- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04808219
Causes of Traffic Collisions of Ambulance Cars at the Prague Emergency Medical Services
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Praha, Czechia, 10100
- Prague Emergency Medical Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- disagreement with participating in the study
- video recording of the collision cannot be obtained
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Severity of the collision
Time Frame: Through study completion, an average of 2 year or until collection of 100 observations in total.
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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.
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Through study completion, an average of 2 year or until collection of 100 observations in total.
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Time frame of the collision
Time Frame: Through study completion, an average of 2 year or until collection of 100 observations in total.
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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.
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Through study completion, an average of 2 year or until collection of 100 observations in total.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: David Peran, Dr., Prague Emergency Medical Services
- Study Director: Jaroslav Pekara, Ph.D., Prague Emergency Medical Services
Publications and helpful links
General 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.
- Tanaka 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.
- Wolfberg DM. Red Lights and Siren: High risk, high liability, little reward. JEMS. 2017 Feb;42(2):18-9. No abstract available.
- Watanabe 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.
- Murray 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. Erratum In: Prehosp Disaster Med. 2019 Jun;34(3):345.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZZSHMP_001_2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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