Clinical trial NCT01603537: The Impact of Prehospital Trauma Life Support (PHTLS) on Outcome of Traffic Injury
Official title: Impact of Prehospital Trauma Life Support (PHTLS) Training of Ambulance Caregivers on Outcome of Traffic Injury Victims
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traffic Accidents
Keywords: Traumatic injuries
Prehospital Trauma Life Support
Traffic accidents
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2012-05-23
Enrollment: 40000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population: Motor vehicle traffic crashes were selected using the causes of injury matrix developed by the National Center for Health Statistics, Centers for Disease Control and Prevention, USA.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality before hospital admission.
timeFrame: Patients will be followed up to death or at least one year after inclusion.
measure: Mortality within 30 days.
timeFrame: Patients will be followed up to death or at least one year after inclusion.
measure: Time to death among survivors to hospital admission.
timeFrame: Patients will be followed up to death or at least one year after inclusion.
measure: Return to work among survivors to hospital discharge.
timeFrame: Patients will be followed up to occured event or at least one year after inclusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
state: County of Uppsala
Study officials:
affiliation: Uppsala University
name: Rolf Gedeborg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000 Apr;90(4):523-6. doi: 10.2105/ajph.90.4.523.
citation: Trunkey DD, Lim RC Jr, Blaisdell FW. Traumatic injury. A health care crisis. West J Med. 1974 Jan;120(1):92-4. No abstract available.
citation: Collicott PE, Hughes I. Training in advanced trauma life support. JAMA. 1980 Mar 21;243(11):1156-9.
citation: Jayaraman S, Sethi D. Advanced trauma life support training for ambulance crews. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003109. doi: 10.1002/14651858.CD003109.pub2.
citation: Jayaraman S, Sethi D. Advanced trauma life support training for hospital staff. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004173. doi: 10.1002/14651858.CD004173.pub3.
citation: Drimousis PG, Theodorou D, Toutouzas K, Stergiopoulos S, Delicha EM, Giannopoulos P, Larentzakis A, Katsaragakis S. Advanced Trauma Life Support certified physicians in a non trauma system setting: is it enough? Resuscitation. 2011 Feb;82(2):180-4. doi: 10.1016/j.resuscitation.2010.10.005. Epub 2010 Nov 30.
citation: Johansson J, Blomberg H, Svennblad B, Wernroth L, Melhus H, Byberg L, Michaelsson K, Karlsten R, Gedeborg R. Prehospital Trauma Life Support (PHTLS) training of ambulance caregivers and impact on survival of trauma victims. Resuscitation. 2012 Oct;83(10):1259-64. doi: 10.1016/j.resuscitation.2012.02.018. Epub 2012 Feb 23.
citation: Recommended framework for presenting injury mortality data. MMWR Recomm Rep. 1997 Aug 29;46(RR-14):1-30.