This trial is active, not recruiting.

Condition traffic accidents
Sponsor Uppsala University Hospital
Collaborator Uppsala University
Start date January 2011
End date May 2012
Trial size 40000 participants
Trial identifier NCT01603537, Dnr 2007/264


Trauma is the leading cause of death among persons below 60 years of age. It is a well-established belief that optimal treatment in the early phase after trauma has a major impact on mortality, and the implementation of specific educational programs for trauma care have been a widely adopted strategy aimed at improving the outcome. This strategy has high face validity, but the underlying evidence is poor. The Prehospital Trauma Life Support (PHTLS) program was introduced in 1983 aiming to integrate prehospital trauma care with the Advanced Trauma Life Support (ATLS) program. Approximately half a million prehospital caregivers in over 50 countries have taken the PHTLS course. It has been recognized as one of the leading educational programs for prehospital emergency trauma care. However, the scientific support for improved patient outcome from courses such as PHTLS and ATLS is limited. According to a Cochrane analysis published 2010 there is no evidence to recommend advanced life-support (ALS) training for ambulance crews. Another Cochrane analysis concerning ATLS gave similar results and a recent study indicated even worsened outcome after the implementation of ATLS. An observational study in the county of Uppsala indicated reduced mortality after the implementation of PHTLS but the estimate was uncertain due to a low overall mortality. The aim of this study is to further investigate the association between PHTLS training of ambulance crew members and the outcome in trauma patients in a larger study population. To accomplish this the investigators will use an epidemiological semi-individual design applied to all victims of traffic injury that occurred during the implementation period of the PHTLS course in Sweden (1998-2004). Four outcomes and subsets of patients will be analyzed: Mortality before hospital admission, mortality within 30 days, time to death among survivors to hospital admission and return to work among survivors to hospital discharge.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective retrospective
The exposure is defined from the dichotomization of the probability in each event/accident that at least one of the caring ambulance crew members was PHTLS certified.
Not exposed to PHTLS

Primary Outcomes

Mortality before hospital admission.
time frame: Patients will be followed up to death or at least one year after inclusion.
Mortality within 30 days.
time frame: Patients will be followed up to death or at least one year after inclusion.
Time to death among survivors to hospital admission.
time frame: Patients will be followed up to death or at least one year after inclusion.
Return to work among survivors to hospital discharge.
time frame: Patients will be followed up to occured event or at least one year after inclusion.

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Primary incident hospital admissions due to traffic accidents or - Death due to traffic accidents Exclusion Criteria: - If a patient appears more than once, all but the first event will be excluded from the dataset.

Additional Information

Official title Impact of Prehospital Trauma Life Support (PHTLS) Training of Ambulance Caregivers on Outcome of Traffic Injury Victims
Principal investigator Rolf Gedeborg, PhD
Description Source Population: Sweden is divided in 21 administrative regions providing health care (counties). In 2004 Sweden had a population of about 9 million inhabitants with an average population density of 20 inhabitants/km2. The Emergency Medical Service (EMS)-System: The ambulance staff in Sweden consists of registered nurses and emergency medical technician (EMT) equivalents (nursing assistants with special ambulance training). Statistics: Hierarchical random effects models will be used to model the binary outcomes. Cox proportional hazards models to analyze the time to event outcomes. The difference in mean predicted outcome between the PHTLS group and the non-PHTLS group will be used to estimate the absolute risk reduction.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Uppsala University Hospital.