The Impact of Prehospital Trauma Life Support (PHTLS) on Outcome of Traffic Injury

Traffic Accidents Clinical Trial

Official title:

Impact of Prehospital Trauma Life Support (PHTLS) Training of Ambulance Caregivers on Outcome of Traffic Injury Victims

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01603537
• Other study ID #: Dnr 2007/264
• Status: Active, not recruiting
• Phase: N/A
• First received: May 15, 2012
• Last updated: May 18, 2012
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: May 2012
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40000
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Traffic Accidents

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala	County of Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University Hospital	Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (8)

Collicott PE, Hughes I. Training in advanced trauma life support. JAMA. 1980 Mar 21;243(11):1156-9. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2014;8:CD003109. — View 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. Review. Update in: Cochrane Database Syst Rev. 2014;8:CD004173. — View Citation

Johansson J, Blomberg H, Svennblad B, Wernroth L, Melhus H, Byberg L, Michaëlsson 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. — View Citation

Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000 Apr;90(4):523-6. — View Citation

Recommended framework for presenting injury mortality data. MMWR Recomm Rep. 1997 Aug 29;46(RR-14):1-30. — View Citation

Trunkey DD, Lim RC Jr, Blaisdell FW. Traumatic injury. A health care crisis. West J Med. 1974 Jan;120(1):92-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality before hospital admission.	Injury deaths not associated with a hospital admission.	Patients will be followed up to death or at least one year after inclusion.	No
Primary	Mortality within 30 days.	Deaths within 30 days including all deaths, prehospital and hospital, up to 30 days from the injury event.	Patients will be followed up to death or at least one year after inclusion.	No
Primary	Time to death among survivors to hospital admission.	Time to death among patients associated with a hospital admission.	Patients will be followed up to death or at least one year after inclusion.	No
Primary	Return to work among survivors to hospital discharge.	Number of patients returned to work per time-unit of observation after the injury event among all patients discharged from hospital, not dead, and that was working before the accident.	Patients will be followed up to occured event or at least one year after inclusion.	No