Traffic CollisionNCT04808219
Causes of Traffic Collisions of Ambulance Cars at the Prague Emergency Medical Services
An observational study of Traffic Collision and Transport Accident, run by David Peran at 1 site in Czechia.
Trial summary
The aim of the project is to increase the protection of patients, employees and the organization by means of data collection about traffic collisions of ambulance cars. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traffic Collision, Transport Accident
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2021to 31 Dec 2023
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ambulance drivers of the Prague Emergency Medical Services with traffic collision.
Who may be able to join
- ambulance driver involved in a traffic collision of ambulance car
- consent to participate in the study
- video recording of the collision exists and can be used
Who cannot join
- disagreement with participating in the study
- video recording of the collision cannot be obtained
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the project is to increase the protection of patients, employees and the organization by means of data collection about traffic collisions of ambulance cars.
Read the detailed description
Published research studies have shown not only that approximately half of Emergency Medical Services (EMS) providers show signs of severe fatigue before traffic collision, but also that drowsy or tired EMS providers are significantly more often injured at work. Among the circumstances and factors contributing to the collisions, including environmental, road or equipment factors, the real causes of the collisions remain unclear, but might be investigated through interviews with participating drivers. The aim is to increase the protection of patients, employees and the organization by collect data in both qualitative and quantitative ways and to identify factors and measurable variables that might lead to strengthen healthy driving habits under the blue lights. The factors associated with ambulance accidents are not similar to those of the general driving population. The in-depth analysis of the whole problem aims not only to clarify the causes of collisions, but especially to create prevention steps so that such situations occur as little as possible.
The methodology will use the so-called mixed design - a combination of in-depth interviews with participating members of collisions (employees, or patient / relative), data from the road-scans and qualitative data including measurable variables.
A video-analysis of the collision will be performed. All data will be recorded anonymously - each participant in the accident will receive a special number for coding, under which they will appear. Data will be presented both in descriptive statistics and after statistical analysis (chi square test for independence and Fischer's exact test at the level of significance = 0.05).
In terms of qualitative data, in-depth interviews and their coding will be performed using grounded theory (based on Strauss and Corbin methodology). The aim is to gain the same view of events and their actions as the members of the group.
The sample of participants depends on collision rate, which was 50 incidents in the year 2020 (expecting approx. 100 cases in 2 years).
- Conditions
- Traffic Collision, Transport Accident
- Keywords
- traffic collision, safety, ambulances, emergency medical services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Driver | Ambulance driver who was involved in a traffic collision - video analysis of the collision records and in-depth interview aiming to find the cause of the collision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of the collision
3 levels of collisions' severity were set: (1) minor collision outside the public road, (2) minor collision caused on a public road and (3) severe collision.
Measured: Through study completion, an average of 2 year or until collection of 100 observations in total.
Time frame of the collision
The time frame of the collision - includes the interval in which the collision happened - (1) way to the patient, (2) transport of the patient, (3) handover of the patient, (4) way from the hospital to the base, (5) out of duty.
Measured: Through study completion, an average of 2 year or until collection of 100 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 posted22 Mar 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traffic CollisionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Peran
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, David Peran, Emergency Medical Service, Prague
- Investigators
- David Peran, Dr., Study chair, Prague Emergency Medical ServicesJaroslav Pekara, Ph.D., Study director, Prague Emergency Medical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808219
- Sponsor's protocol ID
- ZZSHMP_001_2021
- Status last verified
- Aug 2021
- First submitted
- 25 Feb 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiu PW, Lin CH, Wu CL, Fang PH, Lu CH, Hsu HC, Chi CH. Ambulance traffic accidents in Taiwan. J Formos Med Assoc. 2018 Apr;117(4):283-291. doi: 10.1016/j.jfma.2018.01.014. Epub 2018 Feb 7.
PubMed 29428195Tanaka K, De Lorenzo RA. Lights and Siren: A Risky Business? Ann Emerg Med. 2019 Jul;74(1):110-111. doi: 10.1016/j.annemergmed.2019.01.026. Epub 2019 Feb 21. No abstract available.
PubMed 30797574Wolfberg DM. Red Lights and Siren: High risk, high liability, little reward. JEMS. 2017 Feb;42(2):18-9. No abstract available.
PubMed 29215247Watanabe BL, Patterson GS, Kempema JM, Magallanes O, Brown LH. Is Use of Warning Lights and Sirens Associated With Increased Risk of Ambulance Crashes? A Contemporary Analysis Using National EMS Information System (NEMSIS) Data. Ann Emerg Med. 2019 Jul;74(1):101-109. doi: 10.1016/j.annemergmed.2018.09.032. Epub 2019 Jan 12.
PubMed 30648537Murray B, Kue R. The Use of Emergency Lights and Sirens by Ambulances and Their Effect on Patient Outcomes and Public Safety: A Comprehensive Review of the Literature. Prehosp Disaster Med. 2017 Apr;32(2):209-216. doi: 10.1017/S1049023X16001503. Epub 2017 Jan 30.
PubMed 28134063
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Traffic Collisions of Ambulance Cars at the Prague Emergency Medical Services
- ClinicalTrials.gov ID
- NCT04808219
- Acronym / sponsor ID
- ZZSHMP_001_2021
- Conditions
- Traffic Collision, Transport Accident
- Keywords
- traffic collision, safety, ambulances, emergency medical services
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- David PeranOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Mar 2021 (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 project is to increase the protection of patients, employees and the organization by means of data collection about traffic collisions of ambulance cars.
Detailed description
Published research studies have shown not only that approximately half of Emergency Medical Services (EMS) providers show signs of severe fatigue before traffic collision, but also that drowsy or tired EMS providers are significantly more often injured at work. Among the circumstances and factors contributing to the collisions, including environmental, road or equipment factors, the real causes of the collisions remain unclear, but might be investigated through interviews with participating drivers. The aim is to increase the protection of patients, employees and the organization by collect data in both qualitative and quantitative ways and to identify factors and measurable variables that might lead to strengthen healthy driving habits under the blue lights. The factors associated with ambulance accidents are not similar to those of the general driving population. The in-depth analysis of the whole problem aims not only to clarify the causes of collisions, but especially to create prevention steps so that such situations occur as little as possible.
The methodology will use the so-called mixed design - a combination of in-depth interviews with participating members of collisions (employees, or patient / relative), data from the road-scans and qualitative data including measurable variables.
A video-analysis of the collision will be performed. All data will be recorded anonymously - each participant in the accident will receive a special number for coding, under which they will appear. Data will be presented both in descriptive statistics and after statistical analysis (chi square test for independence and Fischer's exact test at the level of significance = 0.05).
In terms of qualitative data, in-depth interviews and their coding will be performed using grounded theory (based on Strauss and Corbin methodology). The aim is to gain the same view of events and their actions as the members of the group.
The sample of participants depends on collision rate, which was 50 incidents in the year 2020 (expecting approx. 100 cases in 2 years).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Driver | – | –Ambulance driver who was involved in a traffic collision - video analysis of the collision records and in-depth interview aiming to find the cause of the collision. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulance drivers of the Prague Emergency Medical Services with traffic collision.
Key inclusion criteria (3 listed)
- ambulance driver involved in a traffic collision of ambulance car
- consent to participate in the study
- video recording of the collision exists and can be used
Key exclusion criteria (2 listed)
- disagreement with participating in the study
- video recording of the collision cannot be obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of the collision
Time frame: Through study completion, an average of 2 year or until collection of 100 observations in total.
3 levels of collisions' severity were set: (1) minor collision outside the public road, (2) minor collision caused on a public road and (3) severe collision.
Time frame of the collision
Time frame: Through study completion, an average of 2 year or until collection of 100 observations in total.
The time frame of the collision - includes the interval in which the collision happened - (1) way to the patient, (2) transport of the patient, (3) handover of the patient, (4) way from the hospital to the base, (5) out of duty.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 29428195Chiu PW, Lin CH, Wu CL, Fang PH, Lu CH, Hsu HC, Chi CH. Ambulance traffic accidents in Taiwan. J Formos Med Assoc. 2018 Apr;117(4):283-291. doi: 10.1016/j.jfma.2018.01.014. Epub 2018 Feb 7.
- Background: PubMed 30797574Tanaka K, De Lorenzo RA. Lights and Siren: A Risky Business? Ann Emerg Med. 2019 Jul;74(1):110-111. doi: 10.1016/j.annemergmed.2019.01.026. Epub 2019 Feb 21. No abstract available.
- Background: PubMed 29215247Wolfberg DM. Red Lights and Siren: High risk, high liability, little reward. JEMS. 2017 Feb;42(2):18-9. No abstract available.
- Background: PubMed 30648537Watanabe BL, Patterson GS, Kempema JM, Magallanes O, Brown LH. Is Use of Warning Lights and Sirens Associated With Increased Risk of Ambulance Crashes? A Contemporary Analysis Using National EMS Information System (NEMSIS) Data. Ann Emerg Med. 2019 Jul;74(1):101-109. doi: 10.1016/j.annemergmed.2018.09.032. Epub 2019 Jan 12.
- Background: PubMed 28134063Murray B, Kue R. The Use of Emergency Lights and Sirens by Ambulances and Their Effect on Patient Outcomes and Public Safety: A Comprehensive Review of the Literature. Prehosp Disaster Med. 2017 Apr;32(2):209-216. doi: 10.1017/S1049023X16001503. Epub 2017 Jan 30.
- Individual participant dataSharing planned: No
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, Dr. study chair
Prague Emergency Medical Services
Jaroslav Pekara, Ph.D. study director
Prague Emergency Medical Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traffic Collision and Transport Accident, run by David Peran at 1 site 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 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: status not confirmed, as of the sponsor's last update on 18 Aug 2021. 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 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?
Results are not available in the source record.
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?
Severity of the collision (time frame: Through study completion, an average of 2 year or until collection of 100 observations in total.). The study lists 2 primary outcomes in all. 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 NCT04808219, which also lists 5 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 18 Aug 2021.