heart Association (AHA) Courses) is with a group of students, where one student is the team leader to be assessed and the others are his team not being assessed. The second approach might be more realistic; however there is no evidence around with regard to effectiveness (pass/fail rate, ability to test non-technical skills (NTS)) or participant/assessor satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERC | Other | Other: assessmentAssessment as used by the European Resuscitation Council |
| AHA | Other | Other: assessmentAssessment as used by the American Heart Association |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All medical students at the University of Bern, study year 2017/2018, 5th and 6th study year
Key exclusion criteria (1 listed)
- Refusal 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 |
|---|---|---|
| assessmentdifferent assessments in both arms | Other | AHA, ERC |
Primary outcome
Team leadership
Time frame: 1 minute after the assessment is completed
Subjective rating of team leadership
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 5 Feb 2020.
- 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.
Robert Greif study chair
University of Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment in people with Self-Assessment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 Feb 2020. 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 Switzerland. 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?
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?
Team leadership (time frame: 1 minute after the assessment is completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.