Medical EmergenciesTECRISISNCT04621682
Non-technical Skills Training and Checklists Versus Standard Training With Checklists for Prevention of Medical Error
A study testing Non technical skills and checklist training in simulation and Checklist training simulation in people with Medical Emergencies, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
The purpose of this study is to reduce medical error by omitting management steps in medical crises. The Interventions will be: training in non-technical skills and checklists versus Control: standard training with checklists Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Emergencies
- What is being tested?
- Non technical skills and checklist training in simulation and Checklist training simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteColombia
- Study dates
- 20 Mar 2021to 1 Aug 2021
- 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
- over 18 years old.
- Final semester student of medicine at the University of Antioquia.
- Have passed the theoretical knowledge exam for handling crisis events with a score of 100%.
- On-site availability on training days
Who cannot join
- Having received training in a specific crisis resource management course.
- Refusing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-technical Skills Training and Checklists Versus Standard Training With Checklists in Boarding School Students to Reduce Simulation Crisis Medical Error, Randomized Controlled Clinical Trial
The purpose of this study is to reduce medical error by omitting management steps in medical crises. The Interventions will be: training in non-technical skills and checklists versus Control: standard training with checklists
Read the detailed description
56 participants will be searched for simulation training, randomly assigned in assignment 1 to 1, the follow-up will be 10 days, the primary outcome will be Proportion of omissions of treatment steps per group, and secondary outcomes will be sought. Crisis resolution time, detection time. and discrimination from the crisis Global score of non-technical skills, Discriminated score between dimensions of non-technical skills, Student satisfaction and Incidence of inadequate crisis management.
- Conditions
- Medical Emergencies
- Being tested
- Non technical skills and checklist training in simulation, Checklist training simulation
- Keywords
- medical error, high fidelity simulation, non technical skills, checklist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non technical skills and checklist training in simulationOther
using structured debrifing, in three random medical simulation crises, training in non-technical skills will be carried out
Checklist training simulationOther
using structured debrifing, in three random medical simulation crises, training in checklist will be carried out
| Study group | Role | What they receive |
|---|---|---|
| Non technical skills and check list | Active comparator | 10 hours of training in non-technical skills and checklists in high Fidelity simulation Receives: Other: Non technical skills and checklist training in simulation |
| check list | Active comparator | Control: 10 hours of standard training with checklists in high Fidelity simulation Receives: Other: Checklist training simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical error
Proportion of omission of treatment steps over the total number of steps per group.
Measured: 3 days after finishing the training
Secondary outcomes (6)
Overall score on non-technical skills scale Ottawa
Mean interval difference per group between 1 to 45
Brief Name: Ottawa Global Rating Scale (GRS) Minimum value: 1 Maximum value: 45 Higher scores mean a better outcome
Measured: 3 days after finishing the training
score for each non-technical skill category on the ottawa scale
Mean interval difference per group between 1 to 7
Brief Name: Ottawa Global Rating Scale (GRS)/ For Category Minimum value: 1 Maximum value: 7 Higher scores mean a better outcome
Measured: 3 days after finishing the training
Crisis resolution time
Mean interval difference per group
Measured: 3 days after finishing the training
Time in detection and discrimination of the crisis
Mean interval difference per group
Measured: 3 days after finishing the training
Incidence of improper handling
relative risk
Measured: 3 days after finishing the training
Student understanding of strategies
qualitative analysis with grounded theory after conducting semi-structured interviews
Measured: 10 days after finishig the primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start20 Mar 2021
- Primary completion18 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EmergenciesStudies 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
- Model description
- TECRISIS is a study designed as a controlled clinical trial of superiority with parallel groups, random allocation and blinding of investigators who measure outcome.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Zamudio, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621682
- Sponsor's protocol ID
- F070
- Acronym
- TECRISIS
- Status last verified
- Mar 2022
- First submitted
- 12 Jun 2020
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: through email communication with the lead author
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-technical Skills Training and Checklists Versus Standard Training With Checklists in Boarding School Students to Reduce Simulation Crisis Medical Error, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04621682
- Acronym / sponsor ID
- TECRISIS / F070
- Conditions
- Medical Emergencies
- Keywords
- medical error, high fidelity simulation, non technical skills, checklist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 18 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 9 Nov 2020 (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 purpose of this study is to reduce medical error by omitting management steps in medical crises. The Interventions will be: training in non-technical skills and checklists versus Control: standard training with checklists
Detailed description
56 participants will be searched for simulation training, randomly assigned in assignment 1 to 1, the follow-up will be 10 days, the primary outcome will be Proportion of omissions of treatment steps per group, and secondary outcomes will be sought. Crisis resolution time, detection time. and discrimination from the crisis Global score of non-technical skills, Discriminated score between dimensions of non-technical skills, Student satisfaction and Incidence of inadequate crisis management.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- TECRISIS is a study designed as a controlled clinical trial of superiority with parallel groups, random allocation and blinding of investigators who measure outcome.
| Arm | Type | Receives |
|---|---|---|
| Non technical skills and check list | Active comparator | Other: Non technical skills and checklist training in simulation10 hours of training in non-technical skills and checklists in high Fidelity simulation |
| check list | Active comparator | Other: Checklist training simulationControl: 10 hours of standard training with checklists in high Fidelity simulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 18 years old.
- Final semester student of medicine at the University of Antioquia.
- Have passed the theoretical knowledge exam for handling crisis events with a score of 100%.
- On-site availability on training days
Key exclusion criteria (2 listed)
- Having received training in a specific crisis resource management course.
- Refusing 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 |
|---|---|---|
| Non technical skills and checklist training in simulationusing structured debrifing, in three random medical simulation crises, training in non-technical skills will be carried out | Other | Non technical skills and check list |
| Checklist training simulationusing structured debrifing, in three random medical simulation crises, training in checklist will be carried out | Other | check list |
Primary outcome
Medical error
Time frame: 3 days after finishing the training
Proportion of omission of treatment steps over the total number of steps per group.
6 secondary outcomes
Overall score on non-technical skills scale Ottawa
Time frame: 3 days after finishing the training
score for each non-technical skill category on the ottawa scale
Time frame: 3 days after finishing the training
Crisis resolution time
Time frame: 3 days after finishing the training
Time in detection and discrimination of the crisis
Time frame: 3 days after finishing the training
Incidence of improper handling
Time frame: 3 days after finishing the training
Student understanding of strategies
Time frame: 10 days after finishig the primary outcome
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 8 Mar 2022.
- Individual participant dataSharing planned: Yes. through email communication with the lead author
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non technical skills and checklist training in simulation and Checklist training simulation in people with Medical Emergencies, run by Universidad de Antioquia at 1 site in Colombia.
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 4 inclusion and 2 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 8 Mar 2022. 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 Colombia. 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?
Medical error (time frame: 3 days after finishing the training). 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 8 Mar 2022.