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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04808219
Other study ID # ZZSHMP_001_2021
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date December 31, 2023

Study information

Verified date August 2021
Source Emergency Medical Service, Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Czechia Prague Emergency Medical Services Praha

Sponsors (1)

Lead Sponsor Collaborator
David Peran

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

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. — View Citation

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. Review. Erratum in: Prehosp Disaster Med. 2019 Jun;34(3):345. — View Citation

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. — View Citation

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. — View Citation

Wolfberg DM. Red Lights and Siren: High risk, high liability, little reward. JEMS. 2017 Feb;42(2):18-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through study completion, an average of 2 year or until collection of 100 observations in total.
Primary 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. Through study completion, an average of 2 year or until collection of 100 observations in total.