Non-technical SkillsNTSNCT04503369
Observation of Non-technical Skills in the Pre-hospital Care in the Czech Republic
An observational study of Non-technical Skills, run by David Peran at 3 sites in Czechia.
Trial summary
The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using the non-technical skills (e.g. communication, decision making, situational awareness etc.) in the real practice and how well they use them. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non-technical Skills
- What is being tested?
- Non-technical skills
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 359 participants
- Where
- 3 sitesCzechia
- Study dates
- 1 Jul 2019to 31 Dec 2020
- Phase
- Observational
- 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
Study population: All patient of EMS in participated regions of the Czech Republic where the pre-hospital care is provided by 2 or more crews and the field supervisor is present.
Who may be able to join
- EMS called
- More than 2 crews on the scene
- Field supervisor present
Who cannot join
- TEAM tool not filled completely
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
Emergency Medical Services of the Karlovy Vary region
Karlovy Vary, 36006
Emergency Medical Services of the Pilsner region
Pilsen, 30100
Prague Emergency Medical Services
Prague, 10100
About this study
Official title: Observation of Non-technical Skills (e.g. Communication, Team Leader Skills, Teamwork, Situational Awareness Etc.) in the Pre-hospital Care in the Czech Republic
The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using the non-technical skills (e.g. communication, decision making, situational awareness etc.) in the real practice and how well they use them.
Read the detailed description
The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using the non-technical skills (teamwork and team leading, communication, decision making, situational awareness and task management) in the real practice and how well they use them. According to the observations of individual crews by field supervisors the use of non-technical skills will be compared between different groups (e.g. resuscitation, trauma, medical problems, non-emergency situations etc.). The comparison between the collaborators of the study is not the subject of the study.
Main hypothesis: The EMS crews are using all of the aspects of non-technical skills appropriately.
The field supervision is also the limitation of the study because it is done by different observers / supervisors, the observation therefore might by affected by subjective feelings. To minimise the subjective view of the situation all of the field supervisors undergo a uniform training of non-technical skills and how to observe and evaluate them.
- Conditions
- Non-technical Skills
- Being tested
- Non-technical skills
- Keywords
- non-technical skills, pre-hospital care, emergency medical services, communication, situational awareness, task management, decision making, teamwork, team leading
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-technical skillsBehavioural
Teamwork The work of the team consists of information exchange and coordination of all activities performed. In-team communication is always calm and assertive, and team members support each other.
Task management With the right planning and preparation of individual activities, the likelihood that all standards of care and best practices will be followed increases.
Situational awareness Situational awareness refers primarily to the collection of information, its understanding and, on that basis, prediction of direction into which the situation will develop. Maintaining situational awareness is crucial in order to move towards the right goal.
Decision-making With good situational awareness, one is able to keep in mind all information needed to make the correct decision at the right time. In some cases, it is advisable to consult with other team members or to verify their consent to the proposed procedure.
Communication Communication is a vital tool when working in a team.
| Study group | Role | What they receive |
|---|---|---|
| EMS crews | Crews of Emergency Medical Services Receives: Behavioral: Non-technical skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
NTS incidence
The measurement of non-technical skills usage will be evaluated according to the form developed and published by Cooper et al. (2010) as a Team Emergency Assessment Measure (TEAM) tool based on the Likert scale - Never/Hardly ever (0), Seldom (1), About as often as not (2), Often (3), Always/Nearly always (4).
Measured: Through study completion, an average of 1 year and until 100 cases from each organization will be collected - 300 observations in total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Jul 2019
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
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 Non-technical SkillsStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Peran
- Sponsor type
- Other government
- Collaborators
- Emergency Medical Services of the Karlovy Vary region, Czech Republic, Emergency Medical Services of the Pilsner region, Czech Republic
- Responsible party
- Sponsor-investigator, David Peran, Emergency Medical Service, Prague
- Investigators
- David Peran, DrPH, Study chair, Prague Emergency Medical ServicesRoman Sykora, PhD, Study director, Emergency Medical Services of the Karlovy Vary RegionJana Vidunová, MD, Study director, Emergency Medical Services of the Pilsner RegionIvana Krsova, MSc., Principal investigator, Emergency Medical Services of the Pilsner RegionJaroslav Pekara, PhD, Principal investigator, Prague Emergency Medical ServicesPatrik C Cmorej, PhD, Principal investigator, Emergency Medical Services of the Usti nad Labem RegionNikola Brizgalová, DrPH, Principal investigator, Emergency Medical Services of the Karlovy Vary Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503369
- Sponsor's protocol ID
- ZZSMHP_001_2020
- Acronym
- NTS
- Status last verified
- Feb 2021
- First submitted
- 29 Jul 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cooper SJ, Cant RP. Measuring non-technical skills of medical emergency teams: an update on the validity and reliability of the Team Emergency Assessment Measure (TEAM). Resuscitation. 2014 Jan;85(1):31-3. doi: 10.1016/j.resuscitation.2013.08.276. Epub 2013 Sep 12.
PubMed 24036193Napier F, Davies RP, Baldock C, Stevens H, Lockey AS, Bullock I, Perkins GD. Validation for a scoring system of the ALS cardiac arrest simulation test (CASTest). Resuscitation. 2009 Sep;80(9):1034-8. doi: 10.1016/j.resuscitation.2009.04.043. Epub 2009 Jun 13.
PubMed 19525052PERAN, D., KUBALOVÁ, J..: Observation of non-technical skills during resuscitation (Sledování netechnických dovedností při resuscitaci) [article in Czech language]. Urgentní medicína: Časopis pro neodkladnou lékařskou péči. Mediprax CB s.r.o., 2017 (4). ISSN 1212-1924.
Peran D, Sykora R, Vidunova J, Krsova I, Pekara J, Renza M, Brizgalova N, Cmorej PC. Non-technical skills in pre-hospital care in the Czech Republic: a prospective multicentric observational study (NTS study). BMC Emerg Med. 2022 May 13;22(1):83. doi: 10.1186/s12873-022-00642-4.
PubMed 35562664
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Non-technical Skills (e.g. Communication, Team Leader Skills, Teamwork, Situational Awareness Etc.) in the Pre-hospital Care in the Czech Republic
- ClinicalTrials.gov ID
- NCT04503369
- Acronym / sponsor ID
- NTS / ZZSMHP_001_2020
- Conditions
- Non-technical Skills
- Keywords
- non-technical skills, pre-hospital care, emergency medical services, communication, situational awareness, task management, decision making, teamwork
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- David PeranOther government
- Collaborators
- Emergency Medical Services of the Karlovy Vary region, Czech Republic, Emergency Medical Services of the Pilsner region, Czech Republic
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Aug 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 aim of the study is to find out if the Emergency Medical Services (EMS) crews are using the non-technical skills (e.g. communication, decision making, situational awareness etc.) in the real practice and how well they use them.
Detailed description
The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using the non-technical skills (teamwork and team leading, communication, decision making, situational awareness and task management) in the real practice and how well they use them. According to the observations of individual crews by field supervisors the use of non-technical skills will be compared between different groups (e.g. resuscitation, trauma, medical problems, non-emergency situations etc.). The comparison between the collaborators of the study is not the subject of the study.
Main hypothesis: The EMS crews are using all of the aspects of non-technical skills appropriately.
The field supervision is also the limitation of the study because it is done by different observers / supervisors, the observation therefore might by affected by subjective feelings. To minimise the subjective view of the situation all of the field supervisors undergo a uniform training of non-technical skills and how to observe and evaluate them.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMS crews | – | Behavioral: Non-technical skillsCrews of Emergency Medical Services |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient of EMS in participated regions of the Czech Republic where the pre-hospital care is provided by 2 or more crews and the field supervisor is present.
Key inclusion criteria (3 listed)
- EMS called
- More than 2 crews on the scene
- Field supervisor present
Key exclusion criteria (1 listed)
- TEAM tool not filled completely
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 skillsTeamwork The work of the team consists of information exchange and coordination of all activities performed. In-team communication is always calm and assertive, and team members support each other. Task management With the right planning and preparation of individual activities, the likelihood that all standards of care and best practices will be followed increases. Situational awareness Situational awareness refers primarily to the collection of information, its understanding and, on that basis, prediction of direction into which the situation will develop. Maintaining situational awareness is crucial in order to move towards the right goal. Decision-making With good situational awareness, one is able to keep in mind all information needed to make the correct decision at the right time. In some cases, it is advisable to consult with other team members or to verify their consent to the proposed procedure. Communication Communication is a vital tool when working in a team. | Behavioural | EMS crews |
Primary outcome
NTS incidence
Time frame: Through study completion, an average of 1 year and until 100 cases from each organization will be collected - 300 observations in total.
The measurement of non-technical skills usage will be evaluated according to the form developed and published by Cooper et al. (2010) as a Team Emergency Assessment Measure (TEAM) tool based on the Likert scale - Never/Hardly ever (0), Seldom (1), About as often as not (2), Often (3), Always/Nearly always (4).
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 2 Feb 2021.
- Background: PubMed 24036193Cooper SJ, Cant RP. Measuring non-technical skills of medical emergency teams: an update on the validity and reliability of the Team Emergency Assessment Measure (TEAM). Resuscitation. 2014 Jan;85(1):31-3. doi: 10.1016/j.resuscitation.2013.08.276. Epub 2013 Sep 12.
- Background: PubMed 19525052Napier F, Davies RP, Baldock C, Stevens H, Lockey AS, Bullock I, Perkins GD. Validation for a scoring system of the ALS cardiac arrest simulation test (CASTest). Resuscitation. 2009 Sep;80(9):1034-8. doi: 10.1016/j.resuscitation.2009.04.043. Epub 2009 Jun 13.
- BackgroundPERAN, D., KUBALOVÁ, J..: Observation of non-technical skills during resuscitation (Sledování netechnických dovedností při resuscitaci) [article in Czech language]. Urgentní medicína: Časopis pro neodkladnou lékařskou péči. Mediprax CB s.r.o., 2017 (4). ISSN 1212-1924.
- Derived from this study: PubMed 35562664Peran D, Sykora R, Vidunova J, Krsova I, Pekara J, Renza M, Brizgalova N, Cmorej PC. Non-technical skills in pre-hospital care in the Czech Republic: a prospective multicentric observational study (NTS study). BMC Emerg Med. 2022 May 13;22(1):83. doi: 10.1186/s12873-022-00642-4.
- 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.
David Peran, DrPH study chair
Prague Emergency Medical Services
Roman Sykora, PhD study director
Emergency Medical Services of the Karlovy Vary Region
Jana Vidunová, MD study director
Emergency Medical Services of the Pilsner Region
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-technical Skills, run by David Peran at 3 sites in Czechia.
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 3 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. 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?
NTS incidence (time frame: Through study completion, an average of 1 year and until 100 cases from each organization will be collected - 300 observations in total.). 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 NCT04503369, 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 2 Feb 2021.